GORE® DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2021-01828
- Event Type
- Injury
- Date Received
- March 30, 2021
- Date of Event
- July 9, 2004
- Report Date
- June 21, 2023
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- UDI-DI
- 00733132601103
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT PROCEDURE: VENTRAL HERNIORRHAPHY USING A PIECE OF 15 X 20 CENTIMETERS DUALMESH. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP03/(B)(6); 15 X 10 CM) IMPLANT DATE: (B)(6) 2004 (HOSPITALIZATION UNKNOWN) (B)(6) 2004 [ASSIGNED]: (B)(6) MEDICAL CENTER. (B)(6) MD. OPERATIVE REPORT. FIRST ASSISTANT: (B)(6) SA, REPLACED MID-CASE BY (B)(6) SA. ANESTHESIA: GENERAL. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. DESCRIPTION OF PROCEDURE: ¿UNDER GENERAL ENDOTRACHEAL ANESTHESIA ADMINISTERED BY (B)(6) WITH FIRST ASSISTANT OF (B)(6) S.A., REPLACED MID-CASE BY (B)(6), S.A., THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL MANNER. THE ABDOMEN WAS ENTERED THROUGH THE OLD MIDLINE ABDOMINAL INCISION. THE INCISION WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE UNTIL SOME OF THE PERITONEAL FAT CREPT OUT IN BETWEEN HOLES IN THE FASCIA. THE ABDOMEN WAS OPENED. THERE WERE TWO FAIRLY LARGE HERNIAS WITH OMENTUM STUCK IN THEM ON THE LEFT SIDE OF THE MIDLINE AND ONE LARGE ONE NEAR THE UMBILICUS ON THE RIGHT SIDE OF THE MIDLINE. THE OMENTUM WAS STICK INTO THESE HERNIA SACS AND TEDIOUS DISSECTION WAS REQUIRED TO FREE THE OMENTUM FROM THEIR INCARCERATED POSITION WITHIN THESE HERNIA SACS, BUT EVENTUALLY, THE OMENTUM CAME FREE. GOOD HEMOSTASIS WAS ESTABLISHED AND DISSECTION OF FAT FROM THE ABDOMINAL WALL WAS CARRIED OUT LATERALLY AND A 15 CENTIMETERS LONG X 10 CENTIMETERS WIDE PIECE OF DUALMESH, SHINY SIDE DOWN TOWARDS THE PERITONEUM, RIGHT SIDE UP TOWARDS THE WOUND, WAS PLACED AND SUTURED IN POSITION WITH 0 PROLENE, GOING WELL LATERAL TO ALL HERNIA DEFECTS BY AT LEAST 5 CENTIMETERS ON EITHER SIDE. AFTER SUTURING THE DUALMESH IN POSITION WITH THE 0 PROLENE, THE FASCIA WAS CLOSED IN THE MIDLINE WITH 0 PROLENE. THE SKIN WAS CLOSED WITH STAPLES. DRY DRESSINGS WERE APPLIED. THE PATIENT WAS TRANSFERRED TO THE RECOVER.¿ (B)(6) 2004: (B)(6) HEALTH. IMPLANT STICKER. IMPLANT: DUALMESH PLUS ANTIMICROBIAL. LOT: 02827028. ITEM: 1DLMCP03. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP03/(B)(6)) WAS IMPLANTED DURING THE PROCEDURE. EXPLANT PROCEDURE: EXCISION OF INFECTED GRAFT MATERIAL FROM VENTRAL HERNIA. EXPLANT DATE: (B)(6) 2004 (HOSPITALIZATION UNKNOWN) (B)(6) 2004: (B)(6) MEDICAL CENTER. (B)(6), MD. OPERATIVE REPORT. ANESTHESIA: GENERAL ANESTHESIA. PREOPERATIVE DIAGNOSIS: INFECTED GRAFT TO HERNIA AND ABDOMINAL WALL. POSTOPERATIVE DIAGNOSIS: SAME. DESCRIPTION OF OPERATION: ¿UNDER GENERAL ENDOTRACHEAL ANESTHESIA ADMINISTERED BY DR. (B)(6) WITH (B)(6), PA, AS FIRST ASSISTANT, THE ABDOMEN WAS PREPPED AND DRAPED AND INCISION WAS MADE THROUGH OLD ABDOMINAL INCISION WHERE THE GRAFT WAS PROTRUDING THROUGH THE SKIN. GRAFT WAS GRASPED WITH KOCHER CLAMP AND THE SUTURES HOLDING IT TO THE FASCIA WERE CUT AND THE GRAFT WAS REMOVED IN ITS ENTIRETY ALONG WITH SUTURES THAT WERE HOLDING IT. BLEEDERS WERE CAUTERIZED WITH THE BOVIE CURRENT. THE WOUND WAS PACKED OPEN WITH IODOFORM GAUZE. THE PATIENT TOLERATED THE PROCEDURE WELL AND RETURNED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2004: (B)(6) MEDICAL CENTER. (B)(6), MD. PATHOLOGY. SPECIMEN: VENTRAL HERNIA WOUND AND MESH. PATHOLOGICAL DIAGNOSIS: VENTRAL HERNIA WOUND MESH: ENTRAPPED ACUTE INFLAMMATORY CELLS AND BACTERIA. GROSS DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN, LABELED ¿VENTRAL HERNIA WOUND/MESH,¿ AND CONSISTS OF A 10.7 X 8.6 X 0.2 CM GREEN-YELLOW-TAN IRREGULAR PORTION OF SYNTHETIC MATERIAL. AROUND THE PERIPHERY ARE SEVERAL ATTACHED SUTURES. SECTIONING REVEALS RATHER DOUGHY CUT SURFACES. THERE IS NO ADHERENT SOFT TISSUE. MICROSCOPIC DESCRIPTION: SECTIONS SHOW SYNTHETIC MESH MATERIAL ENTRAPPING SCATTERED ACUTE INFLAMMATORY CELLS AND COLONIES OF BACTERIA. (B)(6) 2005: (B)(6). RADIOLOGY- CT ABDOMEN. REASON FOR EXAM: HERNIA. FINDINGS: AT THE LEFT ASPECT OF THE FASCIA, THERE IS AN APPROXIMATELY 2 CM DEFECT. THERE IS A SMALL AMOUNT OF HERNIATION OF MESENTERIC FAT INTO THE DEFECT. NO HERNIATION OF BOWEL LOOPS OF BOWEL OBSTRUCTION IS PRESENT. IMPRESSION: FINDINGS ARE CONSISTENT WITH SIGMOID DIVERTICULITIS, WITH EITHER A LARGE DIVERTICULUM OR CONTAINED PERFORATION. NO INTRAABDOMINAL FREE AIR OR FREE FLUID IS SEEN. THERE IS A 2 CM DEFECT IN THE LEFT ASPECT OF THE ANTERIOR ABDOMINAL WALL, WITH HERNIATED MESENTERIC FAT. NO BOWEL LOOPS ARE SEEN WITHIN THE HERNIA SAC. SIMPLE CYST IN LEFT LOBE OF LIVER. RESULTS OF STUDY WERE DISCUSSED WITH DR. (B)(6) AT THE TIME OF DICTATION. (B)(6) 2006: (B)(6) CLINICS. (B)(6), MD. OFFICE NOTES. HISTORY OF PRESENT ILLNESS: BRINGS ME A LETTER FROM THE VICE PRESIDENT OF HIS UNION ASKING ME IF HE IS ELIGIBLE FOR TOTAL DISABILITY WHETHER ALL HIS PROBLEMS ARE RELATED TO THE HERNIA AND WHETHER HE CAN GO BACK TO DO ANY WORK. THE PATIENT HAD A HERNIA, WHICH WAS REPAIRED BY DR. (B)(6) AND DR. (B)(6) WENT AHEAD AND REMOVED AN INFECTED THE MESH. THE PATIENT HAD THIS SURGERY DONE IN (B)(6) 2004. EXAM: AT THIS POINT, HE HAS SOME DISFIGURATION FROM HIS SURGERY. HE HAS A HERNIA TO LEFT OF MIDLINE, WHICH SEEMED TO BE WIDE MOUTHED. IT SEEMS TO CONTAIN BOWEL, BUT THIS IS REDUCIBLE WITH EASE. NO ABDOMINAL TENDERNESS. IMPRESSION/PLAN: I TOLD THEM THAT I COULD BE REPLY TO A PHYSICIAN FROM THE COMPANY OR THE COMPANY. I TOLD THE PATIENT THAT I DO NOT FEEL THAT HE IS TOTALLY DISABLED. HE IS RELUCTANT TO HAVE SURGERY. HOWEVER, SURGERY WOULD BE AN OPTION. IF HE WANTED TO HAVE SURGERY, HE COULD GO BACK TO WORK. THERE WAS NO GUARANTEE WHETHER THIS HERNIA WOULD INCARCERATE AND THAT IT COULD INCARCERATE EVEN IF HE DID NOTHING. WE DISCUSSED THAT IF HE HAD DISCOMFORT HE COULD LIMIT HIS LIFTING TO 50 POUNDS BUT OTHERWISE HE COULD GO BACK TO REGULAR DUTIES AND WHEN HE DECIDED HE COULD GO AHEAD AND THE HERNIA REPAIRED WITH A RETRO MUSCULAR TYPE OF REPAIR. I TOLD HIM I DID NOT THINK THERE WAS ANY CONTRAINDICATION TO HIS RETURNING TO WORK AND THAT IF HIS PHYSICIAN HAD ANY QUESTIONS THEY SHOULD GET IN TOUCH WITH ME DIRECTLY AND I WOULD BE HAPPY TO RESPOND TO THEM. HE AND HIS WIFE HAD NO QUESTIONS WHEN THEY LEFT. (B)(6) 2010: (B)(6) HEALTH CENTER. (B)(6) , MD. OFFICE NOTES. CHIEF COMPLAINT: HERE FOR PREOP CLEARANCE AT THE REQUEST OF DR.(B)(6) FOR RIGHT INGUINAL HERNIA REPAIR. SOCIAL HISTORY: DENIED TOBACCO; ALCOHOL 3 BEERS ON WEEKENDS; DENIES STREET DRUGS. HISTORY OF UMBILICAL HERNIA REPAIR IN 2005, DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA. EXAM: WEIGHT 228 POUNDS. ABDOMEN WITHOUT MASSES, TENDERNESS OR HEPATOSPLENOMEGALY, BILATERAL CENTRAL SWELLING WHICH IS REDUCIBLE, RIGHT INGUINAL HERNIA SWELLING. IMPRESSION: PREOP CLEARANCE AT REQUEST OF DR. (B)(6) . RIGHT INGUINAL HERNIA. ABNORMAL EKG. DM2. HYPERTENSION. HYPERLIPIDEMIA. PLAN: CMP, CBC, HEMOGLOBIN A1C, UA. REFERRED FOR EXERCISE CARDIOLITE STRESS TEST. (B)(6) 2010: (B)(6) CAMPUS. (B)(6) , MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: NON-REUSABLE RIGHT INGUINAL MASS COMPATIBLE WITH INDIRECT INGUINAL HERNIA. POSTOPERATIVE DIAGNOSIS: SLIDING RIGHT INGUINAL HERNIA WITH DIRECT AND INDIRECT COMPONENT. OPERATION PERFORMED: REPAIR REDUCTION OF SLIDING RIGHT INGUINAL HERNIA. USE OF MEDIUM-SIZED PREFIX PLUG AND KEYHOLE MESH. PROCEDURE: ¿THIS PATIENT HAD RIGHT GROIN PAIN AND PALPABLE MASS AFTER APPROPRIATE GENERAL ANESTHESIA. IN PREVIOUSLY EXPLAINING THE PATIENT RISK, COMPLICATIONS, AND OPTIONS, AND AFTER THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS, I INFILTRATED 0.5% ROPIVACAINE IN THE RIGHT LOWER QUADRANT, DIVIDED THE EPIGASTRIC VESSELS, AS I EXPOSED THE EXTERNAL OBLIQUE. THERE WAS A MASS OUTSIDE THE EXTERNAL RING. THE CORD WAS MOBILIZED. THE NERVES WERE PRESERVED, BOTH ILIOINGUINAL AND ILIOHYPOGASTRIC. THERE WAS A MODERATE-SIZED INDIRECT HERNIA THAT CONTAINED BOWEL WITH A SLIDING COMPONENT. THE SAC WAS OPENED, INTESTINE WAS REDUCED, AND THE SAC WAS EXCISED AND CLOSED WITH RUNNING, LOOKING 2-0 CHROMIC SUTURE. THE LARGEST COMPONENT, HOWEVER, WAS A FAIRLY LARGE DIRECT HERNIA. I INCISED THE TRANSVERSALIS FASCIA, REDUCED THE HERNIA, SELECTED A MEDIUM-SIZED PREFIX PLUG THAT WAS APPLIED TO THE ILIOPUBIC TRACT, [ILLEGIBLE] LIGAMENT, AND TRANSVERSE ABDOMINIS ARCH. WE THEN SELECTED A KEYHOLE MESH THAT WAS APPLIED OVER THIS, AND THIS SURROUNDED THE CORD BY 360 DEGREES, AND WAS APPLIED TO THE ILIOPUBIC TRACT, AND TRANSVERSE ABDOMINAL ARCH. 0.5% ROPIVACAINE WAS ALSO INJECTED LOCALLY. THE WOUND WAS IRRIGATED AND CLOSED ANATOMICALLY. THE PATIENT TOLERATED THE PROCEDURE WELL.¿ (B)(6) 2010: (B)(6) CAMPUS. IMPLANT STICKER. IMPLANT: BARD MESH PERLIX PLUG. 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 RESULTS CODE. CONCLUSION CODE 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.
H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. 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. MEDICAL RECORDS THAT INDICATE MESH EXPOSURE MAY REFLECT ABDOMINAL WALL WOUND DEHISCENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY OR LOSS OF ANCHORAGE OF FIXATION OR MAY BE RELATED TO INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND/OR PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, FIXATION TYPE, SUTURE TECHNIQUE, TYPE OF AND TENSION ON THE INCISION, AND WOUND CLASSIFICATION AT TIME OF PROCEDURE. POST-OPERATIVE FACTORS SUCH AS THE DEVELOPMENT OF A POST-OPERATIVE INFECTION, AN INCISION AND DRAINAGE PROCEDURE, OR WOUND PACKING COULD RESULT IN MESH EXPOSURE. ADDITIONALLY, PATIENT COMORBIDITIES THAT COULD INFLUENCE WOUND DEHISCENCE LEADING TO MESH EXPOSURE INCLUDE, BUT ARE NOT LIMITED TO, SMOKING AND OBESITY. 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.
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".
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION; MESH REMOVAL; RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487078 | GORE® DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC. | 1DLMCP03 | 00733132601103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Hospitalization| R |