UNKNOWN
Report
- Report Number
- 2017233-2018-00478
- Event Type
- Injury
- Date Received
- August 16, 2018
- Date of Event
- July 29, 2015
- Report Date
- October 22, 2020
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- OWZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: ON (B)(6) 1987: (B)(6) HOSPITAL. [ILLEGIBLE]. ANESTHESIA NOTE. HISTORY OF OBESITY, STATUS POST GASTROPLASTY 1982, LIPOPLASTY 1984. SMOKING FOR 10 YEARS. ON (B)(6) 1987:(B)(6) HOSPITAL. (B)(6) , MD. OPERATIVE REPORT. OPERATION PERFORMED: CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAMS. ON (B)(6) 1987: (B)(6) HOSPITAL. (B)(6) , MD. DISCHARGE SUMMARY. GASTRIC BYPASS DONE SIX YEARS AGO. NOW HAS MULTIPLE EPISODES OF BILIARY COLIC WITHOUT EVIDENCE OF CHOLECYSTITIS. ULTRASOUND DEMONSTRATED CHOLELITHIASIS. SHE HAS LOST ABOUT 100 POUNDS SINCE BYPASS. SHE HAD A SUCTION LIPECTOMY AND A TUMMY TUCK. COURSE IN HOSPITAL: WAS ADMITTED ON THE DAY OF SURGERY AND UNDERWENT CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAMS. NO COMPLICATIONS WERE FOUND. DID WELL AND WAS TAKING LIQUIDS POSTOPERATIVELY ON DAY 1 AND EATING ON DAY 2. RECOMMENDATIONS: NO HEAVY LIFTING AND NO DRIVING. ON (B)(6) 1997:(B)(6) HOSPITAL. (B)(6) , MD. HISTORY AND PHYSICAL. HISTORY OF HAVING A GASTRIC STAPLING MANY YEARS AGO. SUBSEQUENTLY DEVELOPED AND INCISIONAL HERNIA, AND THIS WAS REPAIRED BY DR. (B)(6) APPROXIMATELY 1 ½ YEARS AGO. NOW HAS DEVELOPED A RECURRENT VENTRAL HERNIA AND WILL HAVE THIS REPAIRED. PAST MEDICAL AND SURGICAL HISTORY: INCISIONAL HERNIA REPAIR. EXAM: WEIGHT 250 POUNDS. THE ABDOMEN IS OBESE. THERE IS A WELL HEALED OPEN CHOLECYSTECTOMY SCAR AT THE RIGHT COSTAL MARGIN, AND THERE IS A WELL-HEALED MIDLINE INCISION. THERE IS A LARGE 10 CM REDUCIBLE VENTRAL HERNIA JUST TO THE LEFT OF THE MIDLINE. IMPRESSION: LARGE VENTRAL HERNIA. PLAN: WILL UNDERGO A REPAIR OF HER LARGE VENTRAL HERNIA WITH MESH ON (B)(6) 1997. THE RISKS, BENEFITS, AND ALTERNATIVES TO THE PROCEDURE WERE EXPLAINED TO THE PATIENT INCLUDING BLEEDING, BRUISING, INFECTION, SCARRING, NUMBNESS, AND RECURRENCE. SHE DOES UNDERSTAND ALL THESE AND WISHES TO PROCEED. ON (B)(6) 1997: (B)(6) HOSPITAL. [ILLEGIBLE]. ANESTHESIA RECORD. ANESTHESIA HISTORY: VENTRAL HERNIA REPAIR X 2. WEIGHT 113.4 KG. SMOKES ½ PACKS PER DAY X 8 YEARS. ASA III. ON (B)(6) 1997: (B)(6) HOSPITAL. (B)(6) , MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: LARGE VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: SAME. FINDING OF 3 FASCIAL DEFECTS. OPERATION PERFORMED: REPAIR OF LARGE VENTRAL HERNIA WITH GORE-TEX MESH AND PARTIAL OMENTECTOMY. ASSISTANT: HELEN HOBBS, PA-C. ANESTHESIA: GENERAL WITH ENDOTRACHEAL INTUBATION AND INFILTRATION OF WOUND WITH 0.5% MARCAINE AT THE COMMENCEMENT OF THE OPERATION. INTRAOPERATIVE ESTIMATED BLOOD LOSS: APPROXIMATELY 100 CC. FLUID RESUSCITATION: WITH CRYSTALLOIDS. DESCRIPTION OF OPERATION: ¿WITH THE PATIENT ON THE OPERATING TABLE IN SUPINE POSITION AND GENERAL ANESTHESIA INDUCED, THE REGION OF THE ABDOMEN WAS PREPPED AND DRAPED IN A STERILE MANNER UTILIZING BETADINE SOLUTION. THE PATIENT¿S AREA OF HERNIATION, HAVING BEEN MARKED OUT IN THE INDUCTION AREA, WERE EXPLORED THROUGH A LONGITUDINAL INCISION IN THE UPPER ABDOMEN. THE INCISION WAS DEEPENED THROUGH THE DERMAL AND SUBCUTANEOUS TISSUE PLANES. THREE FASCIAL DEFECTS, 2 APPROXIMATELY EACH 1.5 CM TO 2 CM IN SIZE NEAR THE LEVEL OF THE XIPHOID, WERE ENCOUNTERED IN THE MIDLINE AND A MUCH LARGER DEFECT JUST BELOW THIS. THESE DEFECTS WERE JOINED INTO ONE, AND THE FASCIAL EDGES ABOUT THE DEFECTS WERE DEFINED AND FREED FROM SURROUNDING FIBRO-AREOLAR TISSUE WITHIN THE RIGHT-SIDED PORTION OF THE LARGE DEFECT WHICH SPANNED APPROXIMATELY 5 INCHES IN LENGTH. AN INDURATED AREA WAS ENCOUNTERED. THIS WAS FELT TO PROBABLY REPRESENT MESH WHICH HAD PULLED AWAY FROM THE LEFT SIDE OF THE WOUND. THE SAC, WHICH WAS GREATLY REDUNDANT, THEREFORE, WAS OPENED. ADHERENT TRANSVERSE COLON WITHIN THE SAC WAS FREED FROM ITS ADHESIONS TO THE SAC. REDUCED OMENTUM WAS SIMILARLY MOBILIZED, AND A PORTION OF THE OMENTUM WAS ON A SMALL, SHORTENED PEDICLE AND WAS, THEREFORE, RESECTED. THIS CONSTITUTED, HOWEVER, A MAJOR VOLUME PORTION OF THE PATIENT¿S OMENTUM. THE REDUNDANCY OF THE SAC WAS RESECTED AS WAS THE OLD MESH. THE 3 DEFECTS WERE JOINED TO A SINGLE DEFECT. METICULOUS HEMOSTASIS THROUGHOUT THE CASE WAS AFFECTED WITH THE JUDICIOUS USE OF ELECTROCAUTERY ON A LOW AMPERAGE SETTING. IN THE AREA WHERE THE OLD MESH WAS, THERE WAS A SMALL FLUID COLLECTION. CULTURES WERE OBTAINED, AND THIS AREA WAS IRRIGATED OUT WITH COPIOUS QUANTITIES OF WARM SALINE. IT WAS FELT THAT THIS WAS PROBABLY REPRESENTED AN EITHER STERILE ABSCESS OR UNRESOLVED SEROMA. OF CURIOSITY, LARGE CHROMIC SUTURES, PRESUMABLY FROM THE PATIENT¿S GASTRIC WEIGHT REDUCTION SURGERY MANY YEARS AGO, WERE STILL IN PLACE INTACT. IT WAS ELECTED TO CARRY OUT A TENSION-FREE REPAIR WITH DOUBLE-SIDED GORE-TEX MESH WITH A SMOOTH SIDE PLACED IN OPPOSITION TO THE PERITONEUM SURFACE AND THE ROUGHER SIDE PLACED IN OPPOSITION TO THE SUBCUTANEOUS TISSUE. THIS WAS SECURED IN PLACE WITH MULTIPLE INTERRUPTED SUTURES OF #0 PROLENE PLACED IN A U-FASHION. METICULOUS HEMOSTASIS THROUGHOUT THE CASE WAS AFFECTED WITH THE JUDICIOUS USE OF ELECTROCAUTERY ON A LOW AMPERAGE SETTING IN CONJUNCTION WITH LIGATURES OF #4-0 VICRYL. IT WAS CONFIRMED AT EACH LAYER OF CLOSURE. THE SUBCUTANEOUS TISSUE WAS THEN REAPPROXIMATED TO OBLITERATE THE DEAD SPACE WITH INTERRUPTED SIMPLE SUTURES OF #3-0 VICRYL WITH KNOTS BURIED. THE SKIN EDGES WERE THEN OPPOSED WITH STAINLESS STEEL SURGICAL CLIPS. THE WOUND WAS CLEANSED. A DRY, STERILE DRESSING WAS APPLIED. THE PATIENT WAS PLACED IN A LARGE ABDOMINAL BINDER. FINAL SPONGE, NEEDLE, AND INSTRUMENT COUNTS WERE ALL CORRECT. THE PATIENT WAS REVERSED FROM GENERAL ANESTHESIA, EXTUBATED, TRANSFERRED TO A GURNEY, AND THEN TRANSFERRED TO THE RECOVERY ROOM STABLE AND AWAKE.¿ ON (B)(6) 1997: (B)(6) HOSPITAL. IMPLANT STICKER. GORE-TEX DUALMESH BIOMATERIAL. ITEM#: 1DLM07. LOT#: 10730-080. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLM07/10730-080) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 1997: (B)(6) HOSPITAL. (B)(6) , MD. PATHOLOGY REPORT. S.P. NO. S97-783. DIAGNOSIS: SOFT TISSUE, VENTRAL ABDOMINAL REGION, HERNIORRHAPHY ¿ HERNIA SAC, CONSISTENT WITH SHOWING SUTURE GRANULOMAS AND FIBROSIS. OMENTUM, EXCISION ¿ RECENT HEMORRHAGE. CLINICAL DIAGNOSIS AND HISTORY: PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: SAME. GROSS EXAMINATION: LABELLED VENTRAL HERNIA SAC AND OMENTUM. RECEIVED UNFIXED ARE TWO SEPARATE FRAGMENTS OF TISSUE. THE LARGER IS A 19 X 14 X 2 CM FRAGMENT OF OMENTAL FAT WHICH IS FOCALLY HEMORRHAGIC AND HAS ADHERENT TO IT SMALL AMOUNTS OF FIBROMEMBRANOUS TISSUE. THE SECOND IS AN 8 X 4.5 X 3 CM FRAGMENT OF FIBROMEMBRANOUS, FIBROFATTY AND FOCALLY DENSE FIBROUS TISSUE WITH SCATTERED FRAGMENTS OF SUTURE EMBEDDED IN IT. REPRESENTATIVE SECTIONS ARE SUBMITTED IN CASSETTES 1 AND 2. COMMENTS ON MICROSCOPIC: SECTIONS OF SOFT TISSUE SHOW VASCULARIZED FIBROMEMBRANOUS CONNECTIVE TISSUE WHICH IS PARTIALLY LINED BY MESOTHELIUM AND SHOWS SUTURE GRANULOMAS, FIBROSIS AND RECENT HEMORRHAGE. SECTIONS OF OMENTUM SHOW RECENT HEMORRHAGE. ON (B)(6) 1997: (B)(6) HOSPITAL. MICROBIOLOGY. CULTURE/SMEAR PERITONEAL FLUID. ACCESSION #: 24777. BODY SITE: PERITONEAL FLUID. GRAM STAIN: 0-1+ POLYS SEEN, NO EPITH CELLS SEEN, NO ORGANISMS SEEN. PERITONEAL FLUID CULTURE: NO GROWTH 4 DAYS. ON (B)(6) 1997: (B)(6) HOSPITAL. (B)(6) , MD. DISCHARGE SUMMARY. COURSE IN HOSPITAL: WAS ADMITTED AND TAKEN TO THE OPERATING ROOM WHERE REPAIR OF A VENTRAL HERNIA WAS CARRIED OUT IN A TENSION FREE FASHION WITH GORE-TEX MESH. THE PATIENT DID WELL POSTOPERATIVELY AND TOLERATED A DIET THE FOLLOWING MORNING AND ANALGESICS AND WAS SUBSEQUENTLY DISCHARGED HOME. OPERATION: REPAIR OF RECURRENT VENTRAL HERNIA CARRIED OUT ON (B)(6) 1997. FOLLOW-UP PLAN: ACTIVITY: THE PATIENT IS TO UTILIZE HER ABDOMINAL BINDER FOR THE NEXT SIX WEEKS WITHOUT EXCEPTION. CARE: FOLLOW-UP CARE IN OUR OFFICES IN ONE WEEKS TIME. DISCHARGE DIAGNOSIS: LARGE RECURRENT VENTRAL HERNIA. ON (B)(6) 1997:[MISSING RECORDS: RECORDS FOR THE CT SCAN SHOWING THE ¿ABDOMINAL WALL COLLECTION¿ WERE NOT PROVIDED.] ON (B)(6) 1997: (B)(6) HOSPITAL. [ILLEGIBLE]. AMBULATORY RECORD FOR INVASIVE PROCEDURES. RELEVANT HISTORY: PRIOR HERNIA REPAIR WITH ENLARGING ABDOMINAL GIRTH ESPECIALLY EPIGASTRIC AREA. EXAM: BULGING ABDOMINAL WALL ¿ NONTENDER. CT ¿ ABDOMINAL WALL COLLECTION. POSTOPERATIVE: CHECK OFF SHEET: CALL IF PAIN, FEVER, INFLAMMATION, REDNESS OR RECURRENT/LEAK OCCURS. PRE-OP DIAGNOSIS: ? HEMATOMA NOW SUBACUTE/CHRONIC. PROCEDURE: TROCAR DRAINAGE 5F/8F: GUIDELINES FOR 12F. DESCRIPTION OF OP: DRAINED DARK RED FLUID 1100 CC¿S. GRAM STAIN NO BACTERIA 0-1 WBC/HPF. CULTURE PENDING. CATHETER WITHDRAWN PATIENT DISCHARGED. COMPLICATIONS: NONE. ON (B)(6) 1997: (B)(6) HOSPITAL. [ILLEGIBLE]. PROCEDURE NOTE. CT DEMONSTRATES 15 X 11 CM COLLECTION ANTERIOR ABDOMINAL WALL WITH FABRIC MESH AT FLOOR OF COLLECTION. ? SUBACUTE OR CHRONIC HEMATOMA. DRAINED WITH STERILE TECHNIQUE INITIALLY WITH 5 AND 8 FR CATHETER WITH INTERMITTENT DRAINAGE. FOLLOW UP WITH 12 FR ([ILLEGIBLE]) WITH SUBSEQUENT ASPIRATION 75-85 CC OF FLUID BUT 14 X 3 CM FLUID COLLECTION AT END. ON (B)(6) 1997: (B)(6) HOSPITAL. MICROBIOLOGY. ACCESSION #: 4024. CULTURE/SMEAR PERITONEAL FLUID. BODY SITE: PERITONEAL FLUID: ABDOMINAL ABSCESS. GRAM STAIN: NO POLYS SEEN, NO EPITHELIAL CELLS SEEN, 0-1+ WBC¿S SEEN, NO ORGANISMS SEEN. PERITONEAL FLUID CULTURE: NO GROWTH 5 DAYS. ON (B)(6) 2002: (B)(6) HOSPITAL. (B)(6) , MD. RADIOLOGY-ABDOMEN FLAT & UPRIGHT. HISTORY: PAIN. DISCUSSION: THERE ARE DILATED LOOPS OF SMALL BOWEL WITH MULTIPLE AIR FLUID LEVELS. A SMALL AMOUNT OF AIR IS SEEN IN THE COLON. IMPRESSION: EARLY SMALL BOWEL OBSTRUCTION. ON (B)(6) 2002: (B)(6) HOSPITAL. (B)(6) , MD. CONSULTATION. HAS A HISTORY OF PREVIOUS PARTIAL BOWEL OBSTRUCTION AND IS STATUS POST GASTRIC STAPLING FOR MORBID OBESITY AND HAS A LONG HISTORY OF A VENTRAL HERNIA STATUS POST REPAIR FAILURE, WHO NOW PRESENTS TO THE EMERGENCY ROOM WITH THE ONSET OF 2 DAYS OF ABDOMINAL PAIN WITH RECENT ONSET OF NAUSEA. PAST MEDICAL HISTORY IS REMARKABLE FOR THYROID DISEASE. PAST SURGICAL HISTORY IS POSITIVE MULTIPLE VENTRAL HERNIA REPAIRS WITH MESH AND WITH REOCCURRENCE AND STILL RECURS. ALSO HAS A HISTORY OF A PARTIAL BOWEL OBSTRUCTION 11/00 ADMITTED AT RHODE ISLAND HOSPITAL. SOCIAL HISTORY: HAS NO ALCOHOL OR TOBACCO USE. EXAM: ABDOMEN MARKEDLY OBESE WITH A LARGE VENTRAL HERNIA IN THE MIDLINE; ABDOMEN IS QUITE DISTENDED. IMPRESSION: PARTIAL SMALL BOWEL OBSTRUCTION. ON (B)(6) 2002: (B)(6) HOSPITAL. (B)(6) , MD. RADIOLOGY-ABDOMEN FLAT & UPRIGHT. HISTORY: SMALL BOWEL OBSTRUCTION. DISCUSSION: THERE ARE MULTIPLE STAPLES UPPER ABDOMEN. THE SMALL BOWEL IS SIGNIFICANTLY LESS DISTENDED THAN ON PREVIOUS DAY. THERE IS MORE AIR NOW SEEN IN THE COLON. IMPRESSION: RESOLVED SMALL BOWEL OBSTRUCTION. ON (B)(6) 2002: (B)(6) HOSPITAL. (B)(6) , MD. DISCHARGE SUMMARY. ADMITTED WITH NAUSEA AND VOMITING, X-RAY WITH SMALL BOWEL OBSTRUCTION. IV FLUIDS, NOTHING BY MOUTH, NASOGASTRIC TUBE; POSITIVE FLATUS/ BOWEL MOVEMENT ON HOSPITAL DAY #2. DIET ADVANCED ON HOSPITAL DAY #3 AND DISCHARGE. SIGNIFICANT FINDINGS: PARTIAL SMALL BOWEL OBSTRUCTION. FINAL DIAGNOSIS: PARTIAL BOWEL OBSTRUCTION. INCISIONAL HERNIA. ON (B)(6) 2012: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. HERE AS NEW PATIENT TO ESTABLISH CARE. PAST MEDICAL HISTORY: DEPRESSION, ANXIETY, FIBROMYALGIA. SURGICAL HISTORY: STOMACH STAPLING AT AGE 30, HERNIA REPAIRS (SEVERAL), TAH 2005. EXAM: WEIGHT 278.2, BMI 52.56. ASSESSMENTS: DIABETES, OBESITY. TREATMENT: DIABETES: PATIENT ACKNOWLEDGES SHE IS VERY INCONSISTENT WITH TAKING HER MEDS, DOES NOT FOLLOW DIABETIC. DOES NOT COOK, EATS OUT OR TAKE OUT. DISCUSSED SELF MONITORING BLOOD SUGAR. SHE HAS NO DESIRE TO DO THIS. DISCUSSED BEING CONSISTENT WITH MEDS, TAKING ALL DOSES AS PRESCRIBED. ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. HERE FOR PHYSICAL. STATES SHE HAS BEGUN TAKING HER MEDICATIONS REGULARLY NOW, INCLUDING DIABETES. ON (B)(6) 2014: [MISSING RECORDS: RECORDS FOR THE OPERATIVE REPORT FOR ¿EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION FOR TAKEDOWN OF ANTERIOR CUTANEOUS FISTULA¿ WERE NOT PROVIDED.] ON (B)(6) 2014: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. 2 WEEK FOLLOW UP ABDOMINAL SURGERY. FOLLOW-UP COLON RESECTION FOR TAKEDOWN OF FISTULA. SAW HER SURGEON, STILL DRAINING FOR [SIC] WOUND SITE AND SO WAS STARTED ON ANTIBIOTICS. PAST SURGICAL HISTORY: EXPLORATORY LAPAROTOMY (B)(6) 2014, SMALL BOWEL RESECTION FOR TAKEDOWN OF ANTERIOR CUTANEOUS FISTULA (B)(6) 2014. ASSESSMENTS: OPEN WOUND OF ABDOMINAL WALL, ANTERIOR, COMPLICATED. FOLLOWING CLOSELY WITH SURGEON. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. PRESENTS TO CLINIC TODAY COMPLAINING OF REDNESS, HEAT, SWELLING AND MILD TENDERNESS ALONG A HEALED SURGICAL SCAR ON HER ABDOMEN X 3 DAYS. SHE IS STATUS POST BOWEL RESECTION (B)(6) 2014, HEALING WAS COMPROMISED BY ABSCESS IN THE PAST; NO LONGER FOLLOWING WITH SURGEON AS INCISION HAD FULLY HEALED PREVIOUSLY. ASSESSMENTS: ABDOMINAL ABSCESS. TREATMENT: ABDOMINAL ABSCESS: EXAM CONSISTENT WITH ABSCESS; ADVISED THIS MUST BE EVALUATED BY HER SURGEON AS SOON AS POSSIBLE. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. HERE FOR FOLLOW-UP. HAS AN ABDOMINAL ABSCESS THAT WAS SUPPOSED TO HAVE BEEN OPENED, DRAINED, REPAIRED ABOUT 3 WEEKS AGO BUT SHE HAS AN ANAPHYLACTIC REACTION AND ARRESTED ON THE OR TABLE JUST AFTER INDUCTION AND RECEIVING CLINDAMYCIN IV. WAS INTUBATED AND ON A VENTILATOR FOR SEVERAL DAYS BUT DID RECOVER AND WAS DISCHARGED HOME. NINE DAYS AGO HER ABDOMINAL ABSCESS, WHICH NEVER TO BE TREATED SURGICALLY, ¿OPENED AND EXPLODED¿ WHILE AT HOME. EXAM: ABDOMEN: DRAINING ABSCESS. SOCIAL HISTORY: FORMER SMOKER. ASSESSMENT: OPEN WOUND OF ABDOMINAL WALL, ANTERIOR, COMPLICATED. PERSISTENT DRAINING ABSCESS OF ABDOMEN SINCE HERNIA REPAIR. FOLLOWING CLOSELY WITH SURGEON. IS IN A HOLDING PATTERN WITH REGARD TO CORRECTING THE ABSCESS UNTIL SHE CAN GET TESTED FOR ALLERGENS. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. WHILE AT THE ALLERGIST OFFICE, SPIROMETRY WAS DONE AND RESULT SHOWED PATIENT LIKELY HAS SIGNIFICANT CHRONIC OBSTRUCTIVE PULMONARY DISEASE. SHE IS A CURRENT SMOKER AND HAS SMOKED FOR MANY YEARS. SURGICAL REPAIR OF A ABDOMINAL WOUND HAS NOT BEEN DONE YET. IT DOES LEAK A LARGE AMOUNT OF FLUID EVERY ONCE IN AWHILE. ON (B)(6) 2015: (B)(6) ASSOCIATES. (B)(6) , MD. HISTORY AND PHYSICAL. PRESENTS FOR EVALUATION OF WOUND INFECTION. STATUS POST EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION FOR EC FISTULA. HAD BEEN DOING WELL RECENTLY UNTIL SHE NOTED A RAISED, RED AREA IN THE UPPER PORTION OF THE INCISION SITE. THE AREA DRAINED SPONTANEOUSLY. DESPITE WATCHING CONSERVATIVELY, THE AREA CONTINUES TO DRAIN. EXAM: WEIGHT 231 LB, BMI 43.67. ASSESSMENT/PLAN: WOUND INFECTION. THE ABOVE DIAGNOSIS AND NEED FOR SURGICAL INTERVENTION WERE DISCUSSED WITH THE PATIENT AT LENGTH. I HAD AN EXTENSIVE DISCUSSION WITH HER ABOUT WHAT WE MIGHT FIND DURING OUR WOUND EXPLORATION AND THAT WE COULD POTENTIALLY BE FORCED TO TAKE OUT HER OLD VENTRAL HERNIA MESH IF IT IS INVOLVED IN ANY WAY WITH THIS DRAINING AREA. PATIENT VOICES UNDERSTANDING OF RISKS, BENEFITS, AND ALTERNATIVES, INCLUDING BUT NOT LIMITED TO MESH RESECTION, RECURRENT HERNIA, RECURRENT INFECTION, POSSIBLE BOWEL RESECTION. SOCIAL HISTORY: CURRENT EVERYDAY SMOKER, 0.5 PACKS/DAY FOR 15 YEARS. ON (B)(6) 2015:[MISSING RECORDS: RECORDS FOR THE OPERATIVE REPORT FOR ¿ABDOMINAL WOUND DEBRIDEMENT¿ WERE NOT PROVIDED.] ON (B)(6) 2015: (B)(6) HOSPITAL. [ILLEGIBLE]. ANESTHESIA RECORD. ASA 3. PROCEDURE: ABDOMINAL WOUND DEBRIDEMENT. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. ROUTINE FOLLOW-UP. SINCE LAST VISIT, SHE HAD A REVISION OF ABDOMINAL SURGERY IN WHICH THE MESH SHE HAS IN HER ABDOMEN WAS REMOVED, AND AN ANIMAL SKIN WAS PLACED INSTEAD (PER PATIENT). AN ABDOMINAL ABSCESS HAD DEVELOPED IN HER ABDOMEN FROM THE MESH A FEW WEEKS AFTER SHE WAS IN A MOTOR VEHICLE ACCIDENT SEVERAL MONTHS AGO. CURRENTLY HAS A NURSE COMING TO HOUSE TO ASSIST WITH WOUND CARE. SHE SAYS THEY ARE BECOMING CONCERNED ABOUT A SECOND DRAINING SINUS TRACT DEVELOPING WITHIN THE WOUND. REPORTS QUIT SMOKING CIGARETTES. ASSESSMENTS: OPEN WOUND OF ABDOMINAL WALL, ANTERIOR, COMPLICATED: ABDOMINAL MESH REMOVAL, WITH ABSCESS CLEAN-UP A FEW WEEKS AGO. FOLLOWING WITH SURGEON AND HAS VISITING NURSES ASSISTING WITH WOUND CARE. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , NP. OFFICE NOTES. ROUTINE FOLLOW-UP FOR DIABETES. ABDOMINAL ABSCESS STILL OPEN AND DRAINING SMALL AMOUNT YELLOWISH DRAINAGE. THIS OPENING IS BEING LEFT TO CLOSE ON ITS OWN PER SURGEONS ORDER. ON (B)(6) 2017: THE (B)(6) HOSPITAL. (B)(6) , MD. OFFICE NOTES. COMING TODAY TO DISCUSS HER DEPRESSION. HAS BEEN SEEING LICSW (B)(6) EXTENSIVELY, AND HAS BEEN WORKING ON HER RELATIONSHIP ISSUES WITH HER HUSBAND. SITUATION COMPLICATED BY POVERTY, FOOD SCARCITY. NOTES A LOT OF IMPROVEMENT WITH RELATIONSHIP COUNSELING WITH HER HUSBAND WITH (B)(6). FEELS HER DEPRESSION WORSENED IN (B)(6) 2015 WITH MOVING INTO HER NEW HOUSE (SMALL PLACE, CAN¿T DO THINGS). STAYS IN BEDROOM ONLY BECAUSE OF ORGANIZATION; HOUSE IS DIRTY. KEEPS TALKING ABOUT HER SITUATIONS ¿ PAIN, MONEY, SPACE AND ORGANIZATION, BUT WANTS TO CHANGE HER MEDICATION. ON (B)(6) 2018: THE (B)(6) HOSPITAL. (B)(6) , MD. EMERGENCY ROOM VISIT. PRESENTS WITH LEFT UPPER EXTREMITY WEAKNESS. PAST MEDICAL HISTORY: DIABETES TYPE 2, CONTROLLED DIAGNOSED 2012, ON PILLS, WAS ON INSULIN IN 2016 FOR 2 MONTHS. NO COMPLICATIONS, GASTROINTESTINAL REFLUX DISEASE. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE 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. THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL. 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.
PREVIOUS PATIENT CODES (1690, 1695,1930, 3191 APPROPRIATE TERM/CODE NOT AVAILABLE) USED FOR "CHRONIC DRAINING ABDOMINAL WALL SINUS", "OPEN DRAINING WOUND" AND "LOSS OF CONSORTIUM") WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. 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. THIS EVENT WILL BE CLOSED AS NO PROBLEM DETECTED. THE FOLLOWING INFORMATION WAS DETERMINED FROM THE MEDICAL RECORDS. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 1986 THROUGH (B)(6) 2019 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE-TEX® DUALMESH® BIOMATERIAL. MEDICAL RECORDS FROM (B)(6) 1997 THROUGH (B)(6) 2002, FROM (B)(6) 2002 THROUGH (B)(6) 2005, AND FROM (B)(6) 2005 THROUGH (B)(6) 2012 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: CHRONIC OBSTRUCTIVE PULMONARY DISEASE [COPD]. GASTROESOPHAGEAL REFLUX DISEASE [GERD]. DIABETES. ON (B)(6) 2012: ¿PATIENT ACKNOWLEDGES SHE IS VERY INCONSISTENT WITH TAKING HER MEDS, DOES NOT FOLLOW DIABETIC. DOES NOT COOK, EATS OUT OR TAKE OUT. DISCUSSED SELF MONITORING BLOOD SUGAR. SHE HAS NO DESIRE TO DO THIS.¿ ON (B)(6) 2013: ¿STATES SHE HAS BEGUN TAKING HER MEDICATIONS REGULARLY NOW, INCLUDING DIABETES.¿ ON (B)(6) 2018: ¿DIABETES TYPE 2, CONTROLLED DIAGNOSED 2012, ON PILLS, WAS ON INSULIN IN 2016 FOR 2 MONTHS.¿ SMOKING (B)(6) 1987: ¿SMOKING FOR 10 YEARS.¿ (B)(6) 1997: ¿SMOKES ½ PACKS PER DAY X 8 YEARS.¿ (B)(6) 2015: ¿CURRENT EVERYDAY SMOKER, 0.5 PACKS/DAY FOR 15 YEARS.¿ (B)(6) 2015: ¿REPORTS QUIT SMOKING CIGARETTES.¿ MORBID OBESITY (B)(6) 1987: ¿SHE HAS LOST ABOUT 100 POUNDS SINCE BYPASS.¿ (B)(6) 1997: 250 LBS., BMI 47.2. (B)(6) 2012: 278 LBS., BMI 52.5. (B)(6) 2015: 231 LBS., BMI 43.6. PRIOR SURGICAL PROCEDURES: 1982: GASTROPLASTY [GASTRIC STAPLING]. 1984: LIPOPLASTY [SUCTION LIPECTOMY AND TUMMY TUCK]. (B)(6) 1987: CHOLECYSTECTOMY. 1995: INCISIONAL HERNIA REPAIR. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 1997: HISTORY AND PHYSICAL: ¿HISTORY OF HAVING A GASTRIC STAPLING MANY YEARS AGO. SUBSEQUENTLY DEVELOPED AN INCISIONAL HERNIA, AND THIS WAS REPAIRED BY DR. (B)(6)APPROXIMATELY 1½ YEARS AGO. NOW HAS DEVELOPED A RECURRENT VENTRAL HERNIA AND WILL HAVE THIS REPAIRED. THE ABDOMEN IS OBESE. THERE IS A WELL HEALED OPEN CHOLECYSTECTOMY SCAR AT THE RIGHT COSTAL MARGIN, AND THERE IS A WELL-HEALED MIDLINE INCISION. THERE IS A LARGE 10 CM REDUCIBLE VENTRAL HERNIA JUST TO THE LEFT OF THE MIDLINE. LARGE VENTRAL HERNIA.¿ IMPLANT PROCEDURE: REPAIR OF LARGE VENTRAL HERNIA WITH ¿GORE-TEX¿ MESH AND PARTIAL OMENTECTOMY. IMPLANT: GORE-TEX® DUALMESH® BIOMATERIAL (1DLM07/10730-080, 20 CM X 30 CM) IMPLANT DATE: (B)(6) 1997 [HOSPITALIZATION (B)(6) 1997]. DESCRIPTION OF HERNIA BEING TREATED: ¿THE PATIENT¿S AREA OF HERNIATION, HAVING BEEN MARKED OUT IN THE INDUCTION AREA, WERE EXPLORED THROUGH A LONGITUDINAL INCISION IN THE UPPER ABDOMEN. THE INCISION WAS DEEPENED THROUGH THE DERMAL AND SUBCUTANEOUS TISSUE PLANES. THREE FASCIAL DEFECTS, 2 APPROXIMATELY EACH 1.5 CM TO 2 CM IN SIZE NEAR THE LEVEL OF THE XIPHOID, WERE ENCOUNTERED IN THE MIDLINE AND A MUCH LARGER DEFECT JUST BELOW THIS. THESE DEFECTS WERE JOINED INTO ONE, AND THE FASCIAL EDGES ABOUT THE DEFECTS WERE DEFINED AND FREED FROM SURROUNDING FIBRO-AREOLAR TISSUE WITHIN THE RIGHT-SIDED PORTION OF THE LARGE DEFECT WHICH SPANNED APPROXIMATELY 5 INCHES IN LENGTH. AN INDURATED AREA WAS ENCOUNTERED. THIS WAS FELT TO PROBABLY REPRESENT MESH WHICH HAD PULLED AWAY FROM THE LEFT SIDE OF THE WOUND. THE SAC, WHICH WAS GREATLY REDUNDANT, THEREFORE, WAS OPENED. ADHERENT TRANSVERSE COLON WITHIN THE SAC WAS FREED FROM ITS ADHESIONS TO THE SAC. REDUCED OMENTUM WAS SIMILARLY MOBILIZED, AND A PORTION OF THE OMENTUM WAS ON A SMALL, SHORTENED PEDICLE AND WAS, THEREFORE, RESECTED. THIS CONSTITUTED, HOWEVER, A MAJOR VOLUME PORTION OF THE PATIENT¿S OMENTUM. THE REDUNDANCY OF THE SAC WAS RESECTED AS WAS THE OLD MESH. THE 3 DEFECTS WERE JOINED TO A SINGLE DEFECT. METICULOUS HEMOSTASIS THROUGHOUT THE CASE WAS AFFECTED WITH THE JUDICIOUS USE OF ELECTROCAUTERY ON A LOW AMPERAGE SETTING. IN THE AREA WHERE THE OLD MESH WAS, THERE WAS A SMALL FLUID COLLECTION. CULTURES WERE OBTAINED, AND THIS AREA WAS IRRIGATED OUT WITH COPIOUS QUANTITIES OF WARM SALINE. IT WAS FELT THAT THIS WAS PROBABLY REPRESENTED AN EITHER STERILE ABSCESS OR UNRESOLVED SEROMA. OF CURIOSITY, LARGE CHROMIC SUTURES, PRESUMABLY FROM THE PATIENT¿S GASTRIC WEIGHT REDUCTION SURGERY MANY YEARS AGO, WERE STILL IN PLACE INTACT.¿ IMPLANT SIZE AND FIXATION: ¿IT WAS ELECTED TO CARRY OUT A TENSION-FREE REPAIR WITH DOUBLE-SIDED GORE-TEX MESH WITH A SMOOTH SIDE PLACED IN OPPOSITION TO THE PERITONEUM SURFACE AND THE ROUGHER SIDE PLACED IN OPPOSITION TO THE SUBCUTANEOUS TISSUE. THIS WAS SECURED IN PLACE WITH MULTIPLE INTERRUPTED SUTURES OF #0 PROLENE PLACED IN A U-FASHION. METICULOUS HEMOSTASIS THROUGHOUT THE CASE WAS AFFECTED WITH THE JUDICIOUS USE OF ELECTROCAUTERY ON A LOW AMPERAGE SETTING IN CONJUNCTION WITH LIGATURES OF #4-0 VICRYL. IT WAS CONFIRMED AT EACH LAYER OF CLOSURE. THE SUBCUTANEOUS TISSUE WAS THEN REAPPROXIMATED TO OBLITERATE THE DEAD SPACE WITH INTERRUPTED SIMPLE SUTURES OF #3-0 VICRYL WITH KNOTS BURIED. THE SKIN EDGES WERE THEN OPPOSED WITH STAINLESS STEEL SURGICAL CLIPS. THE WOUND WAS CLEANSED.¿ (B)(6) 1997: PATHOLOGY REPORT: MICROBIOLOGY: ¿PERITONEAL FLUID. GRAM STAIN: 0-1+ POLYS SEEN, NO EPITH CELLS SEEN, NO ORGANISMS SEEN. PERITONEAL FLUID CULTURE: NO GROWTH 4 DAYS.¿ (B)(6) 1997: DISCHARGE SUMMARY: ¿THE PATIENT DID WELL POSTOPERATIVELY AND TOLERATED A DIET THE FOLLOWING MORNING AND ANALGESICS AND WAS SUBSEQUENTLY DISCHARGED HOME.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 1997: PRIOR HERNIA REPAIR WITH ENLARGING ABDOMINAL GIRTH ESPECIALLY EPIGASTRIC AREA. EXAM: BULGING ABDOMINAL WALL ¿ NONTENDER. CT ¿ ABDOMINAL WALL COLLECTION. (B)(6) 1997: CT ABDOMEN: ¿15 X 11 CM COLLECTION ANTERIOR ABDOMINAL WALL WITH FABRIC MESH AT FLOOR OF COLLECTION. QUESTION SUBACUTE OR CHRONIC HEMATOMA. DRAINED WITH STERILE TECHNIQUE INITIALLY WITH 5 AND 8 FR CATHETER WITH INTERMITTENT DRAINAGE. FOLLOW UP WITH 12 FR ([ILLEGIBLE]) WITH SUBSEQUENT ASPIRATION 75-85 CC OF FLUID BUT 14 X 3 CM FLUID COLLECTION AT END.¿ DESCRIPTION OF OP: DRAINED DARK RED FLUID 1100 CC¿S. CATHETER WITHDRAWN PATIENT DISCHARGED.¿ (B)(6) 1997: MICROBIOLOGY: ¿CULTURE/SMEAR PERITONEAL FLUID. BODY SITE: PERITONEAL FLUID: ABDOMINAL ABSCESS. GRAM STAIN: NO POLYS SEEN, NO EPITHELIAL CELLS SEEN, 0-1+ WBC¿S SEEN, NO ORGANISMS SEEN. PERITONEAL FLUID CULTURE: NO GROWTH 5 DAYS.¿ (B)(6) 2002 - (B)(6) 2002: HOSPITALIZATION. (B)(6) 2002: X-RAY ABDOMEN FOR PAIN: ¿IMPRESSION: EARLY SMALL BOWEL OBSTRUCTION.¿ (B)(6) 2002: CONSULTATION: PAST SURGICAL HISTORY IS POSITIVE MULTIPLE VENTRAL HERNIA REPAIRS WITH MESH AND WITH REOCCURRENCE AND STILL RECURS. ALSO HAS A HISTORY OF A PARTIAL BOWEL OBSTRUCTION 11/00 ADMITTED AT RHODE ISLAND HOSPITAL. SOCIAL HISTORY: HAS NO ALCOHOL OR TOBACCO USE. EXAM: ABDOMEN MARKEDLY OBESE WITH A LARGE VENTRAL HERNIA IN THE MIDLINE; ABDOMEN IS QUITE DISTENDED. IMPRESSION: PARTIAL SMALL BOWEL OBSTRUCTION.¿ (B)(6) 2002: THERE ARE MULTIPLE STAPLES UPPER ABDOMEN. THE SMALL BOWEL IS SIGNIFICANTLY LESS DISTENDED THAN ON PREVIOUS DAY. THERE IS MORE AIR NOW SEEN IN THE COLON. IMPRESSION: RESOLVED SMALL BOWEL OBSTRUCTION. (B)(6) 2002: DISCHARGE SUMMARY: ¿ADMITTED WITH NAUSEA AND VOMITING, X-RAY WITH SMALL BOWEL OBSTRUCTION. IV FLUIDS, NOTHING BY MOUTH, NASOGASTRIC TUBE; POSITIVE FLATUS/ BOWEL MOVEMENT ON HOSPITAL DAY #2. DIET ADVANCED ON HOSPITAL DAY #3 AND DISCHARGE.¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2005: ¿WHO INITIALLY PRESENTED TO HER PRIMARY GYNECOLOGIST COMPLAINING OF VAGINAL BLEEDING. ON ENDOMETRIAL BIOPSY THE PATIENT WAS NOTED TO HAVE A GRADE 2-3 ENDOMETRIOID ADENOCARCINOMA OF THE UTERUS. THE PATIENT ALSO HAS A LONG STANDING HISTORY OF A LARGE, ABDOMINAL HERNIA. THE PATIENT HAS UNDERGONE THREE PREVIOUS HERNIA REPAIRS WITH MESH, WHICH HAVE NOT BEEN SUCCESSFUL. THE PATIENT IS SYMPTOMATIC FROM HER LARGE, ABDOMINAL HERNIA AND DESIRES REPAIR.¿ EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION, STAGING, ABDOMINAL HERNIA REPAIR, AND ABDOMINAL WALL RECONSTRUCTION WITH AN ALLODERM GRAFT (NON-GORE DEVICE). EXPLANT DATE: (B)(6) 2005 [HOSPITALIZATION DATES UNKNOWN]. FINDINGS: ¿THE PATIENT WAS NOTED TO HAVE AN APPROXIMATELY 30 CM LONG AND 40 CM WIDE FASCIAL DEFECT. THE PATIENT'S ENTIRE SMALL BOWEL WAS OUTSIDE OF THE PERITONEAL CAVITY ENCLOSED IN MULTIPLE HERNIA SACS INCLUDING THE PATIENT'S SMALL BOWEL MESENTERY. THERE WERE EXTENSIVE ADHESIONS AND AS MENTIONED ABOVE TOO NUMEROUS TO COUNT HERNIA SACS. ONCE IN THE ABDOMEN, THE PATIENT'S UPPER ABDOMEN WAS GROSSLY NORMAL TO PALPATION, ALL PERITONEAL SURFACES WERE SMOOTH, THE LIVER SURFACE APPEARED GROSSLY NORMAL, AS DID THE KIDNEY SURFACES AS WELL AS THE SPLEEN. NO EVIDENCE OF DISEASE IN THE UPPER ABDOMEN. THE PATIENT'S OMENTUM WAS DENSELY ADHERENT TO THE ANTERIOR ABDOMINAL WALL, BUT THERE WAS NO EVIDENCE OF DISEASE. IN THE PELVIS, THE PATIENT'S UTERUS APPEARED ONLY MINIMALLY ENLARGED, BOTH ADNEXA APPEARED NORMAL, NO EVIDENCE OF TUMOR IN THE PELVIS. GROSS EXAMINATION ON FROZEN SECTION REVEALED APPROXIMATELY 10-15% MYOMETRIAL INVASION OF AN ENDOMETRIOID ADENOCARCINOMA OF THE ENDOMETRIUM. THE PATIENT'S UTERUS AND ADNEXA WERE PROCESSED FOR GOG 210. THERE WERE NO OTHER SIGNIFICANT FINDINGS. THE PATIENT WAS DEEMED TO BE COMPLETELY STAGED AT THE COMPLETION OF THIS PROCEDURE.¿ ¿NEXT, A MIDLINE VERTICAL INCISION, EXTENDING FROM THE PUBIC SYMPHYSIS TO 3 CM BELOW THE XIPHOID PROCESS WAS MADE IN THE MIDLINE. ONCE THE SUBCUTANEOUS TISSUES WERE DIVIDED MULTIPLE HERNIA SACS WERE ENCOUNTERED IMMEDIATELY. AT THIS POINT, EXTENSIVE LYSIS OF ADHESIONS LASTING APPROXIMATELY TWO HOURS WERE NECESSARY TO ENTER THE PATIENT'S ABDOMINAL CAVITY AND PELVIS. FOLLOWING EXTENSIVE LYSIS OF ADHESIONS, WHICH WERE PERFORMED IN A SHARP FASHION WITH THE METZENBAUM SCISSORS, RESECTION OF MULTIPLE HERNIA SACS WAS THEN PERFORMED. WITH THIS ACCOMPLISHED A BOOKWALTER RETRACTOR WAS THEN PLACED, AND THE PATIENT'S BOWEL WAS HELD OUT OF THE PELVIS. THE UTERINE CORNUA WERE THEN GRASPED WITH TWO LONG KELLY CLAMPS, AND HELD ON TENSION. THE ROUND LIGAMENTS WERE THEN SUTURE LIGATED BILATERALLY AND DIVIDED WITH THE ELECTROCAUTERY. THIS ALLOWED ENTRY INTO THE PELVIC RETROPERITONEAL SPACES WHICH WERE FURTHER DEVELOPED IN A SHARP, AND BLUNT FASHION.¿ ¿AT THIS POINT, THE PATIENT WAS DEEMED TO BE COMPLETELY STAGED. OF NOTE, PELVIC WASHINGS HAD BEEN OBTAINED UPON ENTERING THE ABDOMEN. AT THIS POINT, DR. (B)(6) COMPLETED THE REMOVAL OF THE HERNIA SACS WHICH WAS ACCOMPLISHED IN A SHARP FASHION. AGAIN, GREATER THAN TWO HOURS OF EXTENSIVE LYSIS OF ADHESIONS, AND ENTEROLYSIS WAS PERFORMED TO FREE THE PATIENT'S SMALL BOWEL FROM IT'S SIGNIFICANT ADHESIONS. THE PATIENT'S BOWEL WAS THEN EXAMINED IN IT'S ENTIRETY AND NO DEFECTS WERE NOTED. WITH THIS COMPLETED, THE PATIENT'S ANTERIOR ABDOMINAL WALL WAS RECONSTRUCTED IN THE FOLLOWING FASHION.¿ ¿THE PATIENT'S SUBCUTANEOUS TISSUES WERE FURTHER DISSECTED FROM THE REMNANT OF THE ANTERIOR RECTUS SHEATH LATERALLY TO THE EXTERNAL OBLIQUE MUSCLES. AGAIN, AN APPROXIMATELY 30 X 40 DEFECT WAS NOTED. THE DECISION WAS MADE TO REPAIR THIS DEFECT WITH ALLODERM GRAFT. TWO, 6 X 12, AND TWO, 4 X 16 PIECES OF ALLODERM EXTRA THICK WERE THEN CHOSEN. THESE WERE PRE-REHYDRATED IN SALINE. THE TWO, 6 X 12 PIECES WERE THEN SUTURED TO THE FASCIA WITH #1 PROLENE IN A RUNNING FASHION. THE TWO, 4 X 16 PIECES WERE SEWN TOGETHER USING #1 PROLENE. THEY WERE THEN SEWN TO THE FASCIA AT THE FOUR CORNERS USING #1 PROLENE. THE TOP 6 X 12 ALLODERM WAS THEN SEWN TO THE TWO 4 X 16 PIECES USING A #1 PROLENE IN A RUNNING FASHION.¿ ¿AT THIS POINT, THE PATIENT'S BOWEL WAS RETURNED TO THE ABDOMEN. THE DISTAL PORTION OF THE 4 X 16 ALLODERM GRAFT WAS THEN SEWN TO THE REMAINING 6 X 12 DISTAL GRAFT, AGAIN USING #1 PROLENE IN A RUNNING FASHION. THIS ALLOWED ADEQUATE COVERAGE OF THE HERNIA DEFECT IN ALL DIRECTIONS. TWO, #10 FLAT JACKSONPRATT DRAINS WERE THEN PLACED INTO THE SUBCUTANEOUS TISSUES, ABOVE THE ALLODERM GRAFT. THE SUBCUTANEOUS TISSUE WAS THEN REAPPROXIMATED USING #0 VICRYL IN AN INTERRUPTED FASHION. THE SKIN WAS CLOSED WITH STAPLES.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2005: OPEN REPAIR OF A RECURRENT INCISIONAL HERNIA WITH ALLODERM MESH (NON-GORE DEVICE). ¿THE PREVIOUS MIDLINE INCISION WAS OPENED, CONSIDERABLE TIME WAS TAKEN TO TAKE DOWN THE PLANE BETWEEN THE SUBCUTANEOUS FAT AND THE RECURRENT HERNIATION. THE ALLODERM WAS IDENTIFIED ON THE LEFT HAND SIDE OF THE ABDOMEN NEAR THE MID LINE, BUT HAD OBVIOUSLY TORN AWAY FROM THE FASCIA ON THE RIGHT HAND SIDE. THE FASCIAL PLANE WAS DEVELOPED ON THE RIGHT HAND SIDE, AND AFTER A CONSIDERABLE AMOUNT OF TIME, THE FASCIA AND ALLODERM WERE COMPLETELY CLEARED UP CIRCUMFERENTIALLY. TWO PIECES OF 6 X 12 CM ALLODERM WERE THEN RE-HYDRATED AND SEWN TOGETHER USING #0-NYLON SUTURE. SEVERAL RUNNING SUTURES WERE USED TO FILL THE TWO PIECES OF ALLODERM FROM THE PREVIOUS ALLODERM ON THE LEFT HAND SIDE OF THE ABDOMEN TO THE FASCIA ON THE RIGHT HAND SIDE OF THE PATIENT. AT LEAST EIGHT DIFFERENT SUTURES WERE UTILIZED. AFTER DOING SO, A COMPLETE HERNIA REPAIR WAS OBTAINED. TWO JACKSON PRATTS WERE PLACED INTO THE PATIENT COMING OUT THE RIGHT HAND SIDE OF THE ABDOMEN AND SEWN TO THE SKIN USING #2-0 SILK.¿ (B)(6) 2014: EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION FOR TAKEDOWN OF ANTERIOR CUTANEOUS FISTULA. (B)(6) 2015: ¿ABDOMINAL ABSCESS STILL OPEN AND DRAINING SMALL AMOUNT YELLOWISH DRAINAGE. THIS OPENING IS BEING LEFT TO CLOSE ON ITS OWN PER SURGEON¿S ORDER.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE-TEX® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE 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.¿ AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. AFTER MULTIPLE REQUESTS, SPECIFIC LOT NUMBER INFORMATION WAS NOT PROVIDED FOR THIS DEVICE BUT PRODUCT TYPE WAS CONFIRMED THROUGH OTHER RECORDS PROVIDED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. ALTHOUGH A REVIEW OF MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED, ALL PRE-RELEASE SPECIFICATIONS ARE CONFIRMED PRIOR TO RELEASE AS PART OF QUALITY SYSTEM PROCESSES. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE FOR USE IN PRODUCT SURVEILLANCE TRACKING, TRENDING AND FOLLOW-UP. 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.
ADDED DATE OF BIRTH. ADDED PATIENT MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IT WAS REPORTED THAT THIS PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON 2/3/1997 WHEREBY AN ALLEGED GORE DEVICE WAS IMPLANTED. OPERATIVE RECORDS DETAILING THE 2/3/1997 IMPLANT PROCEDURE WERE NOT PROVIDED. ADDITIONALLY, PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WERE NOT PROVIDED. RECORDS PRIOR TO 3/30/2005 WERE NOT PROVIDED, INCLUDING ANY RELATED TO THE ¿LONG STANDING HISTORY OF A LARGE, ABDOMINAL HERNIA¿ AND ¿THREE PREVIOUS HERNIA REPAIRS WITH MESH, WHICH HAVE NOT BEEN SUCCESSFUL¿ REFERRED TO IN THE 3/30/2005 OPERATIVE RECORDS. OPERATIVE RECORDS DATED (B)(6)2005 INDICATE THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION, STAGING, ABDOMINAL HERNIA REPAIR, AND ABDOMINAL WALL RECONSTRUCTION WITH AN ALLODERM GRAFT (NON-GORE DEVICE). POSTOPERATIVE DIAGNOSES ARE NOTED AS UTERINE CANCER AND SYMPTOMATIC LARGE ABDOMINAL HERNIA. THE RECORDS STATE: ¿THIS IS A 56-YEAR-OLD G 2, P 2, WHO INITIALLY PRESENTED TO HER PRIMARY GYNECOLOGIST COMPLAINING OF VAGINAL BLEEDING. ON ENDOMETRIAL BIOPSY THE PATIENT WAS NOTED TO HAVE A GRADE 2-3 ENDOMETRIOID ADENOCARCINOMA OF THE UTERUS. THE PATIENT ALSO HAS A LONG STANDING HISTORY OF A LARGE, ABDOMINAL HERNIA. THE PATIENT HAS UNDERGONE THREE PREVIOUS HERNIA REPAIRS WITH MESH, WHICH HAVE NOT BEEN SUCCESSFUL. THE PATIENT IS SYMPTOMATIC FROM HER LARGE, ABDOMINAL HERNIA AND DESIRES REPAIR. THE PATIENT WAS THEREFORE ADMITTED TO THE OPERATING ROOM ON(B)(6)2005 FOR THE ABOVE DESCRIBED PROCEDURES.¿ FINDINGS FROM THE (B)(6)2005 PROCEDURE STATE: ¿THE PATIENT WAS NOTED TO HAVE AN APPROXIMATELY 30 CM LONG AND 40 CM WIDE FASCIAL DEFECT. THE PATIENT'S ENTIRE SMALL BOWEL WAS OUTSIDE OF THE PERITONEAL CAVITY ENCLOSED IN MULTIPLE HERNIA SACS INCLUDING THE PATIENT'S SMALL BOWEL MESENTERY. THERE WERE EXTENSIVE ADHESIONS AND AS MENTIONED ABOVE TOO NUMEROUS TO COUNT HERNIA SACS. ONCE IN THE ABDOMEN, THE PATIENT'S UPPER ABDOMEN WAS GROSSLY NORMAL TO PALPATION, ALL PERITONEAL SURFACES WERE SMOOTH, THE LIVER SURFACE APPEARED GROSSLY NORMAL, AS DID THE KIDNEY SURFACES AS WELL AS THE SPLEEN. NO EVIDENCE OF DISEASE IN THE UPPER ABDOMEN. THE PATIENT'S OMENTUM WAS DENSELY ADHERENT TO THE ANTERIOR ABDOMINAL WALL, BUT THERE WAS NO EVIDENCE OF DISEASE. IN THE PELVIS, THE PATIENT'S UTERUS APPEARED ONLY MINIMALLY ENLARGED, BOTH ADNEXA APPEARED NORMAL, NO EVIDENCE OF TUMOR IN THE PELVIS. GROSS EXAMINATION ON FROZEN SECTION REVEALED APPROXIMATELY 10-15% MYOMETRIAL INVASION OF AN ENDOMETRIOID ADENOCARCINOMA OF THE ENDOMETRIUM. THE PATIENT'S UTERUS AND ADNEXA WERE PROCESSED FOR GOG 210. THERE WERE NO OTHER SIGNIFICANT FINDINGS. THE PATIENT WAS DEEMED TO BE COMPLETELY STAGED AT THE COMPLETION OF THIS PROCEDURE.¿ OPERATIVE NOTES FROM THE (B)(6)2005 PROCEDURE STATE: ¿NEXT, A MIDLINE VERTICAL INCISION, EXTENDING FROM THE PUBIC SYMPHYSIS TO 3 CM BELOW THE XIPHOID PROCESS WAS MADE IN THE MIDLINE. ONCE THE SUBCUTANEOUS TISSUES WERE DIVIDED MULTIPLE HERNIA SACS WERE ENCOUNTERED IMMEDIATELY. AT THIS POINT, EXTENSIVE LYSIS OF ADHESIONS LASTING APPROXIMATELY TWO HOURS WERE NECESSARY TO ENTER THE PATIENT'S ABDOMINAL CAVITY AND PELVIS. FOLLOWING EXTENSIVE LYSIS OF ADHESIONS, WHICH WERE PERFORMED IN A SHARP FASHION WITH THE METZENBAUM SCISSORS, RESECTION OF MULTIPLE HERNIA SACS WAS THEN PERFORMED. WITH THIS ACCOMPLISHED A BOOKWALTER RETRACTOR WAS THEN PLACED, AND THE PATIENT'S BOWEL WAS HELD OUT OF THE PELVIS. THE UTERINE CORNUA WERE THEN GRASPED WITH TWO LONG KELLY CLAMPS, AND HELD ON TENSION. THE ROUND LIGAMENTS WERE THEN SUTURE LIGATED BILATERALLY AND DIVIDED WITH THE ELECTROCAUTERY. THIS ALLOWED ENTRY INTO THE PELVIC RETROPERITONEAL SPACES WHICH WERE FURTHER DEVELOPED IN A SHARP, AND BLUNT FASHION.¿ THE (B)(6)2005 OPERATIVE NOTES CONTINUE: ¿THE PARA-VESICLE, AND PARA-RECTAL SPACES WERE THEN OPENED BILATERALLY IN A BLUNT FASHION. THE URETERS WERE IDENTIFIED ALONG THE MEDIAL LEAF OF THE BROAD LIGAMENTS, AND WINDOWS IN THE MEDIAL LEAVES OF THE BROAD LIGAMENTS WERE MADE IN A BLUNT FASHION. THIS WAS PERFORMED UNDER DIRECT VISUALIZATION OF THE URETERS. THE INFUNDIBULOPELVIC LIGAMENTS WERE THEN DOUBLY CLAMPED AND DIVIDED. THEY WERE THEN LIGATED WITH #0 VICRYL FOR EXCELLENT HEMOSTASIS TIMES TWO. THE MEDIAL LEAVES OF THE BROAD LIGAMENTS WERE THEN FURTHER DIVIDED TO THE LEVEL OF THE UTERO-OVARIAN LIGAMENTS.¿ THE (B)(6)2005 OPERATIVE NOTES STATE: ¿NEXT, THE VESICOUTERINE PERITONEUM WAS DIVIDED SHARPLY WITH THE ELECTROCAUTERY. THIS ALLOWED DISSECTION OF THE BLADDER FROM THE LOWER UTERINE SEGMENT AND CERVIX. THE UTERINE ARTERIES WERE THEN CLAMPED BILATERALLY, DIVIDED, AND SUTURE LIGATED WITH #0 VICRYL. THE CARDINAL LIGAMENTS WERE THEN SERIALLY CLAMPED WITH STRAIGHT ROGER CLAMPS, DIVIDED, AND SUTURE LIGATED WITH #0 VICRYL, AGAIN FOR EXCELLENT HEMOSTASIS. THE VAGINAL TISSUE BELOW THE CERVICAL OS WAS THEN CLAMPED WITH RIGHT ANGLE PARAMETRIAL CLAMPS AND DIVIDED. THE PATIENT'S CERVIX, UTERUS, AND ADNEXA, WERE SENT TO PATHOLOGY FOR EXAMINATION AND GOG 210 PROCESSING. THE VAGINAL CUFF WAS THEN CLOSED AT THE ANGLES WITH #0 VICRYL AND A HEANEY STITCH. THE REMAINING VAGINAL CUFF WAS CLOSED WITH #0 VICRYL IN AN INTERRUPTED FIGURE-OF-EIGHT FASHION.¿ THE (B)(6)2005 OPERATIVE NOTES CONTINUE: ¿AT THIS POINT, OUR ATTENTION WAS TURNED TO THE PELVIC LYMPH NODE DISSECTION. OF NOTE, SURGICAL CLIPS WERE USED FOR HEMOSTASIS AS LYMPH NODE DISSECTION PROCEEDED. LYMPHATIC TISSUE REMOVED IN THIS FASHION WAS THEN SENT TO PATHOLOGY FOR PERMANENT SECTION.¿ THE (B)(6)2005 OPERATIVE NOTES STATE: ¿AT THIS POINT, ATTENTION WAS TURNED TO THE RIGHT PARA-AORTIC LYMPH NODE DISSECTION.¿ ¿ATTENTION WAS THEN TURNED TO THE PATIENT'S LEFT PELVIC LYMPH NODE DISSECTION, AS ON THE RIGHT, THE LYMPHATIC BUNDLE PRESENT AT THE BIFURCATION OF THE COMMON ILIAC VESSELS WAS THEN ELEVATED AND DIVIDED.¿ ¿ATTENTION WAS THEN TURNED TO THE PATIENT'S LEFT PERI-AORTIC LYMPH NODE DISSECTION TISSUE REMOVED WITHIN THIS FASCIA WAS THEN SENT TO PATHOLOGY FOR PERMANENT SECTION. AGAIN, SURGICAL CLIPS WERE USED FOR HEMOSTASIS.¿ THE (B)(6)2005 OPERATIVE NOTES CONTINUE: ¿AT THIS POINT, THE PATIENT WAS DEEMED TO BE COMPLETELY STAGED. OF NOTE, PELVIC WASHINGS HAD BEEN OBTAINED UPON ENTERING THE ABDOMEN. AT THIS POINT, DR. KONESS COMPLETED THE REMOVAL OF THE HERNIA SACS WHICH WAS ACCOMPLISHED IN A SHARP FASHION. AGAIN, GREATER THAN TWO HOURS OF EXTENSIVE LYSIS OF ADHESIONS, AND ENTEROLYSIS WAS PERFORMED TO FREE THE PATIENT'S SMALL BOWEL FROM IT'S SIGNIFICANT ADHESIONS. THE PATIENT'S BOWEL WAS THEN EXAMINED IN IT'S ENTIRETY AND NO DEFECTS WERE NOTED. WITH THIS COMPLETED, THE PATIENT'S ANTERIOR ABDOMINAL WALL WAS RECONSTRUCTED IN THE FOLLOWING FASHION.¿ THE (B)(6)2005 OPERATIVE NOTES CONTINUE: ¿THE PATIENT'S SUBCUTANEOUS TISSUES WERE FURTHER DISSECTED FROM THE REMNANT OF THE ANTERIOR RECTUS SHEATH LATERALLY TO THE EXTERNAL OBLIQUE MUSCLES. AGAIN, AN APPROXIMATELY 30 X 40 DEFECT WAS NOTED. THE DECISION WAS MADE TO REPAIR THIS DEFECT WITH ALLODERM GRAFT. TWO, 6 X 12, AND TWO, 4 X 16 PIECES OF ALLODERM EXTRA THICK WERE THEN CHOSEN. THESE WERE PRE-REHYDRATED IN SALINE. THE TWO, 6 X 12 PIECES WERE THEN SUTURED TO THE FASCIA WITH #1 PROLENE IN A RUNNING FASHION. THE TWO, 4 X 16 PIECES WERE SEWN TOGETHER USING #1 PROLENE. THEY WERE THEN SEWN TO THE FASCIA AT THE FOUR CORNERS USING #1 PROLENE. THE TOP 6 X 12 ALLODERM WAS THEN SEWN TO THE TWO 4 X 16 PIECES USING A #1 PROLENE IN A RUNNING FASHION.¿ THE (B)(6)2005 OPERATIVE NOTES STATE: ¿AT THIS POINT, THE PATIENT'S BOWEL WAS RETURNED TO THE ABDOMEN. THE DISTAL PORTION OF THE 4 X 16 ALLODERM GRAFT WAS THEN SEWN TO THE REMAINING 6 X 12 DISTAL GRAFT, AGAIN USING #1 PROLENE IN A RUNNING FASHION. THIS ALLOWED ADEQUATE COVERAGE OF THE HERNIA DEFECT IN ALL DIRECTIONS. TWO, #10 FLAT JACKSONPRATT DRAINS WERE THEN PLACED INTO THE SUBCUTANEOUS TISSUES, ABOVE THE ALLODERM GRAFT. THE SUBCUTANEOUS TISSUE WAS THEN REAPPROXIMATED USING #0 VICRYL IN AN INTERRUPTED FASHION. THE SKIN WAS CLOSED WITH STAPLES.¿ THE 3/30/2005 RECORDS INDICATE THREE NON-GORE DEVICES WERE USED DURING THE PROCEDURE. THERE WAS NO MENTION OF A GORE DEVICE IN THE RECORDS. ADDITIONALLY, THERE WAS NO MENTION OF INFECTION OR DEVICE REMOVAL IN THE RECORDS. RECORDS DATED (B)(6)20058 INDICATE THE PATIENT UNDERWENT REPAIR OF A RECURRENT INCISIONAL HERNIA WITH ALLODERM MESH (NON-GORE DEVICE). THE RECORDS STATE: ¿THIS IS A 56-YEAR-OLD FEMALE WHO HAD A TAH/BSO AND REPAIR OF AN EXCEEDINGLY LARGE INCISIONAL HERNIA APPROXIMATELY SEVEN MONTHS AGO. THE PATIENT WAS RECENTLY NOTED TO HAVE BREAK-DOWN ON THE RIGHT HAND SIDE OF THE ABDOMEN, THIS WAS CONFIRMED BY CT SCANNING. THE PATIENT REQUESTED RE-REPAIR.¿ THE (B)(6)2005 RECORDS STATE: ¿THE PREVIOUS MIDLINE INCISION WAS OPENED, CONSIDERABLE TIME WAS TAKEN TO TAKE DOWN THE PLANE BETWEEN THE SUBCUTANEOUS FAT AND THE RECURRENT HERNIATION. THE ALLODERM WAS IDENTIFIED ON THE LEFT HAND SIDE OF THE ABDOMEN NEAR THE MID LINE, BUT HAD OBVIOUSLY TORN AWAY FROM THE FASCIA ON THE RIGHT HAND SIDE. THE FASCIAL PLANE WAS DEVELOPED ON THE RIGHT HAND SIDE, AND AFTER A CONSIDERABLE AMOUNT OF TIME, THE FASCIA AND ALLODERM WERE COMPLETELY CLEARED UP CIRCUMFERENTIALLY. TWO PIECES OF 6 X 12 CM ALLODERM WERE THEN RE-HYDRATED AND SEWN TOGETHER USING #0-NYLON SUTURE. SEVERAL RUNNING SUTURES WERE USED TO FILL THE TWO PIECES OF ALLODERM FROM THE PREVIOUS ALLODERM ON THE LEFT HAND SIDE OF THE ABDOMEN TO THE FASCIA ON THE RIGHT HAND SIDE OF THE PATIENT. AT LEAST EIGHT DIFFERENT SUTURES WERE UTILIZED. AFTER DOING SO, A COMPLETE HERNIA REPAIR WAS OBTAINED. TWO JACKSON PRATTS WERE PLACED INTO THE PATIENT COMING OUT THE RIGHT HAND SIDE OF THE ABDOMEN AND SEWN TO THE SKIN USING #2-0 SILK. THE MIDLINE INCISION WAS THEN CLOSED IN TWO LAYERS USING #2-0 VICRYL AND STAPLES.¿ THE 12/6/2005 RECORDS CONFIRM A NON-GORE MESH DEVICE WAS USED DURING THE PROCEDURE. THERE WAS NO MENTION OF A GORE DEVICE IN THE RECORDS. ADDITIONALLY, THERE WAS NO MENTION OF INFECTION OR DEVICE REMOVAL IN THE RECORDS. 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: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ ¿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)(4). PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE INITIAL REPORTER'S COMPLETE ADDRESS IS: (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: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ ¿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 VENTRAL HERNIA REPAIR ON (B)(6) 1997, WHEREBY AN ALLEGED GORE DEVICE WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, EXTENSIVE ADHESIONS, CHRONIC DRAINING ABDOMINAL WALL SINUS, ABSCESS, OPEN DRAINING WOUND, ADDITIONAL SURGERIES TO REPAIR HERNIA, MESH INFECTION, MESH REMOVAL, LOSS OF CONSORTIUM. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629576 | UNKNOWN | OWZ | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |