GORE® DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2023-03870
- Event Type
- Injury
- Date Received
- April 18, 2023
- Date of Event
- February 25, 2016
- Report Date
- July 10, 2024
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- UDI-DI
- 00733132601134
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
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)]. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1, #2, #3 PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2002: (B)(6) MEDICAL CENTER. (B)(6), MD. EE. (B)(6) MEDICAL CENTER. (B)(6) , MD. EMERGENCY ROOM NOTE: ¿PT RETURNS FROM CT SCANNER AT 1200 WITH EXTRA ABDOMINAL FLUID COLLECTION AND NON DILATED LOOP OF BOWEL IN ANT [ANTERIOR] ABDOMEN. PT HAD THREE PREVIOUS ABDOMINAL HERNIA REPAIRS UPPER ABD [ABDOMINAL] MIDLINE, RIGHT LOWER QUADRANT AND LOWER ABD MIDLINE OVER LAST TEN YEARS LAST IN 1997. CT DONE LAST YEAR OF THE ABD SHOWS SIMILAR FLUID COLLECTION AND BOWEL LOOP CHARACTERIZED AS SEROMA¿ DR. GREER HAS BEEN CALLED AND WILL SEE PATIENT AS I CANNOT RULE OUT ABSCESS IN ABDOMINAL HERNIA REPAIR. PT HAS ELEVATED WBC OF 19000¿. ¿ (B)(6) 2002: THE (B)(6) MEDICAL GROUP, INC. RADIOLOGY. CT ABDOMEN AND PELVIS. IMPRESSION: ¿1. STATUS POST VENTRAL HERNIA REPAIR WITH RECURRENT HERNIATION OF SMALL BOWEL LOOPS. THIS HAS CLEARLY PROGRESSED FROM THE PRIOR EXAM. THERE ARE MILDLY DILATED SMALL BOWEL LOOPS WITHIN THE MID ABDOMEN, WHICH COULD REPRESENT AN ILEUS OR DEVELOPING BOWEL OBSTRUCTION. 2. PERSISTENT BUT DECREASED RIGHT ANTERIOR ABDOMINAL WALL FLUID COLLECTION, NOW MEASURING APPROXIMATELY 9.5 X 3.0 X 8.0 CM. AN INFECTED COLLECTION CANNOT BE EXCLUDED. 3. FATTY INFILTRATION OF THE LIVER¿. ¿ (B)(6) 2002: (B)(6) MEDICAL CENTER. [PROVIDER SIGNATURE CUT OFF]. SURGERY CONSULT: ¿51 YO [FEMALE] PRESENTS + NAUSEA SATURDAY. BEGAN VOMITING [AFTER] INTAKE OF FOOD. STATES SOME DIFFICULTY [WITH] BM [BOWEL MOVEMENTS]. DENIES BURNING [WITH] URINATION... PE [PHYSICAL EXAM]: SOFT, TENDER L [LEFT] MID ABD, MIDLINE SCAR, R [RIGHT] MID ABD SCAR... CT SCAN ¿ FLUID COLLECTION R ABD [DECREASED] SIZED COMPARED [WITH] 8/01. NEW AREA L ANT [WITH] SM [SMALL] BOWEL LOOP ¿ NO CONTRAST, SOMEWHAT DELATED (SIC) PROXIMALLY¿. ¿ (B)(6) 2002: (B)(6) MEDICAL CENTER. (B)(6), MD. OPERATIVE REPORT. ASSISTANT #1: (B)(6), MD. PROCEDURE: EXPLORATORY LAPAROTOMY, REDUCTION OF INCARCERATED HERNIA, CLOSURE OF JEJUNAL PERFORATION, REMOVAL OF MARLEX MESH. PREOPERATIVE DIAGNOSIS: INCARCERATED INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCARCERATED INCISIONAL HERNIA, PERFORATION OF JEJUNUM. ANESTHESIA: GENERAL. BLOOD LOSS: MINIMAL. - HISTORY OF PRESENT ILLNESS: ¿THE PATIENT IS A 40+- YEAR-OLD FEMALE WHO PRESENTS WITH A HISTORY OF NAUSEA, VOMITING, ABDOMINAL PAIN AND A PALPABLE MASS. WHITE BLOOD CELL COUNT WAS NOTED TO BE 22,000. THE PATIENT UNDERWENT CT SCAN WHICH SHOWS AN INCARCERATED LOOP OF BOWEL WITH FREE FLUID IN THE PELVIS AND MULTIPLE AREAS OF MESH WITH A LARGE SEROMA. THE RISKS OF SURGERY WERE DISCUSSED WITH THE PATIENT INCLUDING BLEEDING, INFECTION, NEED FOR MESH REMOVAL, POSSIBLE BOWEL RESECTION. SHE UNDERSTANDS THESE RISKS AND WISHES TO PROCEED¿. - PROCEDURE: ¿THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED ON THE OPERATING TABLE IN SUPINE POSITION AFTER GENERAL ANESTHESIA WAS INDUCED. THE ABDOMEN WAS BETADINE PREPPED AND DRAPED IN STERILE FASHION. AN INCISION WAS MADE THROUGH THE MIDLINE EXTENDING THE PREVIOUS UPPER MIDLINE INCISION. THE PALPABLE MASS WAS TO THE LEFT OF THE UMBILICUS AND SO ONCE THE SUBCUTANEOUS TISSUES WERE DIVIDED, THE FASCIA WAS VISUALIZED AND INCISED WITH THE SCALPEL, THIS WAS EXTENDED WITH BOVIE ELECTROCAUTERY. THE ABDOMINAL CAVITY WAS THEN ENTERED. THE LOOP OF BOWEL PALPATED FROM WITHIN THE ABDOMINAL CAVITY AND FOUND TO BE FAIRLY FIXED INTO POSITION REQUIRING THE INCISION TO BE CARRIED SUPERIORLY AND MESH EASILY VISUALIZED AT THAT POINT. THE LOOP OF BOWEL WAS REDUCED WITH NO EVIDENCE OF ISCHEMIA. IT APPEARED TO BE DILATED PROXIMALLY AND DECOMPRESSED DISTALLY. HOWEVER, THERE WAS WHAT APPEARED TO BE SUCCUS ENTERICUS IN THE ABDOMINAL CAVITY. THE SMALL BOWEL WAS NOT EASILY MOBILIZED THROUGH THIS INCISION AND SO IT WAS DECIDED TO EXTEND THIS INCISION SUPERIORLY THROUGH THE PREVIOUS INCISION SITE WHERE MESH WAS KNOWN TO BE LOCATED. IN DOING SO, THE SEROMA NOTED ON CAT SCAN WAS ENTERED AND THERE WAS COPIOUS TURBID FLUID REMOVED. THIS WAS CULTURED AND SENT TO PATHOLOGY. THE MESH APPEARED TO BE NOT WELL FIXED, HOWEVER, THERE WAS A LOOP OF BOWEL WHICH WAS ADHERENT TO THE MARLEX MESH THAT WAS DIRECTLY ABOVE IT. THIS WAS DISSECTED APART AND THE PROXIMAL SMALL BOWEL VISUALIZED. THERE WAS A SMALL PERFORATION NOTED WITHIN THE VERY DILATED JEJUNUM AND THIS WAS OVERSEWN WITH 3-0 SILK SUTURE IN THE INTERRUPTED FASHION. THE ENTIRE SMALL BOWEL WAS RUN WITH NO OTHER ABNORMALITY NOTED OTHER THAN THE DILATED PROXIMAL BOWEL AND DECOMPRESSED DISTAL SMALL BOWEL. THE FLUID WAS THEN MILKED BACK TO THE NG TUBE WHERE 750 CC WAS REMOVED. BECAUSE THE MESH WAS IN CONTACT WITH INTESTINAL CONTENTS, IT WAS DECIDED THAT THE MESH WOULD BE REMOVED AND THE INFECTION ALLOWED TO CLEAR. THE MESH WAS THEN DISSECTED AWAY FROM THE FASCIA AND SENT TO PATHOLOGY. THE SIGHT OF SEROMA WAS EXCISED WITH A THICK SAC. ONCE THE MESH HAD BEEN EXCISED THERE WAS A GENEROUS DEFECT IN THE ANTERIOR ABDOMINAL WALL. COPIOUS IRRIGATION AND SUCTIONING WAS PERFORMED AND A STERILE IV BAG WAS PLACED INTO THE ABDOMINAL CAVITY OVER THE BOWEL. THERE WAS LITTLE OMENTUM TO COVER THE AREA. THE NG TUBE WAS PALPATED WITHIN THE STOMACH AND AT THIS TIME THE ABDOMINAL CAVITY WAS CLOSED USING INTERRUPTED NYLON RETENTION SUTURES AND A RUNNING LOCKING NYLON SUTURE TO APPROXIMATE JUST THE SKIN. THE PATIENT WAS INTUBATED TO THE INTENSIVE CARE UNIT IN FAIR CONDITION. ALL NEEDLE, SPONGE, AND INSTRUMENT COUNTS WERE NOTED TO BE CORRECT. ESTIMATED BLOOD LOSS WAS LESS THAN 200CC'S¿. ¿ (B)(6) 2002: (B)(6) LABORATORY. (B)(6), MD. PATHOLOGY: ¿CLINICAL DATA: EXPLORATORY LAPAROTOMY, MESH REMOVAL ¿ CLOSURE OF PERFORATED JEJUNUM ¿ INFECTED MESH, PERFORATION. GROSS DESCRIPTION: SIX IRREGULAR PORTIONS OF INDURATED AND SCARIFIED FAT RANGING FROM 6.5 - 16.0 CM IN GREATEST DIMENSION, SOME WITH PORTIONS OF MESH ATTACHED. DIAGNOSIS: NONSPECIFIC CHRONIC INFLAMMATION AND FIBROSIS: FAT, MESH AND SCAR TISSUE, REMOVAL OF MESH AND CLOSURE OF PERFORATION¿. ¿ (B)(6) 2002: (B)(6) RADIOLOGY. CT ABDOMEN AND PELVIS. IMPRESSION: 1. LARGE VENTRAL ABDOMINAL WALL HERNIA, WHICH NOW CONTAINS NUMEROUS SMALL AND LARGE BOWEL SEGMENTS, IN ADDITION TO SOME FLUID WITHIN I¿S INFERIOR MOST EXTENT. 2. BOWEL GAS PATTERN MOST SUGGESTIVE OF A PARTIAL MID-SMALL BOWEL OBSTRUCTION¿. IMPLANT #1, #2, #3 PROCEDURE: EXPLORATORY LAPAROTOMY, CLOSURE OF FASCIA WITH DUAL MESH. [IMPLANT: #1 GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP07/(B)(4), 20CM X 30CM X 1MM THICK. #2 GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP06/(B)(4), 18CM X 24CM X 1MM THICK. #3 GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP03/(B)(4), 10CM X 15CM X 1MM THICK, OVAL] [NO OPERATIVE REPORT PROVIDED] . IMPLANT #1, #2, #3 DATE: (B)(6) 2002 (HOSPITALIZATION DATES (B)(6) - (B)(6) 2002). ¿ (B)(6) 2002: (B)(6) MEDICAL CENTER. (B)(6), MD. SURGERY PROGRESS NOTE. ASSISTANT #1: PARK. PRE- AND POSTOPERATIVE DIAGNOSIS: VENTRAL HERNIA. ANESTHESIA. GENERAL. ESTIMATED BLOOD LOSS: < 200 CC. ¿ (B)(6) 2002: WOUND CLASSIFICATION: ¿2¿ CLEAN CONTAMINATED. ¿ (B)(6) 2002: (B)(6) MEDICAL CENTER. IMPLANT STICKERS X 3: ¿DUALMESH CORDUROY ANTIMICROBIAL. ITEM#: 1DLMCP07. LOT#: 01289265. DUALMESH CORDUROY ANTIMICROBIAL. ITEM#: 1DLMCP06. LOT#: 01310988. DUALMESH CORDUROY ANTIMICROBIAL. ITEM#: 1DLMCP03. LOT#: 01404010.¿ ¿ (B)(6) 2002: (B)(6) MEDICAL CENTER. (B)(6), MD. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: ABDOMINAL PAIN, INCARCERATED INCISIONAL HERNIA, STATUS POST EXPLORATORY LAPAROTOMY WITH REMOVAL OF INFECTED MESH AND CLOSURE OF JEJUNAL PERFORATION. ANOTHER EXPLORATORY LAPAROTOMY WITH CLOSURE OF FASCIA WITH DUAL MESH. SECONDARY DIAGNOSIS: MORBID OBESITY. HISTORY OF MULTIPLE INCISIONAL HERNIA REPAIRS. ¿THE PATIENT TOLERATED THE (FIRST) OPERATIVE PROCEDURE WELL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENTS POST OPERATIVE COURSE IN THE INTENSIVE CARE UNIT REVEALED A TEMPERATURE MAXIMUM OF 100.1 AND A TENDER ABDOMEN WHICH WAS MILDLY DISTENDED WITH NO BOWEL SOUNDS NOTED. HER WOUND WAS INTACT WITH SOME MINOR SATURATION OF THE DRESSING IN THE INFERIOR ASPECTS¿ ON (B)(6) 2002, THE PATIENT REPORTS FLATUS TIMES ONE. THE PAIN WAS WELL-CONTROLLED AND TEMPERATURE MAXIMUM WAS 100.8¿ SHE STILL REMAINED IN THE INTENSIVE CARE UNIT AND WILL BE DISCHARGED TO THE FLOOR ON (B)(6) 2002¿ A CT SCAN WAS ORDERED FOR (B)(6) 2002, TO EVALUATE FOR INTRA-ABDOMINAL FLUID COLLECTIONS. THE PLAN WAS TO RETURN TO THE OPERATING ROOM FOR MESH PLACEMENT AND CLOSURE OF THE WOUND. THE WOUND SITE WAS RED AND HEALTHY WITHOUT ANY SIGNS OF INFECTION¿ THE CT SCAN RESULTS REVEALED NO ABSCESS. THERE WAS CONTRAST IN THE PROXIMAL BOWEL. SHE WAS SCHEDULED TO TAKE TO THE OPERATING ROOM FOR A SECOND OPERATION ON (B)(6) 2002. PREOPERATIVE DIAGNOSIS AT THIS TIME WAS VENTRAL HERNIA AND THE PROCEDURE WAS AN EXPLORATORY LAPAROTOMY AND CLOSURE AS A (SIC) WITH DUAL MESH. THE PATIENT TOLERATED THE OPERATIVE PROCEDURE WELL AND WAS RETURNED TO THE INTENSIVE CARE UNIT¿ POST OPERATIVE DAY EIGHT FROM THE SECOND OPERATION, THE PATIENT FELT GREAT, NO COMPLAINTS, TEMPERATURE WAS 100.4 DOWN TO 99.2, 105/46 WAS HER BLOOD PRESSURE WITH HEART RATE OF 94... HALF OF HER STAPLES WERE DISCONTINUED AND THE REST WILL BE TAKING OUT WHEN SHE RETURNS TO THE SURGERY CLINIC FOR HER POSTOPERATIVE VISIT. HER DIET WAS ADVANCED TO FULL LIQUIDS AND WHITE COUNT ON THIS DAY WAS 14 WITH A HEMOGLOBIN OF 8.4 AND HEMATOCRIT OF 25.5. ON (B)(6) 2002 THE PATIENT WAS DISCHARGED¿. RELEVANT MEDICAL INFORMATION: ¿ (B)(6) 2015: KAISER (B)(6) INTERNAL MEDICINE. (B)(6) , MD. OFFICE VISIT. HPI [HISTORY OF PRESENT ILLNESS]: ¿64 YO WOMAN C/O [COMPLAINING OF] RIGHT SIDED ABDOMINAL PAIN X 3 MONTHS. PAIN COMES AND GOES, WORSE WITH MOVEMENT. SHE IS CAREGIVER FOR HER PARTNER AND PAIN IS WORSE WHEN SHE TRIES TO ROTATE HER PARTNER IN BED.¿ ¿ASSESSMENT & PLAN: NOTE: S/P CHOLECYSTECTOMY. LIKELY M/S [MUSCLE SPASMS]. WILL CHECK CXR [CHEST X-RAY] AND LABS. ASKED HER TO DISCUSS HER POSTURE WHILE CARING FOR HER PARTNER WITH HOME PT [PHYSICAL THERAPY]. CONSIDER U/S [ULTRASOUND] OF LIVER AND RIGHT KIDNEY¿. ¿ (B)(6) 2015: (B)(6) INTERNAL MEDICINE. (B)(6), MD. LETTER. ¿LABS ARE OK OTHER THAN THE SMALL AMT [AMOUNT] OF RED CELLS IN URINE. YOU SHOULD STILL DO THE ABDOMINAL ULTRASOUND WHICH LOOKS AT KIDNEYS TOO¿. ¿ (B)(6) 2015: (B)(6). (B)(6). RADIOLOGY. RIGHT UPPER QUADRANT ULTRASOUND. IMPRESSION: STATUS POST CHOLECYSTECTOMY. NO BILE DUCT DILATION. DIFFUSE FATTY INFILTRATION OF THE LIVER¿. ¿ (B)(6) 2015: (B)(6). (B)(6), MD. TELEPHONE ENCOUNTER. ¿C/O CONTINUED RIGHT SIDED BACK AND UPPER ABDOMINAL PAIN. WORK UP NEGATIVE. LIKELY MUSCULOSKELETAL PAIN. CAN USE NSAIDS [NON-STEROIDAL ANTI-INFLAMMATORY DRUGS] SPARINGLY¿. 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. 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 A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. 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: 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® BIOMATERIAL PLUS 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. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. 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.¿ 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. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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.
RETRACTING ALL MEDWATCHES ASSOCIATED WITH THIS REPORT NUMBER AS THIS WAS FOUND TO BE A DUPLICATE EVENT. THIS EVENT WAS CAPTURED PREVIOUSLY UNDER MEDWATCH 2017233-2023-03869.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS TO BOWEL, HERNIA RECURRENCE, MESH DISRUPTION, SMALL BOWEL OBSTRUCTION, ADHESIONS, OPEN DRAINING WOUND, SURGERY TO REMOVE PARTIAL MESH, EXPOSED MESH, INFECTION, FISTULA, BOWEL RESECTION, SCARRING, SURGERY TO REMOVE MESH, ABDOMINAL WALL RECONSTRUCTION, GROSS PURULENCE ON MESH, ABSCESS, MESH DETACHMENT, SUCCUS STAINING ON MESH, SMALL BOWEL FISTULA TO MESH, ADHESIONS TO SMALL INTESTINE, CHRONIC INFLAMMATION, INFLAMMATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1092015 | GORE® DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC. | 1DLMCP06 | 00733132601134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Hospitalization| R |