GORE® DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2022-02936
- Event Type
- Injury
- Date Received
- May 19, 2022
- Date of Event
- January 15, 2021
- Report Date
- January 2, 2024
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- UDI-DI
- 00733132601110
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
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)]. 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." 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."
H6: UPDATED INVESTIGATION FINDINGS CODE, HEALTH EFFECT - CLINICAL CODE, AND HEALTH EFFECT - IMPACT CODES. CONCLUSION REMAINS UNCHANGED 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. 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. 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.
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2004: (B)(6). (B)(6). HISTORY: ¿THE PATIENT IS A 64-YEAR-OLD GENTLEMAN WHO PREVIOUSLY HAD A SIGMOIDECTOMY THROUGH MIDLINE INCISION APPROXIMATELY A YEAR AGO. THIS WAS PERFORMED WITH INJECTION SUPRAPUBIC. HE SUBSEQUENTLY CAME TO OUR CLINIC AND WILL BE [SIC] PROCEED FOR A LAPAROSCOPIC REPAIR OF THIS HERNIA. DR. (B)(6) EVALUATED HIM IN CLINIC AND FELT THAT IT WOULD BE FEASIBLE TO ATTEMPT AND WE DISCUSSED THE RISKS, BENEFITS, AND CONSENTING TO HAVE PROCEDURE. THE PATIENT AGREED WITH THIS AND UNDERSTOOD THE RISKS AND BENEFITS .¿ IMPLANT PROCEDURE: LYSIS OF ADHESIONS. LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH GORTEX [SIC] PLUS MESH 15 X 19 CM. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/02766895, 15CM X 19CM X 1MM THICK, OVAL]. IMPLANT DATE: (B)(6) 2004 [HOSPITALIZATION DATES UNKNOWN]. (B)(6) 2004: (B)(6). (B)(6). OPERATIVE REPORT. ASSISTNATS: (B)(6) AND (B)(6). PRE AND POSTOPERATIVE DIAGNOSIS: INCISIONAL HERNIA. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: MINIMAL. COMPLICATIONS: NONE. WOUND CLASSIFICATION: ¿CLEAN .¿ FINDINGS: ¿LARGE AMOUNT OF ADHESIONS.¿ PROCEDURE: ¿AFTER PROPER CONSENT WAS OBTAINED, THE PATIENT WAS TAKEN TO THE OPERATING THEATER AND PLACED IN SUPINE POSITION AND GENERAL ANESTHESIA HAD INDUCED. THE PATIENT WAS PREPPED AND DRAPED IN NORMAL STERILE FASHION. WE THEN STARTED IN THE LEFT UPPER QUADRANT MAKING APPROXIMATELY 12 MM INCISION TO INSERT THE VISIPORT THROUGH. THE VISIPORT THEN ALLOWED ME TO DISSECT THE FIBERS AS IT WENT THROUGH THE ABDOMINAL WALL ENTERING THE ABDOMINAL CAVITY. NEXT, UPON ENTERING THE CAVITY, THE ABDOMEN WAS THOROUGHLY EXPLORED WITH THE CAMERA AND NOTED TO HAVE ANY SIGNIFICANT AMOUNT OF ADHESIONS ESPECIALLY ON THE LEFT SIDE JUST APPROXIMATELY 5 CM BELOW THE VISIPORT. WE THEN FOUND A SPOT FOR A 5 MM TROCAR PLACEMENT AND THIS WAS THEN PLACED AND AGAIN WORKING ON ADHESIONS. THIS WAS TRULY DIFFICULT ADHESIOLYSIS NECESSITATING MOVING OF THE 5 MM PORTS X 2. WHEN THAT WAS FINALLY DONE, WE USED BOTH BLUNT AND SHARP DISSECTION TO REMOVE THE ADHESIONS AND REDUCE THE HERNIAS. THEY APPEARED [SIC] APPROXIMATELY FOUR HERNIAS ALONG THE MIDLINE INCISION AND MOST SUPERIOR WAS AT THE EDGE OF THE FALCIFORM LIGAMENT. SO, WE NEEDED TO TAKE THE FALCIFORM LIGAMENT DOWN TO BRING THE UMBILICAL VEINS. ARTERY WAS SUTURE LIGATURED USING AN ENDOLOOP. WE ENSURED HEMOSTASIS. ONCE THIS WAS COMPLETED WE MEASURED THE SIZE OF THE DEFECT. IT IS SMOOTH MEASURED TO BE 14 CM SUPERIOR TO INFERIOR AND 12 CM RIGHT TO LEFT. WE FELT LIKE THAT 19 X 15 CM GORTEX [SIC] MESH WILL BE APPROPRIATE. THEN, WE USED 0 VICRYL SUTURES ON THE MESH. THEN, INSERTED THE MESH INSIDE THE ABDOMEN AND THEN, USED THE ENDOSTITCH TO BRING STITCHES THROUGH THE ABDOMEN. WE USED SIX OF THESE SUTURES. ONCE THESE WERE TIED WE USED THE ENDOSCOPIC TACKING GUN TO GO CIRCUMFERENTIALLY AROUND THE PATCH OF THE OUTER EDGE. TO COMPLETE THIS WE HAD TO PLACE ANOTHER 5 MM PORT ON THE OPPOSITE SIDE OF THE CAMERA AND THIS WAS DONE. ONCE ALL OF THIS WAS SLOWLY COMPLETED THE ABDOMEN WAS INSPECTED AGAIN. NO EXCESSIVE AMOUNT OF BLOOD OR OTHER FLUID WAS NOTED ESPECIALLY WITHIN THE SMALL BOWEL FOR ANY QUESTION MUCOSAL SEROSAL TEAR. THIS ALL APPEARED TO BE WITHIN NORMAL LIMITS AND SO, WE THEN REMOVED ALL TROCAR PORTS AND EVACUATED THE PNEUMOPERITONEUM. NEXT, USING A 3-0 VICRYL SUTURES, WE REAPPROXIMATED ALL THE SKIN EDGES FROM ALL DIFFERENT SITES APPROXIMATELY FIVE TROCAR SITES AND SIX STAB WOUNDS FOR PLACEMENT OF VICRYL SUTURES. ONCE THIS WAS DONE, THIS HAS BEEN BANDAGED IN APPROPRIATE MANNER AND HAD THE ANESTHESIA REVERSED WITH SECOND POSTANESTHESIA CARE UNIT IN GOOD CONDITION." (B)(6) 2004: (B)(6). IMPLANT RECORD: ¿ITEM: MESH. GORE DUALMESH PLUS. MODEL #: 1DLMCP04, LOT #: 02766895. SIZE: 15CM X 19CM. QUANTITY: 1." EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2021: (B)(6). (B)(6). INDICATIONS: ¿(B)(6) IS A 81 YOM [YEAR OLD MALE] WITH HX [HISTORY] OF DIVERTICULITIS S/P [STATUS POST] SIGMOIDECTOMY 2003 COMPLICATED BY INCISIONAL HERNIA S/P REPAIR WITH MESH IN 2004 WHO PRESENTS WITH CELLULITIS AND PURULENT DRAINAGE OF ANTERIOR ABDOMINAL WALL. DUE TO THESE FINDINGS AND FAILURE TO RESOLVE WITH BEDSIDE DRAINAGE AND IV ABX [ANTIBIOTICS], THE PATIENT WAS TAKEN FOR OPERATIVE EXPLORATION AND MESH EXPLANTATION. THE RISKS, BENEFITS, AND ALTERNATIVES TO THE PROCEDURE WERE DISCUSSED WITH THE PATIENT AND INFORMED CONSENT WAS OBTAINED." EXPLANT PROCEDURE: LAPAROTOMY. EXCISION OF INFECTED HERNIA MESH. LYSIS OF ADHESIONS >30 MIN. ABDOMINAL WASH OUT. PRIMARY CLOSURE OF VENTRAL HERNIA. EXPLANT DATE: (B)(6) 2021 [HOSPITALIZATION DATES (B)(6) 2021]. (B)(6) 2021: (B)(6). (B)(6). OPERATIVE REPORT. ASSISTANTS: DR. (B)(6) AND (B)(6). PRE AND POST-OPERATIVE DIAGNOSIS: ABDOMINAL SOFT TISSUE INFECTION. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: 50ML. SPECIMENS: HERNIA MESH AND ABSCESS CULTURE. COMPLICATIONS: NONE. WOUND CLASSIFICATION: ¿DIRTY/INFECTED .¿ FINDINGS: ¿CRUMPLED, DISLODGED GORETEX [SIC] MESH WITH ASSOCIATED ABSCESS AND MULTIPLE TACKS. THICK RIND OF INFLAMMATORY TISSUE. NO CONNECTION TO BOWEL.¿ PROCEDURE: ¿MR. (B)(6) WAS IDENTIFIED AND MARKED IN THE PRE-OPERATIVE AREA AND INFORMED CONSENT WAS VERIFIED. HE WAS TAKEN TO THE OPERATING ROOM AND TRANSFERRED TO THE OPERATING ROOM TABLE IN THE SUPINE POSITION. GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED WITHOUT INCIDENT. ALL PRESSURE POINTS WERE PADDED. THE SKIN OF THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A TIME-OUT WAS PERFORMED AND DOCUMENTED, VERIFYING THE CORRECT PATIENT, PROCEDURE, AND OPERATIVE SITE. A DOSE OF PROPHYLACTIC ANTIBIOTICS WAS ADMINISTERED. A #10 BLADE WAS USED TO CREATE A MIDLINE LAPAROTOMY INCISION THAT EXTENDED THROUGHT [SIC] HE [SIC] DRAINING AREA OF THE PATIENT¿S ABDOMEN. BOVIE ELECTROCAUTERY WAS USED TO EXTEND THE INCISION THROUGH THE SUBCUTANEOUS FAT AND FASCIA. A LARGE AMOUNT OF CHRONIC APPEARING INFLAMMATORY TISSUE WAS ENCOUNTERED DURING THE DISSECTION. JUST BEFORE THE PATIENT¿S MESH WAS UNCOVERED A LARGE POCKET OF PURULENT MATERIAL WAS ENCOUNTERED AND A SAMPLE WAS COLLECTED FOR CULTURE. THE ABSCESS POCKET WAS SUCTIONED AND EXPLORED AND ALL TRACTS WERE BROKEN UP AND ALL PURULENT MATERIAL WAS EVACUATED. UNDERLYING THIS WE IDENTIFIED THE PATIENT¿S HERNIA MESH WHICH APPEARED CRMPLED [SIC] AT THE MIDLINE WITH MULTIPLE TACKS ATTACHED. THE MESH WAS FREED FROM THE UNDERLYING FASCIA AND THE INCISION WAS THOROUGHLY EXPLORED TO ENSURE ALL TACKS WERE REMOVED FROM THE ABDOMEN. THE WOUND WAS ALSO EXPLORED AT THIS TIME FOR AN EVIDENCE OF BOWEL FISTULA TO THE MESH AND NON WAS IDENTIFIED AT THIS TIME. THE WOUND WAS THOROUGHLY IRRIGATED WITH STERILE SALINE AND SUCTIONED. ALL BLEEDING WAS CONTROLLED WITH ELECTROCAUTERY AND VICRYL TIES. THE WALLS OF THE PATIENT¿S PREVIOUS ABSCESS WERE ALSO IRRIGATED AND FULGURATED WITH BOVIE ELECTROCAUTERY. DUE TO THE EVIDENCE OF INFECTION AND EASILY OPPOSABLE FASCIAL EDGES, WE ELECTED TO CLOSE THE PATIENT¿S ABDOMEN PRIMARILY AND TO NOT IMPLANT ANY ADDITIONAL MESH AT THIS TIME. A RUNNING PDS SUTURE WAS SUED TO CLOSE THE FASCIAL LAYERS AND INTERRUPTED VICRYL SUTURES WERE PLACED INTERMITTENTLY ALONG THE SUTURE LINE TO REINFORCE IT. THE SKIN OF THE INCISION WAS LEFT OPEN AND WAS PACKED WITH MOISTENED KRILES AND COVERED WITH A DRY ABD [ABDOMINAL] PAD. THIS CONCLUDED OUR PROCEDURE. THE PATIENT WAS AWAKENED FROM ANESTHESIA, EXTUBATED, AND TAKEN TO THE PACU [POST ANESTHESIA CARE UNIT] IN STABLE CONDITION. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE OR IMMEDIATE POSTOPERATIVE COMPLICATIONS. ALL COUNTS OF NEEDLES, INSTRUMENTS, AND SPONGES WERE CORRECT X2. DR. ACOTT WAS PRESENT AND SCRUBBED FOR THE ENTIRE PROCEDURE .¿ PATHOLOGY: NOT PROVIDED. (B)(6) 2021: (B)(6). (B)(6). DISCHARGE SUMMARY. PRIMARY DIAGNOSIS: ¿SURGICAL SITE INFECTION.¿ OPERATING ROOM PROCEDURE PERFORMED DURING HOSPITALIZATION: ¿EXPLORATORY LAPAROTOMY, VENTRAL HERNIA REPAIR WITH MESH REMOVAL.¿ BRIEF COURSE STAY: ¿THOMAS PEPPER IS AN 81 YEAR OLD MALE WITH HX [HISTORY] OF CELIAC AND ILIAC ARTERY ANEURYSMS (STABLE, ON ASA [ASPIRIN]), OA [OSTEO ARTHRITIS], HTN [HYPERTENSION], AND DIVERTICULOSIS S/P [STATUS POST] SIGMOIDECTOMY THROUGH MIDLINE INCISION IN 2003. THIS WAS COMPLICATED BY VENTRAL HERNIA S/P REPAIR IN 2004, WITH GORETEX PLUS MESH 15 X 19 CM. HE PRESENTED TO ER ON (B)(6) 2021 WITH DRAINAGE FROM ABDOMINAL SKIN WOUND NEAR THE BELLY BUTTON. HE REPORTS SKIN WOUND FOR 2 WEEKS AT HIS ANTERIOR ABDOMEN WITH WORSENING DRAINAGE, PAIN, AND SURROUNDING REDNESS. HE HAS HAD NORMAL BOWEL FUNCTION AND DENIES STOOL OUTPUT FROM WOUND. DENIES BLEEDING. NOTABLY HE HAS BEEN TAKING PREDNISONE 5MG DAILY FOR JOINT PAINT¿ON CHART REVIEW, DROPLES [SIC] OF AIR WERE NOTED ASSOCIATED WITH MESH ON IMAGING IN (B)(6) 2020. WORKUP IN THE ED: AFEBRILE, HDS [HEMODYNAMICALLY STABLE], LEUKOCYTOSIS TO 16, BCX [BLOOD CULTURES] DRAWN, EMPIRIC ABX INITIATED, MADE NPO [NOTHING BY MOUTH.] HE WAS ADMITTED TO GENERAL SURGERY FOR ABDOMINAL WALL CELLULITIS AND WAS MANAGED WITH IV [INTRAVENOUS] ANTIBIOTICS. HE WAS TAKEN TO THE OR ON (B)(6) FOR MESH EXPLANTATION. HE WAS TRANSFERRED TO SICU [SURGICAL INTENSIVE CARE UNIT] IN STABLE CONDITION. HE WAS TRANSFERRED TO THE FLOOR ON (B)(6). HIS MESH CULTURE GREW E. COLI AND GPC THAT WAS PAN SUSCEPTIBLE, TO HIS ANTIBIOTIC THERAPY WAS DEESCALATED. HE CONTINUED WOT MEET POST-OP GOALS AND TOLERATED BID WET TO DRY DRESSING CHANGES WELL. WOUND VAC WAS APPLIED ON (B)(6), PATIENT STABLE FOR DISCHARGE WITH HOME HEALTH FOLLOW UP AND GENERAL SURGERY FOLLOW UP IN 2 WKS. HE WILL COMPLETE A COURSE OF AUGMENTIN AT HOME FOR E. COLI AND GRANULICATELLA ADIACENS POSITIVE CULTURES.¿ DISCHARGE INSTRUCTIONS: ¿NO HEAVY LIFTING, WEAR BINDER AT ALL TIMES.¿ FOLLOW UP: ¿WITHIN 2 WEEK (B)(6) 2021." RELEVANT MEDICAL INFORMATION: (B)(6) 2021 ¿ (B)(6) 2021: (B)(6). INPATIENT HOSPITALIZATION. (B)(6) 2021: (B)(6). (B)(6). GENERAL SURGERY CONSULT. CHIEF COMPLAINT: ¿ABDOMINAL WOUND.¿ HISTORY OF PRESENT ILLNESS: ¿THOMAS PEPPER IS AN 81M [MALE] WITH PMH [PAST MEDICAL HISTORY} OF CELIAC¿AND DIVERTICULOSIS S/P [STATUS POST] SIGMOIDECTOMY IN 2003 S/P VENTRAL HERNIA S/P REPAIR IN 2004 WHO WAS RECENTLY ADMITTED FOR ABDOMINAL WALL CELLULITIS NOW S/P MESH EXPLANTATION ON (B)(6). HE WAS DISCHARGE 1/19 WITH A MIDLINE WOUND VAC IN PLACE AND RX¿D [PRESCRIBED] AUGMENTIN. HE NOW PRESENTS TO THE ED FOR DRAINAGE FROM MIDLINE ABDOMINAL WOUND. HE REPORTS THAT HE HAS BEEN SEEN BY THE WOUND CARE NURSES EVERY OTHER DAY SINCE DISCHARGE AND TODAY, HIS WOUND CARE NURSE SAID THAT SHE WAS CONCERNED ABOUT ¿GREEN STUFF¿ COMPING FROM HIS MIDLINE WOUND, SO TOLD HIM TO COME TO BE EVALUATED IN THE ED.¿ PHYSICAL EXAM: ¿GI [GASTROINTESTINAL]: SOFT, NTTP [NONTENDER TO PALPATION], ND [NON DISTENDED]. POSITIVE MIDLINE WOUND WITH VISIBLE SUTURE WITH MINIMAL FASCIAL DEHISCENCE, NO VISIBLE BOWEL, SMALL AMOUNT OF GREEN DRAINAGE, NO BLOOD.¿ ASSESSMENT: ¿ON EXAM, THE MIDLINE WOUND APPEARS TO HAVE DEHISCED, UNCLEAR IF DRAINAGE IS STOOL CONTENT OF NOT, SO WILL OBTAIN A CTAP [COMPUTERIZED TOMOGRAPHY SCAN ABDOMEN PELVIS] ¿TO DELINEATE BOWEL INVOLVEMENT .¿ (B)(6) 2021: (B)(6). (B)(6). DISCHARGE SUMMARY. ¿PRIMARY DIAGNOSIS: WOUND DEHISCENCE.¿ BRIEF COURSE OF STAY: ¿81 YOM [YEAR OLD MALE] WITH PMHX [PAST MEDICAL HISTORY] OF VENTRAL REPAIR S/P MESH EXPLANTATION ON 1/15 WITH MIDLINE ABSCESS. DISCHARGED ON 1/19 ON AUGMENTIN. PRESENTED WITH WOUND DEHISCENCE ON (B)(6). ABSCESS WAS DRAINED. CULTURE GREW E. COLI AND CANDIDA. ID [INFECTIOUS DISEASE] RECOMMENDED 6 WKS [WEEKS] OF AUGMENTIN AND 2 WKS OF FLUCONAZOLE. DISCHARGED 2/2 WITH BID [TWO TIMES PER DAY] DRESSING CHANGES. RTC [RETURN TO CLINIC] IN 1 WK." 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® 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. 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. 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: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED TYPE OF INVESTIGATION. H6: UPDATED INVESTIGATION CONCLUSIONS. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. FOLLOWING GORE¿S INVESTIGATION, THE PREVIOUSLY SUBMITTED ANNEX F CODE HAS BEEN UPDATED TO REFLECT GORE¿S FINAL CONCLUSION. 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 DEVICE.¿ 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. C1: 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.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2021, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, CONTRACTION, INFECTION, ABSCESS, CRUMPLED MESH, AND MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392457 | GORE® DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC. | 1DLMCP04 | 00733132601110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Hospitalization| R |