GORE DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-01072
- Event Type
- Injury
- Date Received
- October 22, 2019
- Report Date
- June 3, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601097
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
H6: CONCLUSION CODE REMAINS UNCHANGED. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2008: (B)(6) HEALTHCARE, INC. (B)(6), MD. HISTORY AND PHYSICAL. HERNIA FOR 7 YEARS NOW. IN UMBILICAL AREA. DOES CAUSE PAIN SOMETIMES, USUALLY NOT SYMPTOMATIC. IMPRESSION/PLAN: UMBILICAL HERNIA. LAPAROSCOPIC UMBILICAL HERNIA WITH MESH PLACEMENT, POSSIBLE OPEN. PROCEDURE SCHEDULED. I INFORMED THE PATIENT THAT HE IS GOING TO HAVE TO BE ON ORABASE [SIC], AND HE CANNOT LIFT ANYTHING MORE THAN 5-10 POUND FOR ABOUT 6 WEEKS AFTER THE SURGERY. (B)(6) 2008: (B)(6) HEALTHCARE, INC. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: UMBILICAL HERNIA. POSTOPERATIVE DIAGNOSIS: UMBILICAL HERNIA. PROCEDURE: LAPAROSCOPIC REPAIR OF UMBILICAL HERNIA WITH PLACEMENT OF MESH. ANESTHESIA: GENERAL ENDOTRACHEAL. COMPLICATIONS: NONE. ESTIMATED BLOOD LOSS: MINIMAL. PROCEDURE IN DETAIL: AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS TAKEN TO THE OPERATING ROOM. IN THE OPERATING ROOM, THE PATIENT WAS PLACED IN THE SUPINE POSITION. AFTER INDUCTION OF GENERAL ENDOTRACHEAL ANESTHESIA AND PLACEMENT OF OG TUBE, THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STANDARD FASHION. AN INCISION WAS MADE IN THE LEFT UPPER QUADRANT. DISSECTION WAS CARRIED DOWN THROUGH THE FASCIA INTO THE ABDOMINAL CAVITY USING STANDARD HASSAN TECHNIQUE. A 5 MM TROCAR WAS THEN PLACED. AFTER THAT WAS DONE, I DID PROCEED WITH PLACEMENT OF TWO OTHER 5 MM TROCARS UNDER DIRECT VISUALIZATION, ONE IN THE RIGHT UPPER QUADRANT AND ON IN THE RIGHT LOWER QUADRANT. ALSO UNDER DIRECT VISUALIZATION, ANOTHER 5 MM TROCAR WAS PLACED IN THE LEFT LOWER QUADRANT. AFTER THAT WAS DONE, THE HERNIA WAS MEASURED AND IT APPEARED TO BE MEASURING ABOUT 1.0 X 1.0 CM IN SIZE IN MAXIMUM DIAMETER. I DID FASHION AN 8.0 X 10.0 CM GORE DUALMESH. THAT WAS USED. THEN, GORE-TEX SUTURES WERE PLACED IN THE MIDLINE AT THE END OF THE MESH ON EACH CORNER. AFTER THAT WAS DONE, THE MESH WAS THEN PLACED INSIDE THE ABDOMINAL CAVITY THROUGH THE 5 MM TROCAR. THEN, I DID PROCEED WITH PLACEMENT OF THE MARKERS IN THE SKIN FOR A 10.0 X 8.0 MESH. AFTER THAT WAS DONE, THOSE GORE SUTURE PREVIOUSLY PLACED ON THE MESH WERE THEN RETRIEVED THROUGH THE FASCIA WITH A GORE SUTURE PASSER. THEN, IT WAS TAKEN OUT THROUGH THE ABDOMINAL WALL INTO THE OUTSIDE USING A GORE SUTURE PASSER WITH STAB INCISION ON THE SKIN AND SEPARATE FASCIAL INCISIONS FOR EACH END OF THE SUTURE. THAT WAS DONE FOR THE FOUR SUTURES. AFTER THAT WAS DONE, THE SUTURE WERE PULLED UP AND THEY WERE TIED DOWN. THERE APPEARED TO BE GOOD ADHERENCE OF THE MESH TO THE ABDOMINAL WALL. THERE WAS GOOD TENSION ON THE MESH. AFTER THAT WAS DONE, THE TACKER WAS USED TO TACK THE PERIPHERY OF THE MESH TO PREVENT SLIPPAGE OF THE BOWEL BETWEEN THE MESH AND ABDOMINAL WALL. AFTER THAT WAS DONE, THERE WAS GOOD HEMOSTASIS. I DID REMOVE THE TROCARS UNDER DIRECT VISUALIZATION FROM THE TROCAR SITES. I THEN DID PROCEED WITH CLOSURE OF THE LEFT UPPER QUADRANT INCISION FOR CLOSURE OF THE FASCIA USING 0-VICRYL IN AN INTERRUPTED FASHION. AFTER ADEQUATE CLOSURE WAS DONE, ABOUT 18 CC OF 0.25% MARCAINE WAS USED FOR LOCAL ANESTHESIA. THEN, DERMABOND WAS USED AFTER APPROXIMATING THE SUBCUTICULAR AREA WITH 4-0 MONOCRYL. DERMABOND WAS USED OVER THE WOUNDS. THEN, STERI-STRIPS WERE ALSO USED OVER THE STAB INCISIONS FOR THE FASCIAL CLOSURE SUTURES. AFTER THAT WAS DONE, I DID PROCEED WITH PLACEMENT OF STERI-STRIPS OVER THE STAB INCISIONS. THE PATIENT WAS THEN EXTUBATED AND SENT BACK TO THE RECOVERY ROOM IN STABLE CONDITION WITH NO COMPLICATIONS.¿ (B)(6) 2008: (B)(6) HEALTHCARE, INC. INTRAOPERATIVE NURSING RECORD. IMPLANT STICKER. GORE DUALMESH® PLUS BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMCP02. LOT BATCH CODE: 05721447. W.L. GORE & ASSOCIATES. [HANDWRITTEN]: ABDOMINAL BINDER. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP02/05721447) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2016: HARH MEDICAL RECORDS. (B)(6), MD. OFFICE NOTES. FOLLOW UP EPIGASTRIC PAIN AND INCARCERATED RECURRENT UMBILICAL HERNIA. PREVIOUSLY SCHEDULED FOR ESOPHAGOGASTRODUODENOSCOPY, DUE TO SEVERE HYPERTENSION PROCEDURE WAS CANCELLED. RECURRENT UMBILICAL HERNIA REMAINS SYMPTOMATIC. WEIGHT 202 LBS, BMI 29.06. IMPRESSION/PLAN: ESOPHAGOGASTRODUODENOSCOPY FOLLOW BY LAPAROSCOPIC CHOLECYSTECTOMY NEXT WEEK. REPAIR OF INCARCERATED RECURRENT UMBILICAL HERNIA AFTER LAP CHOLE. (B)(6) 2016: (B)(6) HEALTHCARE, INC. (B)(6), MD. OPERATIVE REPORT. ANESTHESIA PROVIDER: (B)(6), MD. ANESTHESIA TYPE: IV GENERAL. PREOPERATIVE DIAGNOSIS: GASTROESOPHAGEAL REFLUX DISEASE. POSTOPERATIVE DIAGNOSIS: SAME AS PREOPERATIVE DIAGNOSIS. PROCEDURE: ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY. FINDINGS: MILD DUODENITIS, GASTRITIS, GASTRIC EROSIONS, LARGE HIATAL HERNIA, GE JUNCTION AT 39 CM, MILD ESOPHAGITIS. SPECIMENS: DUODENUM, CLO, BODY, FUNDUS. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 43 YEAR OLD MALE, EVALUATED IN MY OFFICE WITH SYMPTOMS CONSISTENT WITH GASTROESOPHAGEAL REFLUX DISEASE. FOLLOWING EVALUATION, I RECOMMENDED EGD WITH BIOPSIES. INFORMED CONSENT WAS OBTAINED AFTER EXPLAINING THE RISKS, BENEFITS, AND ALTERNATIVES OF THE PROCEDURE TO THE PATIENT, WHICH INCLUDED BUT WERE NOT LIMITED TO, BLEEDING, ASPIRATION, AND PERFORATION. THE PATIENT UNDERSTOOD, AGREED, AND ELECTED TO GO AHEAD WITH THE PROCEDURE. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS BROUGHT INTO THE ENDOSCOPY SUITE, WAS LAID IN THE LEFT LATERAL POSITION WITH A MOUTHGUARD IN PLACE. THE THROAT WAS SPRAYED WITH CETACAINE AND IV SEDATION WAS ADMINISTERED BY THE NURSE ANESTHETIST AND TITRATED TO THE PATIENT¿S COMFORT. THE OLYMPUS GASTROSCOPE WAS INSERTED THROUGH THE MOUTHGUARD INTO THE HYPOPHARYNX, AND UNDER DIRECT VISION INTO THE ESOPHAGUS, STOMACH AND DUODENUM. CIRCUMFERENTIAL EVALUATION OF THE DUODENAL MUCOSA REVEALED MILD DUODENITIS. THE SCOPE WAS WITHDRAWN TO THE STOMACH AND RETROFLEXED. FINDINGS IN THE STOMACH INCLUDE GASTRITIS, GASTRIC EROSIONS AND LARGE HIATAL HERNIA. MULTIPLE BIOPSIES WERE TAKEN FROM CLO, BODY, AND FUNDUS. THE STOMACH WAS THEN GENTLY DESUFFLATED AND THE SCOPE WAS WITHDRAWN TO THE ESOPHAGUS WHERE THE PATIENT WAS FOUND TO HAVE MILD ESOPHAGITIS. THE GE JUNCTION WAS AT ABOUT 39 CM. THE SCOPE WAS WITHDRAWN WITHOUT ANY PERIPROCEDURAL EVENT.¿ ESTIMATED BLOOD LOSS: MINIMAL. POSTOPERATIVE STATUS: STABLE. DISPOSITION: THE PATIENT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN STABLE CONDITION. 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 INSTRUCTIONS FOR GORE® DUALMESH® PLUS BIOMATERIAL 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.
H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS: D15: CAUSE NOT ESTABLISHED; D17: APPROPRIATE CODE/TERM NOT AVAILABLE FOR ¿WITHDRAWN¿ COMPLAINT¿. H6: HEALTH EFFECT IMPACT CODE: F24: INSUFFICIENT INFORMATION. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THIS CLAIM WAS WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. 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. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. 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 INSUFFICIENT INFORMATION AND NO FINDINGS AVAILABLE AND WILL BE CLOSED AS WITHDRAWN¿ AND ¿CAUSE NOT ESTABLISHED¿. 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.¿ 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 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: 05721447. 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.
H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED.
(B)(6). 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.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: TO BE SUPPLEMENTED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1013069 | GORE DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP02 | 05721447 | 00733132601097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Male | Hospitalization| R |