GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-00534
- Event Type
- Injury
- Date Received
- July 17, 2019
- Date of Event
- August 11, 2006
- Report Date
- October 11, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601110
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
H6: HEALTH EFFECT IMPACT CODE: F1903: DEVICE EXPLANTATION. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THE INVESTIGATION HAS BEEN COMPLETED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2004 THROUGH (B)(6) 2008 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL DEVICES. RECORDS FROM (B)(6) 2004 THROUGH (B)(6) 2006 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: OBESITY UNKNOWN DATE: 190 LBS. (B)(6) 2012: 225 LBS. SMOKING: (B)(6) 2011: ¼ PACK PER DAY. DIABETES MELLITUS: (B)(6) 2006: HISTORY OF INSULIN DEPENDENT. (B)(6) 2011: ¿DIABETES MELLITUS CURED WITH PANCREAS TRANSPLANT IN 2003.¿ INCISIONAL HERNIA, RECURRENT. (B)(6) 2008: SMALL BOWEL OBSTRUCTION. SURGICAL PROCEDURES: 1990: APPENDECTOMY: (B)(6) 2003: SIMULTANEOUS CADAVERIC KIDNEY-PANCREAS TRANSPLANTATION (B)(6) 2004: REPAIR OF INCISIONAL HERNIA WITH MESH. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL (B)(6) 2006: REPAIR OF INCISIONAL HERNIA WITH MESH. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL (B)(6) 2006: INFECTED PROSTHETIC MASS. REMOVAL OF MASS AND PRIMARY INCISIONAL HERNIA REPAIR. BOTH MESHES REMOVED. (B)(6) 2008: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS. REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH POLYESTER MESH. IMPLANT: PARIETEX. IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2004: ¿PATIENT IS A 40-YEAR-OLD GENTLEMAN WITH A HISTORY OF INSULIN-DEPENDENT DIABETES MELLITUS WHO UNDERWENT A SUCCESSFUL SIMULTANEOUS CADAVERIC KIDNEY-PANCREAS TRANSPLANTATION IN (B)(6) 2003. HE PRESENTED WITH A SYMPTOMATIC INCISIONAL HERNIA AND WAS TAKEN TO THE OPERATING ROOM ELECTIVELY FOR REPAIR OF THIS HERNIA.¿ IMPLANT #1 PROCEDURE: REPAIR OF INCISIONAL HERNIA WITH MESH. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP06/02767421, 18CM X 24CM X 1MM THICK] IMPLANT #1 (B)(6) 2004: DESCRIPTION OF HERNIA BEING TREATED: ¿THE UPPER BORDER OF THE INCISION HAD A LARGE HERNIA SAC WHICH WAS DISSECTED FREE OF THE FASCIAL EDGES AND IT WAS NOTED THAT THERE WERE SMALL HERNIA DEFECTS ALL THE WAY DOWN THE INCISION ALL THE WAY TO THE LEVEL OF THE PUBIC TUBERCLE. THEREFORE, THE ENTIRE INCISION WAS OPENED EXCEPT FOR THE LAST 2 CM, WHICH HAD EXCELLENT FASCIAL CLOSURE. THE FASCIAL EDGES WERE DISSECTED FREE OF THEIR SURROUNDING TISSUES SUPERIORLY AND INFERIORLY ON THE FASCIA TO CREATE A 1.5 CM LEDGE WHICH WOULD BE USED FOR CLOSURE.¿ IMPLANT SIZE AND FIXATION: ¿A PIECE OF DUALMESH WAS THEN FASHIONED TO FIT THE HERNIA DEFECT, AND THIS WAS SECURED TO THE UNDERSURFACE OF THE FASCIA USING RUNNING #1 PROLENE SUTURES. AFTER THE MESH WAS SECURED TO THE UNDERSURFACE OF THE FASCIAL EDGES, THE FASCIAL EDGES THEMSELVES WERE CLOSED OVER THE MESH USING AGAIN #1 PROLENE SUTURES. THE HERNIA CLOSURE SEEMED GOOD. THE WOUND WAS IRRIGATED COPIOUSLY; 3-0 VICRYLS WERE USED FOR SUBCUTANEOUS TISSUE CLOSURE AND STAPLES FOR SKIN CLOSURE.¿ IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2006: ¿THE PATIENT IS A 42-YEAR-OLD GENTLEMAN STATUS POST A SUCCESSFUL SIMULTANEOUS KIDNEY-PANCREAS TRANSPLANT WHO HAD A POSTOPERATIVE INCISIONAL HERNIA WHICH WAS FIXED WITH DUALMESH. UNFORTUNATELY, THE PATIENT NOW HAS A RECURRENT INCISIONAL HERNIA AT THE UPPER BORDER OF HIS MESH CLOSURE AND A DECISION WAS MADE TO FIX THIS ELECTIVELY IN THE OPERATING ROOM.¿ IMPLANT #2 PROCEDURE: REPAIR OF INCISIONAL HERNIA WITH MESH. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/04335933, 15CM X 19CM X 1MM THICK, OVAL] IMPLANT #2 DATE: (B)(6) 2006: DESCRIPTION OF HERNIA BEING TREATED: ¿APPROXIMATELY 6 CM INCISION WAS MADE FROM THE UPPER BORDER OF THE OLD INCISION SUPERIORLY. DISSECTION USING CAREFULLY [SIC] TECHNIQUE TO IDENTIFY THE HERNIA SAC WAS DONE. THE HERNIA SAC WAS REDUCED AND THE ABDOMEN WAS ENTERED. GOOD FASCIA EDGES WERE IDENTIFIED SUPERIORLY, LATERALLY ON THE RIGHT AND LEFT. INFERIORLY THE SUPERIOR BORDER OF THE MESH WAS IDENTIFIED.¿ IMPLANT SIZE AND FIXATION: ¿APPROXIMATELY A 5 X 3 CM PIECE OF DUALMESH WAS THEN PLACED WITH THE APPROPRIATE SIDE WITHIN THE ABDOMEN AND SECURED TO THE FASCIA USING INTERRUPTED FIGURE OF 8, 2-0 NYLON STITCHES AND EXCELLENT CLOSURE WAS ACHIEVED. THE FASCIA WAS THEN CLOSED OVER THE MESH USING 2-0 NYLON SUTURES, 3-0 VICRYL WERE USED FOR SUBCUTANEOUS CLOSURE AND 4-0 VICRYL FOR SUBCUTANEOUS CLOSURE.¿ EXPLANT #1 & #2 PREOPERATIVE COMPLAINTS: (B)(6) 2006: ¿THE PATIENT IS A 42-YEAR-OLD GENTLEMAN WITH INSULIN-DEPENDENT DIABETES WHO IS STATUS POST A SUCCESSFUL KIDNEY/PANCREAS TRANSPLANT WHO IS STATUS POST A RE-OPERATIVE MESH REPAIR OF AN INCISIONAL HERNIA 1 MONTH PRIOR TO PRESENTATION. AT PRESENTATION, HE PRESENTED WITH ELEVATED TEMPERATURE, A WHITE BLOOD CELL COUNT AND ERYTHEMA AT HIS WOUND , AND A CT SCAN WHICH DEMONSTRATED INFECTED MESH. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AFTER IV ANTIBIOTIC SUPPRESSION FOR REMOVAL OF MESH.¿ EXPLANT #1 & #2 PROCEDURE: REMOVAL OF MASS AND PRIMARY INCISIONAL HERNIA REPAIR. EXPLANT #1 & #2 DATE: (B)(6) 2006: ¿IMMEDIATELY UPON OPENING THE INCISION, ABOUT 20 CC OF PURULENT MATERIAL WAS EXPRESSED . THE WOUND WAS EXPOSED, THE PRIOR PROLENE¿S WERE IDENTIFIED AND CUT OPEN. THE MESH IMMEDIATELY CAME INTO VIEW. IT WAS REMOVED FROM THE UNDERSURFACE OF THE FASCIA IN ITS ENTIRETY. OF NOTE, THERE WERE 2 PIECES OF MESH FROM BOTH MESH REPAIRS AND BOTH WERE REMOVED. ONLY THE UPPER PORTION OF THE FASCIA HAD BEEN OPENED AND ON PALPATION INTRA-ABDOMINALLY THE LOWER PORTION OF THE ABDOMEN HAD GOOD CLOSURE AND THE UPPER PORTION OF THE FASCIA, SINCE WE DID NOT WANT TO PLACE MORE PROSTHETIC MATERIAL IN THE SETTING OF THIS INFECTION, WE TRIED A PRIMARY CLOSURE. THE PATIENT HAD BEEN COUNSELED PREOPERATIVELY THAT THIS MIGHT RESULT IN A RECURRENT HERNIA NECESSITATING REPAIR AT A LATER DATE WITH PROSTHETIC MATERIAL. #1 TYCRON [SIC] POPOFF SUTURES WERE USED IN AN INTERRUPTED FASHION TO ALLOW OPTIMAL CLOSURE WITH GOOD RESULT. THE WOUND WAS COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATION AND WAS PACKED OPEN BECAUSE OF THE INFECTION.¿ (B)(6) 2006: PATHOLOGY REPORT NOT PROVIDED. RELEVANT MEDICAL INFORMATION: (B)(6) 2008: RECURRENT INCISIONAL HERNIA REPAIR, STATUS POST SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANT. EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS. REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH POLYESTER MESH. IMPLANT: PARIETEX. CONCLUSION: #2 GORE® DUALMESH® PLUS BIOMATERIAL (04335933). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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 WARN: ¿AS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. 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 CONTRACTION, 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. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 04335933. ADDITIONAL MANUFACTURER NARRATIVE: THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. 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. IT SHOULD BE NOTED THAT THE GORE DUALMESH® PLUS 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.¿ 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: RECORDS PRIOR TO (B)(6) 2004; INCLUDING SIMULTANEOUS CADAVERIC KIDNEY-PANCREAS TRANSPLANTATION, WERE NOT PROVIDED. (B)(6) 2004: (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA STATUS POST SIMULTANEOUS KIDNEY-PANCREAS TRANSPLANT. OPERATION: REPAIR OF INCISIONAL HERNIA WITH MESH. INDICATION: PATIENT IS A 40-YEAR-OLD GENTLEMAN WITH A HISTORY OF INSULIN-DEPENDENT DIABETES MELLITUS WHO UNDERWENT A SUCCESSFUL SIMULTANEOUS CADAVERIC KIDNEY-PANCREAS TRANSPLANTATION IN (B)(6) 2003. HE PRESENTED WITH A SYMPTOMATIC INCISIONAL HERNIA AND WAS TAKEN TO THE OPERATING ROOM ELECTIVELY FOR REPAIR OF THIS HERNIA. PROCEDURE: HE WAS TAKEN TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. AFTER UNEVENTFUL INDUCTION OF GENERAL ENDOTRACHEAL ANESTHESIA, THE PRIOR MIDLINE INCISION WAS OPENED AFTER THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE UPPER BORDER OF THE INCISION HAD A LARGE HERNIA SAC WHICH WAS DISSECTED FREE OF THE FASCIAL EDGES AND IT WAS NOTED THAT THERE WERE SMALL HERNIA DEFECTS ALL THE WAY DOWN THE INCISION ALL THE WAY TO THE LEVEL OF THE PUBIC TUBERCLE . THEREFORE, THE ENTIRE INCISION WAS OPENED EXCEPT FOR THE LAST 2 CM, WHICH HAD EXCELLENT FASCIAL CLOSURE. THE FASCIAL EDGES WERE DISSECTED FREE OF THEIR SURROUNDING TISSUES SUPERIORLY AND INFERIORLY ON THE FASCIA TO CREATE A 1.5 CM LEDGE WHICH WOULD BE USED FOR CLOSURE. A PIECE OF DUALMESH WAS THEN FASHIONED TO FIT THE HERNIA DEFECT, AND THIS WAS SECURED TO THE UNDERSURFACE OF THE FASCIA USING RUNNING #1 PROLENE SUTURES. AFTER THE MESH WAS SECURED TO THE UNDERSURFACE OF THE FASCIAL EDGES, THE FASCIAL EDGES THEMSELVES WERE CLOSED OVER THE MESH USING AGAIN #1 PROLENE SUTURES. THE HERNIA CLOSURE SEEMED GOOD. THE WOUND WAS IRRIGATED COPIOUSLY; 3-0 VICRYLS WERE USED FOR SUBCUTANEOUS TISSUE CLOSURE AND STAPLES FOR SKIN CLOSURE. THE PATIENT WAS EXTUBATED WITHOUT EVENT AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. (B)(6) 2004: (B)(6) HOSPITAL. INTRAOPERATIVE REPORT. IMPLANT RECORD. IMPLANT IDENTIFICATION: DESCRIPTION: MESH, GORE-TEX DUAL PLUS 18 X 24 (1DLMCP06). CATALOGUE NUMBER: 1DLMCP06. LOT NUMBER: 02767421. MANUFACTURER: N/A. BATCH: N/A. QUANTITY: 1. IMPLANT SIDE: N/A. SITE: ABDOMEN. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL ((B)(6)) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2006: (B)(6) HOSPITAL. (B)(6) MD. OPERATIVE REPORT. PRE/ POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. OPERATION: REPAIR OF INCISIONAL HERNIA WITH MESH. INDICATIONS: THE PATIENT IS A 42-YEAR-OLD GENTLEMAN STATUS POST A SUCCESSFUL SIMULTANEOUS KIDNEY-PANCREAS TRANSPLANT WHO HAD A POSTOPERATIVE INCISIONAL HERNIA WHICH WAS FIXED WITH DUALMESH. UNFORTUNATELY, THE PATIENT NOW HAS A RECURRENT INCISIONAL HERNIA AT THE UPPER BORDER OF HIS MESH CLOSURE AND A DECISION WAS MADE TO FIX THIS ELECTIVELY IN THE OPERATING ROOM. PROCEDURE: THE PATIENT WAS TAKEN TO THE OPERATING ROOM, PLACED IN THE SUPINE POSITION. AFTER UNEVENTFUL INDUCTION OF GENERAL ENDOTRACHEAL ANESTHESIA AND PLACEMENT OF A FOLEY CATHETER, THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. APPROXIMATELY 6 CM INCISION WAS MADE FROM THE UPPER BORDER OF THE OLD INCISION SUPERIORLY. DISSECTION USING CAREFULLY [SIC] TECHNIQUE TO IDENTIFY THE HERNIA SAC WAS DONE. THE HERNIA SAC WAS REDUCED AND THE ABDOMEN WAS ENTERED. GOOD FASCIA EDGES WERE IDENTIFIED SUPERIORLY, LATERALLY ON THE RIGHT AND LEFT. INFERIORLY THE SUPERIOR BORDER OF THE MESH WAS IDENTIFIED. APPROXIMATELY A 5 X 3 CM PIECE OF DUALMESH WAS THEN PLACED WITH THE APPROPRIATE SIDE WITHIN THE ABDOMEN AND SECURED TO THE FASCIA USING INTERRUPTED FIGURE OF 8, 2-0 NYLON STITCHES AND EXCELLENT CLOSURE WAS ACHIEVED . THE FASCIA WAS THEN CLOSED OVER THE MESH USING 2-0 NYLON SUTURES, 3-0 VICRYL WERE USED FOR SUBCUTANEOUS CLOSURE AND 4-0 VICRYL FOR SUBCUTANEOUS CLOSURE. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. ALL COUNTS WERE CORRECT. THE ATTENDING WAS PRESENT FOR THE KEY PORTION OF THE PROCEDURE. (B)(6) 2006 (B)(6) HOSPITAL. INTRAOPERATIVE REPORT IMPLANT RECORD. IMPLANT IDENTIFICATION: DESCRIPTION: MESH, GORE-TEX DUAL PLUS 15 X 19 (1DLMCP04). SERIAL NUMBER: N/A. CATALOGUE NUMBER: 1DLMCP04. LOT NUMBER: 04335933. MANUFACTURER: GORETEX. BATCH: N/A. QUANTITY: 1. IMPLANT SIDE: N/A. SITE: ABDOMEN. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL ((B)(6)) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2006: (B)(6) HOSPITAL. (B)(6) MD. OPERATIVE REPORT. PRE/ POSTOPERATIVE DIAGNOSIS: INFECTED PROSTHETIC MASS. PROCEDURE: REMOVAL OF MASS AND PRIMARY INCISIONAL HERNIA REPAIR. ASSISTANT: (B)(6) PA. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 42-YEAR-OLD GENTLEMAN WITH INSULIN-DEPENDENT DIABETES WHO IS STATUS POST A SUCCESSFUL KIDNEY/PANCREAS TRANSPLANT WHO IS STATUS POST A RE-OPERATIVE MESH REPAIR OF AN INCISIONAL HERNIA 1 MONTH PRIOR TO PRESENTATION. AT PRESENTATION, HE PRESENTED WITH ELEVATED TEMPERATURE, A WHITE BLOOD CELL COUNT AND ERYTHEMA AT HIS WOUND, AND A CT SCAN WHICH DEMONSTRATED INFECTED MESH. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AFTER IV ANTIBIOTIC SUPPRESSION FOR REMOVAL OF MESH. DESCRIPTION OF PROCEDURE: THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED IN SUPINE POSITION. AFTER UNEVENTFUL INDUCTION OF ENDOTRACHEAL ANESTHESIA, THE UPPER PART OF THE MIDLINE INCISION WAS OPENED. IMMEDIATELY UPON OPENING THE INCISION, ABOUT 20 CC OF PURULENT MATERIAL WAS EXPRESSED. THE WOUND WAS EXPOSED, THE PRIOR PROLENE¿S WERE IDENTIFIED AND CUT OPEN. THE MESH IMMEDIATELY CAME INTO VIEW. IT WAS REMOVED FROM THE UNDERSURFACE OF THE FASCIA IN ITS ENTIRETY. OF NOTE, THERE WERE 2 PIECES OF MESH FROM BOTH MESH REPAIRS AND BOTH WERE REMOVED. ONLY THE UPPER PORTION OF THE FASCIA HAD BEEN OPENED AND ON PALPATION INTRA-ABDOMINALLY THE LOWER PORTION OF THE ABDOMEN HAD GOOD CLOSURE AND THE UPPER PORTION OF THE FASCIA, SINCE WE DID NOT WANT TO PLACE MORE PROSTHETIC MATERIAL IN THE SETTING OF THIS INFECTION, WE TRIED A PRIMARY CLOSURE. THE PATIENT HAD BEEN COUNSELED PREOPERATIVELY THAT THIS MIGHT RESULT IN A RECURRENT HERNIA NECESSITATING REPAIR AT A LATER DATE WITH PROSTHETIC MATERIAL. #1 TYCRON [SIC] POPOFF SUTURES WERE USED IN AN INTERRUPTED FASHION TO ALLOW OPTIMAL CLOSURE WITH GOOD RESULT. THE WOUND WAS COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATION AND WAS PACKED OPEN BECAUSE OF THE INFECTION. THE PATIENT WAS EXTUBATED WITHOUT EVENT AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THE ATTENDING PHYSICIAN WAS PRESENT THROUGHOUT. THERE IS NO INFORMATION DETAILING THE ETIOLOGY OF THE INFECTION. (B)(6) 2006: [MISSING RECORDS: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICES REMOVED DURING THE (B)(6) 2006 PROCEDURE AND CT SCAN DEMONSTRATING ¿INFECTED MESH¿ WERE NOT PROVIDED.] (B)(6) 2008: (B)(6) HOSPITAL. (B)(6) MD. OPERATIVE REPORT. ¿PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA REPAIR, STATUS POST SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANT. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA REPAIR, STATUS POST SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANT WITH PARTIAL SMALL BOWEL OBSTRUCTION. OPERATION: 1) EXPLORATORY LAPAROTOMY. 2) LYSIS OF ADHESIONS. 3) REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH POLYESTER MESH. PAT. TYPE: I. ASSISTANT: (B)(6) MD; (B)(6) MD. INDICATION: THE PATIENT IS A PLEASANT 44-YEAR-OLD GENTLEMAN WHO UNDERWENT SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANTATION WHICH WAS COMPLICATED BY A VENTRAL HERNIA. THIS WAS REPAIRED, BUT BECAME INFECTED AND THE MESH NEEDED TO BE REMOVED. HE HAS HAD INTERMITTENT SYMPTOMS OF BOWEL OBSTRUCTION AND, AS SUCH, PRESENTS NOW FOR REPAIR OF RECURRENT VENTRAL HERNIA WITH MESH. PROCEDURE: AFTER THE APPROPRIATE PREOPERATIVE MULTI-DISCIPLINARY TEAM EVALUATION, FULL INFORMED CONSENT HAD BEEN OBTAINED. THIS INCLUDED A DISCUSSION OF THE RISKS AND BENEFITS OF PROCEDURE. OF NOTE, WE DISCUSSED THE RISK OF MESH INFECTION. THE PATIENT WISHED TO PROCEED. WE DECIDED TO TAKE THE PATIENT BACK TO THE OPERATIVE THEATER UNDER THE BENEFIT OF GENERAL ENDOTRACHEAL ANESTHESIA. THE ABDOMEN WAS PREPPED WITH CHLOROHEXIDINE AND DRAPED IN THE USUAL MANNER. AT THIS POINT, WE PAUSED FOR A SURGICAL TIMEOUT IN WHICH THE PATIENT¿S NAME, SIDE/ SITE, SURGICAL PROCEDURE WERE CONFIRMED. THE PATIENT RECEIVED INTRAVENOUS CEFAZOLIN WITHIN 1 HOUR OF THE START OF THE PROCEDURE AND DISCONTINUED POSTOPERATIVELY FOR ANTIMICROBIAL PROPHYLAXIS. PNEUMATIC COMPRESSION STOCKINGS WERE UTILIZED FOR DVT PROPHYLAXIS. AT THIS POINT, THE UPPER MIDLINE INCISION WAS REENTERED. SHARP DISSECTION CARRIED DOWN TO THE LEVEL OF THE HERNIA SAC. THE HERNIA SAC WAS CAREFULLY ENTERED. THE ABDOMINAL PERITONEAL CAVITY WAS ENTERED WITHOUT INCIDENT. THERE WERE SEVERAL DENSE ADHESIONS OF SMALL BOWEL AND OMENTUM TO THE UPPER MIDLINE INCISION. THIS WAS TAKEN DOWN AND EXTENSIVE LYSIS OF ADHESIONS ENSUED. ADHESIONS WERE FREED FROM THE OVERLYING THE [SIC] INCISION. THIS WAS WIDENED TO ENCOMPASS THE ENTIRE LENGTH OF THE HERNIA. ONCE WE HAD ADEQUATE EXPOSURE TO THE ABDOMINAL VISCERA, FURTHER LYSIS OF ADHESIONS ENSUED. AT THIS POINT, THERE WERE SEVERAL INTERLOOP ADHESIONS. IN THE PROXIMAL JEJUNUM, THERE WAS AN AREA OF ADHESION TO THE ANTERIOR ABDOMINAL WALL AND INTERLOOP WHICH HAD A PROMPT TRANSITION FROM DILATED BOWEL TO COLLAPSED DISTAL BOWEL. THIS WAS TAKEN DOWN. WE RAN THE SMALL BOWEL FROM THE LIGAMENT OF TREITZ TO THE ILEOCECAL/ TERMINAL ILEAL REGION. NOW THAT WE WERE SATISFIED THAT ALL ADHESIONS WERE LYSED, WE THEN DIVERTED ATTENTION TO THE HERNIA. THE FASCIAL MARGIN WAS DISSECTED OFF THE SKIN AND SUBCUTANEOUS FLAP ABOVE. THIS WAS DONE TO FACILITATE PLACEMENT OF THE SUTURES FOR THE MESH UNDERLAY. ONCE THIS HAD BEEN COMPLETED CIRCUMFERENTIALLY, WE MEASURED THE DEFECT. THERE WERE 3 DEFECTS IN TOTAL. THERE WAS A 4 X 6 CM DEFECT IN THE MIDLINE, A SMALL CENTIMETER SATELLITE DEFECT OFF THE MIDLINE ON THE RIGHT, AND A 2 X 3 CM SATELLITE INCISIONAL DEFECT ON THE LEFT. WE THEN MEASURED THE NECESSARY SIZE OF MESH WHICH WAS A 15 CM X 20 CM PARIETEX POLYESTER MESH. AT THIS POINT, THE SURGEON¿S GLOVES WERE CHANGED. A FURTHER DOSE OF ANTIMICROBIAL AGENT WAS ADMINISTERED APPROXIMATELY 2 HOURS AFTER THE ORIGINAL DOSE AND WE BEGAN SEWING IN THE PARIETEX MESH IN AN UNDERLAY FASHION. THIS WAS DONE CIRCUMFERENTIALLY USING INTERRUPTED 0 PROLENE HORIZONTAL MATTRESS SUTURES. ONCE THE MESH WAS SEWN IN ITS ENTIRETY, WE SURVEILLED THE ABDOMEN FOR ANY SIGNS OF BLEEDING. THERE WAS NONE. ONCE ADEQUATE HEMOSTASIS HAD BEEN ACHIEVED, WE THEN REAPPROXIMATED THE FASCIA IN THE MIDLINE USING A CONTINUOUS #1 MAXON SUTURE. AGAIN, HEMOSTASIS WAS ACHIEVED. WE IRRIGATED WITH APPROXIMATELY 1 LITER OF WARM STERILE SALINE SOLUTION. WE THEN PROCEEDED WITH CLOSING THE INCISION IN LAYERS. A 10 MM JACKSON-PRATT DRAIN WAS THEN PLACED IN THE SUBCUTANEOUS TISSUE AND EXITED THE SKIN THROUGH A SEPARATE STAB INCISION. WE THEN REAPPROXIMATED THE SKIN USING STAPLES. THE INCISION WAS CLEANSED WITH STERILE SALINE, DRIED, AND A DRY GAUZE DRESSING WITH AN ABDOMINAL BINDER WAS APPLIED AS A DRESSING. ESTIMATED BLOOD LOSS WAS MINIMAL. ALL SPONGE, SHARP, AND INSTRUMENT COUNTS WERE REPORTED AS CORRECT. TOTAL LENGTH OF THE PROCEDURE WAS APPROXIMATELY 2.5 HOURS. I WAS PRESENT FOR ALL PORTIONS OF THE PROCEDURE. THE ANESTHETIC WAS THEN DISCONTINUED. THE PATIENT AWOKE AND WAS TRANSFERRED TO THE POSTANESTHETIC CARE UNIT IN STABLE CONDITION AND TOLERATED THE PROCEDURE VERY WELL. DUE TO THE EXTENSIVE DISSECTION, THE PATIENT HAD A NASOGASTRIC TUBE INSERTED FOR TEMPORARY DECOMPRESSION AND GI REST.¿ 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® PLUS 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.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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.¿ THE GORE® DUALMESH® PLUS 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.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2004 AND (B)(6) 2006 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON AUGUST 11, 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL 2X, MESH INFECTION, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593497 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP04 | 04335933 | 00733132601110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| R |