GORE DUALMESH® BIOMATERIAL
Report
- Report Number
- 2017233-2019-00702
- Event Type
- Injury
- Date Received
- August 21, 2019
- Date of Event
- August 8, 2007
- Report Date
- March 9, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600960
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
B7: ADDED MEDICAL HISTORY. 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: (B)(6) 2008: NORTHWEST MEDICAL CENTER. WI. RICHARD CARNAHAN, MD HISTORY AND PHYSICAL. NOTED PAIN AND BULGING OF ABDOMINAL WALL PAST 2 MONTHS. NO NAUSEA, VOMITING, DIARRHEA OR CONSTIPATION. CT OF ABDOMEN SHOWS MIDLINE VENTRAL HERNIA CONTAINING SMALL BOWEL. MEDICATIONS: RANITIDINE, IBUPROFEN. WEIGHT 302 LBS. EXAM: EASILY REDUCIBLE VENTRAL HERNIA SUPERIOR TO UMBILICUS. ASSESSMENT: VENTRAL HERNIA. MORBID OBESITY. [MISSING RECORDS: RECORDS FOR THE CT OF ABDOMEN SHOWING ¿MIDLINE VENTRAL HERNIA CONTAINING SMALL BOWEL¿ WERE NOT PROVIDED.] (B)(6) 2008: NORTHWEST MEDICAL CENTER. WILLARD R. CARNAHAN, MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: VENTRAL INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: VENTRAL INCISIONAL HERNIA. PROCEDURE PERFORMED: LAPAROSCOPIC REPAIR OF VENTRAL INCISIONAL HERNIA. FIRST ASSISTANT: ROSLYN R. DUNNING, RNFA. ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA. ANESTHESIOLOGIST: MICHELLE J. HERMAN, MD. INDICATIONS FOR OPERATION: THE PATIENT IS A 45-YEAR-OLD FEMALE WHO PREVIOUSLY HAD A LAPAROSCOPIC CHOLECYSTECTOMY AND THEN DEVELOPED AN INCISIONAL HERNIA AT THE PERIUMBILICAL INCISION. OPERATIVE FINDINGS: THERE WAS A 5.5 X 4.5 CM DEFECT SUPERIOR TO THE UMBILICUS. THIS WAS REPAIRED WITH A DUAL MESH THAT WAS CUT TO 14 X 13 CM IN SIZE. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AFTER INDUCTION OF A GENERAL ENDOTRACHEAL ANESTHETIC, THE ABDOMEN WAS PREPPED AND DRAPED IN A STERILE MANNER AND 0.5% MARCAINE WITH EPINEPHRINE INJECTED LOCALLY IN THE LEFT UPPER QUADRANT OF THE ABDOMEN. A TRANSVERSE SKIN INCISION WAS MADE AND CARRIED DOWN THROUGH THE EXTERNAL OBLIQUE APONEUROSIS WHICH WAS INCISED. THE UNDERLYING MUSCLE WAS SPREAD IN THE DIRECTION OF ITS FIBERS, AND THE PERITONEUM WAS IDENTIFIED. THE PERITONEUM WAS ENTERED UNDER DIRECT VISION WITH METZENBAUM SCISSORS, AND A HASSON TROCAR WAS INSERTED INTO THE PERITONEAL CAVITY. THE PERITONEUM WAS INSUFFLATED TO A PRESSURE OF 15 MMHG WITH CARBON DIOXIDE. TWO 5 MM PORTS WERE PLACED IN THE LEFT LOWER QUADRANT VISUALIZING THEIR INSERTION WITH THE LAPAROSCOPE. THERE WERE NO ADHESIONS NOTED. THE HERNIA DEFECT WAS EASILY IDENTIFIED. IT WAS MEASURED INTERNALLY TO BE 4.5 X 5.5 CM IN SIZE. AN APPROPRIATELY SIZED MESH TO ALLOW 4 CM OVERLAP WAS OBTAINED. THIS WAS ABOUT 14 X 13 CM IN SIZE. GORE-TEX SUTURE WAS SUTURED IN 4 CORNERS OF THIS PROSTHESIS. GORE-TEX WAS THEN INSERTED THROUGH THE HASSON TROCAR INTO THE PERITONEAL CAVITY. THE STAY SUTURES WERE BROUGHT THROUGH THE INTERIOR ABDOMINAL WALL AND WERE TIED. THE EDGES OF THE MESH WERE THEN ATTACHED TO THE ANTERIOR ABDOMINAL WALL WITH PROTACK STAPLER. THE MESH SATISFACTORILY COVERED THE DEFECT WITH AT LEAST 4 CM OVERLAP AROUND ALL THE EDGES OF THE HERNIA. A SEPRAFILM SLURRY WAS THEN INJECTED THROUGH A TOOMEY SYRINGE INTO THE PERITONEAL CAVITY. THE ABDOMEN WAS THEN DESUFFLATED. THE TROCARS WERE REMOVED. THE FASCIA IN THE LEFT UPPER QUADRANT WAS CLOSED WITH 0 VICRYL FIGURE-OF-EIGHT SUTURE. ALL THE SKIN INCISIONS WERE REAPPROXIMATED WITH 4-0 MONOCRYL AS RUNNING SUBCUTICULAR SUTURES. THE WOUNDS WERE DRESSED WITH DERMABOND. THE PATIENT WAS TAKEN TO THE POST ANESTHESIA CARE UNIT IN GOOD CONDITION.¿ 10/29/08: NORTHWEST MEDICAL CENTER. POSTOPERATIVE/POST PROCEDURE NOTE. IMPLANT STICKER. GORE DUALMESH® PLUS BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMCP04. LOT BATCH CODE: 05739429. W.L. GORE & ASSOCIATES. (B)(6) 2008: (B)(6) MEDICAL CENTER. INTRAOPERATIVE RECORD. IMPLANTS. MESH DUAL PLUS 15 X 19 X 1 CONSIGN. QUANTITY: 1. MANUFACTURER: 000630. LOT NUMBER: 05739429. CATALOG NUMBER: 1DLMCP04. GORE DUALMESH BIOMATERIAL. SITE: ABDOMEN. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/05739429) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2009: (B)(6) MEDICAL CENTER. JED SADALLA, MD. EMERGENCY RECORD. PRESENTED WITH LUMBAR PAIN, INCREASINGLY WORSE OVER PAST 3 DAYS. STARTED AFTER WALKING UP STAIRS CARRYING HER APPROXIMATELY 30 LB GRANDSON. PAIN AROUND BELLY BUTTON AFTER DOING THIS LIFTING. STATED PAIN VERY MILD. ABDOMEN SOFT, NONTENDER. DO NOT SEE ANY HERNIA OR ERYTHEMA AROUND BELLY BUTTON. IMPRESSION: ACUTE SCIATICA. (B)(6) 2009: (B)(6) MEDICAL CENTER-TUCSON. WILLARD R. CARNAHAN, MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. PROCEDURE: LAPAROSCOPIC REPAIR OF VENTRAL INCISIONAL HERNIA. FIRST ASSISTANT: TOM SMITH, RNFA. ANESTHESIOLOGIST: GARY SHARP, MD. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 45-YEAR-OLD FEMALE WHO SEVERAL MONTHS AGO HAD LAPAROSCOPIC REPAIR OF A VENTRAL INCISIONAL HERNIA. THE PATIENT HAS RECENTLY NOTICED PAIN AND BULGING AND ON PHYSICAL EXAMINATION HAS A RECURRENCE OF HER HERNIA. OPERATIVE FINDINGS: THE PATIENT HAD A HERNIA DEFECT THAT WAS ABOUT 4 X 4 CM IN SIZE. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AFTER INDUCTION OF A GENERAL ANESTHETIC, A FOLEY CATHETER WAS INSERTED INTO THE BLADDER AND THE ABDOMEN WAS THEN PREPPED AND DRAPED IN A STERILE MANNER. 0.5% MARCAINE WITH EPINEPHRINE WAS INJECTED LOCALLY IN THE RIGHT UPPER QUADRANT AND A TRANSVERSE SKIN INCISION WAS MADE. THIS WAS CARRIED DOWN THROUGH THE EXTERNAL OBLIQUE APONEUROSIS, WHICH WAS INCISED. THE MUSCLES WERE SPLIT IN THE DIRECTION OF THEIR FIBERS AND THE PERITONEUM WAS ENTERED UNDER DIRECT VISION WITH METZENBAUM SCISSORS. A HASSON TROCAR WAS INSERTED INTO THE PERITONEAL CAVITY AND THE PERITONEUM WAS INSUFFLATED TO A PRESSURE OF 12 MMHG OF CARBON DIOXIDE. TWO 5 MM PORTS WERE PLACED IN THE RIGHT LOWER QUADRANT AND LATER DURING THE CASE 2 MORE 5 MM PORTS WERE PLACED, 1 IN THE LEFT UPPER QUADRANT AND ANOTHER IN THE LEFT LOWER QUADRANT. THERE WERE SOME ADHESIONS NOTED BETWEEN THE OMENTUM AND THE HERNIA MESH. THESE WERE TAKEN DOWN WITH SHARP AND BLUNT DISSECTION. THE HERNIA DEFECT WAS IDENTIFIED. IT WAS INFERIOR TO THE LEFT OF THE MESH. THE HERNIA DEFECT AND EXTENT OF THE PREVIOUS MESH WAS MEASURED TO BE 8 X 9 CM AND A GORE DUAL MESH WAS OBTAINED, WHICH WAS 19 X 15 CM AND FOUR #2 GORE SUTURES WERE THEN SUTURED TO 4 EQUIDISTANT AREAS ON THE MESH. THE MESH WAS INSERTED INTO THE PERITONEUM THROUGH THE HASSON TROCAR. THE STAY SUTURES WERE BROUGHT OUT THROUGH THE ANTERIOR ABDOMINAL WALL SECURING THE MESH TIGHTLY WITHOUT ANY SLACK OVER THE HERNIA DEFECT AND OVER THE OLD MESH. THE GORE-TEX SUTURES WERE TIED. THE MESH WAS SECURED TO THE ANTERIOR ABDOMINAL WALL WITH THE PROTACK STAPLER. THE ABDOMINAL CAVITY WAS THEN DESUFFLATED. THE TROCARS WERE REMOVED. THE FASCIA AND THE INCISION AT THE RIGHT UPPER QUADRANT WERE CLOSED WITH 0 VICRYL FIGURE-OF-EIGHT SUTURE. THE SKIN INCISIONS WERE ALL REAPPROXIMATED WITH 4-0 MONOCRYL AS A RUNNING SUBCUTICULAR SUTURE. THE WOUNDS WERE DRESSED WITH DERMABOND AND THE PATIENT TAKEN TO THE POST-ANESTHETIC CARE UNIT IN GOOD CONDITION.¿ (B)(6) 2009: (B)(6) MEDICAL CENTER. POSTOPERATIVE/ POST PROCEDURE NOTE. IMPLANT STICKER. GORE DUALMESH® PLUS BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMCP04. LOT BATCH CODE: 06257309. EXP: 07/2011. (B)(6) 2009: (B)(6) MEDICAL CENTER. INTRAOPERATIVE RECORD. IMPLANTS. MESH DUAL PLUS 15 X 19 X 1 CONSIGN. QUANTITY: 1. MANUFACTURER: 000630. LOT NUMBER: 06257309. CATALOG NUMBER: 1DLMCP04. MESH DUAL PLUS. SITE: ABDOMEN. EXPIRATION DATE: 07/01/11. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/06257309) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2009: (B)(6) MEDICAL CENTER. JANELLE L. OLSON, MD. DISCHARGE SUMMARY. INSTRUCTIONS: NO HEAVY LIFTING OR STRENUOUS ACTIVITY. SHE MAY SHOWER. NO BATHS, NO SWIMMING. WEAR ABDOMINAL BINDER AT ALL TIMES. (B)(6) 2016: (B)(6) MEDICAL CENTER. MICHAEL R. SCHOENHALS, MD. DISCHARGE SUMMARY. ADMITTED FOR CHEST PAIN AND PERSISTENT VOMITING. HAD VERTICAL SLEEVE GASTRECTOMY APPROXIMATELY 2 YEARS AGO. BARIATRIC SURGEON SAW HER AND PERFORMED EGD WHICH REVEALED GASTRITIS, A 2-CM HIATAL HERNIA AND SOME TWISTING OF THE SLEEVE AT THE HIATAL OPENING. IMPRESSION: VOMITING, POSTOP ANATOMICAL IRREGULARITY PROBABLY THE ETIOLOGY; ACID PEPTIC GASTRITIS WITH GERD [GASTROESOPHAGEAL REFLUX DISEASE] AND HIATAL HERNIA; HISTORY OF ADULT ONSET DIABETES, RESOLVED SINCE GASTRIC SLEEVE. FULL LIQUID DIET, ACTIVITY AS TOLERATED. (B)(6) 2016: (B)(6) MEDICAL CENTER. GABRIEL H. HINTZSCHE, MD. EMERGENCY RECORD. REPORTS VOMITING UNRELIEVED BY ZOFRAN. UPPER & LOWER ABDOMINAL PAIN CONSTANT, SHARP, MODERATE AT ONSET/PRESENTATION, RADIATES TO CHEST, EXACERBATED BY LYING DOWN, NOT RELIEVED. IMPRESSION: EPIGASTRIC ABDOMINAL PAIN RELIEVED BY GI COCKTAIL AND REGLAN. (B)(6) 2016: (B)(6) MEDICAL CENTER. GREGORY LABENZ, MD. RADIOLOGY-UPPER GI WITH KUB BARIUM. INDICATION: 2 MONTHS OF VOMITING, GASTRIC SLEEVE SURGERY 2 YEARS AGO. IMPRESSION: GASTROESOPHAGEAL REFLUX. NO ULCERATION OR EROSION. (B)(6) 2016: (B)(6) ARIZONA CENTER FOR MINIMALLY INVASIVE SURGERY. STEPHEN BURPEE, MD. OFFICE NOTE. SEEN IN FOLLOW-UP AFTER GI SERIES. THIS SHOWED GASTROESOPHAGEAL REFLUX BUT SURPRISINGLY NO OBVIOUS HIATAL HERNIA. CONTINUES TO HAVE EPISODES OF RECURRENT VOMITING ALMOST DAILY AND SENSATION OF FOOD GETTING STUCK. OK WITH LIQUIDS. ASSESSMENT: RECURRENT VOMITING AFTER SLEEVE GASTRECTOMY. UPPER ENDOSCOPY SEEMED TO INDICATE A HIATAL HERNIA WITH SLIGHT TWISTING THAT COULD EXPLAIN HER SYMPTOMS AND UPPER GI DID NOT CORRELATE. I THINK MOST LIKELY SHE WOULD BENEFIT REPAIR OF HIATAL HERNIA BUT I WOULD LIKE TO REPEAT UPPER ENDOSCOPY FIRST IN CONJUNCTION WITH PH MONITORING FOR DEFINITIVE SURGICAL PLANNING. (B)(6) 2016: (B)(6) MEDICAL CENTER. STEPHEN E. BURPEE, MD. PROCEDURE REPORT. UPPER GI ENDOSCOPY. IMPRESSION: NORMAL ESOPHAGUS; SMALL HIATUS HERNIA; LA GRADE A REFLUX ESOPHAGITIS; NORMAL EXAMINED DUODENUM. (B)(6) 2016: (B)(6) MEDICAL CENTER. MATTHEW W. PRALL, MD. PATHOLOGY REPORT. ACCESSION: 400-SP-16-0009660. GASTRIC BIOPSY. DIAGNOSIS: FUNDIC TYPE GASTRIC MUCOSA, MILD CHRONIC INACTIVE GASTRITIS; NEGATIVE FOR HELICOBACTER SPECIES PER IMMUNOCHEMISTRY. PREOPERATIVE DIAGNOSIS: GERD [GASTROESOPHAGEAL REFLUX DISEASE]. POSTOPERATIVE DIAGNOSIS: MILD GASTRITIS. [MREYES-2PPR-BRN-00210] (B)(6) 2016: (B)(6) MEDICAL CENTER. MARCIN TURECKI, MD. RADIOLOGY-NM GASTRIC EMPTYING STUDY. INDICATION: ABDOMINAL PAIN, GERD [GASTROESOPHAGEAL REFLUX DISEASE]. IMPRESSION: NORMAL GASTRIC EMPTYING TIME. SEVERE GASTROESOPHAGEAL REFLUX. (B)(6) 2017: (B)(6) MEDICAL CENTER. STEPHEN BURPEE, MD. OPERATIVE REPORT. INDICATION FOR SURGERY: MRS. REYES IS A PLEASANT 53-YEAR-OLD FEMALE WHO HAS SIGNIFICANT GERD [GASTROESOPHAGEAL REFLUX DISEASE]. SHE UNDERWENT A LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY 2 YEARS AGO. SHE HAS NOW DEVELOPED A HIATAL HERNIA AND SIGNIFICANT GERD. SHE PRESENTED ELECTIVELY TODAY FOR A LAPAROSCOPIC CONVERSION OF SLEEVE GASTRECTOMY TO GASTRIC BYPASS WITH CONCURRENT REPAIR OF HIATAL HERNIA. PREOPERATIVE DIAGNOSIS: GERD [GASTROESOPHAGEAL REFLUX DISEASE]/HIATAL HERNIA. POSTOPERATIVE DIAGNOSIS: SAME. OPERATION: LAPAROSCOPIC GASTRIC BYPASS. LAPAROSCOPIC HIATAL HERNIA REPAIR. LAPAROSCOPIC LYSIS OF ADHESIONS. ASSISTANT: RENEE CORRIGAN, PA. ANESTHESIOLOGIST: LYNN BIANCHI, MD. ANESTHESIA: GEN [GENERAL]/ENDOTRACHEAL TUBE. ESTIMATED BLOOD LOSS: 25 CC. FINDINGS: EXTENSIVE INTRA-ABDOMINAL ADHESIONS, HIATAL HERNIA. SPECIMEN: NONE. COMPLICATIONS: NONE. TECHNIQUE: ¿THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. GENERAL ANESTHESIA WAS INDUCED AND AN ENDOTRACHEAL TUBE WAS PLACED WITHOUT DIFFICULTY. A FOLEY CATHETER WAS PLACED WITHOUT DIFFICULTY. FLUOROSCOPY WAS THEN USED TO MARK THE SPIRAL TACKS USED IN PRIOR LAPAROSCOPIC VENTRAL HERNIA REPAIR. THE ARMS WERE PLACED ON ARM BOARDS AND SECURED WITH ACE WRAPS. THE PATIENT WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE FASHION. MARCAINE 0.25% WAS INFILTRATED IN THE LEFT UPPER QUADRANT LATERAL TO THE SITE OF THE MESH. A 5 MM INCISION WAS MADE. A 5 MM OPTIVIEW TROCAR WAS INSERTED UNDER DIRECT VISION INTO THE PERITONEAL CAVITY WITHOUT DIFFICULTY. A PNEUMOPERITONEUM WAS CREATED UP TO 15 MMHG. A 5 MM LAPAROSCOPE WAS INSERTED AND THE ABDOMINAL CAVITY SURVEYED. WE NOTED SIGNIFICANT ADHESIONS OF OMENTUM TO THE ANTERIOR ABDOMINAL WALL AT THE SITE OF THE MESH. A 5 MM PORT WAS PLACED LATERALLY IN THE LEFT UPPER QUADRANT. A 5 MM 35° SCOPE WAS INSERTED. THE INITIAL PORT WAS INSPECTED AND WE NOTED THAT THE PORT ACTUALLY HAD GONE THROUGH THE SMALL BOWEL MESENTERY BUT UNFORTUNATELY AVOIDED INJURY TO THE BOWEL. THERE WAS SOME CARBON DIOXIDE GAS WITHIN THE LEAVES OF SMALL BOWEL MESENTERY. A THIRD 5 MM PORT WAS THEN PLACED LATERALLY IN THE LEFT MIDABDOMEN. THE INITIAL PORT WAS PULLED BACK OUT OF THE SMAII BOWEL MESENTERY AND THE SMAII BOWEL MESENTERY WAS FURTHER INSPECTED AND WE CONFIRMED THAT THERE WAS INDEED NO BOWEL INJURY. THERE WAS ALSO NO EVIDENCE OF BLEEDING. THE INITIAL 5 MM PORT WAS THEN CHANGED TO A 12 MM PORT. WE THEN PROCEEDED TO LYSE ALL OF THE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL THEREBY EXPOSING THE MESH AND THE REST OF THE UNDERSIDE OF THE ABDOMINAL WALL. THIS PROCESS TOOK ABOUT 30 MINUTES. WE THEN PLACED A 12 MM PORT IN THE MIDLINE JUST ABOVE THE LEVEL OF THE MESH. ANOTHER 12 MM PORT WAS PLACED IN THE MID RIGHT UPPER QUADRANT AND A 5 MM PORT PLACED LATERALLY IN THE RIGHT UPPER QUADRANT. WE THEN REFLECTED THE GREATER OMENTUM INTO THE UPPER ABDOMEN TO EXPOSE THE LIGAMENT OF TREITZ. THE SMALL BOWEL WAS FOLLOWED FROM THE LIGAMENT OF TREITZ APPROXIMATELY 200 CM DISTALLY TO MAKE SURE THERE WAS NO ADHESIONS TO THE SMALL BOWEL WHICH THERE WERE NOT. WE THEN PROCEEDED TO THE UPPER ABDOMEN. A NATHANSON LIVER RETRACTOR WAS INSERTED THROUGH A STAB INCISION IN THE EPIGASTRIUM AND USED TO RETRACT THE LEFT LOBE OF THE LIVER. THE PATIENT WAS PLACED IN STEEP REVERSE TRENDELENBURG POSITION. THE SLEEVE GASTRECTOMY WAS NOTED. WE THEN MOBILIZED OMENTAL ADHESIONS FROM THE LATERAL ASPECT OF THE SLEEVE FROM THE MIDPORTION PROXIMALLY TO THE LEFT CRUS. ELECTROCAUTERY WAS USED TO PERFORM THIS. A HIATAL HERNIA WAS NOTED AND THEN WE PROCEEDED TO FULL HIATAL DISSECTION. THE PARS FLACCIDA WAS OPENED UP USING ELECTROCAUTERY. THE PHRENOESOPHAGEAL MEMBRANE ANTERIOR TO THE ESOPHAGUS WAS DIVIDED. WE THEN DISSECTED ALONG THE MEDIAL EDGE OF THE RIGHT CRUS THE DIAPHRAGM EXTENDING FROM THE ANTERIOR ARCH BACK TO THE CONFLUENCE OF THE LEFT AND RIGHT CRURA. WE THEN DISSECTED ALONG THE MEDIAL EDGE OF THE LEFT CRUS OF THE DIAPHRAGM AND DIVIDED PERITONEAL ATTACHMENTS AT THE REGION OF THE ANGLE OF HIS. A WINDOW WAS THEN MADE POSTERIOR TO THE ESOPHAGUS. AT THIS JUNCTURE, WE HAD GOOD CIRCUMFERENTIAL DISSECTION OF THE HIATUS. THE GASTROESOPHAGEAL JUNCTION WAS 4-5 CM BELOW THE LEVEL OF THE HIATUS. THE VAGAL NERVES WERE IDENTIFIED AND PRESERVED. REPAIR WAS THEN PERFORMED USING INTERRUPTED FIGURE-OF-EIGHT 0 SURGIDAC SUTURES. 2 INTERRUPTED SUTURES WERE PLACED. THE REPAIR WAS INSPECTED. THE CRURA WERE NICELY APPROXIMATED WITHOUT BEING TOO TIGHT. DR. BIANCHI THEN PLACED AN OROGASTRIC TUBE WITH THE SIZING BALLOON INTO THE STOMACH. WE INFLATED THIS TO 20 CC AND BROUGHT THIS BACK SNUGLY TO THE GASTROESOPHAGEAL JUNCTION. THIS WAS USED TO ASSESS THE SIZE OF THE GASTRIC POUCH. THE BALLOON WAS THEN DEFLATED AND REMOVED. WE THEN PROCEEDED TO THE SMALL BOWEL PORTION OF THE CASE. THE PATIENT WAS THEN PLACED IN SLIGHT TRENDELENBURG POSITION. THE GREATER OMENTUM WAS REFLECTED IN THE UPPER ABDOMEN TO EXPOSE THE TRANSVERSE COLON. THE TRANSVERSE MESOCOLON WAS RETRACTED SUPERIORLY TO EXPOSE THE LIGAMENT OF TREITZ. THE JEJUNUM WAS THEN MEASURED 50 CM DISTAL TO THE LIGAMENT OF TREITZ AND TRANSECTED AT THIS LOCATION USING AN ENDOSCOPIC LINEAR STAPLER WITH A WHITE CARTRIDGE. THE MESENTERY WAS THEN DIVIDED USING THE HARMONIC SCALPEL DOWN TO THE ROOT OF THE MESENTERY. THE DISTAL JEJUNUM WAS THEN MEASURED 100 CM TO CREATE A ROUX LIMB. A SIDE-TO-SIDE ANASTOMOSIS WAS THEN MADE BETWEEN THE BILIOPANCREATIC LIMB AND THE ROUX LIMB. CARE WAS TAKEN TO MAKE SURE THAT THE 2 LIMBS OF BOWEL HAD NOT BEEN TWISTED. ENTEROTOMIES WERE MADE IN THE ANTIMESENTERIC BORDER OF EACH LIMB OF BOWEL AND THEN 2 SEQUENTIAL FIRINGS OF THE ECHELON ENDOSCOPIC LINEAR STAPLER, 45 MM IN LENGTH WITH A WHITE CARTRIDGE WAS PERFORMED IN ORDER TO CREATE THE ANASTOMOSIS. THE ENTEROTOMY WAS THEN OVERSEWN USING A RUNNING 2-0 POLYSORB WITH LAPRA-TY'S ON EITHER END. THE ANASTOMOSIS WAS REINFORCED WITH 2-0 POLYSORB INTERRUPTED SUTURES BOTH MEDIALLY AND LATERALLY. THE MESENTERIC DEFECT WAS THEN CLOSED WITH A RUNNING 2-0 SURGIDAC. THE GREATER OMENTUM WAS THEN DIVIDED USING THE HARMONIC SCALPEL. THE ROUX LIMB WAS BROUGHT INTO THE UPPER ABDOMEN BETWEEN THE DIVIDED LEAVES OF GREATER OMENTUM. THE LESSER OMENTUM WAS THEN DIVIDED USING THE HARMONIC SCALPEL AND THE STOMACH WAS TRANSECTED USING AN ENDOSCOPIC LINEAR STAPLER WITH A GOLD CARTRIDGE IN OBLIQUE FASHION HEADING TOWARDS THE LEFT UPPER QUADRANT. ONLY ONE FIRING OF THE 45 MM STAPLER WAS REQUIRED TO COMPLETE THE TRANSECTION OF THE SLEEVE LEAVING A POUCH APPROXIMATELY 20-30 CC IN SIZE. THE STAPLE LINE WAS INSPECTED FOR HEMOSTASIS WHICH WAS EXCELLENT. THE ROUX LIMB WAS THEN BROUGHT UP TO THE POSTERIOR SURFACE OF THE GASTRIC POUCH AND SECURED IN PLACE WITH A RUNNING 2-0 POLYSORB SUTURE. ENTEROTOMIES WERE MADE IN THE ANTIMESENTERIC BORDER OF THE ROUX LIMB AND THE POSTERIOR ASPECT OF THE GASTRIC POUCH. AN ENDOSCOPIC LINEAR STAPLER WITH A BLUE CARTRIDGE WAS INSERTED 25 MM AND FIRED TO CREATE THE ANASTOMOSIS. THE STAPLE LINE WAS INSPECTED FOR INTEGRITY AND HEMOSTASIS WHICH WAS EXCELLENT. THE ENTEROTOMY WAS THEN CLOSED USING RUNNING 2-0 POLYSORB, ONE FROM EACH SIDE AND TIED IN THE MIDDLE. AN ANTERIOR ROW OF 2-0 POLYSORB WAS THEN PLACED. A BOWEL CLAMP WAS PLACED ON THE ROUX LIMB AND A GASTROSCOPE WAS PASSED WITHOUT DIFFICULTY DOWN THROUGH THE OROPHARYNX, DOWN THE ESOPHAGUS AND INTO THE GASTRIC POUCH. THE ANASTOMOSIS WAS SUBMERGED UNDER SALINE SOLUTION DURING THIS PROCESS AND NO BUBBLING ENSUED INDICATING A NEGATIVE LEAK TEST. THE POUCH WAS INSPECTED AND HEMOSTASIS WAS COMPLETE. THE SCOPE WAS PASSED WITHOUT DIFFICULTY THROUGH THE ANASTOMOSIS AND INTO THE ROUX LIMB. THE ROUX LIMB AND THE POUCH WAS THEN SUCTIONED OUT AND THE SCOPE WAS REMOVED. THE OPERATIVE FIELD WAS INSPECTED FOR HEMOSTASIS WHICH WAS EXCELLENT. THE ROUX LIMB WAS FOLLOWED FROM THE GASTRIC POUCH BACK TO THE JEJUNOJEJUNOSTOMY AND THERE WAS NO EVIDENCE OF KINK OR TWIST. THE NATHANSON LIVER RETRACTOR WAS REMOVED AND THE PATIENT WAS PLACED IN SUPINE POSITION. THE MESENTERIC DEFECT BETWEEN THE ROUX LIMB MESENTERY AND THE MESENTERY OF THE TRANSVERSE COLON WAS CLOSED WITH A RUNNING 2-0 SURGIDAC. THE ENTIRE OPERATIVE FIELD WAS AGAIN INSPECTED FOR HEMOSTASIS. THE SITE OF MESENTERIC INJURY BY THE INITIAL PORT SITE WAS AGAIN INSPECTED AND THERE WAS NO EVIDENCE OF DAMAGE TO THE BOWEL OR BLEEDING INTO THE MESENTERY. THE FASCIA TO ALL 3 12 MM PORT SITES WAS CLOSED USING A 0 VICRYL SUTURE WITH A LAPAROSCOPIC SUTURE PASSER DEVICE. THE PNEUMOPERITONEUM WAS THEN RELEASED AND ALL TROCARS WERE REMOVED. ALL SKIN INCISIONS WERE CLOSED WITH 4-0 SUBCUTICULAR VICRYL. SKIN GLUE WAS THEN APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.¿ (B)(6) 2017 (B)(6) MEDICAL CENTER. STEPHEN BURPEE, MD. DISCHARGE INSTRUCTIONS: AVOID LIFTING ANYTHING OVER 10 POUNDS FOR 6 WEEKS AFTER SURGERY, OR UNTIL APPROVED BY YOUR SURGEON. (B)(6) 2018: (B)(6) HOSPITAL. STEPHEN HOCHEDER, MD. DISCHARGE SUMMARY. PRESENTED WITH COMPLAINTS OF EPIGASTRIC ABDOMINAL PAIN, VOMITING AND DIARRHEA. HAD PAIN X 1 WEEK. REPORTED IT ¿FEELS LIKE A HERNIA.¿ DIAGNOSIS: ABDOMINAL PAIN UNDIFFERENTIATED. MEDICALLY CLEARED, DISCHARGED. (B)(6) 2018: (B)(6) HOSPITAL. GUY BORDERS. RADIOLOGY-CT ABDOMEN/PELVIS. ANTERIOR ABDOMINAL WALL MESH PRESENT. NO ACUTE INTRA-ABDOMINAL OR PELVIC ABNORMALITY IDENTIFIED. (B)(6) 2018: (B)(6) HOSPITAL. KYLE P. TIEMEIR, MD/ LORENA S. EVANS, NP. EMERGENCY RECORD. PRESENTED WITH COMPLAINTS OF 2 DAYS OF NAUSEA, VOMITING AND DIARRHEA. REPORTS EPIGASTRIC BURNING PAIN. ON EXAM: EPIGASTRIC GERD. INITIALLY GIVEN GI COCKTAIL. LABS AND CT UNREMARKABLE. CONCERN OF POSSIBLE GASTRITIS. DISCHARGED. (B)(6) 2018: (B)(6) HOSPITAL. GREGORY LABENZ, MD. RADIOLOGY-CT ABDOMEN/PELVIS. NO ACUTE FINDINGS IN ABDOMEN OR PELVIS. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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.¿ 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.
B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. H10/11: ADDED MEDICAL RECORD INFORMATION. CORRECTION: THE ADDED PATIENT MEDICAL RECORD INFORMATION IN H10/11 ON THE PREVIOUS MEDWATCH #251272 WAS SENT IN ERROR AND DOES NOT PERTAIN TO THIS EVENT. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: [MISSING RECORDS: RECORDS PRIOR TO 06/22/07 INCLUDING RECORDS FOR LAP BANDING AND CHOLECYSTECTOMY WERE NOT PROVIDED.] (B)(6) 2007:UNIVERSITY HOSPITAL. STEVEN CASOS, MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INCISIONAL UMBILICAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCISIONAL UMBILICAL HERNIA. PROCEDURE PERFORMED: LAPAROSCOPIC INCISIONAL HERNIA REPAIR AT THE UMBILICUS. (THIS HERNIA WAS REDUCED AND NOT INCARCERATED). INDICATIONS: ¿MS. BUSH IS A 46-YEAR-OLD FEMALE WHO HAS PRESENTED TO CLINIC WITH COMPLAINTS OF A PAINFUL INCISIONAL UMBILICAL HERNIA. SHE HAS THIS HERNIA FROM HER PRIOR LAP BANDING AND LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURES. SHE HAS BEEN EXPLAINED THE NATURE OF THE SURGERY, THE RISKS, BENEFITS AND ALTERNATIVES AND BEEN AFFORDED THE OPPORTUNITY TO ASK QUESTIONS. SHE HAS DONE ALL OF THESE THINGS AND UNDERSTANDS THE PROCEDURE WE HAVE PLANNED FOR HER TODAY. FINDINGS: DESCRIPTION OF PROCEDURE: THE PATIENT RECEIVED KEFZOL PREOPERATIVE ANTIBIOTIC BEFORE GOING INTO THE OPERATING ROOM. WE THEN PLACED THE PATIENT IN TEDS AND SCDS AND ON THE OPERATING ROOM TABLE IN THE SUPINE POSITION GENERAL ENDOTRACHEAL ANESTHESIA WAS ESTABLISHED. AFTER DOING THIS, WE PREPPED AND DRAPED THE PATIENT'S ABDOMEN IN THE STANDARD STERILE FASHION USING AN LOBAN FOR SKIN PROTECTION. WE BEGAN BY PALPATING HER UMBILICAL HERNIA WHICH WAS NOTED TO BE COMPLETELY REDUCED BY PHYSICAL EXAMINATION. WE THEN PLACED A LEFT UPPER QUADRANT 5 MILLIMETER OPTIVIEW UNDER DIRECT VISUALIZATION, ENTERING HER PERITONEUM WITHOUT INCIDENT. WE PLACED AN ADDITIONAL TROCAR IN THE LEFT LATERAL ABDOMINAL WALL WHICH WAS 10 MILLIMETERS WITHOUT INCIDENT. WE ANESTHETIZED BOTH THESE SITES WITH 1.1% MARCAINE AS WE DID WITH ALL OF OUR TROCAR SITES. WE THEN BEGAN IDENTIFYING HER HERNIA EXTERNALLY AND MEASURING FOR OUR MESH. THERE WAS NO OMENTUM OR BOWEL MATERIAL IN HER HERNIA. ALL CONTENTS WERE REDUCED PRIOR TO THE OPERATION. WE THEN MEASURED OUR MESH, MEASURING FOR 3 CENTIMETERS FROM EACH MARGIN OF HER HERNIA DEFECT OVERLAP. WE THEN USED A PIECE OF GORE-TEX DUALMESH AND CUT TO FIT OUR MEASURED DIAMETER. WE THEN USED FOUR GORE-TEX SUTURES TO TIE TO THE MESH AND ORIENTED THE MESH WITH NUMERICAL MARKINGS ON THE SURFACE OF THE MESH. WE THEN PLACED THE MESH INTRAABDOMINAL AND ESTABLISHED A FURTHER UPPER MIDEPIGASTRIC 5 MILLIMETER TROCAR SITE FOR FURTHER MESH MANIPULATION WITH ANOTHER ASCU LAP. WE ORIENTED THE MESH, USED THE ENDOSTITCH PASSER TO PASS THE GORE-TEX SUTURES THROUGH THE FASCIA TIMES FOUR, ONE AT EACH NUMERICAL CORNER OF THE MESH. THESE WERE THEN TIED DOWN AND WE INTRODUCED A TACKER AND BEGAN TACKING THE EDGE OF THE MESH. WE NOTED AFTER PLACING SEVEN TACKS THAT THE MESH WAS PULLING AWAY FROM ONE OF ITS GORE-TEX STAY SUTURES. WE REINFORCED THIS WITH ADDITIONAL GORE-TEX SUTURE AND REMOVED THE ORIGINAL SUTURE. WE THEN PLACED ONE MORE GORE-TEX SUTURE IN THIS AREA AND THEN CIRCUMFERENTIALLY SECURED THE MESH WITH TACKS. WE DID HAVE TO REMOVE FOUR OF OUR ORIGINALLY PLACED TACKS TO ALLOW FOR THE MESH TO RETURN TO ITS MORE NATURAL POSITION TO COVER THE DEFECT WITH 3 CENTIMETERS OVERLAP AT EACH EDGE. THE PATIENT TOLERATED ALL PORTIONS OF THIS PROCEDURE WELL. WE IDENTIFIED HER LAPAROSCOPIC GASTRIC BAND PORT WHICH APPEARED TO BE IN GOOD POSITION AND WITHOUT ANY ABNORMALITY. AFTER PLACING THE MESH, WE USED THE ENDOSTITCH SUTURE PASSER TO REPAIR THE FASCIA AT OUR 10 MILLIMETER LEFT LOWER QUADRANT TROCAR SITE WITH AN 0 ETHIBOND. WE DE-INSUFFLATED THE PATIENT'S ABDOMEN. THERE WAS NO EVIDENCE OF BLEEDING AND SPECIFICALLY NO EVIDENCE OF INJURY UNDER ANY OF OUR TROCAR SITES TO THE BOWEL OR OMENTAL STRUCTURES. THE PATIENT'S SKIN INCISIONS WERE THEN CLOSED WITH 4-0 VICRYL IN SUBCUTICULAR FASHION AND PLACED STERI-STRIPS AND BAND-AIDS OVER EACH OF THESE. THE PATIENT TOLERATED ALL PORTIONS OF THE PROCEDURE WELL.¿ (B)(6) 2007:UNIVERSITY HOSPITAL. IMPLANT STICKER. GORE DUALMESH® BIOMATERIAL. REF: 1DLMC03. LOT: 04997410. W. L. GORE & ASSOCIATES. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC03/04997410) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2007:UNIVERSITY HOSPITAL. STEVEN CASOS, MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE PERFORMED: LAPAROSCOPIC RECURRENT INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. INDICATIONS: ¿MS. BUSH IS A 46-YEAR-OLD LADY, MORBIDLY OBESE, WHO HAD A PREVIOUS LAP BAND WITH A POOR RESULT. HOWEVER, SHE HAD BEEN NONCOMPLIANT WITH THE FOLLOW-UP. SHE REMAINS MORBIDLY OBESE AND HAD A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED-MORE RECENTLY. SHE DEVELOPED A HERNIA AT THE UMBILICAL TROCAR SITE. I PERFORMED LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON HER ABOUT TWO MONTHS AGO, AND SHE RECURRED SHORTLY THEREAFTER, AFTER SHE WAS GETTING UP FROM HER COUCH AND STRAINING. SHE FELT SOMETHING POP AND HAD A MASS IN HER UMBILICUS. I SAW HER IN THE OFFICE AND FELT SHE HAD AN EARLY RECURRENCE. SHE WAS BROUGHT TO THE OPERATING ROOM TODAY FOR LAPAROSCOPY AND REPAIR OF RECURRENCE OF INCISIONAL HERNIA. FINDINGS: OMENTAL HERNIA ON THE LEFT INFEROLATERAL BORDER OF PREVIOUS HERNIA REPAIR. DESCRIPTION OF PROCEDURE: AFTER RECEIVING AN INFORMED CONSENT INCLUDING POSSIBLE OPEN PROCEDURE, THE PATIENT WAS BROUGHT TO THE OPERATING THEATER AND POSITIONED SUPINE. SHE WAS ADMINISTERED GENERAL ANESTHESIA AND INTUBATED. SHE RECEIVED PREOPERATIVE ANTIBIOTICS IN THE FORM OF KEFZOL 2 GRAMS IV PRIOR TO INCISION. I PLACED A 5- MILLIMETER TROCAR IN THE LEFT UPPER QUADRANT LATERAL TO WHERE THE PREVIOUS TROCAR SITE WAS PLACED. THE OPTIVIEW TROCAR WAS ENTERED WITHOUT DIFFICULTY AND WE INSUFFLATED THE ABDOMEN. WE FOUND THAT SHE DID HAVE A LARGE AMOUNT OF OMENTUM STUCK UP TO THE LATERAL LEFT INFERIOR BORDER OF THE PREVIOUS HERNIA REPAIR. WE PLACED ADDITIONAL 5-MILLIMETER TROCARS IN THE LEFT LOWER QUADRANT IN THE EPIGASTRIC AREA. WE THEN UP-SIZED OUR INITIAL TROCAR TO A 10-MILLIMETER TROCAR. WE THEN USED A 30-DEGREE 10-MILLIMETER SCOPE AND TWO VASCULAR GRASPERS TO REDUCE THE HERNIA. THE HERNIA DEFECT ITSELF WAS NOT THAT IMPRESSIVE. WE THEN TOOK A 10 X 15-CENTIMETER PIECE OF GORE-TEX MESH, AFFIXED THE GORE-TEX ON THE FLOOR AREAS AND THEN PLACED THE MESH IN THE ABDOMEN. WE SITUATED THIS MESH AT AN ANGLE WITH THE LARGEST PORTION OF IT EXTENDING DOWN TOWARDS THE LEFT LOWER QUADRANT. IT OVERLAPPED THE PREVIOUS MESH ENTIRELY. IT WAS TACKED IN PLACE WITH PROTACK AS WELL AS FOUR SUTURES THAT WE HAD PLACED. WE ALSO PLACED TWO ADDITIONAL PROLENE SUTURES IN THE LEFT UPPER QUADRANT ASPECT OF THE MESH. WE WERE VERY SATISFIED WITH THE MESH REPAIR ESPECIALLY OVER THE AREA OF CONCERN WHERE THE OVERLAY FROM THE PREVIOUS MESH WAS PROBABLY NOT SUFFICIENT AND WHERE THE RECURRENCE OCCURRED. WE THEN CLOSED THE 10-MILLIMETER TROCAR SITE WITH A PARKER-THOMPSON TROCAR SITE CLOSURE SYSTEM. WE WATCHED THE PROLENE SUTURE BEING TIED UNDER DIRECT VISUALIZATION WITH GOOD CLOSURE OF THAT TROCAR SITE. WE DID NOT CLOSE THE 5-MILLIMETER TROCAR SITE. THE SKIN WAS CLOSED WITH MONOCRYL AND STERI-STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN GOOD ORDER. SHE WAS THEN DISCHARGED TO HOME.¿ THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿GORE-TEX MESH¿ 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 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.¿ 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.
B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULTS CODE. 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: [MISSING RECORDS: RECORDS PRIOR TO 06/22/07 INCLUDING RECORDS FOR LAP BANDING AND CHOLECYSTECTOMY WERE NOT PROVIDED.] (B)(6) 2007: (B)(6). OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INCISIONAL UMBILICAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCISIONAL UMBILICAL HERNIA. PROCEDURE PERFORMED: LAPAROSCOPIC INCISIONAL HERNIA REPAIR AT THE UMBILICUS. (THIS HERNIA WAS REDUCED AND NOT INCARCERATED). INDICATIONS: ¿MS. (B)(6) IS A 46-YEAR-OLD FEMALE WHO HAS PRESENTED TO CLINIC WITH COMPLAINTS OF A PAINFUL INCISIONAL UMBILICAL HERNIA. SHE HAS THIS HERNIA FROM HER PRIOR LAP BANDING AND LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURES. SHE HAS BEEN EXPLAINED THE NATURE OF THE SURGERY, THE RISKS, BENEFITS AND ALTERNATIVES AND BEEN AFFORDED THE OPPORTUNITY TO ASK QUESTIONS. SHE HAS DONE ALL OF THESE THINGS AND UNDERSTANDS THE PROCEDURE WE HAVE PLANNED FOR HER TODAY. FINDINGS: DESCRIPTION OF PROCEDURE: THE PATIENT RECEIVED KEFZOL PREOPERATIVE ANTIBIOTIC BEFORE GOING INTO THE OPERATING ROOM. WE THEN PLACED THE PATIENT IN TEDS AND SCDS AND ON THE OPERATING ROOM TABLE IN THE SUPINE POSITION GENERAL ENDOTRACHEAL ANESTHESIA WAS ESTABLISHED. AFTER DOING THIS, WE PREPPED AND DRAPED THE PATIENT'S ABDOMEN IN THE STANDARD STERILE FASHION USING AN LOBAN FOR SKIN PROTECTION. WE BEGAN BY PALPATING HER UMBILICAL HERNIA WHICH WAS NOTED TO BE COMPLETELY REDUCED BY PHYSICAL EXAMINATION. WE THEN PLACED A LEFT UPPER QUADRANT 5 MILLIMETER OPTIVIEW UNDER DIRECT VISUALIZATION, ENTERING HER PERITONEUM WITHOUT INCIDENT. WE PLACED AN ADDITIONAL TROCAR IN THE LEFT LATERAL ABDOMINAL WALL WHICH WAS 10 MILLIMETERS WITHOUT INCIDENT. WE ANESTHETIZED BOTH THESE SITES WITH 1.1% MARCAINE AS WE DID WITH ALL OF OUR TROCAR SITES. WE THEN BEGAN IDENTIFYING HER HERNIA EXTERNALLY AND MEASURING FOR OUR MESH. THERE WAS NO OMENTUM OR BOWEL MATERIAL IN HER HERNIA. ALL CONTENTS WERE REDUCED PRIOR TO THE OPERATION. WE THEN MEASURED OUR MESH, MEASURING FOR 3 CENTIMETERS FROM EACH MARGIN OF HER HERNIA DEFECT OVERLAP. WE THEN USED A PIECE OF GORE-TEX DUALMESH AND CUT TO FIT OUR MEASURED DIAMETER. WE THEN USED FOUR GORE-TEX SUTURES TO TIE TO THE MESH AND ORIENTED THE MESH WITH NUMERICAL MARKINGS ON THE SURFACE OF THE MESH. WE THEN PLACED THE MESH INTRAABDOMINAL AND ESTABLISHED A FURTHER UPPER MIDEPIGASTRIC 5 MILLIMETER TROCAR SITE FOR FURTHER MESH MANIPULATION WITH ANOTHER ASCU LAP. WE ORIENTED THE MESH, USED THE ENDOSTITCH PASSER TO PASS THE GORE-TEX SUTURES THROUGH THE FASCIA TIMES FOUR, ONE AT EACH NUMERICAL CORNER OF THE MESH. THESE WERE THEN TIED DOWN AND WE INTRODUCED A TACKER AND BEGAN TACKING THE EDGE OF THE MESH. WE NOTED AFTER PLACING SEVEN TACKS THAT THE MESH WAS PULLING AWAY FROM ONE OF ITS GORE-TEX STAY SUTURES. WE REINFORCED THIS WITH ADDITIONAL GORE-TEX SUTURE AND REMOVED THE ORIGINAL SUTURE. WE THEN PLACED ONE MORE GORE-TEX SUTURE IN THIS AREA AND THEN CIRCUMFERENTIALLY SECURED THE MESH WITH TACKS. WE DID HAVE TO REMOVE FOUR OF OUR ORIGINALLY PLACED TACKS TO ALLOW FOR THE MESH TO RETURN TO ITS MORE NATURAL POSITION TO COVER THE DEFECT WITH 3 CENTIMETERS OVERLAP AT EACH EDGE. THE PATIENT TOLERATED ALL PORTIONS OF THIS PROCEDURE WELL. WE IDENTIFIED HER LAPAROSCOPIC GASTRIC BAND PORT WHICH APPEARED TO BE IN GOOD POSITION AND WITHOUT ANY ABNORMALITY. AFTER PLACING THE MESH, WE USED THE ENDOSTITCH SUTURE PASSER TO REPAIR THE FASCIA AT OUR 10 MILLIMETER LEFT LOWER QUADRANT TROCAR SITE WITH AN 0 ETHIBOND. WE DE-INSUFFLATED THE PATIENT'S ABDOMEN. THERE WAS NO EVIDENCE OF BLEEDING AND SPECIFICALLY NO EVIDENCE OF INJURY UNDER ANY OF OUR TROCAR SITES TO THE BOWEL OR OMENTAL STRUCTURES. THE PATIENT'S SKIN INCISIONS WERE THEN CLOSED WITH 4-0 VICRYL IN SUBCUTICULAR FASHION AND PLACED STERI-STRIPS AND BAND-AIDS OVER EACH OF THESE. THE PATIENT TOLERATED ALL PORTIONS OF THE PROCEDURE WELL.¿ (B)(6) 2007: (B)(6). IMPLANT STICKER. GORE DUALMESH® BIOMATERIAL. REF: 1DLMC03. LOT: 04997410. W. L. GORE & ASSOCIATES. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC03/04997410) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2007: (B)(6). OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE PERFORMED: LAPAROSCOPIC RECURRENT INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. INDICATIONS: ¿MS. (B)(6) IS A 46-YEAR-OLD LADY, MORBIDLY OBESE, WHO HAD A PREVIOUS LAP BAND WITH A POOR RESULT. HOWEVER, SHE HAD BEEN NONCOMPLIANT WITH THE FOLLOW-UP. SHE REMAINS MORBIDLY OBESE AND HAD A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED-MORE RECENTLY. SHE DEVELOPED A HERNIA AT THE UMBILICAL TROCAR SITE. I PERFORMED LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON HER ABOUT TWO MONTHS AGO, AND SHE RECURRED SHORTLY THEREAFTER, AFTER SHE WAS GETTING UP FROM HER COUCH AND STRAINING. SHE FELT SOMETHING POP AND HAD A MASS IN HER UMBILICUS. I SAW HER IN THE OFFICE AND FELT SHE HAD AN EARLY RECURRENCE. SHE WAS BROUGHT TO THE OPERATING ROOM TODAY FOR LAPAROSCOPY AND REPAIR OF RECURRENCE OF INCISIONAL HERNIA. FINDINGS: OMENTAL HERNIA ON THE LEFT INFEROLATERAL BORDER OF PREVIOUS HERNIA REPAIR. DESCRIPTION OF PROCEDURE: AFTER RECEIVING AN INFORMED CONSENT INCLUDING POSSIBLE OPEN PROCEDURE, THE PATIENT WAS BROUGHT TO THE OPERATING THEATER AND POSITIONED SUPINE. SHE WAS ADMINISTERED GENERAL ANESTHESIA AND INTUBATED. SHE RECEIVED PREOPERATIVE ANTIBIOTICS IN THE FORM OF KEFZOL 2 GRAMS IV PRIOR TO INCISION. I PLACED A 5- MILLIMETER TROCAR IN THE LEFT UPPER QUADRANT LATERAL TO WHERE THE PREVIOUS TROCAR SITE WAS PLACED. THE OPTIVIEW TROCAR WAS ENTERED WITHOUT DIFFICULTY AND WE INSUFFLATED THE ABDOMEN. WE FOUND THAT SHE DID HAVE A LARGE AMOUNT OF OMENTUM STUCK UP TO THE LATERAL LEFT INFERIOR BORDER OF THE PREVIOUS HERNIA REPAIR. WE PLACED ADDITIONAL 5-MILLIMETER TROCARS IN THE LEFT LOWER QUADRANT IN THE EPIGASTRIC AREA. WE THEN UP-SIZED OUR INITIAL TROCAR TO A 10-MILLIMETER TROCAR. WE THEN USED A 30-DEGREE 10-MILLIMETER SCOPE AND TWO VASCULAR GRASPERS TO REDUCE THE HERNIA. THE HERNIA DEFECT ITSELF WAS NOT THAT IMPRESSIVE. WE THEN TOOK A 10 X 15-CENTIMETER PIECE OF GORE-TEX MESH, AFFIXED THE GORE-TEX ON THE FLOOR AREAS AND THEN PLACED THE MESH IN THE ABDOMEN. WE SITUATED THIS MESH AT AN ANGLE WITH THE LARGEST PORTION OF IT EXTENDING DOWN TOWARDS THE LEFT LOWER QUADRANT. IT OVERLAPPED THE PREVIOUS MESH ENTIRELY. IT WAS TACKED IN PLACE WITH PROTACK AS WELL AS FOUR SUTURES THAT WE HAD PLACED. WE ALSO PLACED TWO ADDITIONAL PROLENE SUTURES IN THE LEFT UPPER QUADRANT ASPECT OF THE MESH. WE WERE VERY SATISFIED WITH THE MESH REPAIR ESPECIALLY OVER THE AREA OF CONCERN WHERE THE OVERLAY FROM THE PREVIOUS MESH WAS PROBABLY NOT SUFFICIENT AND WHERE THE RECURRENCE OCCURRED. WE THEN CLOSED THE 10-MILLIMETER TROCAR SITE WITH A PARKER-THOMPSON TROCAR SITE CLOSURE SYSTEM. WE WATCHED THE PROLENE SUTURE BEING TIED UNDER DIRECT VISUALIZATION WITH GOOD CLOSURE OF THAT TROCAR SITE. WE DID NOT CLOSE THE 5-MILLIMETER TROCAR SITE. THE SKIN WAS CLOSED WITH MONOCRYL AND STERI-STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN GOOD ORDER. SHE WAS THEN DISCHARGED TO HOME.¿ THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿GORE-TEX MESH¿ 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 GORE® DUALMESH® BIOMATERIAL 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. 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: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. 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. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODE (3191: APPROPRIATE TERM NOT AVAILABLE FOR "REVISION") WAS REPORTED BASED ON THE ORIGINAL COMPLAINT AND IS NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2007 THROUGH (B)(6) 2007 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. PATIENT INFORMATION: MEDICAL HISTORY: OBESITY: (B)(6) 2007: 324 LBS., BMI 52.2, (B)(6) 2007: 336 LBS., BMI 54.2, (B)(6) 2007: 320 LBS., BMI 51.6, SEVERE GASTROESOPHAGEAL REFLUX DISEASE [GERD]; OBSTRUCTIVE SLEEP APNEA [OSA]; (B)(6) 2007: INCISIONAL UMBILICAL HERNIA; (B)(6) 2007: OMENTAL HERNIA. SURGICAL PROCEDURES: 2003: LAP BAND PROCEDURE, 2004: PORT REATTACHED, 2005: CHOLECYSTECTOMY. (B)(6) 2007: LAPAROSCOPIC INCISIONAL HERNIA REPAIR AT THE UMBILICUS WITH GORE-TEX DUALMESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL. (B)(6) 2007: LAPAROSCOPIC RECURRENT INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL. [NO ALLEGATIONS FOR THIS DEVICE] IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2007: INDICATIONS: ¿46-YEAR-OLD FEMALE WHO HAS PRESENTED TO CLINIC WITH COMPLAINTS OF A PAINFUL INCISIONAL UMBILICAL HERNIA. SHE HAS THIS HERNIA FROM HER PRIOR LAP BANDING AND LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURES. SHE HAS BEEN EXPLAINED THE NATURE OF THE SURGERY, THE RISKS, BENEFITS AND ALTERNATIVES AND BEEN AFFORDED THE OPPORTUNITY TO ASK QUESTIONS. SHE HAS DONE ALL OF THESE THINGS AND UNDERSTANDS THE PROCEDURE WE HAVE PLANNED FOR HER TODAY.¿ IMPLANT #1 PROCEDURE: LAPAROSCOPIC INCISIONAL HERNIA REPAIR AT THE UMBILICUS. (THIS HERNIA WAS REDUCED AND NOT INCARCERATED). [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC03/04997410, 10CM X 15CM X 1MM THICK, OVAL] IMPLANT #1 DATE: (B)(6) 2007 [HOSPITALIZATION DATE (B)(6) 2007]. WOUND CLASSIFICATION: NOT PROVIDED. DESCRIPTION OF HERNIA BEING TREATED: ¿WE BEGAN BY PALPATING HER UMBILICAL HERNIA WHICH WAS NOTED TO BE COMPLETELY REDUCED BY PHYSICAL EXAMINATION. WE THEN PLACED A LEFT UPPER QUADRANT 5 MILLIMETER OPTIVIEW UNDER DIRECT VISUALIZATION, ENTERING HER PERITONEUM WITHOUT INCIDENT. WE PLACED AN ADDITIONAL TROCAR IN THE LEFT LATERAL ABDOMINAL WALL WHICH WAS 10 MILLIMETERS WITHOUT INCIDENT. WE ANESTHETIZED BOTH THESE SITES WITH 1/4% MARCAINE AS WE DID WITH ALL OF OUR TROCAR SITES. WE THEN BEGAN IDENTIFYING HER HERNIA EXTERNALLY AND MEASURING FOR OUR MESH. THERE WAS NO OMENTUM OR BOWEL MATERIAL IN HER HERNIA. ALL CONTENTS WERE REDUCED PRIOR TO THE OPERATION.¿ IMPLANT SIZE AND FIXATION: ¿WE THEN MEASURED OUR MESH, MEASURING FOR 3 CENTIMETERS FROM EACH MARGIN OF HER HERNIA DEFECT OVERLAP. WE THEN USED A PIECE OF GORE-TEX DUALMESH AND CUT TO FIT OUR MEASURED DIAMETER. WE THEN USED FOUR GORE-TEX SUTURES TO TIE TO THE MESH AND ORIENTED THE MESH WITH NUMERICAL MARKINGS ON THE SURFACE OF THE MESH. WE THEN PLACED THE MESH INTRAABDOMINAL AND ESTABLISHED A FURTHER UPPER MIDEPIGASTRIC 5 MILLIMETER TROCAR SITE FOR FURTHER MESH MANIPULATION WITH ANOTHER ASCU [SIC] LAP. WE ORIENTED THE MESH, USED THE ENDOSTITCH PASSER TO PASS THE GORE-TEX SUTURES THROUGH THE FASCIA TIMES FOUR, ONE AT EACH NUMERICAL CORNER OF THE MESH. THESE WERE THEN TIED DOWN AND WE INTRODUCED A TACKER AND BEGAN TACKING THE EDGE OF THE MESH. WE NOTED AFTER PLACING SEVEN TACKS THAT THE MESH WAS PULLING AWAY FROM ONE OF ITS GORE-TEX STAY SUTURES. WE REINFORCED THIS WITH ADDITIONAL GORE-TEX SUTURE AND REMOVED THE ORIGINAL SUTURE. WE THEN PLACED ONE MORE GORE-TEX SUTURE IN THIS AREA AND THEN CIRCUMFERENTIALLY SECURED THE MESH WITH TACKS. WE DID HAVE TO REMOVE FOUR OF OUR ORIGINALLY PLACED TACKS TO ALLOW FOR THE MESH TO RETURN TO ITS MORE NATURAL POSITION TO COVER THE DEFECT WITH 3 CENTIMETERS OVERLAP AT EACH EDGE. THE PATIENT TOLERATED ALL PORTIONS OF THIS PROCEDURE WELL. WE IDENTIFIED HER LAPAROSCOPIC GASTRIC BAND PORT WHICH APPEARED TO BE IN GOOD POSITION AND WITHOUT ANY ABNORMALITY. AFTER PLACING THE MESH, WE USED THE ENDOSTITCH SUTURE PASSER TO REPAIR THE FASCIA AT OUR 10 MILLIMETER LEFT LOWER QUADRANT TROCAR SITE WITH AN 0 ETHIBOND. WE DE-INSUFFLATED THE PATIENT'S ABDOMEN. THERE WAS NO EVIDENCE OF BLEEDING AND SPECIFICALLY NO EVIDENCE OF INJURY UNDER ANY OF OUR TROCAR SITES TO THE BOWEL OR OMENTAL STRUCTURES. THE PATIENT'S SKIN INCISIONS WERE THEN CLOSED WITH 4-0 VICRYL IN SUBCUTICULAR FASHION AND PLACED STERI-STRIPS AND BAND-AIDS OVER EACH OF THESE.¿ (B)(6) 2007: DISCHARGE INSTRUCTIONS: ¿NO HEAVY LIFTING UNTIL SEEN BY PHYSICIAN. LET STERI-STRIPS FALL OFF. MAY REMOVE BANDAIDS [SIC] SUNDAY. FOLLOW-UP (B)(6) 2007." RELEVANT MEDICAL INFORMATION: (B)(6) 2007: ¿LAPAROSCOPIC UMBILICAL HERNIA REPAIR (REDO). 1ST REPAIR OF UMBILICAL HERNIA (B)(6) 2007 WITH MESH. STITCH CAME LOOSE , TO BE REPAIRED TODAY. ABDOMEN SOFT, TENDER TO PALPATION IN UMBILICAL AREA. CANCELLED DUE TO URINARY TRACT INFECTION.¿ IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2007: ¿RECURRENT UMBILICAL HERNIA. TROCAR HERNIA STATUS POST LAP CHOLECYSTECTOMY AT UMBILICAL PORT. RECURRED SECONDARY TO HEAVY LIFTING . ABDOMEN MASS AT LEFT UMBILICUS.¿ (B)(6) 2007: INDICATIONS: ¿46-YEAR-OLD LADY, MORBIDLY OBESE, WHO HAD A PREVIOUS LAP BAND WITH A POOR RESULT. HOWEVER, SHE HAD BEEN NONCOMPLIANT WITH THE FOLLOW-UP. SHE REMAINS MORBIDLY OBESE AND HAD A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED-MORE RECENTLY. SHE DEVELOPED A HERNIA AT THE UMBILICAL TROCAR SITE. I PERFORMED LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON HER ABOUT TWO MONTHS AGO, AND SHE RECURRED SHORTLY THEREAFTER, AFTER SHE WAS GETTING UP FROM HER COUCH AND STRAINING. SHE FELT SOMETHING POP AND HAD A MASS IN HER UMBILICUS. I SAW HER IN THE OFFICE AND FELT SHE HAD AN EARLY RECURRENCE.¿ IMPLANT #2 PROCEDURE: LAPAROSCOPIC RECURRENT INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC03/05009000, 10CM X 15CM X 1MM THICK, OVAL] [NO ALLEGATIONS FOR THIS DEVICE]. IMPLANT #2 DATE: (B)(6) 2007 [HOSPITALIZATION DATE (B)(6) 2007]. WOUND CLASSIFICATION: NOT PROVIDED. FINDINGS: ¿OMENTAL HERNIA ON THE LEFT INFEROLATERAL BORDER OF PREVIOUS HERNIA REPAIR.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿I PLACED A 5-MILLIMETER TROCAR IN THE LEFT UPPER QUADRANT LATERAL TO WHERE THE PREVIOUS TROCAR SITE WAS PLACED. THE OPTIVIEW TROCAR WAS ENTERED WITHOUT DIFFICULTY AND WE INSUFFLATED THE ABDOMEN. WE FOUND THAT SHE DID HAVE A LARGE AMOUNT OF OMENTUM STUCK UP TO THE LATERAL LEFT INFERIOR BORDER OF THE PREVIOUS HERNIA REPAIR. WE PLACED ADDITIONAL 5-MILLIMETER TROCARS IN THE LEFT LOWER QUADRANT IN THE EPIGASTRIC AREA. WE THEN UP-SIZED OUR INITIAL TROCAR TO A 10-MILLIMETER TROCAR. WE THEN USED A 30-DEGREE 10-MILLIMETER SCOPE AND TWO VASCULAR GRASPERS TO REDUCE THE HERNIA. THE HERNIA DEFECT ITSELF WAS NOT THAT IMPRESSIVE.¿ IMPLANT SIZE AND FIXATION: ¿WE THEN TOOK A 10 X 15-CENTIMETER PIECE OF GORE-TEX MESH, AFFIXED THE GORE-TEX ON THE FLOOR AREAS AND THEN PLACED THE MESH IN THE ABDOMEN. WE SITUATED THIS MESH AT AN ANGLE WITH THE LARGEST PORTION OF IT EXTENDING DOWN TOWARDS THE LEFT LOWER QUADRANT. IT OVERLAPPED THE PREVIOUS MESH ENTIRELY. IT WAS TACKED IN PLACE WITH PROTACK AS WELL AS FOUR SUTURES THAT WE HAD PLACED. WE ALSO PLACED TWO ADDITIONAL PROLENE SUTURES IN THE LEFT UPPER QUADRANT ASPECT OF THE MESH. WE WERE VERY SATISFIED WITH THE MESH REPAIR ESPECIALLY OVER THE AREA OF CONCERN WHERE THE OVERLAY FROM THE PREVIOUS MESH WAS PROBABLY NOT SUFFICIENT AND WHERE THE RECURRENCE OCCURRED . WE THEN CLOSED THE 10-MILLIMETER TROCAR SITE WITH A PARKER-THOMPSON TROCAR SITE CLOSURE SYSTEM. WE WATCHED THE PROLENE SUTURE BEING TIED UNDER DIRECT VISUALIZATION WITH GOOD CLOSURE OF THAT TROCAR SITE. WE DID NOT CLOSE THE 5-MILLIMETER TROCAR SITE. THE SKIN WAS CLOSED WITH MONOCRYL AND STERI-STRIPS.¿ (B)(6) 2007: DISCHARGE INSTRUCTIONS: ¿KEEP DRESSING CLEAN AND DRY. MAY REMOVE DRESSING IN 24 HOURS. STERI-STRIPS WILL FALL OFF ON OWN. FOLLOW-UP (B)(6) 2007.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2007: EMERGENCY RECORD: ¿STATUS POST UMBILICAL HERNIA REPAIR WITH BLOOD ON DRESSING. INCISION SITE ON ABDOMEN CLEAN/DRY/INTACT. [ILLEGIBLE] BLOOD ON [ILLEGIBLE] DRESSING. RETURN TO EMERGENCY ROOM FOR WORSENING SYMPTOMS, ANY CONCERNS.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE 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.¿ THE INSTRUCTIONS FOR USE FURTHER STATE: ¿CUTTING GORE® DUALMESH® BIOMATERIAL TO THE PROPER SIZE IS ESSENTIAL. USE SHARP SURGICAL INSTRUMENTS TO TRIM THE MESH. IF GORE® DUALMESH® BIOMATERIAL IS CUT TOO SMALL, EXCESSIVE TENSION MAY BE PLACED ON THE SUTURE LINE, WHICH MAY RESULT IN RECURRENCE OF THE ORIGINAL, OR DEVELOPMENT OF AN ADJACENT, TISSUE DEFECT.¿ THE INSTRUCTIONS FOR USE FURTHER INCLUDES A PRECAUTION WHICH STATES, ¿ENSURE THE SIZE OF THE DEVICE IS ADEQUATE FOR THE INTENDED REPAIR.¿ INDIVIDUAL MEDICAL DECISIONS, IF INCONSISTENT AND/OR NON-CONFORMING TO THE DEVICE MANUFACTURER¿S RECOMMENDATIONS, IFU, OR RECOGNIZED BEST PRACTICES, MAY RESULT IN OR CONTRIBUTE TO AN ADVERSE EVENT. 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. 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, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH SHRINKAGE, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. 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. BASED UPON THE INFORMATION RECEIVED, THE DEVICE REMAINS IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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.
B7: ADDED MEDICAL HISTORY. 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: 06/22/07: U OF L HEALTHCARE UNIVERSITY HOSPITAL. J. ADAMS, CRNA, AMY HAMILTON, MD. ANESTHESIA RECORD. 324 LBS. MEDICAL PROBLEM LIST: OBESE WITH UMBILICAL HERNIA. CHILDHOOD ASTHMA HISTORY ¿ NO INHALER USE AS ADULT. ? OBSTRUCTIVE SLEEP APNEA, SNORES. SEVERE REFLUX. CURRENTLY NAUSEA. NO SMOKING. ASA 2. 06/22/07: AARON BROWN, MD, ). FELLOW/RESIDENT SURGEON: AARON BROWN, MD. ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA AND 1/4% MARCAINE LOCAL FOR TROCAR SITES. ESTIMATED BLOOD LOSS: 20 MILLILITERS. FLUIDS GIVEN: 800 MILLILITERS. DRAINS: NONE. SPECIMENS: OBTAINED NO SPECIMENS. 06/22/07: UNIVERSITY HOSPITAL. PERI-OPERATIVE RECORD. IMPLANT STICKER. GORE DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMC03. LOT BATCH CODE: 04997410. W. L. GORE & ASSOCIATES. SIZE: 10 X 15 CM. IMPLANT SITE: ABDOMEN. 06/22/07: UNIVERSITY HOSPITAL. ONE DAY SURGERY POST-OPERATIVE INSTRUCTION SHEET. DISCHARGE INSTRUCTIONS. KEEP DRESSINGS CLEAN AND DRY. IF INCISION BECOMES RED, SWOLLEN OR SHOWS PUS OR RED STREAKS, OR FEELS MORE SORE INSTEAD OF LESS SORE AS DAYS GO BY, REPORT TO YOUR DOCTOR RIGHT AWAY. MAY SHOWER SUNDAY. MAY BATHE TUESDAY. ACTIVITY AS TOLERATED. NO HEAVY LIFTING UNTIL SEEN BY PHYSICIAN. LET STERI-STRIPS FALL OFF. MAY REMOVE BANDAIDS [SIC] SUNDAY. FOLLOW-UP DR. CASOS 07/12/07 09:00 AM. 07/24/07: U OF L HEALTHCARE UNIVERSITY HOSPITAL. STEVEN R. CASOS, MD. DAY SURGERY ADMISSION/OBSERVATION. PROGRESS NOTE. LAPAROSCOPIC UMBILICAL HERNIA REPAIR (REDO). 1ST REPAIR OF UMBILICAL HERNIA 06/22/07 WITH MESH. STITCH CAME LOOSE, TO BE REPAIRED TODAY. ABDOMEN SOFT, TENDER TO PALPATION IN UMBILICAL AREA. CANCELLED DUE TO URINARY TRACT INFECTION. 50+ WBC, + NITRITE, + [ILLEGIBLE], + [ILLEGIBLE]. 08/08/07: UNIVERSITY OF LOUISVILLE HOSPITAL JAMES GRAHAM BROWN CANCER CENTER. DAY SURGERY ADMISSION/OBSERVATION. PROGRESS NOTE. RECURRENT UMBILICAL HERNIA. TROCAR HERNIA STATUS POST LAP CHOLECYSTECTOMY AT UMBILICAL PORT. RECURRED SECONDARY TO HEAVY LIFTING. ABDOMEN MASS AT LEFT UMBILICUS. OPERATIVE PROCEDURE: LAPAROSCOPIC RECURRENT INCISIONAL HERNIA. 08/08/07: UNIVERSITY HOSPITAL. STEVEN CASOS, MD. OPERATIVE REPORT. SERVICE: ELECTIVE SURGERY. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE PERFORMED: LAPAROSCOPIC RECURRENT INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. FELLOW/RESIDENT SURGEON: ASSISTANT(S): ARIEL SANTOS, MD. ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA. ESTIMATED BLOOD LOSS: LESS THAN 50 CUBIC CENTIMETERS. FLUIDS GIVEN: 1 LITER. URINE OUTPUT: CHECK ANESTHESIA RECORD. DRAINS: SPECIMENS: NONE. COMPLICATIONS: NONE. 08/08/07: UNIVERSITY OF LOUISVILLE HOSPITAL JAMES GRAHAM BROWN CANCER CENTER. PATIENT PROGRESS NOTES/PERIOPERATIVE RECORD. IMPLANT STICKER. GORE DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMC03. LOT BATCH CODE: 05009000. W. L. GORE & ASSOCIATES. SIZE: 10 CM X 15. IMPLANT SITE: UMBILICAL HERNIA. THE RECORD CONFIRMS A GORE® DUALMESH® BIOMATERIAL (1DLMC03/05009000) WAS IMPLANTED DURING THE PROCEDURE. 08/08/07: UNIVERSITY HOSPITAL. ONE DAY SURGERY POST-OPERATIVE INSTRUCTION SHEET. DISCHARGE INSTRUCTIONS. KEEP DRESSING CLEAN AND DRY. MAY REMOVE DRESSING IN 24 HOURS. TEMPERATURE HIGHER THAN 101° NOTIFY YOUR PHYSICIAN. CLEAR LIQUID DIET ¿ ADVANCE AS TOLERATED. CALL FOR ERYTHEMA, PURULENT DRAINAGE FROM INCISION, INCREASED ABDOMINAL PAIN OR DISTENTION. STERI-STRIPS WILL FALL OFF ON OWN. FOLLOW-UP DR. CASOS 08/23/07 AT 9 AM. 08/09/07: U OF L HEALTHCARE UNIVERSITY HOSPITAL. [SIGNATURE ILLEGIBLE.] EMERGENCY RECORD. STATUS POST UMBILICAL HERNIA REPAIR WITH BLOOD ON DRESSING. INCISION SITE ON ABDOMEN CLEAN/DRY/INTACT. [ILLEGIBLE] BLOOD ON [ILLEGIBLE] DRESSING. RETURN TO EMERGENCY ROOM FOR WORSENING SYMPTOMS, ANY CONCERNS. 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.¿ 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). (B)(6). 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.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL UMBILICAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REVISION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710457 | GORE DUALMESH® BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC03 | 04997410 | 00733132600960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Hospitalization| R |