GORE DUALMESH® BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00299
- Event Type
- Injury
- Date Received
- August 29, 2019
- Date of Event
- February 13, 2018
- Report Date
- May 17, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
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: (B)(6) 2008: (B)(6). RADIOLOGY-CT ABDOMEN/PELVIS. HISTORY: ABDOMINAL MASS. FINDINGS: IN THE LOWER ABDOMEN, THERE IS A CENTRAL, RIGHT PARACENTRAL VENTRAL HERNIA CONTAINING FAT WITH SOME MILD SURROUNDING INFLAMMATORY FAT CHANGE. THE HERNIA DEFECT MEASURING 3.1 CM ACROSS. NO BOWEL LOOPS APPEAR TO BE HERNIATED INTO THIS AREA. THERE ARE A FEW SCATTERED SMALL CENTRAL MESENTERIC LYMPH NODES, BUT NONSPECIFIC. IMPRESSION: VENTRAL HERNIA CONTAINING FAT, ALTHOUGH MAY BE SLIGHTLY INFLAMED. NO OTHER SIGNIFICANT UPPER ABDOMINAL ABNORMALITY. SMALL, NONSPECIFIC MESENTERIC LYMPH NODES. (B)(6) 2008: (B)(6) MD. HISTORY AND PHYSICAL. UMBILICAL HERNIA FOR APPROXIMATELY 22 YEARS. BECOMING VERY PAINFUL; CAN NOT SIT DOWN AFTER EATING. OBESE. PALPABLE MASS ABOVE UMBILICUS, TENDER TO PALPATION, NO BOWEL SOUNDS. PLAN LAPAROSCOPIC VERSUS OPEN REPAIR NEXT THURSDAY. (B)(6) 2008: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INCARCERATED UMBILICAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCARCERATED UMBILICAL HERNIA. CO-MORBIDITIES: MORBID OBESITY AND CONGESTIVE HEART FAILURE. OPERATIVE PROCEDURE: LAPAROSCOPIC UMBILICAL HERNIA REPAIR USING GORE-TEX DUAL MESH. ANESTHESIA: GTA [GENERAL ANESTHESIA]. ESTIMATED BLOOD LOSS: 20 CCS. IV FLUID REPLACEMENT: 1500 CCS CRYSTALLOID. SPECIMENS: NONE. COMPLICATIONS: NONE. COUNTS: SPONGE, NEEDLE AND INSTRUMENT COUNTS CORRECT TIMES TWO. INDICATIONS: MS. (B)(6) IS A 51-YEAR-OLD, MORBIDLY OBESE FEMALE WHO PRESENTED WITH A PAINFUL, INCARCERATED UMBILICAL HERNIA. ON CT SCAN, THE HERNIA MEASURED 3.5 CM IN DIAMETER AND, GIVEN HER CO-MORBIDITY OF MORBID OBESITY, LAPAROSCOPIC REPAIR WAS INDICATED. DESCRIPTION OF PROCEDURE: ¿AFTER DISCUSSING THE PROCEDURE WITH THE PATIENT, OBTAINING HER CONSENT AND ANSWERING ALL OF HER QUESTIONS, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED SUPINE ON THE OPERATING TABLE. AFTER GENERAL ANESTHESIA HAD BEEN PROVIDED, THE ABDOMEN WAS PREPPED AND DRAPED IN STANDARD SURGICAL FASHION. A VERESS NEEDLE WAS INSERTED IN THE RIGHT UPPER QUADRANT OVER THE LIVER, AND THE ABDOMEN WAS INSUFFLATED TO 15 MM MERCURY PRESSURE. TWO 5 MM PORTS WERE PLACED IN THE RIGHT CENTER AND RIGHT LOWER ABDOMEN, A 5 MM SCOPE WAS THEN PLACED IN THE ABDOMEN AND A 12 MM TROCAR WAS PLACED AT THE VERESS NEEDLE INSERTION SITE OVER THE LIVER; THIS WAS DONE UNDER DIRECT VISUALIZATION. THE INCARCERATED HERNIA WAS WELL VISUALIZED AND THE HERNIA .WAS REDUCED. AFTER REDUCTION OF THE HERNIA AND DISSECTING THE HERNIA CONTENTS FREE FROM THE HERNIA SAC, THE HERNIA WAS MEASURED AND FOUND TO BE APPROXIMATELY 3.5 CM. AN 8 CM X 12 CM PIECE OF GORE-TEX DUAL MESH WAS SELECTED FOR THE REPAIR AND EIGHT 0 GORE-TEX SUTURES WERE PLACED APPROXIMATELY 2 CM APART AROUND THE PERIMETER OF THE GORE-TEX PATCH. AFTER PLACEMENT OF THE SUTURES, THE MESH WAS PLACED INTO THE ABDOMEN. THE MESH WAS THEN ANCHORED TO THE ANTERIOR ABDOMINAL WALL USING THE STAY SUTURES THAT WERE PREVIOUSLY PLACED ON THE MESH AND THESE WERE DELIVERED THROUGH THE ABDOMINAL WALL USING A GORE-TEX SUTURE PASSER. AFTER ALL EIGHT STAY SUTURES HAD BEEN PLACED, THE MESH WAS TIED IN PLACE USING THE STAY SUTURES. THE LAPAROSCOPIC TACKING DEVICE WAS USED TO TACK THE PERIMETER OF THE MESH. AN ADDITIONAL 5 MM PORT WAS PLACED IN THE LEFT ABDOMEN TO HELP WITH THIS PROCESS. AFTER THE PERIMETER HAD BEEN TACKED DOWN WITH THE TACKING DEVICE, THE REPAIR WAS INSPECTED AND FOUND TO BE SATISFACTORY. THE PORTS WERE THEN REMOVED UNDER DIRECT VISUALIZATION AND THE ABDOMEN WAS DESUFFLATED. THE FASCIA OF THE LARGER PORT WAS CLOSED WITH SINGLE 0 GORE-TEX SUTURE, AND THE SKIN OF ALL OF THE PORT SITES AND STAY SUTURE SITES WERE CLOSED WITH 4-0 MONACRYL SUBCUTICULAR STITCH. STERI-STRIPS AND STERILE DRESSINGS WERE APPLIED. ANESTHESIA WAS REVERSED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM AWAKE, ALERT AND IN GOOD CONDITION. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS.¿ FINDINGS: SUCCESSFUL LAPAROSCOPIC REPAIR OF INCARCERATED UMBILICAL HERNIA. PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿GORE-TEX DUAL MESH¿ WERE NOT PROVIDED. (B)(6) 2008: (B)(6), MD. PROCEDURE NOTE. DIAGNOSIS: UMBILICAL HERNIA (INCARCERATED). CO-MORBIDITIES: MORBID OBESITY, CONGESTIVE HEART FAILURE. INDICATIONS FOR SURGERY: INCARCERATED UMBILICAL HERNIA. PROCEDURE: LAPAROSCOPIC UMBILICAL HERNIA REPAIR. IMPLANTS: GORTEX DUAL MESH. (B)(6) 2018: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: MINIMAL TO NONE. DISPOSITION: STABLE TO RECOVERY. FINDINGS: LOT OF OMENTUM IN THIS HERNIA. THE BOWEL WAS IN CLOSE PROXIMITY, BUT NOT IN THE HERNIA ITSELF. PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH, WITH LYSIS OF ADHESIONS. DESCRIPTION OF OPERATIVE PROCEDURE: ¿PREPPED AND DRAPED IN A NORMAL FASHION. THIS IS A LADY WHO HAD SURGERY IN BOONEVILLE. WE COUNSELED HER ABOUT THE MESH IN GREAT DETAIL. SHE HAS MESH PLACED BEFORE. WITH HER OBESITY, I AM SURE IT MIGRATED SUPERIORLY. PREPPED AND DRAPED IN A NORMAL FASHION, ENTERED THE LEFT UPPER QUADRANT WITHOUT DIFFICULTY, INSUFFLATED WITH C02, PLACED ANOTHER PORT IN THE ABDOMEN. SHE HAD ALL THIS OMENTUM IN HERNIA SAC. WE COULD REDUCE, WE TOOK IT WITH LIGASURE AND WE TOOK DOWN. THERE WAS SOME LONG FILMY SEE-THROUGH ADHESIONS FROM THE COLON TO THE ANTERIOR ABDOMINAL WALL. WE STAYED CLOSE TO THE ANTERIOR ABDOMINAL WALL AND TOOK THESE DOWN, CLEARING THE EDGES OFF. HER PREVIOUS MESH HAS MIGRATED AND IT WAS INCORPORATED. I DID NOT FEEL LIKE IT WAS INDICATED TO BE REMOVE THAT. I THOUGHT THAT IT WOULD CAUSE MORE ISSUES WITH PAIN. WE THEN INJECTED EXPAREL AND SENSORCAINE HALF AND HALF CIRCUMFERENTIALLY AROUND THE ABDOMINAL WALL. SENSORCAINE WITH EPINEPHRINE 20 ML IN TOTAL. WE CLOSED THE DEFECT PRIMARILY WITH ENDOCLOSE AND PDS SUTURE AND THEN WE PLACED A PIECE OF VENTRALIGHT AND USED THE 4-QUADRANT TECHNIQUE WITH PDS AND BROUGHT THE SUTURE TO THE ANTERIOR ABDOMINAL WALL AND WE USED ABSORBABLE ENDOTACKER CIRCUMFERENTIALLY. WE THEN DESUFFLATED UNDER DIRECT VISION. WE CLOSED THE DEEP LAYERS OF 0 VICRYL AND BIOSYN FOR THE SKIN. ONCE AGAIN, WE COUNSELED HER IN GREAT DETAIL ABOUT THE INFLAMMATORY REACTION OF THE MESH, RECURRENCE OF THE HERNIA, PAIN, INFECTIONS, BOWEL OBSTRUCTIONS. WE FELT LIKE WE COULD NOT ASK HER TO LOSE WEIGHT, BECAUSE THIS WAS INCARCERATED AT THE TIME SHE WAS HAVING PAIN. I WOULD HAVE LIKE HER TO LOSE WEIGHT PRIOR TO THIS HERNIA REPAIR. SHE HAS A HIGHER CHANCE OF RECURRENCE THAN THE NORMAL POPULATION.¿ (B)(6) 2018: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA. PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH VENTRALIGHT MESH. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: MINIMAL TO NONE. DESCRIPTION OF PROCEDURE: ¿PREPPED AND DRAPED IN A NORMAL FASHION. I ENTERED THE LEFT UPPER QUADRANT WITHOUT DIFFICULTY. THE PATIENT HAS A PREVIOUS VENTRAL HERNIA REPAIR. WE PLACED TWO OTHER PORTS ON THE ABDOMEN, ONE ON THE LEFT LOWER QUADRANT AND ONE ON THE SUBXIPHOID. SHE HAD A LOT OF DENSE ADHESIONS AND SHE HAD ADHESIONS TO THE ABDOMINAL WALL, BUT THE BOWEL WAS HANGING DISTALLY FROM THIS. WE TOOK THESE DOWN EASILY WITH LIGASURE. WE REDUCED THE FAT OF THE HERNIA DEFECT. IT APPEARED THAT HER PREVIOUS MESH HAD MIGRATED SUPERIORLY, BUT IT WAS INCORPORATED. AT THAT POINT, I DID NOT THINK IT WAS REASONABLE TO EXCISE THIS. I THEN THOUGHT THAT WOULD PROBABLY DO MORE DAMAGE THAN HELPING HER. WE CLOSED THE DEFECT PRIMARILY WITH ENDOCLOSE IN FIGURE-OF-EIGHT FASHION PDS AND THEN WE USED THE 4-QUADRANT TECHNIQUE COVERING THE DEFECT CIRCUMFERENTIALLY BY 2 CM AND THEN WE USED ABSORBABLE ENDOTACKER TO SECURE THAT AFTER WE SECURED OUR PDS SUTURES. WE DESUFFLATED, MADE SURE WE HAD OMENTUM BETWEEN THE BOWEL AND THE MESH. WE DID USE THE ENDOBAG TO REMOVE SOME FAT THAT WE DISSECTED FREE FROM THE HERNIA SAC ITSELF. WE CLOSED THE DEEP LAYERS WITH 0 VICRYL AND BIOSYN FOR THE SKIN. WE INJECTED 20 ML OF 0.25% SENSORCAINE WITH EPINEPHRINE AND EXPAREL IN THE DISTRIBUTION OF THE ABDOMINAL WALL WHERE THE PLACEMENT OF THE MESH WAS GOING TO BE PRIOR TO PLACING THE MESH TO HELP WITH POSTOP PAIN. WE DESUFFLATED, CLOSED THE DEEP LAYERS WITH 0 VICRYL AND BIOSYN FOR THE SKIN. SHE HAD VENOUS CUFFS AND ANTIBIOTICS PRIOR TO INDUCTION.¿ (B)(6) 2018: (B)(6). IMPLANT RECORD. INVENTORY ITEM: MESH VENTRALIGHT. (B)(6) 2018: [MISSING RECORDS: RECORDS DETAILING THE ALLEGATIONS OF ¿ADDITIONAL SURGERY (B)(6) 2018¿ WERE NOT PROVIDED.] 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® 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 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: D17: APPROPRIATE CODE/TERM NOT AVAILABLE. FOR ¿WITHDRAWN COMPLAINT¿. H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THIS CLAIM WAS WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. 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 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED, AND ¿WITHDRAWN.¿ PREVIOUS PATIENT CODE (3191: APPROPRIATE TERM NOT AVAILABLE FOR "MESH MIGRATION", AND "UNSAFE TO REMOVE MESH.") WAS REPORTED BASED ON THE ORIGINAL COMPLAINT AND IS NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: ¿ THE KNOWN MEDICAL RECORDS SPAN (B)(6), 2008 THROUGH (B)(6), 2018 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. ¿ PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿GORE-TEX DUAL MESH¿ WERE NOT PROVIDED. ¿ MEDICAL RECORDS FROM (B)(6), 2008 THROUGH (B)(6), 2018 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: ¿ OBESITY - (B)(6) 2008: MORBID OBESITY - (B)(6) 2018: OBESITY ¿ CONGESTIVE HEART FAILURE [CHF] ¿ VENTRAL HERNIA ¿ (B)(6) 2008: UMBILICAL HERNIA FOR APPROXIMATELY 22 YEARS, NOW INCARCERATED ¿ (B)(6) 2018: RECURRENT VENTRAL HERNIA SURGICAL PROCEDURES: ¿ (B)(6) 2008: LAPAROSCOPIC UMBILICAL HERNIA REPAIR USING GORE-TEX DUAL MESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL. ¿ (B)(6) 2018: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH, LYSIS OF ADHESIONS RELEVANT MEDICAL INFORMATION: ¿ (B)(6) 2008: CT ABDOMEN/PELVIS [A/P]. ¿HISTORY: ABDOMINAL MASS. FINDINGS: IN THE LOWER ABDOMEN, THERE IS A CENTRAL, RIGHT PARACENTRAL VENTRAL HERNIA CONTAINING FAT WITH SOME MILD SURROUNDING INFLAMMATORY FAT CHANGE. THE HERNIA DEFECT MEASURING 3.1 CM ACROSS. NO BOWEL LOOPS APPEAR TO BE HERNIATED INTO THIS AREA. THERE ARE A FEW SCATTERED SMALL CENTRAL MESENTERIC LYMPH NODES, BUT NONSPECIFIC. IMPRESSION: VENTRAL HERNIA CONTAINING FAT, ALTHOUGH MAY BE SLIGHTLY INFLAMED. NO OTHER SIGNIFICANT UPPER ABDOMINAL ABNORMALITY. SMALL, NONSPECIFIC MESENTERIC LYMPH NODES.¿ IMPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2008: HISTORY AND PHYSICAL. ¿UMBILICAL HERNIA FOR APPROXIMATELY 22 YEARS. BECOMING VERY PAINFUL; CANNOT SIT DOWN AFTER EATING. OBESE. PALPABLE MASS ABOVE UMBILICUS, TENDER TO PALPATION, NO BOWEL SOUNDS. PLAN LAPAROSCOPIC VERSUS OPEN REPAIR.¿ ¿ (B)(6) 2008: INDICATIONS: ¿51-YEAR-OLD, MORBIDLY OBESE FEMALE WHO PRESENTED WITH A PAINFUL, INCARCERATED UMBILICAL HERNIA. ON CT SCAN, THE HERNIA MEASURED 3.5 CM IN DIAMETER AND, GIVEN HER CO-MORBIDITY OF MORBID OBESITY, LAPAROSCOPIC REPAIR WAS INDICATED.¿ IMPLANT PROCEDURE: LAPAROSCOPIC UMBILICAL HERNIA REPAIR USING GORE-TEX DUAL MESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, NO PRODUCT IDENTIFICATION PROVIDED] IMPLANT DATE: (B)(6), 2008 [HOSPITALIZATION (B)(6), 2008] ¿ WOUND CLASSIFICATION: NOT INDICATED ¿ FINDINGS: ¿SUCCESSFUL LAPAROSCOPIC REPAIR OF INCARCERATED UMBILICAL HERNIA.¿ ¿ DESCRIPTION OF HERNIA BEING TREATED: ¿A VERESS NEEDLE WAS INSERTED IN THE RIGHT UPPER QUADRANT OVER THE LIVER, AND THE ABDOMEN WAS INSUFFLATED TO 15 MM MERCURY PRESSURE. TWO 5 MM PORTS WERE PLACED IN THE RIGHT CENTER AND RIGHT LOWER ABDOMEN, A 5 MM SCOPE WAS THEN PLACED IN THE ABDOMEN AND A 12 MM TROCAR WAS PLACED AT THE VERESS NEEDLE INSERTION SITE OVER THE LIVER; THIS WAS DONE UNDER DIRECT VISUALIZATION. THE INCARCERATED HERNIA WAS WELL VISUALIZED AND THE HERNIA WAS REDUCED. AFTER REDUCTION OF THE HERNIA AND DISSECTING THE HERNIA CONTENTS FREE FROM THE HERNIA SAC, THE HERNIA WAS MEASURED AND FOUND TO BE APPROXIMATELY 3.5 CM.¿ ¿ IMPLANT SIZE AND FIXATION: ¿AN 8 CM X 12 CM PIECE OF GORE-TEX DUAL MESH WAS SELECTED FOR THE REPAIR AND EIGHT 0 GORE-TEX SUTURES WERE PLACED APPROXIMATELY 2 CM APART AROUND THE PERIMETER OF THE GORE-TEX PATCH. AFTER PLACEMENT OF THE SUTURES, THE MESH WAS PLACED INTO THE ABDOMEN. THE MESH WAS THEN ANCHORED TO THE ANTERIOR ABDOMINAL WALL USING THE STAY SUTURES THAT WERE PREVIOUSLY PLACED ON THE MESH AND THESE WERE DELIVERED THROUGH THE ABDOMINAL WALL USING A GORE-TEX SUTURE PASSER. AFTER ALL EIGHT STAY SUTURES HAD BEEN PLACED, THE MESH WAS TIED IN PLACE USING THE STAY SUTURES. THE LAPAROSCOPIC TACKING DEVICE WAS USED TO TACK THE PERIMETER OF THE MESH. AN ADDITIONAL 5 MM PORT WAS PLACED IN THE LEFT ABDOMEN TO HELP WITH THIS PROCESS. AFTER THE PERIMETER HAD BEEN TACKED DOWN WITH THE TACKING DEVICE, THE REPAIR WAS INSPECTED AND FOUND TO BE SATISFACTORY. THE PORTS WERE THEN REMOVED UNDER DIRECT VISUALIZATION AND THE ABDOMEN WAS DESUFFLATED. THE FASCIA OF THE LARGER PORT WAS CLOSED WITH SINGLE 0 GORE-TEX SUTURE, AND THE SKIN OF ALL OF THE PORT SITES AND STAY SUTURE SITES WERE CLOSED WITH 4-0 MONOCRYL SUBCUTICULAR STITCH.¿ REVISION PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2018: INDICATIONS: ¿WE COUNSELED HER ABOUT THE MESH IN GREAT DETAIL. SHE HAS [SIC] MESH PLACED BEFORE. WITH HER OBESITY, I AM SURE IT MIGRATED SUPERIORLY.¿ ¿ONCE AGAIN, WE COUNSELED HER IN GREAT DETAIL ABOUT THE INFLAMMATORY REACTION OF THE MESH, RECURRENCE OF THE HERNIA, PAIN, INFECTIONS, BOWEL OBSTRUCTIONS. WE FELT LIKE WE COULD NOT ASK HER TO LOSE WEIGHT, BECAUSE THIS WAS INCARCERATED AT THE TIME SHE WAS HAVING PAIN. I WOULD HAVE LIKE HER TO LOSE WEIGHT PRIOR TO THIS HERNIA REPAIR. SHE HAS A HIGHER CHANCE OF RECURRENCE THAN THE NORMAL POPULATION.¿ REVISION PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH, WITH LYSIS OF ADHESIONS. LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH VENTRALIGHT MESH. [IMPLANT: VENTRALIGHT MESH.] REVISION DATE: (B)(6), 2018 [HOSPITALIZATION DATES (B)(6), 2018] ¿ WOUND CLASSIFICATION: UNKNOWN ¿ FINDINGS: ¿LOT OF OMENTUM IN THIS HERNIA. THE BOWEL WAS IN CLOSE PROXIMITY, BUT NOT IN THE HERNIA ITSELF.¿ ¿ OPERATIVE REPORT: - (B)(6) 2018: PROCEDURE: ¿PREPPED AND DRAPED IN A NORMAL FASHION, ENTERED THE LEFT UPPER QUADRANT WITHOUT DIFFICULTY, INSUFFLATED WITH C02, PLACED ANOTHER PORT IN THE ABDOMEN. SHE HAD ALL THIS OMENTUM IN HERNIA SAC. WE COULD REDUCE, WE TOOK IT WITH LIGASURE AND WE TOOK DOWN. THERE WAS [SIC] SOME LONG FILMY SEE-THROUGH ADHESIONS FROM THE COLON TO THE ANTERIOR ABDOMINAL WALL. WE STAYED CLOSE TO THE ANTERIOR ABDOMINAL WALL AND TOOK THESE DOWN, CLEARING THE EDGES OFF. HER PREVIOUS MESH HAS MIGRATED AND IT WAS INCORPORATED. I DID NOT FEEL LIKE IT WAS INDICATED TO BE REMOVE THAT [SIC]. I THOUGHT THAT IT WOULD CAUSE MORE ISSUES WITH PAIN. WE THEN INJECTED EXPAREL AND SENSORCAINE HALF AND HALF CIRCUMFERENTIALLY AROUND THE ABDOMINAL WALL. SENSORCAINE WITH EPINEPHRINE 20 ML IN TOTAL. WE CLOSED THE DEFECT PRIMARILY WITH ENDOCLOSE AND PDS SUTURE AND THEN WE PLACED A PIECE OF VENTRALIGHT AND USED THE 4-QUADRANT TECHNIQUE WITH PDS AND BROUGHT THE SUTURE TO THE ANTERIOR ABDOMINAL WALL AND WE USED ABSORBABLE ENDOTACKER CIRCUMFERENTIALLY. WE THEN DESUFFLATED UNDER DIRECT VISION. WE CLOSED THE DEEP LAYERS OF 0 VICRYL AND BIOSYN FOR THE SKIN.¿ - (B)(6) 2018: PROCEDURE: ¿I ENTERED THE LEFT UPPER QUADRANT WITHOUT DIFFICULTY. THE PATIENT HAS A PREVIOUS VENTRAL HERNIA REPAIR. WE PLACED TWO OTHER PORTS ON THE ABDOMEN, ONE ON THE LEFT LOWER QUADRANT AND ONE ON THE SUBXIPHOID. SHE HAD A LOT OF DENSE ADHESIONS AND SHE HAD ADHESIONS TO THE ABDOMINAL WALL, BUT THE BOWEL WAS HANGING DISTALLY FROM THIS. WE TOOK THESE DOWN EASILY WITH LIGASURE. WE REDUCED THE FAT OF THE HERNIA DEFECT. IT APPEARED THAT HER PREVIOUS MESH HAD MIGRATED SUPERIORLY, BUT IT WAS INCORPORATED. AT THAT POINT, I DID NOT THINK IT WAS REASONABLE TO EXCISE THIS. I THEN THOUGHT THAT WOULD PROBABLY DO MORE DAMAGE THAN HELPING HER. WE CLOSED THE DEFECT PRIMARILY WITH ENDOCLOSE IN FIGURE-OF-EIGHT FASHION PDS AND THEN WE USED THE 4-QUADRANT TECHNIQUE COVERING THE DEFECT CIRCUMFERENTIALLY BY 2 CM AND THEN WE USED ABSORBABLE ENDOTACKER TO SECURE THAT AFTER WE SECURED OUR PDS SUTURES. WE DESUFFLATED, MADE SURE WE HAD OMENTUM BETWEEN THE BOWEL AND THE MESH. WE DID USE THE ENDOBAG TO REMOVE SOME FAT THAT WE DISSECTED FREE FROM THE HERNIA SAC ITSELF. WE CLOSED THE DEEP LAYERS WITH 0 VICRYL AND BIOSYN FOR THE SKIN. WE INJECTED 20 ML OF 0.25% SENSORCAINE WITH EPINEPHRINE AND EXPAREL IN THE DISTRIBUTION OF THE ABDOMINAL WALL WHERE THE PLACEMENT OF THE MESH WAS GOING TO BE PRIOR TO PLACING THE MESH TO HELP WITH POSTOP PAIN. WE DESUFFLATED, CLOSED THE DEEP LAYERS WITH 0 VICRYL AND BIOSYN FOR THE SKIN.¿ ¿ PATHOLOGY FOR SPECIMENS REMOVED DURING THE (B)(6) 2018 PROCEDURE WAS NOT PROVIDED. CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® 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 LOST ANCHORAGE MAY BE 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. 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 SHRINKAGE, 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. BASED UPON THE INFORMATION RECEIVED, THE DEVICE REMAINS IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. AFTER MULTIPLE REQUESTS, SPECIFIC LOT NUMBER INFORMATION WAS NOT PROVIDED FOR THIS DEVICE, BUT PRODUCT TYPE HAS BEEN CONFIRMED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. 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)(4). PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE INITIAL REPORTER'S COMPLETE ADDRESS IS (B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® 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.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018 AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "MESH MIGRATION, UNSAFE TO REMOVE MESH, ADDITIONAL SURGERY ((B)(6) 2018). ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740819 | GORE DUALMESH® BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Hospitalization| R |