GORE® DUALMESH® BIOMATERIAL
Report
- Report Number
- 3003910212-2020-01071
- Event Type
- Injury
- Date Received
- September 4, 2020
- Date of Event
- November 16, 2011
- Report Date
- March 23, 2023
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- UDI-DI
- 00733132600960
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 PREOPERATIVE COMPLAINTS: ¿ ON (B)(6) 2010: (B)(6) MEDICAL CENTER. (B)(6) , MD. RADIOLOGY ¿ CT ABDOMEN/PELVIS WITH/WITHOUT CONTRAST. INDICATION: ABDOMINAL PAIN. FINDINGS: TINY PERIUMBILICAL HERNIA. FEW PELVIS DILATED SMALL BOWEL LEADS TO THE ANTERIOR ABDOMINAL WALL SUBJACENT TO THE HERNIA. POSSIBILITY OF HERNIATION OF THE WALL OF THE BOWEL LOOP INTO THE SAC SHOULD BE CONSIDERED, ALSO KNOWN IS RICHTER¿S HERNIA. ADDITIONAL FAT-CONTAINING VENTRAL HERNIA WITHOUT EVIDENCE OF INCARCERATION. IMPRESSION: FINDINGS SUGGESTIVE OF MID TO DISTAL SMALL BOWEL OBSTRUCTION WITH POSSIBLE SITE OF TRANSITION AT THE SITE OF VENTRAL HERNIA IN THE PERIUMBILICAL REGION. HEPATIC STEATOSIS, CHOLECYSTECTOMY, FAT-CONTAINING LEFT VENTRAL HERNIA, RIGHT ADRENAL ADENOMA. ¿ ON (B)(6) 2010: (B)(6) MEDICAL CENTER. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 191 POUNDS. MORBID OBESITY. ASA CLASS: 2,3 [NURSE REVIEWER NOTE: BOTH NUMBERS CIRCLED.] ¿ ON (B)(6) 2010: (B)(6) MEDICAL CENTER. (B)(6) , MD. INDICATION: THIS IS A 72-YEAR-OLD OBESE HYPERTENSIVE WHITE FEMALE PATIENT, WHO WAS IN THE HOSPITAL ABOUT TWO MONTHS AGO ABOUT A MONTH WITH GI SYMPTOMS, WHICH WERE FELT TO BE GASTROENTERITIS. AT THAT TIME, SHE WAS ALSO FOUND TO HAVE AN EPIGASTRIC INCISIONAL HERNIA AND ANOTHER HERNIA JUST ABOVE THE UMBILICUS, POSSIBLY PORT SITE RELATED TO PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY. LAPAROSCOPIC REPAIR OF BOTH THESE HERNIA WAS ADVISED. THE PROCEDURE, INDICATIONS, RISKS, AND ALTERNATIVES WERE DISCUSSED WITH THE PATIENT IN DETAIL AND INFORMED CONSENT WAS OBTAINED. IMPLANT #1 AND #2 PROCEDURE: LAPAROSCOPIC REPAIR OF BOTH INCISIONAL HERNIAS WITH 10 X 15 CM DUALMESH PATCH EACH. IMPLANT: GORE® DUALMESH® BIOMATERIAL [1DLMC03/7383345, NI [NOT INDICATED]]; GORE® DUALMESH® BIOMATERIAL [1DLMC03/7351158, [NI]]; GORE® DUALMESH® BIOMATERIAL [1DLMC05/7131993]; GORE® DUALMESH® BIOMATERIAL [1DLMC05/7404854]. [NURSE REVIEWER NOTE: DISCREPANCY; OPERATIVE REPORT INDICATES TWO GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED; WHICH TWO OUT OF THE FOUR LISTED WAS NOT SPECIFIED]. IMPLANT #1 AND #2 DATE: (B)(6) 2010 (SAME DAY SURGERY). ¿ ON (B)(6) 2010: (B)(6) MEDICAL CENTER. (B)(6) , MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: SYMPTOMATIC EPIGASTRIC INCISIONAL HERNIA AND UMBILICAL, PROBABLY PORT SITE HERNIA,? EPIGASTRIC HERNIA, SUPRAUMBILICAL REGION. POSTOPERATIVE DIAGNOSIS: SYMPTOMATIC EPIGASTRIC INCISIONAL HERNIA AND UMBILICAL, PROBABLY PORT SITE HERNIA, ? EPIGASTRIC HERNIA, SUPRAUMBILICAL REGION. ANESTHESIA: GENERAL. ¿ PROCEDURE: ¿THE PATIENT WAS PUT IN SUPINE POSITION ON THE OPERATING TABLE UNDER SATISFACTORY GENERAL ANESTHESIA AND ABDOMEN WAS PREPPED AND DRAPED. BECAUSE OF THE PATIENT¿S PREVIOUS LEFT SUBCOSTAL INCISION FOR SPLENECTOMY I DECIDED TO APPROACH THE HERNIA THROUGH THE RIGHT SIDE. THE RIGHT FLANK TRANSVERSE INCISION WAS MADE ABOUT 12 MM LONG AND INCISION DEEPENED. MUSCLES WERE OPENED ALONG THE FIBERS. A 0 VICRYL STAY SUTURE WAS PLACE ON THE FASCIA. PERITONEAL CAVITY WAS ENTERED UNDER DIRECT VISION. HASSON CANNULA WAS INSERTED AND PERITONEAL CAVITY WAS THEN INSUFFLATED WITH C02. LAPAROSCOPIC CAMERA WAS INSERTED AND FOLLOWING THIS A 5-MM TROCAR WAS PLACED IN THE RIGHT SUBCOSTAL AREA AND ANOTHER ONE 15 MM IN RIGHT LOWER QUADRANT OF ABDOMEN, BOTH UNDER DIRECT VISION. EXAMINATION OF THE ABDOMINAL CAVITY SHOWS THAT UMBILICAL AREA HERNIA AND A PORTION OF OMENTUM STUCK IN IT AND THE [SIC] A LOOP OF BOWEL HUNG UP ON AN ADHESION WITH SLIGHT REACTION AROUND IT. I FELT THAT THE PATIENT MAY HAVE A PARTIAL SMALL BOWEL OBSTRUCTION SECONDARY TO ADHESIONS WHEN SHE CAME IN ORIGINALLY FOR HER GI SYMPTOMS. THESE ADHESIONS WERE LYSED AND BOWEL WAS FREED AND LET IT DROP BACK WITH THE REST OF THE BOWEL. HEMOSTASIS WAS GOOD. THE HERNIA DEFECT WAS ABOUT 2 X 3 CM SIZE. THE EPIGASTRIC AREA HERNIA SHOWED A PORTION OF THE OMENTUM STUCK INTO IT. THIS WAS GRADUALLY REDUCED BACK. SOME OF THE OMENTUM WAS EXCISED AND BROUGHT OUT AFTER PLACING IT IN THE ENDOBAG AND SPECIMEN WAS SENT FOR HISTOPATHOLOGY. THIS DEFECT WAS ABOUT 3 CM X 3 CM ALSO. IT WAS DECIDED TO REPAIR THESE TWO HERNIAS WITH SEPARATE PATCHES AS THEY WERE QUITE FAR APART AND WOULD HAVE REQUIRED RATHER EXTRA LARGE PIECE OF HERNIA MESH. A 10 X 15 CM DUALMESH GORE-TEX PATCH WAS SELECTED AND IT WAS MARKED APPROPRIATELY AND FOUR STAY SUTURES OF 0 GORE-TEX WERE PLACED. THE PATCH WAS THEN PLACED INTO THE ABDOMINAL CAVITY. ABDOMINAL CAVITY WAS THEN DEFLATED TO SOME EXTENT AND THE HERNIA WAS MARKED AND THE ABDOMINAL WALL WAS MARKED WITH A PEN FOR PLACEMENT OF SUTURES. THE FOUR STAY SUTURES WERE THEN TACKED TO THE ABDOMINAL WALL WITH SMALL INCISIONS ABOUT 2 MM SIZE AT THE PREVIOUSLY PLACED MARK, ONE IN EACH CARDINAL DIRECTION AND BROUGHT OUT THROUGH THE ENDOCLOSE. THE SUTURE WAS TIED IN PLACE. THEN THE PATCH WAS TACKED TO THE ANTERIOR ABDOMINAL WALL WITH PROTAC. REPAIR WAS FOUND TO BE SATISFACTORY. UMBILICAL HERNIA SITE INITIALLY WE SELECTED AT 7.5 X 10 CM DUALMESH GORE-TEX PATCH; HOWEVER, ONCE IT WAS PLACED AND IN THE ABDOMINAL CAVITY AND SOME OF THE SUTURES WERE PULLED OUT WITH THE ENDOCLOSE IT WAS NOTED THAT THIS PATCH WILL NOT ADEQUATELY COVER THE INCISION. THIS PATCH WAS REMOVED AND 10 X 15 CM DUALMESH GORE-TEX PATCH WAS SELECTED. THE HERNIA WAS MARKED ON THE ANTERIOR ABDOMINAL WALL, AND THE PROPOSED SUTURE SITES AFTER DEFLATING THE ABDOMINAL CAVITY. A 10 X 15 CM DUALMESH GORE-TEX PATCH WAS THEN PREPARED, PLACED BACK INTO THE ABDOMINAL CAVITY WITH 4 CARDINAL SUTURES OF 0 GORE-TEX PLACED IN THERE. THE SUTURE WAS THEN PULLED WITH ENDOCLOSE AND ONCE THEY WERE TIED AND IT COVERED HERNIA DEFECT QUITE ADEQUATELY. THE SUTURES WERE TIED IN PLACE. THE EDGES OF THE PATCH WERE THEN TACKED TO THE ANTERIOR ABDOMINAL WALL WITH PROTAC. BOTH THE REPAIRS WERE FOUND TO BE SATISFACTORY. HEMOSTASIS WAS GOOD. ABDOMINAL CAVITY WAS THEN EVACUATED OF C02 AND ALL THE PORTS WERE REMOVED. THE RIGHT FLANK HASSON PORT SITE WAS THEN CLOSED WITH 0 VICRYL FIGURE-OF-8 SUTURES FOR THE EXTERNAL OBLIQUE APONEUROSIS. SUBCUTANEOUS TISSUES CLOSED WITH 3-0 VICRYL AND SKIN CLOSED WITH STERI-STRIPS. A STERILE LIGHT PRESSURE DRESSING WAS APPLIED ALONG WITH ABDOMINAL BINDER AND THE PATIENT TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WILL BE DISCHARGED HOME AFTER RECOVERY WITH RECOMMENDATION TO STAY ONLY ON LIGHT ACTIVITY. NO LIFTING, NO DRIVING. SHE IS TO LEAVE THE DRESSING ALONE. THE PATIENT GIVEN PRESCRIPTION FOR LORTAB 5 MG, TOTAL OF 60 GIVEN TO TAKE 1 P.O. Q.4H. P.R.N. FOR PAIN WITH ONE REFILL. SHE WILL RESUME ALL HER PREOP MEDICATIONS. THE PATIENT WILL SEE ME IN THE OFFICE IN A WEEK¿S TIME FOR FOLLOWUP.¿ ¿ ON (B)(6) 2010: (B)(6) MEDICAL CENTER. IMPLANT RECORD. ENTRY 1: GORE® DUALMESH® BIOMATERIAL. LOT NUMBER: 7131993. MANUFACTURER: GORE. EXPIRATION DATE: 10/05/14. IMPLANT SITE: ABDOMEN. QUANTITY: 1. ENTRY 2: GORE® DUALMESH® BIOMATERIAL. LOT NUMBER: 7404854. MANUFACTURER: GORE. EXPIRATION DATE: 12/28/14. IMPLANT SITE: ABDOMEN. QUANTITY: 1. ENTRY 3: GORE® DUALMESH® BIOMATERIAL. SERIAL NUMBER: (B)(6) . LOT NUMBER: 7351158. MANUFACTURER: GORE. EXPIRATION DATE: 12/14/14. IMPLANT SITE: ABDOMEN. QUANTITY: 1. ENTRY 4: GORE® DUALMESH® BIOMATERIAL. SERIAL NUMBER: (B)(6) . LOT NUMBER: 7383345. EXPIRATION DATE: 12/21/14. IMPLANT SITE: ABDOMEN. QUANTITY: 1. [NURSE REVIEWER NOTE: DISCREPANCY; OPERATIVE REPORT INDICATES TWO GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED]. ¿ THE RECORDS CONFIRM TWO GORE® DUALMESH® BIOMATERIAL ([NI]/[NI]) AND ([NI]/[NI]) WERE IMPLANTED DURING THE PROCEDURE. [NURSE REVIEWER NOTE: WHICH TWO MESHES WERE IMPLANTED OUT OF THE FOUR LISTED WAS NOT SPECIFIED]. ¿ ON (B)(6) 2010: (B)(6) MEDICAL CENTER. (B)(6) , MD. PATHOLOGY REPORT. CASE NUMBER: (B)(4). CLINICAL DIAGNOSIS: EPIGASTRIC HERNIA. SPECIMEN SOURCE: HERNIA CONTENTS. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED HERNIA CONTENTS INITIALS SK ARE THREE FRAGMENTS OF TAN-YELLOW LOBULAR TISSUE MEASURING FROM 2.5 X 4.5 CM. NO SUSPICIOUS MASS IS IDENTIFIED. REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE CASSETTE. MICROSCOPIC EXAMINATION: MICROSCOPIC EXAMINATION PERFORMED. PATHOLOGIC DIAGNOSIS: EPIGASTRIC HERNIA CONTENTS, HERNIA REPAIR: BENIGN ADIPOSE TISSUE CONSISTENT WITH THE CLINICAL DIAGNOSIS. IMPLANT PREOPERATIVE COMPLAINTS: ¿ ON (B)(6) 2011: (B)(6) MEDICAL CENTER. (B)(6) , DO. RADIOLOGY ¿ CT ABDOMEN/PELVIS WITH/WITHOUT CONTRAST. INDICATION: ABDOMINAL PAIN. IMPRESSION: SMALL BOWEL OBSTRUCTION DUE TO A VENTRAL HERNIA WHICH CONTAINS A LOOP OF SMALL BOWEL IN THE RIGHT UPPER QUADRANT JUST ABOVE AND LATERAL TO THE UMBILICUS AND ALONG THE LATERAL BORDER OF THE PATIENT¿S SURGICAL MESH. SECOND VENTRAL HERNIA ALSO CONTAINS LOOP OF SMALL BOWEL DISTAL TO POINT OF OBSTRUCTION. HEPATIC STEATOSIS. GASTROESOPHAGEAL REFLUX. 1.6 CM RIGHT ADRENAL MASS. ¿ ON (B)(6) 2011: (B)(6) MEDICAL CENTER. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT: 250. HEREDITARY SPHEROCYTOSIS, GASTROESOPHAGEAL REFLUX DISEASE. ANESTHESIA HISTORY: SPLENECTOMY, CHOLECYSTECTOMY, HYSTERECTOMY, HERNIA. ASA STATUS: 3E [EMERGENCY]. IMPLANT #3 AND #4 PROCEDURE: EXPLORATORY LAPAROTOMY, REPAIR OF INCARCERATED RECURRENT VENTRAL HERNIA, RELEASE OF COMPLETE SMALL BOWEL OBSTRUCTION, TRANSITION POINT AT THE HERNIA. REPAIR OF RIGHT SIDE PORT SITE HERNIA. IMPLANT: GORE® DUALMESH PLUS BIOMATERIAL [1DLMCP05/8704936, 7.5 CM X 10 CM]. GORE® DUALMESH PLUS BIOMATERIAL [1DLMCP04/ 8294895, 15 X 19 CM]. IMPLANT #3 AND #4 DATE: (B)(6) 2011 (HOSPITALIZATION [NI]). ¿ ON (B)(6) 2011: (B)(6) MEDICAL CENTER. (B)(6) , MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INCARCERATED RECURRENT VENTRAL HERNIA, WITH A COMPLETE BOWEL OBSTRUCTION AND A RIGHT FLANK PORT SITE HERNIA. POSTOPERATIVE DIAGNOSIS: INCARCERATED RECURRENT VENTRAL HERNIA, WITH A COMPLETE BOWEL OBSTRUCTION AND A RIGHT FLANK PORT SITE HERNIA. MESH USED: A 19 X 15 MESH IN THE MIDLINE AND A 7 X 10 CM MESH FOR THE FLANK HERNIA. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: ABOUT 100 ML. DRAINS: NONE. SPECIMEN: HERNIA SAC. ¿ DETAILS OF THE PROCEDURE: ¿MS. (B)(6) WAS ADMITTED WITH A BOWEL OBSTRUCTION AND INCARCERATED HERNIA. I WAS ABLE TO REDUCE IT AT LEAST PARTIALLY IN THE ER. AFTER A [SIC] REDUCED IT I ORDERED A SMALL -BOWEL SERIES. I HAVE REVIEWED THE SMALL-BOWEL SERIES THROUGHOUT THE DAY, VERY LITTLE MOVEMENT OF THE CONTRAST. IT ENDS UP IN FEW DILATED LOOPS OF SMALL BOWEL. I THEN WENT BACK TO RE-EVALUATE HER AND THE HERNIA HAD REINCARCERATED. SHE WAS SIGNIFICANTLY NAUSEOUS AND UNCOMFORTABLE. I REVIEWED THE ONE LAST FILM BEFORE MAKING A FINAL DECISION AND THE CONTRAST WAS NOT MOVING FROM THIS PARTICULAR POINT WITH DILATED LOOPS OF BOWEL CONSISTENT WITH A COMPLETE BOWEL OBSTRUCTION, ALSO THE FACT THAT THE HERNIA CONTINUES TO INCARCERATE, I THINK CONSERVATIVE MANAGEMENT WAS [SIC] GOING TO WORK EVEN IN A VERY SHORT TERM. SO, I DISCUSSED WITH THE FAMILY. MY RECOMMENDATION WAS TO PROCEED WITH THE HERNIA REPAIR. I DID STRESS TO THEM THE SIGNIFICANT MORBIDITY THAT CAN BE ASSOCIATED WITH THIS TYPE OF HERNIA. SHE HAS 2 MESHES. SHE IS MORBIDLY OBESE. SHE HAS 2 HERNIAS AND ONE OF THE HERNIA IS COMING RIGHT NEXT TO THE MESH. THE CHANCES OF A BOWEL INJURY, POSTOPERATIVE WOUND INFECTIONS, POSTOPERATIVE DEHISCENCE, HERNIA RECURRENCE, MESH INFECTION, PNEUMONIA, AND PULMONARY EMBOLUS ETC., WERE ALL DISCUSSED. SHE UNDERSTOOD, HER FAMILY WAS ALL PRESENT, AGREED, AND SIGNED CONSENT. PREOPERATIVE ANTIBIOTICS WERE GIVEN. PLEXIPULSES WERE PLACED. SHE WAS THEN BROUGHT TO THE OR AND PLACED ON THE OR TABLE IN SUPINE POSITION. GENERAL ANESTHESIA WAS ESTABLISHED BY THE ANESTHESIA TEAM. AN NG TUBE WAS PLACED BY ANESTHESIA AND A FOLEY CATHETER BY NURSING. HER ABDOMEN WAS PREPPED AND DRAPED IN A STERILE FASHION. MIDLINE INCISION WAS MADE FROM JUST BELOW THE XIPHOID TO JUST BELOW THE UMBILICUS. THE HERNIA WAS BETWEEN THE XIPHOID AND THE UMBILICUS. I ENTERED THE ABDOMEN IN THE LOWER ASPECT OF THE INCISION WHERE I FELT THAT THE MESH WAS NOT PRESENT. ONCE I ENTERED THE ABDOMEN, I WAS ABLE TO SLIDE MOST OF THE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WITH BLUNT DISSECTION AND AT THE SAME TIME, OPENING THE FASCIA AS I WENT ALONG UNTIL I REACHED THE AREA OF THE HERNIA. THE HERNIA CONTAINED AN INCARCERATED LOOP OF SMALL BOWEL THAT HAD SOME ERYTHEMATOUS CHANGES, BUT NO ISCHEMIC CHANGES, AND REALIZING WHEN I THOUGHT I HAD REDUCED IT, I WAS BASICALLY DOING A PARTIAL REDUCTION OF THE HERNIA, BUT THE ACTUAL LOOP OF SMALL BOWEL WAS NOT MOVING FROM THAT SPOT EVEN I TRIED REDUCING EVEN ONCE THE SUBCUTANEOUS TISSUE WAS OPENED AND IT DID NOT REDUCED [SIC], BUT ONCE I WAS ABLE TO SLIDE MY FINGER INTO THE ACTUAL DEFECT AND OPENED THE NECK, THEN I WAS ABLE TO RELEASE THAT LOOP OF SMALL BOWEL. THEN, THE REST OF THE INCISION WAS OPENED. THIS WAS GOING THROUGH THE EXISTING MESH THAT WAS ALREADY BASICALLY WELL INGROWN INTO THE FASCIA, THEN PROCEEDED TO RELEASE ALL THE LATERAL ATTACHMENTS TO THE ANTERIOR ABDOMINAL WALL FROM OMENTUM AND SMALL BOWEL. THIS WAS ALL DONE ON AN AVASCULAR PLANE. IN SOME AREAS, THE ADHESIONS WERE DENSE, BUT I WAS ABLE TO DO WITHOUT ANY ENTEROTOMIES. THERE WAS 1 LOOP WHERE I HAD A SMALL SEROSAL TEAR, WHICH I CLOSED WITH INTERRUPTED 3-0 VICRYL. THEN, IDENTIFIED THIS FLANK PORT SITE HERNIA. IT WAS WELL AWAY FROM THE MIDLINE AND DUE TO THE BOWEL DISTENTION AND HER MORBID OBESITY, I DID NOT THINK THAT THIS WOULD BE AMENABLE FOR THE CLOSURE WITH A SINGLE MESH, SO WITHHELD FROM RETRACTORS, I WAS ABLE TO HAVE THE DEFECT IN VIEW AND PLACED A FIGURE-OF-EIGHT DOUBLE-LOOP PDS THROUGH THE DEFECT, CLOSED THE DEFECT, AND THEN PLACED A 7 X 10 CM GORE-TEX PATCH ON TOP THAT WAS TACKED TO THE ANTERIOR ABDOMINAL WALL COVERING THE DEFECT COMPLETELY. I WAS THEN PLACED WITH THE DECISION ON THE MIDLINE, CONCERNED ABOUT THE BOWEL DISTENTION AND DIFFICULTY OF THE HERNIA REPAIR, BUT DEFINITELY A PRIMARY REPAIR WAS NOT GOING TO BE FEASIBLE IN HER CASE. THE FASCIA DID COME TOGETHER, HOWEVER, THERE WAS SIGNIFICANT TENSION AND HER CHANCES OF POSTOPERATIVE DEHISCENCE ARE EXTREMELY HIGH, SO I DECIDED TO REPAIR THIS WITH A PERMANENT MESH, FASCIAL FLAPS WERE RAISED CIRCUMFERENTIALLY FOR ABOUT 8 CM CIRCUMFERENTIALLY. THIS GAVE ME A LITTLE BIT MORE LAXITY ON THE FASCIA. THE HERNIA SAC HAD BEEN EXCISED TO HEALTHY FASCIA AND THEN PROCEEDED TO PLACE THE MESH WHICH MEASURED 19 X 15 CM. THE MESH WAS SUTURED TO THE FASCIA WITH ABOUT 5 CM OF UNDERLAY USING INTERRUPTED 0 ETHIBOND SUTURES IN A MATTRESS FASHION. THE SUTURES WERE PLACED ABOUT 2 CM APART CIRCUMFERENTIALLY. THE MESH WAS NICE AND TAUT, AND THERE WAS NO REDUNDANCY ON THE MESH. THE WOUND WAS THEN THOROUGHLY IRRIGATED. ALL THE COUNTS WERE CORRECT. THEN THE FASCIA WAS CLOSED OVER THE MESH WITH A RUNNING DOUBLE-LOOPED PDS, ONE WAS STARTED FROM THE TOP, THE OTHER ONE FROM THE BOTTOM. THEY WERE BOTH TIED IN THE MIDDLE. THE SUBCUTANEOUS TISSUES WERE THEN AGAIN IRRIGATED. THE DEEP LAYER WAS CLOSED WITH INTERRUPTED 2-0 VICRYL AND THE SKIN WAS CLOSED WITH STAPLES. AT THIS MOMENT ANESTHESIA IS EVALUATING THE POSSIBILITY OF EXPLORATION VERSUS KEEPING HER INTUBATED IN THE ICU. REGARDING SHE IS GOING TO SPEND THE NIGHT IN THE ICU, ALL THE FINDINGS WERE DISCUSSED WITH THE FAMILY.¿ ¿ ON (B)(6) 2011: (B)(6) MEDICAL CENTER. IMPLANT RECORD. ENTRY 1: GORE® DUALMESH® PLUS. LOT NUMBER: 8704936. MANUFACTURER: GORE. EXPIRATION DATE: 10/30/13. IMPLANT SITE: ABDOMEN (7.5 CM X 10 CM). QUANTITY: 1. ENTRY 2: GORE® DUALMESH® PLUS. LOT NUMBER: 8294895. MANUFACTURER: GORE. EXPIRATION DATE: 5/30/13. IMPLANT SITE: ABDOMEN (15 CM X 19 CM). QUANTITY: 1. ¿ THE RECORDS CONFIRM TWO GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP05/8704936) AND (1DLMCP04/8294895) WERE IMPLANTED DURING THE PROCEDURE. RELEVANT MEDICAL INFORMATION: ¿ ON (B)(6) 2011: (B)(6) MEDICAL CENTER. (B)(6) , MD. PATHOLOGY REPORT. CASE NUMBER: (B)(4). CLINICAL DIAGNOSIS: INCARCERATED HERNIA. SPECIMEN SOURCE: HERNIA SAC. GROSS DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN INITIAL SK HERNIA SAC AND CONSISTS OF MEMBRANOUS SAC-LIKE TISSUE WITH ADHERENT ADIPOSE TISSUE MEASURING 7 X 3 X 2 CM. NO GROSS LESION IDENTIFIED. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES. MICROSCOPIC EXAMINATION: MICROSCOPIC EXAMINATION PERFORMED. PATHOLOGIC DIAGNOSIS: HERNIA SAC, SITE NOT SPECIFIED, REPAIR: HERNIA SAC WITH FIBROSIS AND FOCI WITH PREDOMINATELY CHRONIC INFLAMMATION. ¿ ON (B)(6) 2013: (B)(6) MEDICAL CENTER. (B)(6) , DO. RADIOLOGY ¿ CT ABDOMEN/PELVIS WITHOUT CONTRAST. INDICATION: ABDOMINAL PAIN. IMPRESSION: PROMINENT VENTRAL HERNIA SEEN IN LOW ABDOMINAL AND UPPER PELVIC WALL WITH BOWEL EXTENDING OUTSIDE OF THE HERNIA BUT WITHOUT DEFINITE EVIDENCE FOR STRANGULATION. SOFT TISSUE DENSITY SEEN WITHIN THIS REGION AS WELL. NO FLUID COLLECTIONS. EXTENSIVE ATHEROSCLEROSIS WITHIN MULTIPLE CORONARY ARTERIES. ¿ ON (B)(6) 2013: (B)(6) MEDICAL CENTER. (B)(6) , MD. RADIOLOGY ¿ CT ABDOMEN/PELVIS WITH CONTRAST. INDICATION: ABDOMINAL PAIN WITH NAUSEA. FINDINGS: VENTRAL ABDOMINAL WALL SURGICAL MESH IN SITU. RECURRENT VENTRAL ABDOMINAL WALL HERNIA WITH HERNIATION OF SMALL BOWEL LOOPS THROUGH THE DEFECT WITHIN THE MIDLINE AND SIGNIFICANT INFLAMMATORY CHANGES INVOLVING THE BOWEL LOOPS IN THIS AREA WITHIN THE SUBCUTANEOUS FAT AS WELL AS WITHIN THE OMENTAL AND MESENTERIC FAT. IMPRESSION: FINDINGS CONSISTENT WITH TWO VENTRAL ABDOMINAL WALL HERNIAS ONE SEEN WITHIN THE LEFT LOWER QUADRANT AND SECOND NOTED WITHIN THE MID UPPER ABDOMEN. HERNIATION OF BOWEL LOOPS THROUGH BOTH DEFECTS WITH RESULTANT SMALL BOWEL OBSTRUCTION SECONDARY TO THE HERNIATED SMALL BOWEL LOOPS WITHIN THE LEFT LOWER QUADRANT RESULTING IN INCARCERATION OF THE SMALL BOWEL LOOPS. THE MORE SUPERIOR MIDLINE VENTRAL ABDOMINAL WALL HERNIA MAY ALSO REVEAL PARTIAL INCARCERATION OF THE SMALL BOWEL LOOPS. SURGICAL MESH NOTED IN THESE AREAS WITH RECURRENT HERNIATIONS SEEN. SURGICAL CONSULT HIGHLY RECOMMENDED. RIGHT ADRENAL GLAND NODULE; MAY REPRESENT UNDERLYING ADENOMA 1.8 X 1.4 CM. ¿ ON (B)(6) 2013: (B)(6) , LTD. (B)(6) , MD. OFFICE NOTES. SEEN IN CONSULTATION AT CRMC; HAD PRESENTED WITH ACUTELY INCARCERATED VENTRAL HERNIAS CAUSING SMALL BOWEL OBSTRUCTION. HERNIAS WERE REDUCED, SHE IMPROVED AND WAS DISCHARGED. FEELING WELL, NO FURTHER ABDOMINAL PAIN, TOLERATING DIET, NORMAL BOWEL FUNCTION, THOUGH TAKING DAILY STOOL SOFTENERS. ABDOMEN: OBESE, SOFT, NONDISTENDED, NONTENDER; AT LEAST TWO VENTRAL HERNIA DEFECTS, ONE IN UPPER MIDLINE, ONE IN LOWER MIDLINE EXTENDING TO THE LEFT; BOTH REDUCIBLE. IMPRESSION: MORBID OBESITY WITH VENTRAL INCISIONAL HERNIAS. WOULD NOT ADVOCATE URGENT SURGICAL INTERVENTION AS RISK OF COMPLICATIONS, WOUND ISSUES AND HERNIA RECURRENCE VERY HIGH GIVEN HER MORBID OBESITY. IDEALLY, WOULD LIKE HER TO LOSE SIGNIFICANT WEIGHT; LOST ABOUT THIRTY POUNDS TO DATE. IF LOSES SIGNIFICANT WEIGHT, CONSIDER SURGICAL REPAIR IF SHE DESIRES. SEE BACK IN THREE MONTHS. ¿ ON (B)(6) 2014: (B)(6) , LTD. (B)(6) , MD. OFFICE NOTES. THREE-MONTH FOLLOW UP. HAD SEEN IN FOLLOW UP; PLAN WAS TO STAY ON WEIGHT LOSS REGIMEN, POSSIBLE ELECTIVE HERNIA REPAIR IN FUTURE. HAS NOT HAD ANY SIGNIFICANT PAIN WITH HERNIAS SINCE LAST SEEN. WEIGHT 232 POUNDS, BMI 37.44. ABDOMEN: OBESE, SOFT, NONDISTENDED, NONTENDER; AT LEAST TWO VENTRAL HERNIA DEFECTS, ONE IN UPPER MIDLINE, ONE IN LOWER MIDLINE EXTENDING TO THE LEFT; BOTH REDUCIBLE. IMPRESSION: MORBID OBESITY AND AT LEAST TWO VENTRAL HERNIAS ALONG MIDLINE INCISION. SOFT, NOT BOTHERSOME. REVIEWED HISTORY OF HERNIA DISEASE WITH HER AND HUSBAND; DISCUSSED SURGICAL REPAIR. WOULD LIKE TO CONTINUE WEIGHT LOSS REGIMEN, SEE BACK IN TWO MONTHS. REASONABLE PLAN. ¿ ON (B)(6) 2014: (B)(6) , LTD. (B)(6) , MD. OFFICE NOTES. THREE-MONTH FOLLOW UP. STATES DOING WELL OVERALL; NO PAIN OR SYMPTOMS SINCE LAST VISIT. NOW LEANING TOWARDS NOT HAVING SURGERY UNLESS REQUIRED. TOLERATING DIET, NORMAL BOWEL FUNCTION. WEIGHT 233 POUNDS, BMI 37.60. IMPRESSION: AT LEAST TWO VENTRAL HERNIAS ALONG THE MIDLINE INCISION; SOFT AND NON-BOTHERSOME. PLAN: SHE WOULD LIKE TO WATCH IT AT THIS TIME WHICH IS REASONABLE. IF PROBLEMS, FOLLOW-UP WITH ME OR PRESENT TO HOSPITAL. SEE BACK IN SIX MONTHS. ¿ ON (B)(6) 2014: (B)(6) MEDICAL CENTER. NURSE NOTES. WEIGHT 230 POUNDS.
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. 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® 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. 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. 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.
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® 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.
(B)(4). OTHER DEVICES POSSIBLY INVOLVED IN THIS CASE BUT CAN NOT BE CONFIRMED WHICH OF THE FOUR DEVICES WERE ACTUALLY IMPLANTED AT THIS TIME: GORE® DUALMESH BIOMATERIAL [1DLMC03/7383345 (REPORTED ON #3003910212-2020-01070), NI [NOT INDICATED]]; GORE® DUALMESH BIOMATERIAL [[NI]/7131993]; GORE® DUALMESH BIOMATERIAL [[NI]/7404854]. 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."
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL UMBILICAL, INCISIONAL EPIGASTRIC, HERNIA REPAIR ON (B)(6) 2010, WHEREBY TWO GORE® DUALMESH® BIOMATERIAL'S WERE IMPLANTED. THE PATIENT ALSO UNDERWENT OPEN INCISIONAL RIGHT FLANK, AND INCISIONAL VENTRAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL'S WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, (B)(6) 2014, (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2018 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO IT WAS FOUND BRIDGING AND PULLED AWAY FROM EDGES, BOWEL OBSTRUCTION, MULTIPLE SWISS-CHEESE DEFECT, DENSE ADHESIONS, INCARCERATED RECURRENT VENTRAL HERNIA REPAIRED WITH PLACEMENT OF NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957345 | GORE® DUALMESH® BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC. | 1DLMC03 | 00733132600960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Hospitalization| R |