UNKNOWN
Report
- Report Number
- 3003910212-2019-00089
- Event Type
- Injury
- Date Received
- April 12, 2019
- Date of Event
- September 14, 2007
- Report Date
- June 7, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
ADDED MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2009: (B)(6). OFFICE NOTES. VENTRAL HERNIA, TO HAVE SURGERY BY DR. BRUNS. SHE HAS TO TAKE PAIN MEDICATION AND CAUSES HER CONSTIPATION. ACTIVE MEDICAL CONDITIONS: CONSTIPATION, HIATAL HERNIA, SURGICAL WOUND INFECTION WITH VENTRAL HERNIA (B)(6) 2008. EXAM: LEFT UPPER QUADRANT WITH VENTRAL HER [SIC] NOTED. IMPRESSION: VENTRAL HERNIA WITH PAIN, TAKING ULTRACET. (B)(6) 2010: (B)(6). RADIOLOGY ¿ CT ABDOMEN/PELVIS. REASON FOR STUDY: RECURRENT RECTAL BLEEDING OFF AND ON. HISTORY: LEFT COLECTOMY FOR VOLVULUS A YEAR AGO. IMPRESSION: A LARGE SLIDING HIATAL HERNIA AND A FEW SURGICAL CLIPS ADJACENT TO THE LOW END OF ESOPHAGUS PRESUMABLY DUE TO POSTOPERATIVE CHANGE. RETENTION OF MODERATE AMOUNT OF FECAL MATERIAL IN COLON AND BOWEL DILATATION IN THE UPPER AND MIDDLE ABDOMEN PRESUMABLY DUE TO FECAL IMPACTION OR ILEUS. (B)(6) 2013: (B)(6). OFFICE NOTES. ROUTINE VISIT. EXAM: VENTRAL HERNIA AT LEFT UPPER QUADRANT AREA WITH SOME DISCOMFORT. IMPRESSION: OBESITY. VENTRAL HERNIA ACTING UP WITH LEFT UPPER QUADRANT AREA DISCOMFORT AND HAS AN APPOINTMENT 04/15/13. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: CONCLUSION CODE 4316:-APPROPRIATE TERM/CODE NOT AVAILABLE IS BEING USED FOR "FALSE CLAIM." THE MEDICAL RECORDS RECEIVED ON 09/13/19 CONFIRM THAT DURING THE SURGICAL PROCEDURE ON (B)(6) 2014, A VENTRALEX ST HERNIA PATCH WAS IMPLANTED. THIS DEVICE IS NOT A GORE DEVICE; THEREFORE, THIS IS A FALSE CLAIM AND NO LONGER REPORTABLE.
B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. SEE ATTACHMENT FOR CONTINUATION OF RECORDS. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6) 2005 WERE NOT PROVIDED. ON (B)(6) 2005: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. HISTORY OF SEVERE AND RECURRING HEARTBURN. HAS DIFFICULTY SWALLOWING, HAS LOST 30 POUNDS. A PH STUDY REVEALED REFLUX WITH A VERY LOW PRESSURE, A LITTLE LOWER, LOWER ESOPHAGEAL SPHINCTER PRESSURE. SURGICAL HISTORY: TUBAL LIGATION. EXAM: WT 195. ABDOMEN BENIGN AND SOFT, NO MASSES, NO TENDERNESS. IMPRESSION: SYMPTOMATIC REFLUX DESPITE MEDICATION. PLAN: LAPAROSCOPIC NISSEN FUNDOPLICATION ON (B)(6) 2005. ON (B)(6) 2005: (B)(6) MD. OFFICE NOTES. POSTOP LAPAROSCOPIC NISSEN. WOUNDS LOOK GOOD. IS EATING ANYTHING SHE WANTS TO, TAKING NO MEDICATION, SLEEPING FLAT AT TIMES WITH NO PROBLEMS. WILL BE SEEN BACK IN A YEAR OR PRN. ON (B)(6) 06: (B)(6) MD. OFFICE NOTES. HAD A LAPAROSCOPIC NISSEN DONE, NOW NOTED TO HAVE A PARAESOPHAGEAL HIATAL HERNIA ON UPPER GI SERIES. SHE HAD A SCOPE IN JANUARY THAT SHOWED NO EVIDENCE OF A HERNIA. HAD AN EXPLORATORY LAPAROTOMY FOR A SMALL BOWEL OBSTRUCTION SECONDARY TO A MESENTERIC DEFECT IN MAY BY DR. (B)(6) WHO FELT THAT THE STOMACH WAS NORMAL WITH THE FUNDOPLICATION NORMAL. NOW HAS AN ESOPHAGUS THAT SEEMS TO BE NORMAL WITH A NORMAL NISSEN BUT WITH A PARAESOPHAGEAL HERNIA LATERAL TO THIS WITH A SMALL WAIST [SIC] PRESENT. HAS PAIN FROM TIME TO TIME, I FEEL THIS NEEDS REPAIRED. WE HAVE SCHEDULED SURGERY FOR AN EXPLORATORY LAPAROTOMY WITH REPAIR OF THIS, WITH LIKELY A MESH REPAIR OF THE DEFECT, (B)(6) 2006. ALSO HAS AN INCISIONAL HERNIA AT THE UPPER PORTION OF HER LOWER MIDLINE INCISION, WHICH I PLAN TO FIX AT THE SAME TIME. EXAM: INCISIONAL HERNIA PRESENT JUST ABOVE THE UMBILICUS AT THE TOP OF PREVIOUS LAPAROTOMY INCISION. IMPRESSION: INTERVAL DEVELOPMENT OF PARAESOPHAGEAL HERNIA. PLAN: REPAIR. [MISSING RECORDS: RECORDS FOR UPPER GI SERIES SHOWING PARAESOPHAGEAL HIATAL HERNIA WERE NOT PROVIDED.] [MISSING RECORDS: RECORDS FOR EXPLORATORY LAPAROTOMY IN ¿MAY OF THIS YEAR FOR SMALL BOWEL RESECTION¿ WERE NOT PROVIDED.] ON (B)(6) 2006: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. PREVIOUSLY HAD A LAPAROSCOPIC NISSEN FUNDOPLICATION FOR REFLUX ESOPHAGITIS ON (B)(6) 2005. INITIALLY DID WELL BUT NOW HAS DEVELOPED SOME SYMPTOMATOLOGY OF REFLUX AGAIN AND IS NOTED ON STUDIES TO HAVE A LARGE PARAESOPHAGEAL HERNIA. SHE HAD AN EXPLORATORY LAPAROTOMY CARRIED OUT IN MAY OF THIS YEAR FOR SMALL BOWEL RESECTION THAT SHOWED NO EVIDENCE OF HERNIATION BUT NOW IS NOTED TO HAVE A LARGE PARAESOPHAGEAL HERNIA. PLAN TO PROCEED WITH OPEN LAPAROTOMY WITH REDUCTION OF THE HERNIATED STOMACH, STOMACH CLOSURE OF THE DIAPHRAGM WITH POSSIBLE MESH. EXAM: WT 163. ABDOMEN: INCISIONS FROM PREVIOUS LAPAROSCOPIC SURGERY. IMPRESSION: PARAESOPHAGEAL HIATAL HERNIA. PLAN: EXPLORATORY LAPAROTOMY WITH REDUCTION VERSUS DISTAL GASTRECTOMY AND BYPASS. ON (B)(6) 20006: (B)(6) MD. OFFICE NOTES. DOING WELL POSTOPERATIVE EXPLORATORY LAPAROTOMY, REDUCTION OF PARAESOPHAGEAL HIATAL HERNIA, REDO NISSEN FUNDOPLICATION, AND REPAIR OF INCISIONAL HERNIA WITH MESH. THE WOUND LOOKS EXCELLENT. HAS SOME PAIN AT THE END OF THE DAY WHEN ON HER FEET. I THINK THAT IS THE WIDE SPACED SUTURES FROM HER MESH, BUT IN GENERAL SHE IS DOING VERY WELL. CONTINUE TO INCREASE ACTIVITIES AND FOODS, ALREADY WALKING A MILE A DAY AND HANDLING THAT VERY WELL. ON (B)(6) 2007: (B)(6) MD. OFFICE NOTES. DOING WELL AFTER OPEN REDUCTION OF A HUGE HIATAL HERNIA WITH NISSEN FUNDOPLICATION. ABOUT BACK TO A NORMAL DIET, ALTHOUGH AVOIDS SOME GREASY-SPICY FOODS THAT SEEM TO BOTHER HER 2 DAYS LATER AND NOT AT THE TIME OF SWALLOWING. WAS NOTED TO HAVE AN EXTRA-LONG COLON AT SURGERY, WHICH MAY BE PART OF HER PROBLEMS. ON (B)(6) 2007: (B)(6) MD. OFFICE NOTES. PREVIOUS LAPAROSCOPIC AND OPEN WORK AT THE HIATUS FOR A HIATAL HERNIA AND PARAESOPHAGEAL HIATAL HERNIA. COMPLAINS OF MIDLINE PAIN AND IS NOTED TO HAVE A RECURRENT INCISIONAL HERNIA ABOVE THE UMBILICUS AND TO THE LEFT OF MIDLINE. THIS HAS LIKELY HAD SOME SUTURES PULL THROUGH. HER WEIGHT HAS BEEN STABLE. I THINK THIS DOES NEED TO BE FIXED. I DO NOT FEEL SHE IS AT RISK FOR INCARCERATION. SHE WILL TRY TO LOSE WEIGHT PRIOR TO DOING SURGERY. I WOULD LIKE HER TO LOSE 15 TO 20 POUNDS PRIOR TO ATTEMPTING SURGERY. ON (B)(6) 2007: ST. JOHN MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. PREVIOUSLY HAD AN EXPLORATORY LAPAROTOMY FOR A HUGE PARAESOPHAGEAL HERNIA. POSTOPERATIVELY, HAS DEVELOPED AN INCISIONAL HERNIA, COMES FOR REPAIR. I WILL LIKELY REPAIR THIS WITH MESH. THE HERNIA IS JUST ABOVE THE UMBILICUS AND TO THE LEFT. REVIEW OF SYSTEMS: PAIN IN MID ABDOMEN RELATED TO INCISIONAL HERNIA. EXAM: WT 120 LB. THE ABDOMEN IS SOFT. INCISIONAL HERNIA NOTED ABOVE THE UMBILICUS AND TO THE LEFT. IMPRESSION/PLAN: POSTOPERATIVE INCISIONAL HERNIA. REPAIR ON (B)(6) 2007. ON (B)(6) 2007: (B)(6) MEDICAL SYSTEM. (B)(6) MD. POST PROCEDURE NOTE. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA. SURGEON: DR. MELICHAR. PROCEDURE FINDINGS: ~8 CM INCISIONAL HERNIA REPAIRED WITH DUAL SIDED MESH. COMPLICATIONS: NONE. CONDITION: TOLERATED PROCEDURE WELL, NO PROBLEMS. DISPOSITION: TRANSFER TO PACU. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6) MD. PROGRESS NOTES. ABDOMEN INCISION CLEAN/DRY/INTACT WITH STAPLES, LEFT OPEN TO AIR. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6) MD. PROGRESS NOTES. INCISION OK. DRAIN WITH MINIMAL SEROSANGUINOUS DRAINAGE. POSTOP DAY #3 CONTINUE INCREASING ACTIVITY. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6) MD. DISCHARGE SUMMARY. FINAL DIAGNOSIS: INCISIONAL HERNIA. HOSPITAL COURSE: PREVIOUS MIDLINE SURGERY AND DEVELOPED A LARGE INCISIONAL HERNIA WHICH IS BECOMING INCREASINGLY SYMPTOMATIC. TO SURGERY FOR REPAIR. DURING SURGERY SHE WAS FOUND TO HAVE SEVERAL POT-HOLE-LIKE HOLES UP AND DOWN THE MIDLINE INCISION SO REQUIRED A LARGE PIECE OF MESH FOR REPAIR. DISSECTION WAS CARRIED OUT AT LEAST 2 INCHES AWAY FROM ALL GOOD EDGES OF THE FASCIA AND MUSCLE AND THEN THE MESH PLACED WIDELY CIRCUMFERENTIALLY. A 15 FRENCH BLAKE DRAIN WAS PLACED ABOVE THIS AND THE WOUND WAS CLOSED WITH INTERRUPTED SKIN STAPLES. STERILE DRESSINGS WERE APPLIED. POSTOPERATIVE COURSE FAIRLY BENIGN. HAD A BIT OF AN ILEUS BUT PROGRESSED TO A DIET, WALKING IN THE HALLS, AND WAS ABLE TO BE DISCHARGED ON ORAL LORTAB. ON (B)(6) 2007: (B)(6) MD. OFFICE NOTES. DOING WELL AFTER REPAIR OF AN INCISIONAL HERNIA. WOUND LOOKS VERY GOOD. ALL STAPLES REMOVED. SHE IS RESUMING ACTIVITIES. WILL BE SEEN AGAIN IN SIX WEEKS OR A MONTH. ON (B)(6) 2007: (B)(6) MD. OFFICE NOTES. AGAIN, HAS A RECURRING INCISIONAL HERNIA. HAD SOME DRY HEAVES TWO OR THREE WEEKS AGO AND THEN DID SOME HEAVY LIFTING AND BENT OVER AND FELT SOMETHING POP. THIS NEEDS TO BE REPAIRED. IT IS REDUCIBLE BUT HAS SOME TENSION. THIS WILL REQUIRE A VERY WIDE PIECE OF MARLEX MESH WITH ANCHORING SUTURES ALL AROUND. PLAN SURGERY FOR (B)(6) 2007. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. PLANNED OPERATION: REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH. BACKGROUND INFO: HAD SURGERY IN THE PAST FOR LAPAROSCOPIC NISSEN FUNDOPLICATION. FROM HER MIDLINE INCISION SHE DEVELOPED AN INCISIONAL HERNIA AND THIS WAS REPAIRED BUT AGAIN THE SUTURES HAVE PULLED THROUGH AND THIS HAS RECURRED. SHE DID SOME LIFTING AND BENDING OVER AND FELT SOMETHING BULGE. WE PLAN TO PROCEED WITH EXPLORATORY LAPAROTOMY WITH PLACEMENT OF A WIDE, LIKELY DUAL MESH GAUZE WITH WIDELY SPACED ANCHORING SUTURES. EXAM: ABDOMEN SOFT WITH NO MASSES OR TENDERNESS. THERE IS A DEFINITE INCISIONAL HERNIA IN THE MIDLINE RIGHT ABOVE THE UMBILICUS. IMPRESSION: SYMPTOMATIC INCISIONAL HERNIA. PLAN: REPAIR WITH MESH. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6) MD. POST PROCEDURE NOTE. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA. ASSISTANT: (B)(6). PROCEDURE FINDINGS: REPAIR OF HERNIA WITH GORTEX MESH. EXPLORATORY LAPAROTOMY. FINDINGS-PREVIOUS MESH REPAIR DISRUPTED. SPECIMENS: NONE. COMPLICATIONS: NONE. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. NURSE NOTES. JP PATENT, ACTIVATED WITH SEROSANGUINOUS OUTPUT. MIDLINE DRESSING, 6 BAND AID SITES CLEAN, DRY, INTACT. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. [ILLEGIBLE]. PHYSICIAN ORDERS. DISCHARGE HOME. NO LIFTING OVER 10 POUNDS. NO DRIVING. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. NURSE NOTES. WOUND: SURGICAL INCISION, MIDLINE ABDOMEN 6 LAP SITES. EDGES APPROXIMATED, STAPLED, BAND AIDS ON LAP SITES. DRY, INTACT. ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6) MD. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: RECURRENT VENTRAL HERNIA. HOSPITAL COURSE: PRESENTED WITH A REDUCIBLE RECURRENT INCISIONAL HERNIA. TAKEN TO THE OPERATING ROOM ON (B)(6) 2007, WHERE SHE UNDERWENT EXPLORATORY LAPAROTOMY, EXCISION OF OLD MESH, AND REPAIR OF HER VENTRAL HERNIA WITH GORE-TEX MESH. POSTOPERATIVELY, SHE DID WELL. OVER THE NEXT FEW DAYS, SHE BEGAN TO AMBULATE MORE, VOIDED WITHOUT DIFFICULTY, AND BEGAN TO TOLERATE A REGULAR DIET. SHE DID HAVE SOME EPISODES OF NAUSEA DURING HER STAY. THIS WAS CONTROLLED WITH A SCOPOLAMINE PATCH AND PHENERGAN. THIS NAUSEA RESOLVED BY (B)(6) 2007. SHE WAS ABLE TO TOLERATE A REGULAR DIET. SHE HAD A SURGICAL DRAIN PLACED IN THE SUBCUTANEOUS TISSUES, WHICH CONTINUED TO HAVE SEROUS OUTPATIENT. DISCHARGE PLAN: SHE WAS TAUGHT DRAIN CARE AND HOW TO RECORD HER OUTPUTS. FOLLOW-UP APPOINTMENT ON (B)(6) 2007. AMBULATE AS TOLERATED, NO HEAVY LIFTING, NO DRIVING. ON (B)(6) 2007: (B)(6) MD. OFFICE NOTES. DOING WELL; INCISION LOOKS GOOD. DRAINAGE IS MIDDLE AND SEROUS. THE DRAIN IS REMOVED WITHOUT DIFFICULTY. ALL SUTURES REMOVED. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. LONGSTANDING UPPER GI PAIN AND DISCOMFORT SECONDARY TO HIATAL HERNIA AND GERD. HIATAL HERNIA REPAIRED INITIALLY BY DR. (B)(6) IN 2006. SHE PRESENTS NOW WITH SEVERE ABDOMINAL PAIN, NAUSEA, AND DRY HEAVES SINCE (B)(6) 2008. SHE DESCRIBES FOOD INTOLERANCE; PROGRESSIVE AND CONSTANT NAUSEA AND A SHARP, SOMETIMES DULL, CHRONIC PAIN. PAST HISTORY: GERD, HIATAL HERNIA REPAIR, MULTIPLE VENTRAL HERNIA REPAIRS. EXAM: IN MODERATE DISTRESS. ABDOMEN DISTENDED WITH TENDERNESS TO PALPATION DIFFUSELY. RADIOLOGY DATA CONCERNING FOR MID GUT VOLVULUS, MARKEDLY DISTENDED STOMACH WITH GASTRIC OUTLET OBSTRUCTION. ASSESSMENT/PLAN: ABDOMINAL PAIN WITH RADIOLOGIC FINDINGS CONCERNING FOR MID GUT VOLVULUS. WILL LIKELY GO TO THE OR FOR CORRECTION. ON (B)(6) 2008: [MISSING RECORDS: OPERATIVE REPORT FOR THE PROCEDURE TO CORRECT ¿MID GUT VOLVULUS¿ WERE NOT PROVIDED.] ON (B)(6) 2008: (B)(6) MEDICAL LABORATORY. (B)(6) MD. PATHOLOGY REPORT. CASE #: (B)(4). DIAGNOSIS: A. RIGHT COLON, RESECTION- PORTIONS OF ILEUM, AND RIGHT COLON WITH ACUTE ISCHEMIC CHANGES AND FOCAL MUCOSAL HEMORRHAGIC NECROSIS, CONSISTENT WITH CLINICAL HISTORY OF ACUTE CECAL VOLVULUS (SEE COMMENT). B. SIGMOID COLON, SEGMENTAL RESECTION- PROMINENT VASCULAR ECTASIA OF SUBMUCOSAL VESSELS WITH ASSOCIATED MILD REACTIVE MUCOSAL CHANGES AND COLON DIAMETER VARIABILITY, CONSISTENT WITH CLINICAL IMPRESSION OF CHRONIC SIGMOID VOLVULUS; SURGICAL MARGINS APPEAR VIABLE. COMMENT: A. ACUTE ISCHEMIC CHANGES, CHARACTERIZED BY SLOUGHING OF SUPERFICIAL MUCOSA AND PROMINENT RED BLOOD CELL EXTRAVASATION INTO THE LAMINA PROPRIA ARE PRESENT IN SECTIONS OF THE PROXIMAL SURGICAL MARGIN OF THE SPECIMEN. DISTAL SURGICAL MARGIN APPEARS VIABLE. GROSS EXAMINATION: SPECIMEN A: RECEIVED IN FORMALIN LABELED "RIGHT COLON" IS A 17.5 CM SEGMENT OF COLON WITH A CIRCUMFERENCE UP TO 12.5 CM. ALSO, THERE IS AN ATTACHED SEGMENT OF ILEUM MEASURING 5.7 CM WITH A CIRCUMFERENCE OF 5.5 CM. ATTACHED COLON MEASURES UP TO 4.1 CM. THE SEROSAL SURFACE IS TAN-PINK PURPLE AND DUSKY. NO AREAS OF POSSIBLE PERFORATION ARE IDENTIFIED. THE APPENDIX IS NOT IDENTIFIED. MUCOSAL SURFACE IS DARK RED-PURPLE AND DIFFUSELY EDEMATOUS FROM THE PROXIMAL MARGIN TO THE DISTAL MARGIN. NO MASSES OR LESIONS ARE GROSSLY IDENTIFIED. BLOCK SUMMARY: A 1-PROXIMAL MARGIN; A2-SECTIONS OF ILEAL MUCOSA; A3-ILCOCECAL VALVE; A4-A5-REPRESENTATIVE SECTIONS OF MUCOSA FROM ILEOCECAL VALVE TO DISTAL MARGIN; A6-DISTAL MARGIN. SPECIMEN B: RECEIVED IN FORMALIN LABELED "SIGMOID COLON" IS A 27.6 CM SEGMENT OF COLON WITH A CIRCUMFERENCE OF 6.1 UP TO 11.1 CM. ATTACHED MESOCOLON MEASURES UP TO 5.5 CM. SEROSAL SURFACE IS TAN AND LIGHT PURPLE AND DUSKY. MUCOSAL SURFACE IS TAN-GRAY WITH APPROXIMATELY 20% LOSS OF FOLDING PATTERN. THERE ARE 2 DILATED AND ATTENUATED AREAS. ONE OF THE AREAS EXTENDS TO A MARGIN. THE SECOND AREA COMES TO WITHIN APPROXIMATELY 6.9 CM OF THE OPPOSITE MARGIN. THERE ARE NO OBSTRUCTIONS GROSSLY IDENTIFIED THAT CORRELATE WITH THESE 2 AREAS OF DILATION. BLOCK SUMMARY: B1- DILATED MARGIN; B2- ADJACENT DILATED MUCOSA; B3- REPRESENTATIVE SECTIONS FROM NORMAL MUCOSA; B4- REPRESENTATIVE SECTIONS FROM SECOND DILATED AREA; B5- REPRESENTATIVE SECTIONS FROM NORMAL MUCOSA BETWEEN SECOND DILATED AREA AND SECOND MARGIN; B6- SECOND MARGIN. SPECIMEN: A. RIGHT COLON. B. SIGMOID COLON. PERTINENT HISTORY: ACUTE ABDOMEN. ACUTE CECAL VOLVULUS WITH RIGHT COLON ISCHEMIA. CHRONIC SIGMOID VOLVULUS. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. DISCHARGE SUMMARY. FINAL DIAGNOSIS: GASTRIC OUTLET OBSTRUCTION WITH SMALL BOWEL VOLVULUS, STATUS POST RIGHT COLECTOMY AND SIGMOID RESECTION WITH COLOSTOMY. HOSPITAL COURSE: TAKEN TO THE OPERATING ROOM ON (B)(6) 2008. POSTOP DAY NO. 4, CONTINUED TO TOLERATE CLEAR LIQUIDS, AMBULATING AND SUBSEQUENTLY DISCHARGED WITH GOOD OSTOMY FUNCTION AND NO ISSUES. DISPOSITION: HOME, FOLLOW-UP IN 7 TO 10 DAYS. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. POSTOPERATIVE DAY NINE STATUS POST A RIGHT COLECTOMY WITH ILEOCOLIC ANASTOMOSIS AND SIGMOID COLECTOMY WITH END COLOSTOMY FOR ACUTE CECAL VOLVULUS AND CHRONIC SIGMOID VOLVULUS. WAS DISCHARGED HOME ON (B)(6) 2008; AT THAT TIME SHE WAS AMBULATORY, TOLERATING A DIET AND HER OSTOMY WAS FUNCTIONAL. BACK TODAY WITH ACUTE ONSET OF NAUSEA AND VOMITING. DENIES HEMATEMESIS, DENIES BRIGHT RED BLOOD PER OSTOMY. OSTOMY IS FUNCTIONAL. EXAM: ACUTELY NAUSEATED, NO RECENT EMESIS. ABDOMEN SOFT AND NON-DISTENDED. INCISION LOOKS GOOD, SURGICAL STAPLES IN PLACE WITH NO SIGNS OF WOUND INFECTION, OSTOMY IS PINK AND PATENT. OSTOMY BAG HAS SOFT BROWN STOOL AND GAS. ABDOMINAL X-RAYS SHOW A DISTENDED STOMACH AND SMALL BOWEL. THERE IS GAS TO THE OSTOMY AND QUESTIONABLE SMALL BOWEL OBSTRUCTION. ASSESSMENT/PLAN: STATUS POST RIGHT COLECTOMY AND SIGMOID COLECTOMY WITH END COLOSTOMY NOW POSTOP DAY #9. PRESENTS WITH NAUSEA AND VOMITING. ADMIT, NPO. MAY NEED NG TUBE IF EMESIS RECURS AND PERSISTS. WILL CHECK LABS AND OBSTRUCTIVE SERIES LATER TODAY. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) , MD. RADIOLOGY- XR ABDOMEN AP AND UPRIGHT. INDICATION: ABDOMINAL PAIN. IMPRESSION: DISTENTION OF THE STOMACH AND PROXIMAL SMALL BOWEL. A PROXIMAL SMALL BOWEL OBSTRUCTION IS NOT EXCLUDED. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. RADIOLOGY- XR ABDOMEN AP AND UPRIGHT. INDICATION: VOMITING. IMPRESSION: PERSISTENT SMALL BOWEL DILATATION WHICH MAY BE DUE TO ILEUS OR OBSTRUCTION. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. HAS HAD A LITTLE BIT OF DRAINAGE FROM WOUND. THE INCISION ITSELF DOES HAVE A LITTLE BIT OF DRAINAGE WHICH IS MINIMALLY PURULENT. STARTED HER ON ANTIBIOTICS AND WILL SEE HER BACK IN TWO WEEKS. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. RETURNS TODAY WITH JUST A LITTLE CONTINUED DRAINAGE FROM HER UMBILICUS AND SOME PELVIC CRAMPING TYPE PAIN. THE WOUND IS HEALING NICELY. SHE HAS A SMALL OPEN SINUS BUT MINIMAL DRAINAGE AND HER COLOSTOMY SEEMS TO BE FUNCTIONING NORMALLY. WE DISCUSSED LOCAL WOUND CARE OPTIONS AND ASKED HER TO TAKE A SUPPOSITORY TO EMPTY THE RESIDUAL RECTUM. WE WILL PLAN FOR A CT SCAN. ON (B)(6) 2008: (B)(6) MEDICAL LABORATORY. (B)(6) MD. PATHOLOGY REPORT. DIAGNOSIS: COLON SEGMENT, RESECTION- PORTIONS OF VIABLE BOWEL WALL AND SQUAMOUS EPITHELIUM SHOWING CHRONIC INFLAMMATORY CHANGES CONSISTENT WITH PREVIOUS HISTORY OF HARTMANN¿S PROCEDURE. GROSS EXAMINATION: THE SPECIMEN IS A SEGMENT OF BOWEL MEASURING 2.2 CM IN LENGTH BY A DIAMETER OF 3.1 CM. AT ONE END IS A 3.2 X 1.9 CM CUTANEOUS RING, WHICH MEASURES UP TO 0.7 CM IN MAXIMAL WIDTH. THE EXPOSED MUCOSA IS RED-BROWN, GLISTENING AND ERYTHEMATOUS. THE SPECIMEN IS OPENED TO REVEAL LIGHT-TAN, GLISTENING AND FOCALLY HYPEREMIC MUCOSA. SECTIONING REVEALS UNREMARKABLE LIGHT-TAN MUSCULAR WALL, WHICH MEASURES UP TO 0.1 CM IN MAXIMAL THICKNESS. ALSO RECEIVED IN THE SAME CONTAINER IS A RING-LIKE FRAGMENT OF BOWEL MEASURING 2.9 X 2.5 CM AND UP TO 0.5 CM IN MAXIMAL THICKNESS. THE MUCOSA IS PINK AND GLISTENING WITH NO DISCRETE MASSES OR OTHER GROSSLY SUSPICIOUS AREAS IDENTIFIED. REPRESENTATIVE SECTIONS OF THE BOWEL SEGMENT ARE SUBMITTED IN CASSETTES A1 AND A2. REPRESENTATIVE SECTIONS OF THE RING-LIKE FRAGMENT OF BOWEL ARE SUBMITTED IN CASSETTE A3. SPECIMEN: COLON. PERTINENT HISTORY: STATUS POST HARTMANN PROCEDURE. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. HPI: DOING WELL, TOLERATING A REGULAR DIET, HAVING BOWEL MOVEMENTS. HER WOUND IS HEALING NICELY. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. HPI: RETURNS TODAY WITH SOME WOUND PROBLEMS. SHE HAS HAD SOME PURULENT DRAINAGE FROM THE WOUND. THE WOUND ITSELF DOES HAVE SOME PURULENT DRAINAGE, BUT HAS HEALTHY GRANULATION TISSUE. THE MAIN CONCERN IS THAT SHE HAS MESH IN PLACE, AND BECAUSE OF THIS I THINK IT IS AT RISK. PLAN: ANTIBIOTICS AND HAVE RECOMMENDED AGGRESSIVE LOCAL WOUND CARE. WILL SEE HER BACK IN TWO WEEKS. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. HPI: RETURNS TODAY AND SHE AND I BOTH ARE CONCERNED THAT SHE HAS A MESH INFECTION AND AS SUCH WOULD REQUIRE REMOVAL OF THE MESH. SHE IS STILL DECIDING ON WHETHER SHE WANTS TO PURSUE SURGERY OR CONTINUE TO PUSH LOCAL WOUND CARE. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. CC: INFECTED MESH. HPI: PRESENTED TO THE EMERGENCY ROOM WITH A CECAL VOLVULUS WITH NECROSIS AND A CHRONIC SIGMOID VOLVULUS. SHE UNDERWENT A RIGHT AND LEFT HEMICOLECTOMY AND HAS SUBSEQUENTLY UNDERGONE COLOSTOMY REVERSAL FROM WHICH SHE INITIALLY DID WELL BUT DEVELOPED INFECTED MESH AND SHE NOW PRESENTS FOR MESH REMOVAL AND VENTRAL HERNIA REPAIR. PMH: GASTROESOPHAGEAL REFLUX DISEASE, OPEN NISSEN FUNDOPLICATION, PREVIOUS SIGMOID AND CECAL VOLVULUS. EXAM: ABDOMEN SOFT WITH POSTSURGICAL CHANGES AND MESH CLEARLY VISIBLE IN THE WOUND. IMPRESSION: INFECTED MESH. PLAN: REMOVAL WITH VENTRAL HERNIA REPAIR. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. OPERATIVE REPORT. ASSISTANT: (B)(6) MD. PREOPERATIVE DIAGNOSIS: INFECTED FOREIGN BODY (MESH). POSTOPERATIVE DIAGNOSIS: INFECTED FOREIGN BODY (MESH). PROCEDURE: REMOVAL OF INFECTED FOREIGN BODY. VENTRAL HERNIA REPAIR WITH ALLOMAX BIOLOGIC MESH. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: MINIMAL. FINDINGS: THE PATIENT HAD EXTENSIVE DISRUPTION OF HER MESH WHICH INDICATED CHRONIC INFECTION. SHE HAD SIGNIFICANTLY DETERIORATED FASCIA WITH SWISS-CHEESE DEFECTS THROUGHOUT THE UNDERSURFACE OF THE MESH. AN ALLOMAX REPAIR WAS UTILIZED, SEWN WIDELY TO ENCOMPASS ALL HERNIA DEFECTS. DESCRIPTION OF PROCEDURE: ¿INFORMED CONSENT WAS OBTAINED. THE PATIENT WAS PLACED IN THE SUPINE POSITION. GENERAL ANESTHESIA WAS ADMINISTERED. THE PATIENT'S ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL FASHION. A TIME OUT WAS PERFORMED. A LINEAR INCISION WAS MADE ALONG THE ENTIRE LENGTH OF THE PREVIOUSLY PLACED MESH, AND THIS WAS EXCISED USING DILIGENT DISSECTION. MULTIPLE SUTURES WERE ALSO REMOVED. ONCE THIS HAD BEEN ACHIEVED, THE AREA WAS COPIOUSLY IRRIGATED. COLLAMEND MESH WAS THEN INTRODUCED INTO THE WOUND AND SEWN INTO THE FASCIA. THIS WAS DONE WITH TWO RUNNING #1 PROLENES WHICH AFFORDED EXCELLENT CLOSURE. THE SUBCUTANEOUS TISSUES WERE THEN COPIOUSLY IRRIGATED, AND A 19-FRENCH BLAKE DRAIN WAS PLACED WITHIN THEM. THE DEEP TISSUES WERE APPROXIMATED USING 3-0 VICRYL, AND THE SKIN WAS APPROXIMATED USING SKIN CLIPS. THE DRAIN WAS SEWN INTO PLACE USING SILK SUTURES. THE PATIENT TOLERATED THE PROCEDURE WELL, AND THERE WERE NO COMPLICATIONS.¿ ON (B)(6) 2008: (B)(6) MEDICAL LABORATORY. (B)(6) MD. PATHOLOGY REPORT. DIAGNOSIS: INFECTED MESH, REMOVAL- SOFT TISSUE WITH FOCI OF GRANULATION TISSUE FORMATION AND ACUTE INFLAMMATION, CENTERED ON FOREIGN BODY FRAGMENTS, CONSISTENT WITH THE CLINICAL HISTORY OF INFECTED MESH. MICROSCOPIC EXAMINATION: SECTIONS SHOW FRAGMENTS OF SOFT TISSUE, DEMONSTRATING AREAS OF FIBROSIS AND GRANULATION TISSUE WITH ASSOCIATED MIXED INFLAMMATORY INFILTRATE. FRAGMENTS OF FOREIGN BODY MATERIAL, CONSISTENT WITH MESH ARE IDENTIFIED WITHIN THE AREAS OF INFLAMMATION. SOME OF THE FOREIGN BODY MATERIAL ARE SURROUNDED BY MACROPHAGES. NO MALIGNANCY IDENTIFIED. GROSS EXAMINATION: RECEIVED IN FORMALIN LABELED ¿INFECTED MESH¿ IS A 12.5 X 6.5 X 1.0 CM TAN-PINK SEGMENT OF MESH WITH SCANT ATTACHED SOFT TISSUE. REPRESENTATIVE SOFT TISSUE IS SUBMITTED IN ONE CASSETTE. SPECIMEN: INFECTED MESH. PERTINENT HISTORY: INFECTED MESH. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. POSTOPERATIVE VISIT: RETURNS TODAY COMPLAINING OF DRAINAGE FROM HER WOUND AND SOME LOW-GRADE TEMPERATURES. SHE HAS A SINGLE SINUS IN THE SUPERIOR ASPECT OF HER INCISION, WHICH IS DRAINING SOME THICK FLUID. THE DRAIN ITSELF IS DRAINING THE SAME FLUID ALTHOUGH HER DRAIN OUTPUT HAS DECREASED; AVERAGING 10-15 CC A DAY. IT IS CLEAR THAT HER DRAIN HAS STOPPED FUNCTIONING AND SHE HAS DEVELOPED WHAT LOOKS LIKE A THICKENED SEROMA. SHE HAS NO ERYTHEMA AROUND HER WOUNDS SO I DO NOT SUSPECT CELLULITIS. I DID PLACE HER ON ANTIBIOTICS AND WILL SEE HER BACK AT THE END OF THE WEEK. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. RETURNS TODAY DOING MUCH BETTER. I REMOVED HER DRAIN, DRAINAGE IS MINIMAL AND CLEAR. CONTINUE LOCAL WOUND CARE. ON (B)(6) 2008: (B)(6) MD. OFFICE NOTES. RETURNS TODAY DOING MUCH BETTER. THE WOUND IS HEALING UP NICELY. CONTINUE LOCAL WOUND CARE AND SEE HER BACK IN 2 WEEKS. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. SHE COMES IN TODAY COMPLAINING OF NAUSEA AND VOMITING TIMES THREE DAYS. STATES HAD SOME EMESIS LAST FRIDAY, CAME TO THE HOSPITAL, SUBSEQUENTLY SENT HOME. HAS HAD CONTINUED HICCUPPING AND DRY HEAVING SINCE THAT TIME. NO SIGNIFICANT EMESIS SINCE THIS TIME. DENIES BRIGHT RED BLOOD IN STOOLS, DENIES MELENA, HAS HAD SOME DIARRHEA. EXAM: ABDOMEN SOFT, NONTENDER, NON-DISTENDED, ACTIVE BOWEL SOUNDS, NO REBOUND TENDERNESS, NO GUARDING. THERE ARE OLD INCISION SITES FROM MULTIPLE ABDOMINAL SURGERIES THAT ARE HEALED WELL. RADIOLOGY OF THE ABDOMEN AND PELVIS SHOWS A HIATAL HERNIA. NIGHTHAWK READS AS A QUESTIONABLE POSSIBLE GASTRIC VOLVULUS. ASSESSMENT/PLAN: NAUSEA AND VOMITING. ADMITTED, MADE NPO, GIVEN NASOGASTRIC TUBE WITH BOWEL REST. DOUBT THIS IS GASTRIC VOLVULUS. MAY BE GASTRITIS VERSUS ILEUS. MAY NEED GASTROINTESTINAL EVALUATION IF CONDITION DOES NOT IMPROVE. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. RADIOLOGY- CT PELVIS/ABDOMEN. INDICATION: EVAL POSSIBLE VOLVULUS. IMPRESSION: MODERATELY LARGE HIATAL HERNIA, POSSIBLE PARAESOPHAGEAL. MODERATE GASTRIC DISTENSION. AN ELEMENT OF GASTRIC VOLVULUS IS DIFFICULT TO EXCLUDE. TINY NONOBSTRUCTING LEFT RENAL CALCULUS. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. HISTORY AND PHYSICAL. WAS DISCHARGED ON (B)(6) 2008, FOLLOWING ADMISSION FOR SIMILAR SYMPTOMS OF ABDOMINAL PAIN, POOR PO TOLERANCE AND NAUSEA. SINCE DISCHARGE HAS HAD POOR APPETITE AND FREQUENT NAUSEA AND ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT AND RIGHT UPPER QUADRANT, WHICH, AT TIMES IS PRESENT IN THE EPIGASTRIUM. SHE IS UNABLE TO VOMIT SECONDARY TO HER NISSEN HIATAL HERNIA REPAIR. SHE DENIES ANY CHANGE IN BOWEL MOVEMENTS. HER LAST BOWEL MOVEMENT YESTERDAY WAS NORMAL. EXAM: ABDOMEN SOFT AND OBESE WITH MULTIPLE SCARS WHICH ARE ALL WELL HEALED, MILD TENDERNESS RIGHT LOWER QUADRANT AND RIGHT UPPER QUADRANT, EPIGASTRIUM TENDER TO PALPATION. BOWEL SOUNDS ARE ACTIVE, NO REBOUND OR GUARDING. BILIOUS NG OUTPUT IS NOTED IN THE RESERVOIR. RADIOLOGY SHOWS MULTIPLE LOOPS OF SMALL BOWEL WHICH ARE DILATED SUGGESTING PARTIAL SMALL BOWEL OBSTRUCTION AS WELL AS A HIATAL HERNIA. IMPRESSION/PLAN: RECURRENT ABDOMINAL PAIN. ADMIT, MAKE NPO AND NG TO LOW INTERMITTENT SUCTION. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. RADIOLOGY- CT ABDOMEN/PELVIS. INDICATION: VOMITING. IMPRESSION: SLIGHTLY INCREASED BOWEL DISTENSION PROBABLY SECONDARY TO MILD ILEUS ALTHOUGH LOW-GRADE OBSTRUCTION CANNOT BE COMPLETELY EXCLUDED. NONOBSTRUCTIVE LEFT RENAL CALCULI. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) MD. RADIOLOGY- XR ABDOMEN AP. INDICATION: VOMITING. IMPRESSION: MILD ILEUS. ON (B)(6) 2008: (B)(6) MEDICAL CENTER. (B)(6) DO. RADIOLOGY- XR UPPER GI AIR CONTRAST WITH SMALL BOWEL. IMPRESSION: THERE IS SMOOTH TAPERING OF THE DISTAL ESOPHAGUS AND A STRICTURE IS NOT EXCLUDED. THE ESOPHAGEAL MUCOSAL PATTERN APPEARS UNREMARKABLE. THERE IS A LARGE TO MODERATE HIATAL HERNIA DESPITE EVIDENCE OF PREVIOUS HERNIA REPAIR. GASTROESOPHAGEAL REFLUX WAS DEMONSTRATED. THERE IS EVIDENCE OF PREVIOUS INTESTINAL SURGERIES WITH ALTERATION OF THE ANATOMY. THE JEJUNAL AND ILEAL FOLDS APPEAR TO BE WITHIN NORMAL LIMITS. THE SMALL BOWEL CALIBER APPEARS TO BE WITHIN NORMAL LIMITS. ON (B)(6) 2008: ST. JOHN MEDICAL CENTER. (B)(6) MD. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: ILEUS. HOSPITAL COURSE: HAD RECURRENT FINDINGS OF NAUSEA, VOMITING, AND ABDOMINAL PAIN. SCAN SUGGESTED THE PRESENCE OF AN ILEUS WITH DIFFUSE DILATION OF BOTH LARGE AND SMALL BOWEL. HAD BEEN TAKING NARCOTICS FOR ABDOMINAL PAIN FOR SOME TIME. IT APPEARED THIS CONTRIBUTED TO THOSE CURRENT FINDINGS. UPPER GI AND SMALL BOWEL SERIES WAS UNREMARKABLE. DISCHARGE PLAN: HOME WITH LACTULOSE AND ULTRACET, ASKING HER NOT TO TAKE HER LORTAB.
H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6)2005 WERE NOT PROVIDED. 08/15/05: OPERATIVE REPORT. PREOP DIAGNOSIS: HIATAL HERNIA; REFLUX ESOPHAGITIS. POSTOP DIAGNOSIS: HIATAL HERNIA, LARGE; REFLUX ESOPHAGITIS. PROCEDURE: LAPAROSCOPIC NISSEN FUNDOPLICATION OVER A 44 HURST DILATOR. INDICATIONS: THE PATIENT IS A 49-YEAR-OLD WHITE FEMALE WITH A 25 YEAR HISTORY OF SEVERE REFLUX SYMPTOMATOLOGY. WORK-UP HAS SHOWN LOW PRESSURE LOW ESOPHAGEAL SPHINCTER. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. A 1 CM INCISION WAS CARRIED OUT AN INCH AND A HALF ABOVE THE UMBILICUS. A VERESS NEEDLE WAS LACED IN THE ABDOMINAL CAVITY, A PNEUMOPERITONEUM OBTAINED WITH CARBON DIOXIDE GAS. A 1 CM TROCAR WAS PLACED, FOLLOWED BY A LAPAROSCOPE WITH VIDEO ATTACHMENT. OTHER PORTS WERE PLACED IN THE ANTERIOR AXILLARY LINE ON THE LEFT SIDE, ON THE RIGHT AND LEFT SIDE IN THE MID CLAVICULAR LINE, AND IN THE EPIGASTRIC AREA LEFT OF MIDLINE. ON ENTERING THE ABDOMEN, SHE WAS NOTED TO HAVE A LARGE HIATAL HERNIA. DISSECTION WAS CARRIED OUT TO DISSECT OUT THE LARGE HERNIA SAC AWAY FROM THE RIGHT AND LEFT CRUS OF THE DIAPHRAGM AND AWAY FROM THE STOMACH. THE ESOPHAGUS WAS DISSECTED CIRCUMFERENTIALLY. A 44 HURST DILATOR WAS THEN PLACED INTO THE ESOPHAGUS AND INTO THE STOMACH AND A 360 DEGREE WRAP WAS CARRIED OUT, SUTURING THE FUNDUS ON THE LEFT ANTERIOR ESOPHAGEAL WALL, TO THE FUNDUS ON THE RIGHT. ANOTHER SUTURE WAS PLACED ABOVE THIS FROM THE FUNDUS ON THE RIGHT, TO THE FUNDUS ON THE LEFT. SUTURES WERE THEN PLACED AT THE APEX OF THE WRAP INTO THE RIGHT CRUS OF THE DIAPHRAGM. A FINAL SUTURE WAS PLACED IN THE APEX OF THE CRUS, TO THE FUNDIC WRAP, TO THE APEX OF THE RIGHT CRUS. THE DILATOR WAS THEN REMOVED. A MUCH GAS AND FLUID WAS REMOVED AS POSSIBLE. ALL TROCARS WERE REMOVED. THE WOUNDS WERE CLOSED WITH SUBCUTICULAR SUTURE OF RUNNING 3-0 PROLENE.¿ (B)(6)2006: OPERATIVE REPORT. PREOP DIAGNOSIS: PARAESOPHAGEAL HIATAL HERNIA. ABDOMINAL PAIN. POSTOP DIAGNOSIS: PARAESOPHAGEAL HIATAL HERNIA. PROCEDURE: EXPLORATORY LAPAROTOMY, REDUCTION OF HUGE PARAESOPHAGEAL HIATAL HERNIA RECURRENCE, TAKE DOWN OF PREVIOUS NISSEN FUNDOPLICATION AND RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF ESOPHAGEAL HIATUS OVER A DILATOR AND REPAIR OF INCISIONAL HERNIA. FIXATION WAS DONE WITHIN THE ABDOMEN. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. MIDLINE INCISION WAS CARRIED OUT FROM XIPHOID DOWN TO AND JUST AROUND THE UMBILICUS AND DISSECTION CARRIED DOWN THROUGH MIDLINE FASCIA INTO THE ABDOMINAL CAVITY. SHE WAS NOTED TO HAVE ADHESIONS IN THE UPPER ABDOMEN FROM PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY. SOME ADHESIONS OF THE LIVER TO THE STOMACH. RETRACTORS WERE PLACED. ALL THESE ADHESIONS WERE TAKEN DOWN. DISSECTION WAS CARRIED OUT TO DISSECT OUT THE UPPER ESOPHAGUS AND STOMACH. THE PREVIOUS FUNDOPLICATION WAS IN PLACE. HOWEVER, THE LATERAL ASPECT OF THE FUNDUS HAD HERNIATED BACK INTO THE POSTERIOR MEDIASTINUM. THE STOMACH AND ESOPHAGUS WERE COMPLETELY DISSECTED AND RETURNED TO THE ABDOMINAL CAVITY. THE PREVIOUS FUNDOPLICATION WAS TAKEN DOWN. A 50 HURST DILATOR WAS PLACED IN THE ESOPHAGUS AND DOWN INTO THE STOMACH. THE HIATUS WERE TIGHTENED WITH THREE SUTURES OF #0 NUROLON SUTURE. A FULL REPEAT FUNDOPLICATION WAS THEN CARRIED OUT OVER THIS 50 HURST DILATOR USING PROLENE SUTURE, WITH FULL THICKNESS SUTURES. THE FIRST SUTURES INCORPORATING THE ESOPHAGUS. THE STOMACH WAS THEN FIXED TO THE ABDOMINAL CAVITY WITH MULTIPLE SUTURES PLACED IN THE DIAPHRAGM. THE DILATOR WAS THEN REMOVED AND NG TUBE PLACED. NO OTHER ABNORMALITIES WERE NOTED IN THE ABDOMEN. THE MIDLINE FASCIA WAS CLOSED WITH A RUNNING PDS SUTURE. THE SKIN WAS THEN CLOSED WITH INTERRUPTED SUTURE OF SUBCUTICULAR 3-0 CHROMIC AND A RUNNING SUBCUTICULAR 3-0 PROLENE WITH A CROSS OVER IN THE CENTER. STERILE DRESSINGS WERE APPLIED. PLEASE NOTE THE PATIENT ALSO HAD AN INCISIONAL HERNIA, SO THE OPERATION SHOULD BE RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF THE DIAPHRAGM AND REPAIR OF INCISIONAL HERNIA. THE INCISIONAL HERNIA WAS CLOSED WITH SURGASSIST MESH. THIS WAS APPROXIMATELY 3 X 5 CM IN SIZE. THIS WAS SUTURED WITH DEEP U SUTURES OF #0 NUROLON. SKIN AGAIN WAS CLOSED WITH SUBCUTICULAR 3-0 PROLENE. STERILE DRESSINGS WERE APPLIED. ANESTHESIA WAS DISCONTINUED. THE PATIENT WAS SENT TO RECOVERY IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ (B)(6)2007: OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA. PROCEDURE: EXPLORATORY LAPAROTOMY. REPAIR INCISIONAL HERNIA. BACKGROUND INFORMATION: THE PATIENT IS A 51-YEAR-OLD FEMALE WHO PREVIOUSLY HAD A REPAIR OF A HUGE PARAESOPHAGEAL HIATAL HERNIA BUT DEVELOPED AN INCISIONAL HERNIA. SHE COMES TO SURGERY FOR REPAIR. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. A MIDLINE INCISION WAS CARRIED OUT ABOVE THE UMBILICUS WHERE THE MOST PROMINENT INCISIONAL HERNIA WAS NOTED. DISSECTION WAS CARRIED OUT THROUGH SUBCUTANEOUS TISSUES DOWN TO THE LARGE WHITE BASED HERNIA SAC. UPON CLOSE INSPECTION AFTER ENTERING THE ABDOMEN, IT WAS NOTED SHE HAD LITTLE ¿POTHOLE¿ INCISIONAL HERNIAS UP AND DOWN THE INCISION. INCISION WAS WIDENED FOR APPROXIMATELY 12-15 CM. THIS WAS CARRIED DOWN TO THE FASCIA AND ALL ABNORMAL OR SCAR TISSUE WAS REMOVED BACK TO GOOD FASCIA ON BOTH SIDES. A PIECE OF MESH, DUAL-SIDED GORE-TEX MESH, ¿BROWN SIDE DOWN¿ 3 X 6 INCHES IN SIZE WAS SUTURED INTO PLACE, PLACING EACH OF THE SUTURE APPROXIMATELY AN INCH BACK FROM THE EDGE OF THE FASCIA TO EXCELLENT TISSUE. ¿U¿ SUTURES WERE PLACED OF #1 NUROLON SUTURE WITH INTERRUPTED NUROLON ALSO TO SEAL THIS TO THE ABDOMINAL WALL. A 15-FRENCH BLAKE DRAIN WAS PLACED THROUGH A LATERAL STAB WOUND AND BROUGHT OUT AND SUTURED IN PLACE WITH 2-0 SILK. THE SKIN AND SUBCUTANEOUS TISSUES WERE SUTURED IN PLACE WITH SKIN STAPLES. STERILE DRESSINGS WERE APPLIED AND ANESTHESIA DISCONTINUED. THE PATIENT WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ ¿THE CASE WAS CARRIED OUT WITH MESH WITH A LARGE INCISIONAL HERNIA FOUND. IT WAS CARRIED OUT WITHOUT DIFFICULTY.¿ (B)(6)2007: ST. JOHN HEALTH SYSTEM. INTRAOPERATIVE RECORD. IMPLANT STICKER. PRE/POSTOP DX: POSTOPERATIVE INCISIONAL HERNIA. PROCEDURE: OPEN INCISIONAL HERNIA REPAIR WITH MESH. IMPLANTS: GORE DUALMESH® PLUS BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMCP03. LOT BATCH CODE: 04650685. W.L. GORE & ASSOCIATES. RECORDS CONFIRM A GORE DUALMESH® PLUS BIOMATERIAL (1DLMCP03/04650685) WAS IMPLANTED DURING THE PROCEDURE. (B)(6)2007: OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE: REPAIR RECURRENT INCISIONAL HERNIA, WITH DUAL-SIDED GORE-TEX MESH. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. THE MIDLINE INCISION WAS REOPENED, WITH SHARP DISSECTION THROUGH SUBCUTANEOUS TISSUE DOWN INTO THE HERNIA SAC AND DOWN TO THE AREA OF THE PREVIOUS MESH. THE PREVIOUS MESH WAS EXCISED. THERE WERE FEW ADHESIONS TO BOWEL, SOME ADHESIONS TO OMENTUM. THE MESH WAS DISSECTED OFF THE OMENTUM PRIOR TO REMOVING IT. A VERY LARGE PIECE OF 12 X 15 DUAL-SIDED GORE-TEX MESH WAS USED, BROWN SIDE DOWN WITH ANCHORING SUTURES PLACED AT ALL CORNERS, APPROXIMATELY 2.5 INCHES FROM THE STRONG FASCIAL MARGINS, WITH FULL THICKNESS, EXCEPT FOR SKIN SUTURES PLACED. CIRCUMFERENTIAL SUTURE THEN OF #1 PROLENE WAS PLACED IN THE MESH AT THE FASCIAL EDGES. A 15-FRENCH BLAKE DRAIN WAS USED IN SUBCUTANEOUS TISSUE AND BROUGHT OUT THROUGH A SEPARATE STAB WOUND. THE SKIN OF THE UMBILICUS WAS SUTURED DOWN AND THE SKIN WAS CLOSED WITH INTERMITTENT SKIN STAPLES. STERILE DRESSINGS WERE APPLIED. ANESTHESIA WAS DISCONTINUED. THE PATIENT WAS SENT TO RECOVERY IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ (B)(6)2007: ST. JOHN HEALTH SYSTEM. INTRAOPERATIVE RECORD. IMPLANT STICKER. PRE/POSTOP DX: RECURRENT INCISIONAL HERNIA. PROCEDURE: REPAIR OF INCISIONAL HERNIA WITH GORE DUAL MESH. IMPLANTS: GORE DUALMESH® PLUS BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMCP04. LOT BATCH CODE: 04977951. W.L. GORE & ASSOCIATES. 15 CM X 19 CM X 1 MM. EXP: 2010-02. RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/04977951) WAS IMPLANTED DURING THE PROCEDURE. THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. RECORDS BETWEEN (B)(6)2007 AND (B)(6)2008 WERE NOT PROVIDED. (B)(6)2008 : OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: HARTMANN PROCEDURE. PROCEDURE: COLOSTOMY REVERSAL. FINDINGS: ¿THE PATIENT WAS EXPLORED THROUGH HER MIDLINE INCISION. THE RECTAL STUMP WAS EASILY IDENTIFIED AND DID CONTAIN SOME INSPISSATED STOOL. THIS DID NOT PRECLUDE ANY SAFE DISSECTION. SHE HAD A SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS PERFORMED IN A DOUBLE STAPLED TECHNIQUE WITHIN THE ABDOMEN. SHE TOLERATED THIS WELL.¿ DESCRIPTION OF PROCEDURE: ¿THE ABDOMEN WAS ENTERED WITH A LINEAR INCISION. WE CARRIED OUR DISSECTION THROUGH THE SUBCUTANEOUS TISSUE WITH BOVIE ELECTROCAUTERY. THE ABDOMEN WAS ENTERED DIRECTLY AND THE INCISION EXTENDED BOTH CEPHALAD AND CAUDAD. HER ABDOMEN HAD BEEN PREPARED WITH A PREVIOUS MESH REPAIR, BUT AGAIN THIS DID NOT PRECLUDE SAFE DISSECTION. SHE HAD FAIRLY DENSE SMALL BOWEL ADHESIONS TO THE MESH BUT WE CAREFULLY TOOK THESE DOWN. ONCE THIS HAD BEEN ACHIEVED THE COLOSTOMY WAS IDENTIFIED ON THE LEFT SIDE AND IT WAS TAKEN DOWN CIRCUMFERENTIALLY WITHIN THE ABDOMEN. THEN AN ELLIPTICAL INCISION WAS MADE AROUND THE COLOSTOMY AND THIS WAS BROUGHT INTO THE ABDOMEN. THE PROXIMAL STUMP WAS CLEARED AND USING THE GIA STAPLER THE SKIN PORTION WAS RESECTED. THE PROXIMAL AND DISTAL COLON WERE THEN SECURED USING VICRYL SUTURE AND DOUBLE STAPLED ANASTOMOSIS WAS PERFORMED USING THE GIA STAPLER. THE ENTEROTOMY WAS CLOSED USING THE TA STAPLER AND BOWEL CLAMP WAS APPLIED. WE INSUFFLATED AIR THROUGH THE RECTUM FOR A LEAK TEST AND THERE WAS NO LEAKAGE, AND THE ANASTOMOSIS WAS FOUND TO BE AIR-TIGHT. THE OMENTUM WAS THEN PLACED ADJACENT TO THE ANASTOMOSIS AND SECURED WITH 2 VICRYL SUTURES. THE ABDOMEN WAS COPIOUSLY IRRIGATED AND HEMOSTASIS WAS ASSURED. THE LEFT-SIDED STOMA SITE WAS CLOSED ANTERIORLY AND POSTERIORLY WITH #1 VICRYL SUTURE. THE MIDLINE INCISION WAS APPROXIMATED USING TWO #1 PROLENE SUTURES. THE SUBCUTANEOUS TISSUES WERE COPIOUSLY IRRIGATED. THE SKIN WAS APPROXIMATED USING SKIN CLIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. SHE WAS DISCHARGED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED ADDITIONAL INFORMATION. -RECURRING HERNIA (CONFIRMED (B)(6) 2007); REVISION SURGERY (CONFIRMED (B)(6) 2007, AND (B)(6)2014); BOWEL OBSTRUCTION (CONFIRMED (B)(6) 2014). A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: HEALTH EFFECT IMPACT CODE: F28: APPROPRIATE TERM/CODE NOT AVAILABLE. H6: MEDICAL DEVICE COMPONENT: G07001: PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. PREVIOUS PATIENT CODES (2422, 2240) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THE ORIGINAL COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY AN "ALLEGED GORE DEVICE" WAS IMPLANTED. MEDICAL RECORDS CONFIRM AN ALLODERM MESH WAS IMPLANTED DURING THE SURGICAL PROCEDURE. THROUGH GORE'S INVESTIGATION WE CONFIRMED THE DEVICE WAS NOT A GORE DEVICE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. BASED UPON GORE¿S INVESTIGATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS FALSE CLAIM. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN AUGUST 12, 2005 THROUGH MAY 13, 2014 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE TWO GORE® DUALMESH® PLUS BIOMATERIAL DEVICES. OPERATIVE REPORT FOR THE PROCEDURE TO CORRECT ¿MID GUT VOLVULUS¿ ON 4/15/08 AND OPERATIVE REPORT FOR THE HERNIA REPAIR ON 04/20/09 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: SMOKING. (B)(6) 1988: QUIT SMOKING. (B)(6)2012: SMOKING FOR 6 MONTHS, 8 PER DAY. (B)(6) 2013: QUIT SMOKING IN 1988, WENT BACK TO SMOKING IN 2011, CURRENT USE 10 CIGARETTES DAILY. (B)(6) 2014: SMOKES 1 PACK DAILY. (B)(6) 2018: STOPPED SMOKING WEIGHT: (B)(6) 2005: EXOGENOUS OBESITY, WEIGHT 195 LBS. (B)(6) 2006: WEIGHT 163 LBS. (B)(6) 2007: WEIGHT 172 LBS. (B)(6) 2007: PREVIOUSLY OVERWEIGHT. (B)(6) 2007: WEIGHT. 77 KILOGRAMS, BMI 29.16. (B)(6) 2013: OBESITY HERNIAS: (B)(6) 2005: LARGE HIATAL HERNIA. (B)(6) 2006: PARAESOPHAGEAL HERNIA, INCISIONAL HERNIA AT THE UPPER PORTION OF HER LOWER MIDLINE INCISION. (B)(6) 2007: RECURRENT INCISIONAL HERNIA (B)(6) 2008: LARGE TO MODERATE HIATAL HERNIA DESPITE EVIDENCE OF PREVIOUS HERNIA REPAIR. (B)(6) 2009: RECURRENT VENTRAL HERNIA; LEFT-SIDED. (B)(6) 2010: LARGE SLIDING HIATAL HERNIA. (B)(6) 2013: VENTRAL HERNIA LEFT UPPER QUADRANT (B)(6) 2005: REFLUX ESOPHAGITIS (B)(6) 2007: HISTORY BOWEL OBSTRUCTIONS (B)(6) 2008: GASTRIC OUTLET OBSTRUCTION WITH SMALL BOWEL VOLVULUS (B)(6) 2008: SURGICAL WOUND INFECTION WITH VENTRAL HERNIA. (B)(6) 2014: GASTROESOPHAGEAL REFLUX DISEASE, CHRONIC PAIN WITH CECAL VOLVULUS. PRIOR SURGICAL PROCEDURES: ??/??/??: LAPAROSCOPIC CHOLECYSTECTOMY. ??/??/??: APPENDECTOMY. ??/??/1994: TUBAL LIGATION. (B)(6) 2005: HISTORY HIATAL HERNIA DONE 23 YEARS AGO. (B)(6) 2005: LAPAROSCOPIC NISSEN FUNDOPLICATION OVER A 44 HURST DILATOR. (B)(6) 2006: EXPLORATORY LAPAROTOMY FOR SMALL BOWEL RESECTION. (B)(6) 2006: EXPLORATORY LAPAROTOMY, REDUCTION OF HUGE PARAESOPHAGEAL HIATAL HERNIA RECURRENCE, TAKE DOWN OF PREVIOUS NISSEN FUNDOPLICATION AND RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF ESOPHAGEAL HIATUS OVER A DILATOR AND REPAIR OF INCISIONAL HERNIA. FIXATION WAS DONE WITHIN THE ABDOMEN. HERNIA CLOSED WITH SURGASSIST MESH. (B)(6) 2007: EXPLORATORY LAPAROTOMY, REPAIR INCISIONAL HERNIA, DUAL-SIDED GORE-TEX MESH. (B)(6) 2007: REPAIR RECURRENT INCISIONAL HERNIA, WITH DUAL-SIDED GORE-TEX MESH. (B)(6) 2008: COLOSTOMY REVERSAL. (B)(6) 2008: REMOVAL OF INFECTED MESH, REPAIR OF VENTRAL HERNIA WITH ALLOMAX MESH. (B)(6) 2009: REPAIR OF EXTENSIVE AND RECURRENT VENTRAL HERNIA MEASURING OVER 30 CM. (B)(6) 2014: RELEASE OF SMALL-BOWEL OBSTRUCTION; REPAIR OF INCARCERATED VENTRAL HERNIA WITH MESH. VENTRALEX ST HERNIA PATCH MESH. RELEVANT MEDICAL INFORMATION: (B)(6) 2005: LAPAROSCOPIC NISSEN FUNDOPLICATION OVER A 44 HURST DILATOR. (B)(6) 2006: ¿PREVIOUSLY HAD A LAPAROSCOPIC NISSEN FUNDOPLICATION FOR REFLUX ESOPHAGITIS ON (B)(6) 2005. INITIALLY DID WELL BUT NOW HAS DEVELOPED SOME SYMPTOMATOLOGY OF REFLUX AGAIN AND IS NOTED ON STUDIES TO HAVE A LARGE PARAESOPHAGEAL HERNIA. SHE HAD AN EXPLORATORY LAPAROTOMY CARRIED OUT IN MAY OF THIS YEAR FOR SMALL BOWEL RESECTION THAT SHOWED NO EVIDENCE OF HERNIATION BUT NOW IS NOTED TO HAVE A LARGE PARAESOPHAGEAL HERNIA. PLAN TO PROCEED WITH OPEN LAPAROTOMY WITH REDUCTION OF THE HERNIATED STOMACH, STOMACH CLOSURE OF THE DIAPHRAGM WITH POSSIBLE MESH.¿ (B)(6) 2006: EXPLORATORY LAPAROTOMY, REDUCTION OF HUGE PARAESOPHAGEAL HIATAL HERNIA RECURRENCE, TAKE DOWN OF PREVIOUS NISSEN FUNDOPLICATION AND RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF ESOPHAGEAL HIATUS OVER A DILATOR AND REPAIR OF INCISIONAL HERNIA. FIXATION WAS DONE WITHIN THE ABDOMEN. "MIDLINE INCISION WAS CARRIED OUT FROM XIPHOID DOWN TO AND JUST AROUND THE UMBILICUS AND DISSECTION CARRIED DOWN THROUGH MIDLINE FASCIA INTO THE ABDOMINAL CAVITY. SHE WAS NOTED TO HAVE ADHESIONS IN THE UPPER ABDOMEN FROM PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY. SOME ADHESIONS OF THE LIVER TO THE STOMACH. RETRACTORS WERE PLACED. ALL THESE ADHESIONS WERE TAKEN DOWN. DISSECTION WAS CARRIED OUT TO DISSECT OUT THE UPPER ESOPHAGUS AND STOMACH. THE PREVIOUS FUNDOPLICATION WAS IN PLACE. HOWEVER, THE LATERAL ASPECT OF THE FUNDUS HAD HERNIATED BACK INTO THE POSTERIOR MEDIASTINUM. THE STOMACH AND ESOPHAGUS WERE COMPLETELY DISSECTED AND RETURNED TO THE ABDOMINAL CAVITY. THE PREVIOUS FUNDOPLICATION WAS TAKEN DOWN. A 50 HURST DILATOR WAS PLACED IN THE ESOPHAGUS AND DOWN INTO THE STOMACH. THE HIATUS WERE TIGHTENED WITH THREE SUTURES OF #0 NUROLON SUTURE. A FULL REPEAT FUNDOPLICATION WAS THEN CARRIED OUT OVER THIS 50 HURST DILATOR USING PROLENE SUTURE, WITH FULL THICKNESS SUTURES. THE FIRST SUTURES INCORPORATING THE ESOPHAGUS. THE STOMACH WAS THEN FIXED TO THE ABDOMINAL CAVITY WITH MULTIPLE SUTURES PLACED IN THE DIAPHRAGM. THE DILATOR WAS THEN REMOVED AND NG TUBE PLACED. NO OTHER ABNORMALITIES WERE NOTED IN THE ABDOMEN. THE MIDLINE FASCIA WAS CLOSED WITH A RUNNING PDS SUTURE. THE SKIN WAS THEN CLOSED WITH INTERRUPTED SUTURES OF SUBCUTICULAR 3-0 CHROMIC AND A RUNNING SUBCUTICULAR 3-0 PROLENE WITH A CROSS OVER IN THE CENTER. STERILE DRESSINGS WERE APPLIED. PLEASE NOTE THE PATIENT ALSO HAD AN INCISIONAL HERNIA, SO THE OPERATION SHOULD BE RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF THE DIAPHRAGM AND REPAIR OF INCISIONAL HERNIA. THE INCISIONAL HERNIA WAS CLOSED WITH SURGASSIST MESH. THIS WAS APPROXIMATELY 3 X 5 CM IN SIZE. THIS WAS SUTURED WITH DEEP U SUTURES OF #0 NUROLON.¿ (B)(6) 2007: "PREVIOUS LAPAROSCOPIC AND OPEN WORK AT THE HIATUS FOR A HIATAL HERNIA AND PARAESOPHAGEAL HIATAL HERNIA. COMPLAINS OF MIDLINE PAIN AND IS NOTED TO HAVE A RECURRENT INCISIONAL HERNIA ABOVE THE UMBILICUS AND TO THE LEFT OF MIDLINE. THIS HAS LIKELY HAD SOME SUTURES PULL THROUGH. HER WEIGHT HAS BEEN STABLE. I THINK THIS DOES NEED TO BE FIXED. I DO NOT FEEL SHE IS AT RISK FOR INCARCERATION. SHE WILL TRY TO LOSE WEIGHT PRIOR TO DOING SURGERY. I WOULD LIKE HER TO LOSE 15 TO 20 POUNDS PRIOR TO ATTEMPTING SURGERY.¿ IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2007: ¿PREVIOUSLY HAD AN EXPLORATORY LAPAROTOMY FOR A HUGE PARAESOPHAGEAL HERNIA. POSTOPERATIVELY, HAS DEVELOPED AN INCISIONAL HERNIA, COMES FOR REPAIR. I WILL LIKELY REPAIR THIS WITH MESH. THE HERNIA IS JUST ABOVE THE UMBILICUS AND TO THE LEFT. REVIEW OF SYSTEMS: PAIN IN MID ABDOMEN RELATED TO INCISIONAL HERNIA." IMPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY. REPAIR INCISIONAL HERNIA. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL [(B)(6)/1DLMCP03, 10CM X 15CM, OVAL]. IMPLANT #1 DATE: (B)(6) 2007 [HOSPITALIZATION (B)(6) 2007] DESCRIPTION OF HERNIA BEING TREATED: ¿A MIDLINE INCISION WAS CARRIED OUT ABOVE THE UMBILICUS WHERE THE MOST PROMINENT INCISIONAL HERNIA WAS NOTED. DISSECTION WAS CARRIED OUT THROUGH SUBCUTANEOUS TISSUES DOWN TO THE LARGE WHITE BASED HERNIA SAC. UPON CLOSE INSPECTION AFTER ENTERING THE ABDOMEN, IT WAS NOTED SHE HAD LITTLE ¿POTHOLE¿ INCISIONAL HERNIAS UP AND DOWN THE INCISION. INCISION WAS WIDENED FOR APPROXIMATELY 12-15 CM. THIS WAS CARRIED DOWN TO THE FASCIA AND ALL ABNORMAL OR SCAR TISSUE WAS REMOVED BACK TO GOOD FASCIA ON BOTH SIDES.¿ IMPLANT SIZE AND FIXATION: ¿A PIECE OF MESH, DUAL-SIDED GORE-TEX MESH, ¿BROWN SIDE DOWN¿ 3 X 6 INCHES IN SIZE WAS SUTURED INTO PLACE, PLACING EACH OF THE SUTURE APPROXIMATELY AN INCH BACK FROM THE EDGE OF THE FASCIA TO EXCELLENT TISSUE. ¿U¿ SUTURES WERE PLACED OF #1 NUROLON SUTURE WITH INTERRUPTED NUROLON ALSO TO SEAL THIS TO THE ABDOMINAL WALL. A 15-FRENCH BLAKE DRAIN WAS PLACED THROUGH A LATERAL STAB WOUND AND BROUGHT OUT AND SUTURED IN PLACE WITH 2-0 SILK. THE SKIN AND SUBCUTANEOUS TISSUES WERE SUTURED IN PLACE WITH SKIN STAPLES. STERILE DRESSINGS WERE APPLIED AND ANESTHESIA DISCONTINUED. THE PATIENT WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ ¿THE CASE WAS CARRIED OUT WITH MESH WITH A LARGE INCISIONAL HERNIA FOUND. IT WAS CARRIED OUT WITHOUT DIFFICULTY.¿ PROCEDURE FINDINGS: ¿~8 CM INCISIONAL HERNIA REPAIRED WITH DUAL SIDED MESH.¿ NO IMMEDIATE POST-OPERATIVE RECORDS PROVIDED. RELEVANT MEDICAL INFORMATION: (B)(6) 2007: ¿DOING WELL AFTER REPAIR OF AN INCISIONAL HERNIA. WOUND LOOKS VERY GOOD." EXPLANT #1/IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2007: ¿PLANNED OPERATION: REPAIR OF RECURRENT INCISIONAL HERNIA WITH MESH. BACKGROUND INFO: HAD SURGERY IN THE PAST FOR LAPAROSCOPIC NISSEN FUNDOPLICATION. FROM HER MIDLINE INCISION SHE DEVELOPED AN INCISIONAL HERNIA AND THIS WAS REPAIRED BUT AGAIN THE SUTURES HAVE PULLED THROUGH AND THIS HAS RECURRED. SHE DID SOME LIFTING AND BENDING OVER AND FELT SOMETHING BULGE. WE PLAN TO PROCEED WITH EXPLORATORY LAPAROTOMY WITH PLACEMENT OF A WIDE, LIKELY DUAL MESH GAUZE WITH WIDELY SPACED ANCHORING SUTURES. EXAM: ABDOMEN SOFT WITH NO MASSES OR TENDERNESS. THERE IS A DEFINITE INCISIONAL HERNIA IN THE MIDLINE RIGHT ABOVE THE UMBILICUS. IMPRESSION: SYMPTOMATIC INCISIONAL HERNIA. PLAN: REPAIR WITH MESH.¿ EXPLANT #1/IMPLANT #2 PROCEDURE: ¿REPAIR RECURRENT INCISIONAL HERNIA WITH DUAL-SIDED GORE-TEX MESH.¿ IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL [(B)(6)/1DLMCP04, 15CM X 19CM, OVAL] EXPLANT #1/IMPLANT #2 DATE: (B)(6), 2007: DESCRIPTION OF HERNIA BEING TREATED: ¿THE MIDLINE INCISION WAS REOPENED, WITH SHARP DISSECTION THROUGH SUBCUTANEOUS TISSUE DOWN INTO THE HERNIA SAC AND DOWN TO THE AREA OF THE PREVIOUS MESH. THE PREVIOUS MESH WAS EXCISED. THERE WERE FEW ADHESIONS TO BOWEL, SOME ADHESIONS TO OMENTUM. THE MESH WAS DISSECTED OFF THE OMENTUM PRIOR TO REMOVING IT.¿ IMPLANT SIZE AND FIXATION: ¿A VERY LARGE PIECE OF 12 X 15 DUAL-SIDED GORE-TEX MESH WAS USED, BROWN SIDE DOWN WITH ANCHORING SUTURES PLACED AT ALL CORNERS, APPROXIMATELY 2.5 INCHES FROM THE STRONG FASCIAL MARGINS, WITH FULL THICKNESS, EXCEPT FOR SKIN SUTURES PLACED. CIRCUMFERENTIAL SUTURE THEN OF #1 PROLENE WAS PLACED IN THE MESH AT THE FASCIAL EDGES. A 15-FRENCH BLAKE DRAIN WAS USED IN SUBCUTANEOUS TISSUE AND BROUGHT OUT THROUGH A SEPARATE STAB WOUND. THE SKIN OF THE UMBILICUS WAS SUTURED DOWN AND THE SKIN WAS CLOSED WITH INTERMITTENT SKIN STAPLES.¿ POSTOPERATIVE PERIOD: (B)(6) 2007: ¿SHE HAD A SURGICAL DRAIN PLACED IN THE SUBCUTANEOUS TISSUES, WHICH CONTINUED TO HAVE SEROUS [SIC] OUTPATIENT. DISCHARGE PLAN: SHE WAS TAUGHT DRAIN CARE AND HOW TO RECORD HER OUTPUTS.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2007: "DOING WELL; INCISION LOOKS GOOD. DRAINAGE IS MIDDLE AND SEROUS. THE DRAIN IS REMOVED WITHOUT DIFFICULTY. ALL SUTURES REMOVED.¿ (B)(6) 2008: HISTORY AND PHYSICAL. ¿LONGSTANDING UPPER GI PAIN AND DISCOMFORT SECONDARY TO HIATAL HERNIA AND GERD. HIATAL HERNIA REPAIRED INITIALLY BY DR. (B)(6) IN 2006. SHE PRESENTS NOW WITH SEVERE ABDOMINAL PAIN, NAUSEA, AND DRY HEAVES SINCE (B)(6) 2008. SHE DESCRIBES FOOD INTOLERANCE; PROGRESSIVE AND CONSTANT NAUSEA AND A SHARP, SOMETIMES DULL, CHRONIC PAIN.¿ EXAM: IN MODERATE DISTRESS. ABDOMEN DISTENDED WITH TENDERNESS TO PALPATION DIFFUSELY. RADIOLOGY DATA CONCERNING FOR MID GUT VOLVULUS, MARKEDLY DISTENDED STOMACH WITH GASTRIC OUTLET OBSTRUCTION." ¿WILL LIKELY GO TO THE OR FOR CORRECTION.¿ (B)(6) 2008: DISCHARGE SUMMARY. "GASTRIC OUTLET OBSTRUCTION WITH SMALL BOWEL VOLVULUS, STATUS POST RIGHT COLECTOMY AND SIGMOID RESECTION WITH COLOSTOMY.¿ [NO OPERATIVE RECORDS PROVIDED.] HOSPITAL COURSE: TAKEN TO THE OPERATING ROOM ON (B)(6) 2008. POSTOP DAY NO. 4, CONTINUED TO TOLERATE CLEAR LIQUIDS, AMBULATING AND SUBSEQUENTLY DISCHARGED WITH GOOD OSTOMY FUNCTION AND NO ISSUES. DISPOSITION: HOME, FOLLOW-UP IN 7 TO 10 DAYS. (B)(6) 2008: HOSPITAL ADMISSION: ¿STATUS POST RIGHT COLECTOMY AND SIGMOID COLECTOMY WITH END COLOSTOMY NOW POSTOP DAY #9. PRESENTS WITH NAUSEA AND VOMITING. ADMIT, NPO [NOTHING BY MOUTH]. MAY NEED NG TUBE IF EMESIS RECURS AND PERSISTS." (B)(6) 2008: ¿HAS HAD A LITTLE BIT OF DRAINAGE FROM WOUND. THE INCISION ITSELF DOES HAVE A LITTLE BIT OF DRAINAGE WHICH IS MINIMALLY PURULENT. STARTED HER ON ANTIBIOTICS AND WILL SEE HER BACK IN TWO WEEKS.¿ (B)(6) 2008: ¿RETURNS TODAY WITH JUST A LITTLE CONTINUED DRAINAGE FROM HER UMBILICUS AND SOME PELVIC CRAMPING TYPE PAIN. THE WOUND IS HEALING NICELY. SHE HAS A SMALL OPEN SINUS BUT MINIMAL DRAINAGE AND HER COLOSTOMY SEEMS TO BE FUNCTIONING NORMALLY. WE DISCUSSED LOCAL WOUND CARE OPTIONS" (B)(6) 2008: HARTMANN PROCEDURE. COLOSTOMY REVERSAL. ¿THE PATIENT WAS EXPLORED THROUGH HER MIDLINE INCISION. THE RECTAL STUMP WAS EASILY IDENTIFIED AND DID CONTAIN SOME INSPISSATED STOOL. THIS DID NOT PRECLUDE ANY SAFE DISSECTION. SHE HAD A SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS PERFORMED IN A DOUBLE STAPLED TECHNIQUE WITHIN THE ABDOMEN. SHE TOLERATED THIS WELL.¿ "THE ABDOMEN WAS ENTERED WITH A LINEAR INCISION. WE CARRIED OUR DISSECTION THROUGH THE SUBCUTANEOUS TISSUE WITH BOVIE ELECTROCAUTERY. THE ABDOMEN WAS ENTERED DIRECTLY AND THE INCISION EXTENDED BOTH CEPHALAD AND CAUDAD. HER ABDOMEN HAD BEEN PREPARED [SIC] WITH A PREVIOUS MESH REPAIR, BUT AGAIN THIS DID NOT PRECLUDE SAFE DISSECTION. SHE HAD FAIRLY DENSE SMALL BOWEL ADHESIONS TO THE MESH BUT WE CAREFULLY TOOK THESE DOWN. ONCE THIS HAD BEEN ACHIEVED THE COLOSTOMY WAS IDENTIFIED ON THE LEFT SIDE AND IT WAS TAKEN DOWN CIRCUMFERENTIALLY WITHIN THE ABDOMEN. THEN AN ELLIPTICAL INCISION WAS MADE AROUND THE COLOSTOMY AND THIS WAS BROUGHT INTO THE ABDOMEN. THE PROXIMAL STUMP WAS CLEARED AND USING THE GIA STAPLER THE SKIN PORTION WAS RESECTED. THE PROXIMAL AND DISTAL COLON WERE THEN SECURED USING VICRYL SUTURE AND DOUBLE STAPLED ANASTOMOSIS WAS PERFORMED USING THE GIA STAPLER. THE ENTEROTOMY WAS CLOSED USING THE TA STAPLER AND BOWEL CLAMP WAS APPLIED. WE INSUFFLATED AIR THROUGH THE RECTUM FOR A LEAK TEST AND THERE WAS NO LEAKAGE, AND THE ANASTOMOSIS WAS FOUND TO BE AIR-TIGHT. THE OMENTUM WAS THEN PLACED ADJACENT TO THE ANASTOMOSIS AND SECURED WITH 2 VICRYL SUTURES. THE ABDOMEN WAS COPIOUSLY IRRIGATED AND HEMOSTASIS WAS ASSURED. THE LEFT-SIDED STOMA SITE WAS CLOSED ANTERIORLY AND POSTERIORLY WITH #1 VICRYL SUTURE. THE MIDLINE INCISION WAS APPROXIMATED USING TWO #1 PROLENE SUTURES. THE SUBCUTANEOUS TISSUES WERE COPIOUSLY IRRIGATED. THE SKIN WAS APPROXIMATED USING SKIN CLIPS.¿ (B)(6) 2008: ¿RETURNS TODAY WITH SOME WOUND PROBLEMS. SHE HAS HAD SOME PURULENT DRAINAGE FROM THE WOUND. THE WOUND ITSELF DOES HAVE SOME PURULENT DRAINAGE, BUT HAS HEALTHY GRANULATION TISSUE. THE MAIN CONCERN IS THAT SHE HAS MESH IN PLACE, AND BECAUSE OF THIS I THINK IT IS AT RISK. PLAN: ANTIBIOTICS AND HAVE RECOMMENDED AGGRESSIVE LOCAL WOUND CARE. WILL SEE HER BACK IN TWO WEEKS.¿ (B)(6) 2008: ¿RETURNS TODAY AND SHE AND I BOTH ARE CONCERNED THAT SHE HAS A MESH INFECTION AND AS SUCH WOULD REQUIRE REMOVAL OF THE MESH. SHE IS STILL DECIDING ON WHETHER SHE WANTS TO PURSUE SURGERY OR CONTINUE TO PUSH LOCAL WOUND CARE.¿ EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2008:"PRESENTED TO THE EMERGENCY ROOM WITH A CECAL VOLVULUS WITH NECROSIS AND A CHRONIC SIGMOID VOLVULUS. SHE UNDERWENT A RIGHT AND LEFT HEMICOLECTOMY AND HAS SUBSEQUENTLY UNDERGONE COLOSTOMY REVERSAL FROM WHICH SHE INITIALLY DID WELL BUT DEVELOPED INFECTED MESH AND SHE NOW PRESENTS FOR MESH REMOVAL AND VENTRAL HERNIA REPAIR." EXPLANT #2 PROCEDURE: REMOVAL OF INFECTED FOREIGN BODY. VENTRAL HERNIA REPAIR WITH ALLOMAX BIOLOGIC MESH. EXPLANT #2 DATE: (B)(6) 2008. ¿ ¿FINDINGS: THE PATIENT HAD EXTENSIVE DISRUPTION OF HER MESH WHICH INDICATED CHRONIC INFECTION. SHE HAD SIGNIFICANTLY DETERIORATED FASCIA WITH SWISS-CHEESE DEFECTS THROUGHOUT THE UNDERSURFACE OF THE MESH. AN ALLOMAX REPAIR WAS UTILIZED, SEWN WIDELY TO ENCOMPASS ALL HERNIA DEFECTS.¿ ¿A LINEAR INCISION WAS MADE ALONG THE ENTIRE LENGTH OF THE PREVIOUSLY PLACED MESH, AND THIS WAS EXCISED USING DILIGENT DISSECTION. MULTIPLE SUTURES WERE ALSO REMOVED. ONCE THIS HAD BEEN ACHIEVED, THE AREA WAS COPIOUSLY IRRIGATED. COLLAMEND MESH WAS THEN INTRODUCED INTO THE WOUND AND SEWN INTO THE FASCIA. THIS WAS DONE WITH TWO RUNNING #1 PROLENES WHICH AFFORDED EXCELLENT CLOSURE. THE SUBCUTANEOUS TISSUES WERE THEN COPIOUSLY IRRIGATED, AND A 19-FRENCH BLAKE DRAIN WAS PLACED WITHIN THEM. THE DEEP TISSUES WERE APPROXIMATED USING 3-0 VICRYL, AND THE SKIN WAS APPROXIMATED USING SKIN CLIPS. THE DRAIN WAS SEWN INTO PLACE USING SILK SUTURES.¿ POSTOPERATIVE PERIOD: (B)(6) 2008:PATHOLOGY REPORT. ¿DIAGNOSIS: INFECTED MESH, REMOVAL- SOFT TISSUE WITH FOCI OF GRANULATION TISSUE FORMATION AND ACUTE INFLAMMATION, CENTERED ON FOREIGN BODY FRAGMENTS, CONSISTENT WITH THE CLINICAL HISTORY OF INFECTED MESH.¿ ¿MICROSCOPIC EXAMINATION: SECTIONS SHOW FRAGMENTS OF SOFT TISSUE, DEMONSTRATING AREAS OF FIBROSIS AND GRANULATION TISSUE WITH ASSOCIATED MIXED INFLAMMATORY INFILTRATE. FRAGMENTS OF FOREIGN BODY MATERIAL, CONSISTENT WITH MESH ARE IDENTIFIED WITHIN THE AREAS OF INFLAMMATION. SOME OF THE FOREIGN BODY MATERIAL ARE SURROUNDED BY MACROPHAGES. NO MALIGNANCY IDENTIFIED. GROSS EXAMINATION: RECEIVED IN FORMALIN LABELED ¿INFECTED MESH¿ IS A 12.5 X 6.5 X 1.0 CM TAN-PINK SEGMENT OF MESH WITH SCANT ATTACHED SOFT TISSUE. REPRESENTATIVE SOFT TISSUE IS SUBMITTED IN ONE CASSETTE. SPECIMEN: INFECTED MESH. PERTINENT HISTORY: INFECTED MESH.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2008: "RETURNS TODAY COMPLAINING OF DRAINAGE FROM HER WOUND AND SOME LOW-GRADE TEMPERATURES. SHE HAS A SINGLE SINUS IN THE SUPERIOR ASPECT OF HER INCISION, WHICH IS DRAINING SOME THICK FLUID. THE DRAIN ITSELF IS DRAINING THE SAME FLUID ALTHOUGH HER DRAIN OUTPUT HAS DECREASED; AVERAGING 10-15 CC A DAY. IT IS CLEAR THAT HER DRAIN HAS STOPPED FUNCTIONING AND SHE HAS DEVELOPED WHAT LOOKS LIKE A THICKENED SEROMA. SHE HAS NO ERYTHEMA AROUND HER WOUNDS SO I DO NOT SUSPECT CELLULITIS. I DID PLACE HER ON ANTIBIOTICS AND WILL SEE HER BACK AT THE END OF THE WEEK¿. (B)(6) 2008: ¿RETURNS TODAY DOING MUCH BETTER. THE WOUND IS HEALING UP NICELY. CONTINUE LOCAL WOUND CARE AND SEE HER BACK IN 2 WEEKS.¿ (B)(6) 2008: HOSPITAL ADMISSION: CT A/P: ¿IMPRESSION: MODERATELY LARGE HIATAL HERNIA, POSSIBLE PARAESOPHAGEAL. MODERATE GASTRIC DISTENSION. AN ELEMENT OF GASTRIC VOLVULUS IS DIFFICULT TO EXCLUDE. TINY NONOBSTRUCTING LEFT RENAL CALCULUS.¿ CONCLUSION: #3 DEVICE UNK [ALLODERM]. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THROUGH GORE'S INVESTIGATION WE CONFIRMED THE DEVICE WAS NOT A GORE DEVICE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE COMPLAINT WILL BE CLOSED AS A FALSE CLAIM. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: CODES 4118/3221 - PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6) 2005 WERE NOT PROVIDED. (B)(6) 2005: OPERATIVE REPORT. PREOP DIAGNOSIS: HIATAL HERNIA; REFLUX ESOPHAGITIS. POSTOP DIAGNOSIS: HIATAL HERNIA, LARGE; REFLUX ESOPHAGITIS. PROCEDURE: LAPAROSCOPIC NISSEN FUNDOPLICATION OVER A 44 HURST DILATOR. INDICATIONS: THE PATIENT IS A 49-YEAR-OLD WHITE FEMALE WITH A 25 YEAR HISTORY OF SEVERE REFLUX SYMPTOMATOLOGY. WORK-UP HAS SHOWN LOW PRESSURE LOW ESOPHAGEAL SPHINCTER. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. A 1 CM INCISION WAS CARRIED OUT AN INCH AND A HALF ABOVE THE UMBILICUS. A VERESS NEEDLE WAS LACED IN THE ABDOMINAL CAVITY, A PNEUMOPERITONEUM OBTAINED WITH CARBON DIOXIDE GAS. A 1 CM TROCAR WAS PLACED, FOLLOWED BY A LAPAROSCOPE WITH VIDEO ATTACHMENT. OTHER PORTS WERE PLACED IN THE ANTERIOR AXILLARY LINE ON THE LEFT SIDE, ON THE RIGHT AND LEFT SIDE IN THE MID CLAVICULAR LINE, AND IN THE EPIGASTRIC AREA LEFT OF MIDLINE. ON ENTERING THE ABDOMEN, SHE WAS NOTED TO HAVE A LARGE HIATAL HERNIA. DISSECTION WAS CARRIED OUT TO DISSECT OUT THE LARGE HERNIA SAC AWAY FROM THE RIGHT AND LEFT CRUS OF THE DIAPHRAGM AND AWAY FROM THE STOMACH. THE ESOPHAGUS WAS DISSECTED CIRCUMFERENTIALLY. A 44 HURST DILATOR WAS THEN PLACED INTO THE ESOPHAGUS AND INTO THE STOMACH AND A 360 DEGREE WRAP WAS CARRIED OUT, SUTURING THE FUNDUS ON THE LEFT ANTERIOR ESOPHAGEAL WALL, TO THE FUNDUS ON THE RIGHT. ANOTHER SUTURE WAS PLACED ABOVE THIS FROM THE FUNDUS ON THE RIGHT, TO THE FUNDUS ON THE LEFT. SUTURES WERE THEN PLACED AT THE APEX OF THE WRAP INTO THE RIGHT CRUS OF THE DIAPHRAGM. A FINAL SUTURE WAS PLACED IN THE APEX OF THE CRUS, TO THE FUNDIC WRAP, TO THE APEX OF THE RIGHT CRUS. THE DILATOR WAS THEN REMOVED. A MUCH GAS AND FLUID WAS REMOVED AS POSSIBLE. ALL TROCARS WERE REMOVED. THE WOUNDS WERE CLOSED WITH SUBCUTICULAR SUTURE OF RUNNING 3-0 PROLENE.¿ (B)(6) 2006: OPERATIVE REPORT. PREOP DIAGNOSIS: PARAESOPHAGEAL HIATAL HERNIA. ABDOMINAL PAIN. POSTOP DIAGNOSIS: PARAESOPHAGEAL HIATAL HERNIA. PROCEDURE: EXPLORATORY LAPAROTOMY, REDUCTION OF HUGE PARAESOPHAGEAL HIATAL HERNIA RECURRENCE, TAKE DOWN OF PREVIOUS NISSEN FUNDOPLICATION AND RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF ESOPHAGEAL HIATUS OVER A DILATOR AND REPAIR OF INCISIONAL HERNIA. FIXATION WAS DONE WITHIN THE ABDOMEN. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. MIDLINE INCISION WAS CARRIED OUT FROM XIPHOID DOWN TO AND JUST AROUND THE UMBILICUS AND DISSECTION CARRIED DOWN THROUGH MIDLINE FASCIA INTO THE ABDOMINAL CAVITY. SHE WAS NOTED TO HAVE ADHESIONS IN THE UPPER ABDOMEN FROM PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY. SOME ADHESIONS OF THE LIVER TO THE STOMACH. RETRACTORS WERE PLACED. ALL THESE ADHESIONS WERE TAKEN DOWN. DISSECTION WAS CARRIED OUT TO DISSECT OUT THE UPPER ESOPHAGUS AND STOMACH. THE PREVIOUS FUNDOPLICATION WAS IN PLACE. HOWEVER, THE LATERAL ASPECT OF THE FUNDUS HAD HERNIATED BACK INTO THE POSTERIOR MEDIASTINUM. THE STOMACH AND ESOPHAGUS WERE COMPLETELY DISSECTED AND RETURNED TO THE ABDOMINAL CAVITY. THE PREVIOUS FUNDOPLICATION WAS TAKEN DOWN. A 50 HURST DILATOR WAS PLACED IN THE ESOPHAGUS AND DOWN INTO THE STOMACH. THE HIATUS WERE TIGHTENED WITH THREE SUTURES OF #0 NUROLON SUTURE. A FULL REPEAT FUNDOPLICATION WAS THEN CARRIED OUT OVER THIS 50 HURST DILATOR USING PROLENE SUTURE, WITH FULL THICKNESS SUTURES. THE FIRST SUTURES INCORPORATING THE ESOPHAGUS. THE STOMACH WAS THEN FIXED TO THE ABDOMINAL CAVITY WITH MULTIPLE SUTURES PLACED IN THE DIAPHRAGM. THE DILATOR WAS THEN REMOVED AND NG TUBE PLACED. NO OTHER ABNORMALITIES WERE NOTED IN THE ABDOMEN. THE MIDLINE FASCIA WAS CLOSED WITH A RUNNING PDS SUTURE. THE SKIN WAS THEN CLOSED WITH INTERRUPTED SUTURE OF SUBCUTICULAR 3-0 CHROMIC AND A RUNNING SUBCUTICULAR 3-0 PROLENE WITH A CROSS OVER IN THE CENTER. STERILE DRESSINGS WERE APPLIED. PLEASE NOTE THE PATIENT ALSO HAD AN INCISIONAL HERNIA, SO THE OPERATION SHOULD BE RE-CREATION OF NISSEN FUNDOPLICATION, CLOSURE OF THE DIAPHRAGM AND REPAIR OF INCISIONAL HERNIA. THE INCISIONAL HERNIA WAS CLOSED WITH SURGASSIST MESH. THIS WAS APPROXIMATELY 3 X 5 CM IN SIZE. THIS WAS SUTURED WITH DEEP U SUTURES OF #0 NUROLON. SKIN AGAIN WAS CLOSED WITH SUBCUTICULAR 3-0 PROLENE. STERILE DRESSINGS WERE APPLIED. ANESTHESIA WAS DISCONTINUED. THE PATIENT WAS SENT TO RECOVERY IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ (B)(6) 2007: OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA. PROCEDURE: EXPLORATORY LAPAROTOMY. REPAIR INCISIONAL HERNIA. BACKGROUND INFORMATION: THE PATIENT IS A 51-YEAR-OLD FEMALE WHO PREVIOUSLY HAD A REPAIR OF A HUGE PARAESOPHAGEAL HIATAL HERNIA BUT DEVELOPED AN INCISIONAL HERNIA. SHE COMES TO SURGERY FOR REPAIR. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. A MIDLINE INCISION WAS CARRIED OUT ABOVE THE UMBILICUS WHERE THE MOST PROMINENT INCISIONAL HERNIA WAS NOTED. DISSECTION WAS CARRIED OUT THROUGH SUBCUTANEOUS TISSUES DOWN TO THE LARGE WHITE BASED HERNIA SAC. UPON CLOSE INSPECTION AFTER ENTERING THE ABDOMEN, IT WAS NOTED SHE HAD LITTLE ¿POTHOLE¿ INCISIONAL HERNIAS UP AND DOWN THE INCISION. INCISION WAS WIDENED FOR APPROXIMATELY 12-15 CM. THIS WAS CARRIED DOWN TO THE FASCIA AND ALL ABNORMAL OR SCAR TISSUE WAS REMOVED BACK TO GOOD FASCIA ON BOTH SIDES. A PIECE OF MESH, DUAL-SIDED GORE-TEX MESH, ¿BROWN SIDE DOWN¿ 3 X 6 INCHES IN SIZE WAS SUTURED INTO PLACE, PLACING EACH OF THE SUTURE APPROXIMATELY AN INCH BACK FROM THE EDGE OF THE FASCIA TO EXCELLENT TISSUE. ¿U¿ SUTURES WERE PLACED OF #1 NUROLON SUTURE WITH INTERRUPTED NUROLON ALSO TO SEAL THIS TO THE ABDOMINAL WALL. A 15-FRENCH BLAKE DRAIN WAS PLACED THROUGH A LATERAL STAB WOUND AND BROUGHT OUT AND SUTURED IN PLACE WITH 2-0 SILK. THE SKIN AND SUBCUTANEOUS TISSUES WERE SUTURED IN PLACE WITH SKIN STAPLES. STERILE DRESSINGS WERE APPLIED AND ANESTHESIA DISCONTINUED. THE PATIENT WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ ¿THE CASE WAS CARRIED OUT WITH MESH WITH A LARGE INCISIONAL HERNIA FOUND. IT WAS CARRIED OUT WITHOUT DIFFICULTY.¿ PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿DUAL-SIDED GORE-TEX MESH¿ WERE NOT PROVIDED. (B)(6) 2007: OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE: REPAIR RECURRENT INCISIONAL HERNIA, WITH DUAL-SIDED GORE-TEX MESH. DESCRIPTION OF PROCEDURE: ¿UNDER SATISFACTORY GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED WITH BETADINE SOLUTION AND STERILE DRAPES WERE APPLIED. THE MIDLINE INCISION WAS REOPENED, WITH SHARP DISSECTION THROUGH SUBCUTANEOUS TISSUE DOWN INTO THE HERNIA SAC AND DOWN TO THE AREA OF THE PREVIOUS MESH. THE PREVIOUS MESH WAS EXCISED. THERE WERE FEW ADHESIONS TO BOWEL, SOME ADHESIONS TO OMENTUM. THE MESH WAS DISSECTED OFF THE OMENTUM PRIOR TO REMOVING IT. A VERY LARGE PIECE OF 12 X 15 DUAL-SIDED GORE-TEX MESH WAS USED, BROWN SIDE DOWN WITH ANCHORING SUTURES PLACED AT ALL CORNERS, APPROXIMATELY 2.5 INCHES FROM THE STRONG FASCIAL MARGINS, WITH FULL THICKNESS, EXCEPT FOR SKIN SUTURES PLACED. CIRCUMFERENTIAL SUTURE THEN OF #1 PROLENE WAS PLACED IN THE MESH AT THE FASCIAL EDGES. A 15-FRENCH BLAKE DRAIN WAS USED IN SUBCUTANEOUS TISSUE AND BROUGHT OUT THROUGH A SEPARATE STAB WOUND. THE SKIN OF THE UMBILICUS WAS SUTURED DOWN AND THE SKIN WAS CLOSED WITH INTERMITTENT SKIN STAPLES. STERILE DRESSINGS WERE APPLIED. ANESTHESIA WAS DISCONTINUED. THE PATIENT WAS SENT TO RECOVERY IN SATISFACTORY CONDITION FOR THE PROCEDURE.¿ PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿DUAL-SIDED GORE-TEX MESH¿ WERE NOT PROVIDED. THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. RECORDS BETWEEN (B)(6) 2007 AND (B)(6) 2008 WERE NOT PROVIDED. (B)(6) 2008: OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: HARTMANN PROCEDURE. PROCEDURE: COLOSTOMY REVERSAL. FINDINGS: ¿THE PATIENT WAS EXPLORED THROUGH HER MIDLINE INCISION. THE RECTAL STUMP WAS EASILY IDENTIFIED AND DID CONTAIN SOME INSPISSATED STOOL. THIS DID NOT PRECLUDE ANY SAFE DISSECTION. SHE HAD A SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS PERFORMED IN A DOUBLE STAPLED TECHNIQUE WITHIN THE ABDOMEN. SHE TOLERATED THIS WELL.¿ DESCRIPTION OF PROCEDURE: ¿THE ABDOMEN WAS ENTERED WITH A LINEAR INCISION. WE CARRIED OUR DISSECTION THROUGH THE SUBCUTANEOUS TISSUE WITH BOVIE ELECTROCAUTERY. THE ABDOMEN WAS ENTERED DIRECTLY AND THE INCISION EXTENDED BOTH CEPHALAD AND CAUDAD. HER ABDOMEN HAD BEEN PREPARED WITH A PREVIOUS MESH REPAIR, BUT AGAIN THIS DID NOT PRECLUDE SAFE DISSECTION. SHE HAD FAIRLY DENSE SMALL BOWEL ADHESIONS TO THE MESH BUT WE CAREFULLY TOOK THESE DOWN. ONCE THIS HAD BEEN ACHIEVED THE COLOSTOMY WAS IDENTIFIED ON THE LEFT SIDE AND IT WAS TAKEN DOWN CIRCUMFERENTIALLY WITHIN THE ABDOMEN. THEN AN ELLIPTICAL INCISION WAS MADE AROUND THE COLOSTOMY AND THIS WAS BROUGHT INTO THE ABDOMEN. THE PROXIMAL STUMP WAS CLEARED AND USING THE GIA STAPLER THE SKIN PORTION WAS RESECTED. THE PROXIMAL AND DISTAL COLON WERE THEN SECURED USING VICRYL SUTURE AND DOUBLE STAPLED ANASTOMOSIS WAS PERFORMED USING THE GIA STAPLER. THE ENTEROTOMY WAS CLOSED USING THE TA STAPLER AND BOWEL CLAMP WAS APPLIED. WE INSUFFLATED AIR THROUGH THE RECTUM FOR A LEAK TEST AND THERE WAS NO LEAKAGE, AND THE ANASTOMOSIS WAS FOUND TO BE AIR-TIGHT. THE OMENTUM WAS THEN PLACED ADJACENT TO THE ANASTOMOSIS AND SECURED WITH 2 VICRYL SUTURES. THE ABDOMEN WAS COPIOUSLY IRRIGATED AND HEMOSTASIS WAS ASSURED. THE LEFT-SIDED STOMA SITE WAS CLOSED ANTERIORLY AND POSTERIORLY WITH #1 VICRYL SUTURE. THE MIDLINE INCISION WAS APPROXIMATED USING TWO #1 PROLENE SUTURES. THE SUBCUTANEOUS TISSUES WERE COPIOUSLY IRRIGATED. THE SKIN WAS APPROXIMATED USING SKIN CLIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. SHE WAS DISCHARGED TO THE RECOVERY ROOM IN STABLE CONDITION.¿ RECORDS FOR THE ¿ALLEGED GORE DEVICE¿ IMPLANTED ON (B)(6) 2014 WERE NOT PROVIDED. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(6). IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROTOMY INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY AN ALLEGED "GORE-TEX" WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY AN "ALLEGED GORE DEVICE" WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY AN "ALLEGED GORE DEVICE" WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INTESTINAL BLOCKAGE; RECURRING HERNIA; REVISION SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303617 | UNKNOWN | FTL | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| R |