GORE® DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 3003910212-2023-01482
- Event Type
- Injury
- Date Received
- August 15, 2023
- Date of Event
- February 1, 2016
- Report Date
- April 11, 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
- PA, 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 PREOPERATIVE COMPLAINTS: (B)(6) 2012: (B)(6), MD. PREOPERATIVE DIAGNOSIS: GIANT VENTRAL INCISIONAL HERNIA. IMPLANT #1 PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS AND REPAIR OF VENTRAL INCISIONAL HERNIA WITH MESH. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP06/7874482, 18CM X 24CM X 1MM THICK.] IMPLANT #1 DATE: (B)(6) 2012 [HOSPITALIZATION DATES UNKNOWN] (B)(6) 2012: (B)(6), MD. OPERATIVE REPORT. ANESTHESIA: GENERAL. WOUND CLASSIFICATION: [NOT PROVIDED.] PROCEDURE: ¿THE PATIENT WAS IDENTIFIED, TAKEN TO THE OPERATING ROOM, WHERE AFTER ESTABLISHING GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN STANDARD FASHION. A FOLEY CATHETER WAS INSERTED AND THE PATIENT RECEIVED PERIOPERATIVE ANTIBIOTICS. A PNEUMOPERITONEUM WAS ESTABLISHED IN THE LEFT UPPER QUADRANT USING A VERESS NEEDLE. FIFTEEN CM OF PRESSURE WAS ESTABLISHED. AT THIS POINT A 5 MM TROCAR WAS PASSED INTO THE PERITONEAL CAVITY. THERE WAS EXTENSIVE ADHESIVE PATHOLOGY NOTED. ULTIMATELY, THE ADHESIONS WERE TAKEN DOWN WITH A CAMERA AND ENOUGH TO ALLOW THE PLACEMENT OF A SECOND TROCAR IN THE LEFT LOWER QUADRANT. USING SHARP DISSECTION ADDITIONAL ADHESIVE PATHOLOGY IS TAKEN DOWN SHARPLY. ULTIMATELY A SMALL WINDOW WAS CREATED SUCH THAT THE RIGHT SIDE OF THE ABDOMEN CAN BE VISUALIZED. TWO TROCARS WERE PLACED OVER THE ____, WITH A 5 AND A 10. AT THIS POINT, CAREFUL DISSECTION WAS CARRIED OUT WITH LYSIS OF ADHESIONS. WITH GENTLE TRACTION AND AN INCISION ELECTROCAUTERY WAS UTILIZED FOR HEMOSTASIS. ULTIMATELY ALL OF THE ADHESIONS AND LOOPS OF BOWEL WERE TAKEN DOWN FROM THE PERITONEAL SURFACE AND THE DEFECTS OF THE HERNIA WERE IDENTIFIED. APPROXIMATELY A 15 X 20 CM PIECE OF DUAL-PLUS MESH WAS THEN UTILIZED TO REPAIR THE DEFECT. EIGHT SUTURES WERE PLACED CIRCUMFERENTIALLY WITH 0 GORE-TEX. THE MESH WAS ROLLED AND PLACED WITHIN THE PERITONEAL CAVITY, AND 8 STAB WOUNDS WERE CREATED CIRCUMFERENTIALLY TO FACILITATE BASTING THE SUTURES. THE SUTURES WERE TIED THEN TO THE SUPRAFASCIAL LOCATION AND THEN ENDO-TACK PROTAC WAS USED TO SECURE THE MESH TO BETWEEN THE SUTURES. THE MESH WAS NOTED TO BE LYING FLAT WITH VIRTUALLY NO PNEUMOPERITONEUM AND IS IN GOOD POSITION. AN ENDOCLOSE DEVICE WAS UTILIZED TO APPROXIMATE THE 1 LARGE TROCAR. THE REMAINING TROCAR SITES WERE CLOSED WITH 4-0 VICRYL AND SURGICAL STAPLES. STERILE DRESSINGS WERE APPLIED. OVERALL THE PATIENT TOLERATED THE OPERATIVE PROCEDURE AND ANESTHESIA WELL, SUFFERING NO COMPLICATIONS OR IMMEDIATE SEQUELAE AS A RESULT OF THE OPERATIVE PROCEDURE. SPONGE, NEEDLE AND INSTRUMENT COUNTS ARE CORRECT. THE PATIENT WAS EXTUBATED AND TRANSPORTED TO POSTANESTHETIC CARE UNIT IN STABLE AND SATISFACTORY CONDITION .¿ (B)(6) 2012: (B)(6) HOSPITAL. IMPLANT STICKER. GORE® DUALMESH® PLUS BIOMATERIAL. CAT #: 1DLMCP06. LOT #: 7874482. SIZE: 18CM X 24CM X 1MM THICK . REVISION AND IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2014: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. REVISION AND IMPLANT #2 PROCEDURE: LAPAROSCOPIC INCISIONAL HERNIORRHAPHY WITH LAPAROSCOPIC LYSIS OF ADHESIONS. [IMPLANT GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP08/10985032, 26CM X 34CM X 1MM THICK, OVAL.] REVISION AND IMPLANT #2 DATE: (B)(6) 2014 [HOSPITALIZATION (B)(6) 2014] (B)(6) 2014: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. ANESTHESIA: GENERAL. WOUND CLASSIFICATION: [NOT PROVIDED.] PROCEDURE: ¿THE PATIENT WAS SEEN IN THE PREOPERATIVE HOLDING AREA. THE DETAILS OF HER PROPOSED PROCEDURE WERE AGAIN REVIEWED WITH HER. SHE KNOWS THAT THIS PROCEDURE WILL BE DIFFICULT AND WILL INVOLVE ADHESIOLYSIS AS SHE HAS HAD MULTIPLE LAPAROTOMIES IN THE PAST. SHE KNOWS THAT WE WILL PROCEED LAPAROSCOPICALLY AS LONG AS WE ARE ABLE TO DO SO SAFELY. IF THERE IS ANY QUESTION OR CONCERN, WE WILL NOT HESITATE TO CONVERT TO A LAPAROTOMY. SHE KNOWS THAT HER POSTPROCEDURAL INSTRUCTIONS WILL DEPEND ON OUR FINAL SURGICAL RESULT. SHE KNOWS THERE ARE RISKS INCLUDING BLEEDING AND INFECTION. SHE KNOWS THAT INJURIES CAN OCCUR. THE INTESTINE CAN LEAK. SHE KNOWS THAT THERE IS A CHANCE THAT HIS HERNIA COULD RECUR ALSO. THIS RISK IS ABOUT 10%. OTHER POTENTIAL RISKS INCLUDE HEART DISEASE, LUNG DISEASE AND POTENTIAL ANESTHETIC COMPLICATIONS. SHE MIGHT REQUIRE HOSPITALIZATION AS WELL. SHE KNOWS THAT IF THE PROCEDURE IS VERY QUICK AND VERY EASY I WOULD NOT HESITATE TO SEND HER HOME TODAY. SHE KNOWS THAT I WOULD NOT HESITATE TO KEEP HER IN AN OBSERVATION BED OR PERHAPS HOSPITALIZATION OF A LONGER DURATION DEPENDING ON THE FINAL OUTCOME OF HER PROCEDURE. THE ABDOMEN WAS EXAMINED WITH HER LYING AND ALSO STANDINE [SIC]. THE HERNIA IS LOCALIZED BELOW THE UMBILICUS EXTENDING TO THE LEFT. IT IS SOFT AND REDUCIBLE. SHE VOICED UNDERSTANDING AND WAS ABLE TO GIVE AN INFORMED CONSENT. THE PATIENT WAS TAKEN INTO THE OPERATING SUITE AND SUCCESSFULLY ANESTHETIZED. HER BLADDER WAS DECOMPRESSED WITH A FOLEY CATHETER, AND HER ABDOMEN PREPPED AND DRAPED IN THE NORMAL STERILE FASHION. THE HERNIA WAS IDENTIFIED INFERIOR AND TO THE LEFT OF THE UMBILICUS. THE MASS PROTRUDING THROUGH THE DEFECT FELT TO BE APPROXIMATELY 6 CM IN DIAMETER. I SAW NO CONTRAINDICATION TO PROCEEDING LAPAROSCOPICALLY. A 3 CM TRANSVERSE INCISION WAS MADE IN THE RIGHT ANTERIOR AXILLARY LINE ABOUT HALFWAY BETWEEN THE COSTAL MARGIN AND THE ILIAC CREST. I DISSECTED DOWN THROUGH THE LAYERS OF MUSCLE AND INTO THE PERITONEAL CAVITY. AN 11 MM TROCAR WAS INSERTED AT THIS LOCATION. THE LAPAROSCOPE WAS INTRODUCED. THE ABDOMEN HAD BEEN ENTERED UNEVENTFULLY. SHE WAS INSUFFLATED TO 15 MMHG PRESSURE. A SITE IN THE RIGHT LOWER QUADRANT ABDOMINAL WALL WAS IDENTIFIED AND A 5 MM PORT WAS INSERTED. THERE WERE MULTIPLE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL. OMENTUM WAS ADHERENT HERE. MULTIPLE BOWEL LOOPS WERE ALSO ADHERENT. THE ADHESIONS WERE REASONABLY FINE. THEY ALSO INVOLVED THE INSIDE OF THE HERNIA. I BEGAN DISSECTING THESE ADHESIONS BOTH BLUNTLY AND USING SHARP DISSECTION. CAUTERY AND THE LIGASURE DEVICE WERE ALSO USED. EVENTUALLY, ANOTHER TROCAR WAS BROUGHT INTO THE LEFT MID ABDOMEN. THIS WAS A 5 MM TROCAR BROUGHT IN UNDER DIRECT VISION. I CONTINUED MY DISSECTION OF THE INTRA-ABDOMINAL ADHESIONS BY MOVING MY INSTRUMENTS FROM TROCAR SITE TO TROCAR SITE. THERE WAS A PIECE OF WHAT APPEARED TO BE A DUALMESH FIRMLY ADHERENT TO THE UPPER ABDOMINAL WALL. THE INFERIOR ASPECT HAD PULLED AWAY FROM HER NATIVE ABDOMINAL WALL INFERIOR TO THE UMBILICUS. THE REPAIR ABOVE THE UMBILICUS APPEARED INTACT. THE ADHESIONS WERE EVENTUALLY COMPLETELY TAKEN DOWN FROM THE SPACE BETWEEN THE MESH AND THE UNDERSURFACE OF THE ABDOMINAL WALL (INTERIOR OF THE HERNIA SAC). MULTIPLE SMALLER HERNIA DEFECTS WERE SEEN THROUGH THE HERNIA SAC ITSELF. ONE OF THEM ACCOUNTED FOR THE MASS THAT WAS FELT PREOPERATIVELY. THERE WERE ADHESIONS BETWEEN THE LIVER AND THE ANTERIOR ABDOMINAL WALL. THESE WERE LEFT ALONE. NO PATHOLOGY WAS IDENTIFIED IN THE PELVIS. THE BOWEL WAS INSPECTED IN THE AREAS WHERE THE ADHESIONS WERE TAKEN DOWN. NO INJURIES WERE IDENTIFIED. THIS DEFECT SEEMED AMENABLE TO A LAPAROSCOPIC REPAIR. SOME OF THE PNEUMOPERITONEUM WAS ALLOWED TO ESCAPE. THE MARGINS OF THE DEFECT WERE IDENTIFIED AND MARKED ON HER ABDOMINAL WALL. IT WAS 18 CM IN DIAMETER. IT APPEARED THAT WE COULD SEW THROUGH THE AREA OF MESH IN THE UPPER PORTION OF HER ABDOMINAL WALL. THE AREA IN THE INFERIORMOST ASPECT OF THE DISSECTION WOULD BE APPROXIMATELY 2 CM ABOVE THE SYMPHYSIS. I THEN DREW A CIRCLE 2 CM WIDER THAN THE DEFECT ITSELF. THIS MEANT THAT A 22 CM ROUND GORE-TEX DUALMESH WOULD BE USED FOR THIS REPAIR. IT WAS CUT TO PROPER SIZE . I PLACED 8 GORE-TEX SUTURES AROUND ITS CIRCUMFERENCE. THE MESH WAS THEN ROLLED AND INSERTED THROUGH THE RIGHT MID ABDOMINAL INCISION INTO THE ABDOMINAL CAVITY. IT WAS UNROLLED. THEN, USING A CARTER-THOMASON SUTURE RETRIEVAL DEVICE, THE SUTURES WERE PULLED THROUGH THE ABDOMINAL WALL AT EACH OF THE 8 LOCATIONS. ONCE THIS WAS DONE, THE SUTURES WERE SECURED. I THEN WENT AHEAD AND TACKED THE EDGES OF THE MESH TO THE ANTERIOR ABDOMINAL WALL. I DID HAVE TO INSERT ANOTHER 5 MM PORT IN THE LEFT UPPER QUADRANT IN ORDER TO ACCOMPLISH THIS THROUGH THE ENTIRE CIRCUMFERENCE OF THE REPAIR. THREE TACKING DEVICES WERE REQUIRED. ONCE THIS WAS DONE, THE BOWEL WAS AGAIN INSPECTED. NO INJURIES OR OTHER COMPLICATIONS WERE IDENTIFIED. THE ABDOMINAL CAVITY WAS IRRIGATED AND THEN ASPIRATED. THE FASCIA BENEATH THE ORIGINAL 11 MM TROCAR SITE WAS CLOSED WITH O VICRYL. THE SKIN AT EACH LOCATION WAS THEN CLOSED WITH 4-0 VICRYL SUBCUTICULAR SUTURES AT THE TROCAR SITES. THE SUTURE RETRIEVAL SITES SURROUNDING THE REPAIR WERE CLOSED WITH STERI-STRIPS ALONE. STERILE DRESSINGS WERE APPLIED. I SHOULD ALSO MENTION THAT I DID USE MARCAINE TO INFILTRATE EACH OF THE TROCAR INSERTION SITES PRIOR TO THE TROCARS BEING PLACED. THE PATIENT WAS THEN TAKEN FROM THE OPERATING SUITE TO RECOVERY IN STABLE CONDITION. OUR ESTIMATED BLOOD LOSS WAS 30 ML. THERE WERE NO COMPLICATIONS .¿ (B)(6) 2014: (B)(6) HOSPITAL. IMPLANT STICKER. GORE® DUALMESH® PLUS BIOMATERIAL. CAT #: 1DLMCP08. LOT #: 10985032. SIZE: 26CM X 34CM X 1MM THICK, OVAL . PARTIAL EXPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2016: (B)(6) MEDICAL CENTER. SURGEON: (B)(6), MD. PREOPERATIVE DIAGNOSIS: INCISIONAL HERNIA, RECURRENT STATUS POST MESH INSERTION. PARTIAL EXPLANT #1 PROCEDURE: REPAIR OF THE INCISIONAL HERNIA. REMOVAL OF THE MESH. LYSIS OF EXTENSIVE ADHESIOLYSIS IN THE SMALL BOWEL AND OMENTUM. PARTIAL EXPLANT #1 DATE: (B)(6) 2016 [HOSPITALIZATION DATES UNKNOWN] (B)(6) 2016: (B)(6) MEDICAL CENTER. SURGEON: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. POSTOPERATIVE DIAGNOSIS: INCARCERATED RECURRENT INCISIONAL HERNIA. ANESTHESIA: GENERAL. WOUND CLASSIFICATION: [NOT PROVIDED.] PROCEDURE: ¿PATIENT PUT IN THE SUPINE POSITION UNDER GENERAL ENDOTRACHEAL INTUBATION ANESTHESIA WITH AN NG TUBE, FOLEY CATHETER, SCD STOCKINGS. INFORMED CONSENT AND THE PERIOPERATIVE ANTIBIOTIC IN PLACE. AREA OF THE ABDOMEN WAS SCRUBBED, PREPPED, AND DRAPED IN THE USUAL STERILE FASHION. THE SKIN ___ SCAR TISSUE WAS REMOVED BY DR. (B)(6) AND UPON OPENING THE SUBCUTANEOUS TISSUE, PATIENT WAS FOUND TO HAVE INCISIONAL HERNIA WITH SMALL BOWEL INCARCERATED IN IT. SO I TOOK OVER OPEN UP THE ABDOMEN AND LOWER PART OF THE ABDOMEN. UPPER PART OF THE ABDOMEN, THERE WAS A LARGE MESH WITH LOWER PART OF THE MESH THE HERNIA HAS RECURRED. THE MESH HAD METALLIC TACKS THAT STARTED ERODING INTO THE SMALL INTESTINE. ALL THE ADHESIONS WERE SEPARATED FROM THE SMALL BOWEL TO THE HERNIA SAC AND INTRAILEAL [SIC] ADHESIONS WHICH WERE GENTLY SEPARATED. THE SMALL BOWEL WAS PUT BACK IN NORMAL ANATOMICAL POSITION. AFTER THAT THE ABDOMINAL CAVITY WAS OPENED UP, THE PORTION OF THE MESH WAS REMOVED. VERY METALLIC TACKS WERE REMOVED WHICH WERE READY TO ERODE INTO THE SMALL INTESTINE. AFTER THAT THE SMALL BOWEL ADHESIONS WERE SEPARATED AND DR. (B)(6) DID A GYNECOLOGICAL PART OF THE OPERATION. THEN THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED AND ABDOMINAL CAVITY WAS CLOSED WITH #1 PROLENE LOOP AND INTERRUPTED SUTURES. THEN THE HERNIA REPAIR WAS DONE WITH THE SAME. THE SUBCUTANEOUS TISSUE AND THE SCAR TISSUE APPROXIMATED OVER THE MESH WITH 2-0 VICRYL STITCH, SKIN APPROXIMATED WITH STAPLES . STERILE PRESSURE DRESSING APPLIED. PATIENT TOLERATED THE PROCEDURE WELL .¿ (B)(6) 2016: (B)(6) MEDICAL CENTER. [NO PATHOLOGIST SPECIFIED.] PATHOLOGY REPORT. COLLECTED DATE: (B)(6) 2016. SPECIMENS: A. ABDOMINAL SCAR. B. OLD MESH. PREOPERATIVE DIAGNOSIS: LEFT ADNEXAL MASS. POSTOPERATIVE DIAGNOSIS: NP [UNKNOWN ABBREVIATION]. DIAGNOSIS: A. ABDOMINAL SCAR, EXCISION: SKIN WITH SCAR. B: OLD MESH: DENSE FIBROVASCULAR CONNECTIVE TISSUE WITH GRANULATION TISSUE FORMATION AND FOREIGN BODY GIANT CELL REACTION. GROSS DESCRIPTION: TWO SPECIMENS ARE RECEIVED IN FORMALIN IN CONTAINERS LABELED WITH THE PATIENT¿S NAME, MICHELLA HUDSON, AND DATE OF BIRTH. SPECIMEN A IS LABELED AS ¿ABDOMINAL SCAR" AND CONSISTS OF A 14.0 X 1.0 CM ELONGATED STRIP OF DARK PINK-TAN SKIN WITH ATTACHED YELLOW-WHITE SUBCUTANEOUS TISSUE MEASURING 2.5 CM IN THICKNESS. ON THE EPIDERMIS IS A LINEAR CREASE GROSSLY CONSISTENT WITH SCAR REMNANTS MEASURING 10.5 CM IN GREATEST DIMENSION. SECTIONING SHOWS UNREMARKABLE YELLOW-WHITE CUT SURFACES. REPRESENTATIVE SECTIONS ARE SUBMITTED IN CASSETTES A1 AND A2. SPECIMEN B IS LABELED AS "OLD MESH" AND CONSISTS OF A 6.0 X 2.0 X 0.2 CM FLAT IRREGULAR PORTION OF WHITE SYNTHETIC MESH. THE MESH IS FOCALLY COVERED WITH A SCANT AMOUNT OF PINK MEMBRANOUS TISSUE. REPRESENTATIVE SECTIONS OF THE SOFT TISSUE COMPONENT ARE SUBMITTED IN CASSETTE B . PARTIAL EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2016: (B)(6) MEDICAL CENTER. SURGEON: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. OVARIAN MASS. PARTIAL EXPLANT #2 PROCEDURE: [NO PROCEDURE TITLE PROVIDED, BUT PER MEDICAL RECORDS: LEFT SALPINGO-OOPHERECTOMY. RIGHT OOPHERECTOMY. TOTAL HYSTERECTOMY. RECURRENT HERNIA REPAIR. MESH EXPLANT.] PARTIAL EXPLANT #2 DATE: (B)(6) 2016 [HOSPITALIZATION DATES UNKNOWN] (B)(6) 2016: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA, STATUS POST RECURRENT HERNIA REPAIR WITH MULTIPLE MESH. PERITONEAL ADHESIONS. OVARIAN MASS. ANESTHESIA: GENERAL. WOUND CLASSIFICATION: [NOT PROVIDED.] PROCEDURE: ¿PATIENT PUT IN SUPINE POSITION UNDER GENERAL ENDOTRACHEAL INTUBATION ANESTHESIA WITH AN EMPTY BLADDER, EMPTY STOMACH, PERIOPERATIVE ANTIBIOTIC COVERAGE, AND INFORMED CONSENT IN PLACE. AREA OF THE ABDOMEN WAS SCRUBBED, PREPPED AND DRAPED IN USUAL STERILE SURGICAL FASHION. THE SKIN INCISION WAS MADE, STARTED JUST ABOVE THE UMBILICUS WHERE THERE WAS NO MESH WAS [SIC] PALPABLE. SO THE INCISION WAS DEEPENED INTO THE SUBCUTANEOUS TISSUE ___ ABDOMINAL CAVITY WAS ENTERED. AFTER THAT, THE INCISION WAS CARRIED DOWNWARDS. THE MESH WAS AROUND THE UMBILICUS AND THERE WAS A RECURRENT HERNIA THROUGH THE MESH ON THE LEFT SIDE OF THE ABDOMEN. SO THE PORTION OF THE MESH WAS REMOVED. THERE WERE NUMEROUS ADHESIONS ATTACHED TO THE MESH AND AT THE INCISION, WHICH WAS GENTLY SEPARATED. THE EXCESS OF THE MESH WAS REMOVED ALONG WITH THE HERNIA SAC AND SENT FOR PATHOLOGICAL ANALYSIS. THE ENTIRE INCISION WAS OPENED UP TO SYMPHYSIS PUBIS. AFTER THAT SMALL BOWEL ADHESIONS WERE SEPARATED AND RETRACTED. DR. TUNCA FINISHED THE SURGERY AND THEN THE JACKSON-PRATT DRAIN WAS INSERTED AND HERNIA REPAIR WAS DONE BY APPROXIMATING WITH #1 LOOPED PROLENE SUTURE WITH INTERRUPTED #2 PROLENE SIMPLE SUTURES. SUBCUTANEOUS TISSUE IRRIGATED AND SKIN APPROXIMATED WITH STAPLES. PLCO DRESSING APPLIED. PATIENT TOLERATED THE PROCEDURE WELL .¿ (B)(6) 2016: (B)(6), MD. PATHOLOGY REPORT. SPECIMENS: A. OVARIAN TUMOR, LEFT RUPTURED. B. UTERUS AND CERVIX. C. RIGHT OVARY. D. OLD MESH. PREOPERATIVE DIAGNOSIS: COLON CANCER. POSTOPERATIVE DIAGNOSIS: NP [UNKNOWN ABBREVIATION]. DIAGNOSIS: A. OVARY, LEFT; SALPINGO-OOPHERECTOMY: BENIGN OVARIAN CYST CONSISTENT WITH SEROUS CYSTADENOMA. SEE COMMENT. PORTION OF BENIGN FIBROMUSCULAR WALL OF FALLOPIAN TUBE. SEROSAL FIBROUS ADHESIONS. B. UTERUS AND CERVIX; TOTAL HYSTERECTOMY: ADENOMYOSIS. PROLIFERATIVE PHASE ENDOMETRIUM. CERVIX WITH NABOTHIAN CYSTS. SEROSAL FIBROUS ADHESIONS. C. OVARY, RIGHT; OOPHORECTOMY: BENIGN OVARY WITH CYSTIC FOLLICLES. SEROSAL FIBROUS ADHESIONS. D. OLD MESH: MESH MATERIAL. GROSS ONLY. ADHERENT FIBROUS TISSUE WITH FOREIGN BODY TYPE GRANULOMATA. SPECIMEN A: FROZEN SECTION DIAGNOSIS: ¿OVARY WITH BENIGN CYST, ENDOMETRIOSIS, CORPUS LUTEUM .¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2020: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL, HERNIA WITH INFECTION. EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, REMOVAL OF AN INFECTED MESH, REPAIR OF A COLOCUTANEOUS FISTULA, AND RESECTION OF A MECKEL DIVERTICULUM. REPAIR OF RECURRENT VENTRAL HERNIA. EXPLANT DATE: (B)(6) 2020 [HOSPITALIZATION DATES UNKNOWN] (B)(6) 2020: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6). POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA WITH INFECTED MESH AND COLOCUTANEOUS FISTULA, MECKEL DIVERTICULUM. ANESTHESIA: GENERAL. WOUND CLASSIFICATION: [NOT PROVIDED.] PROCEDURE: ¿THE PATIENT IS A 46-YEAR-OLD FEMALE PRESENTING WITH RECURRENT VENTRAL HERNIA AND SECRETION ON THE SKIN WHERE A PREVIOUS MESH WAS VISIBLE. DECISION WAS MADE TO PROCEED WITH OPEN PROCEDURE AND THE SCAR OF THE PREVIOUS MIDLINE INCISION WAS EXCISED WITH SCALPEL AND THEN THE SUBCUTANEOUS TISSUE WAS INCISED WITH BOVIE AND THE LEVEL OF THE MESH WAS REACHED. THE ENTIRE MESH WAS CAREFULLY DISSECTED FROM THE SURROUNDING TISSUE AND REMOVED. THERE WAS A FISTULA TRACT THAT WAS LEADING FROM THE TRANSVERSE COLON TO THE AREA OF THE MESH AND THE FISTULA WAS MOST LIKELY CAUSED BY METAL STAPLES THAT WERE APPLIED TO THE MESH ON THE PREVIOUS REPAIR. THE FISTULA TRACT WAS EXCISED AND THE OPENING IN THE BOWEL WAS CLOSED WITH INTERRUPTED 3-0 VICRYL SUTURES IN THE SEROSEROUS LAYER. THEN, EXTENSIVE LYSIS OF ADHESION WAS PERFORMED TO RELEASE THE BOWEL FROM THE ADHESIONS OF THE ANTERIOR ABDOMINAL WALL. DURING THE EXAMINATION OF THE SMALL BOWEL, A MECKEL DIVERTICULUM WAS FOUND IN APPROXIMATELY 2 FEET FROM THE ILEOCECAL VALVE AND THAT DIVERTICULUM WAS RESECTED USING GIA STAPLER DEVICE IN TRANSVERSE POSITION TO THE BOWEL. THE STAPLE LINE WAS COVERED WITH SEROSEROUS RUNNING 3-0 VICRYL SUTURE. AT THIS POINT, THE HERNIA AND THE INCISION ON THE ANTERIOR ABDOMINAL WALL WAS REPAIRED WITH 2 RUNNING #1 LOOPED PDS SUTURES. THE SKIN WAS APPROXIMATED WITH STAPLES AND PREVENA VACUUM DRESSING WAS APPLIED TO THE INCISION SITE. DURING THE PROCEDURE, THERE WAS [SIC] NO COMPLICATIONS. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION .¿ (B)(6) 2020: (B)(6). (B)(6), MD. PATHOLOGY REPORT. FINAL DIAGNOSIS: A. MESH: ABDOMINAL MESH. GROSS ONLY. B. FISTULA: FIBROUS TISSUE WITH MIXED ACUTE AND CHRONIC INFLAMMATION AND FOREIGN BODY GRANULOMAS. C. SMALL BOWEL, RESECTION: SEGMENT OF SMALL INTESTINE WITH DIVERTICULUM. NO EVIDENCE FOR MALIGNANCY. SPECIMENS RECEIVED: A. MESH. B. FISTULA. C. SMALL BOWEL, RESECTION, NOT TUMOR. CLINICAL INFORMATION: PRE-OP: SUPRAUMBILICAL HERNIA ABDOMINAL PAIN. GROSS DESCRIPTION: THREE SPECIMENS ARE RECEIVED IN FORMALIN IN CONTAINERS LABELED WITH THE PATIENT¿S NAME ¿(B)(6)¿ AND DATE OF BIRTH. SPECIMEN A IS LABELED ¿MESH,¿ AND CONSISTS OF A 16.0 X 9.5 X 1.5 CM FLAT IRREGULAR PORTION OF WHITE SYNTHETIC MESH. THE MESH IS MOSTLY COVERED WITH A STRONGLY ADHERENT YELLOW-PINK MEMBRANOUS ADIPOSE TISSUE. REPRESENTATIVE SECTIONS OF THE SOFT TISSUE COMPONENT IS SUBMITTED IN CASSETTE A. SPECIMEN B IS LABELED "FISTULA TRACT," AND CONSISTS OF A 5.5 X 1.5 X 0.8 CM IRREGULAR PORTION OF YELLOW-RED FATTY SOFT TISSUE. SECTIONING SHOWS AN UNREMARKABLE YELLOW LOBULATED SURFACE. THE ENTIRE SECTIONED SPECIMEN IS SUBMITTED IN CASSETTES B1 THROUGH B3. SPECIMEN C IS LABELED "MECKEL'S DIVERTICULUM" AND CONSISTS OF A 3.0 CM IN LENGTH X 2.0 CM IN DIAMETER OBTUSE PORTION OF SOFT TISSUE. THE SEROSAL SURFACE IS MOSTLY SMOOTH AND PINK. SECTIONING SHOWS A PATENT LUMEN LINED WITH AN UNREMARKABLE PINK CONVOLUTED MUCOSA. REPRESENTATIVE SECTIONS SUBMITTED AS FOLLOWS: [NO FURTHER INFO ] 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: 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. 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.¿ THE INSTRUCTIONS FOR USE FURTHER WARN: ¿WHEN USING THIS DEVICE AS A PERMANENT IMPLANT AND EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION, OR DEVICE REMOVAL MAY BE NECESSARY.¿ 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 ¿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. INDIVIDUAL MEDICAL DECISIONS AND/OR ACTIONS OF HEALTHCARE PROFESSIONAL OR DEVICE USER, IF INCONSISTENT AND/OR NON-CONFORMING TO THE DEVICE MANUFACTURER¿S RECOMMENDATIONS, IFU, OR RECOGNIZED BEST PRACTICES, MAY RESULT IN OR CONTRIBUTE TO AN ADVERSE EVENT. 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.
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)]. IN SUPINE POSITION UNDER GENERAL ENDOTRACHEAL INTUBATION ANESTHESIA WITH AN EMPTY BLADDER, EMPTY STOMACH, PERIOPERATIVE ANTIBIOTIC COVERAGE, AND INFORMED CONSENT IN PLACE. AREA OF THE ABDOMEN WAS SCRUBBED, PREPPED AND DRAPED IN USUAL STERILE SURGICAL FASHION. THE SKIN INCISION WAS MADE, STARTED JUST ABOVE THE UMBILICUS WHERE THERE WAS NO MESH WAS [SIC] PALPABLE. SO THE INCISION WAS DEEPENED INTO THE SUBCUTANEOUS TISSUE ABDOMINAL CAVITY WAS ENTERED. AFTER THAT, THE INCISION WAS CARRIED DOWNWARDS. THE MESH WAS AROUND THE UMBILICUS AND THERE WAS A RECURRENT HERNIA THROUGH THE MESH ON THE LEFT SIDE OF THE ABDOMEN. SO THE PORTION OF THE MESH WAS REMOVED. THERE WERE NUMEROUS ADHESIONS ATTACHED TO THE MESH AND AT THE INCISION, WHICH WAS GENTLY SEPARATED. THE EXCESS OF THE MESH WAS REMOVED ALONG WITH THE HERNIA SAC AND SENT FOR PATHOLOGICAL ANALYSIS. THE ENTIRE INCISION WAS OPENED UP TO SYMPHYSIS PUBIS. AFTER THAT SMALL BOWEL ADHESIONS WERE SEPARATED AND RETRACTED. DR. TUNCA FINISHED THE SURGERY AND THEN THE JACKSON-PRATT DRAIN WAS INSERTED AND HERNIA REPAIR WAS DONE BY APPROXIMATING WITH #1 LOOPED PROLENE SUTURE WITH INTERRUPTED #2 PROLENE SIMPLE SUTURES. SUBCUTANEOUS TISSUE IRRIGATED AND SKIN APPROXIMATED WITH STAPLES. PLCO DRESSING APPLIED. PATIENT TOLERATED THE PROCEDURE WELL .¿. 11/23/16: (B)(6) MEDICAL CENTER. . PATHOLOGY REPORT. SPECIMENS: A. OVARIAN TUMOR, LEFT RUPTURED. B. UTERUS AND CERVIX. C. RIGHT OVARY. D. OLD MESH. PREOPERATIVE DIAGNOSIS: COLON CANCER. POSTOPERATIVE DIAGNOSIS: NP [UNKNOWN ABBREVIATION]. DIAGNOSIS: A. OVARY, LEFT; SALPINGO-OOPHERECTOMY: BENIGN OVARIAN CYST CONSISTENT WITH SEROUS CYSTADENOMA. SEE COMMENT. PORTION OF BENIGN FIBROMUSCULAR WALL OF FALLOPIAN TUBE. SEROSAL FIBROUS ADHESIONS. B. UTERUS AND CERVIX; TOTAL HYSTERECTOMY: ADENOMYOSIS. PROLIFERATIVE PHASE ENDOMETRIUM. CERVIX WITH NABOTHIAN CYSTS. SEROSAL FIBROUS ADHESIONS. C. OVARY, RIGHT; OOPHORECTOMY: BENIGN OVARY WITH CYSTIC FOLLICLES. SEROSAL FIBROUS ADHESIONS. D. OLD MESH: MESH MATERIAL. GROSS ONLY. ADHERENT FIBROUS TISSUE WITH FOREIGN BODY TYPE GRANULOMATA. SPECIMEN A: FROZEN SECTION DIAGNOSIS: ¿OVARY WITH BENIGN CYST, ENDOMETRIOSIS, CORPUS LUTEUM .¿. EXPLANT PREOPERATIVE COMPLAINTS: 11/25/20: (B)(6) MEDICAL CENTER . PREOPERATIVE DIAGNOSIS: RECURRENT VENTRAL, HERNIA WITH INFECTION. EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, REMOVAL OF AN INFECTED MESH, REPAIR OF A COLOCUTANEOUS FISTULA, AND RESECTION OF A MECKEL DIVERTICULUM. REPAIR OF RECURRENT VENTRAL HERNIA. EXPLANT DATE: (B)(6), 2020 [HOSPITALIZATION DATES UNKNOWN]. 11/25/20: (B)(6) MEDICAL CENTER . OPERATIVE REPORT. ASSISTANT: (B)(6). POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL HERNIA WITH INFECTED MESH AND COLOCUTANEOUS FISTULA, MECKEL DIVERTICULUM. ANESTHESIA: GENERAL. WOUND CLASSIFICATION: [NOT PROVIDED.] PROCEDURE: ¿THE PATIENT IS A 46-YEAR-OLD FEMALE PRESENTING WITH RECURRENT VENTRAL HERNIA AND SECRETION ON THE SKIN WHERE A PREVIOUS MESH WAS VISIBLE. DECISION WAS MADE TO PROCEED WITH OPEN PROCEDURE AND THE SCAR OF THE PREVIOUS MIDLINE INCISION WAS EXCISED WITH SCALPEL AND THEN THE SUBCUTANEOUS TISSUE WAS INCISED WITH BOVIE AND THE LEVEL OF THE MESH WAS REACHED. THE ENTIRE MESH WAS CAREFULLY DISSECTED FROM THE SURROUNDING TISSUE AND REMOVED. THERE WAS A FISTULA TRACT THAT WAS LEADING FROM THE TRANSVERSE COLON TO THE AREA OF THE MESH AND THE FISTULA WAS MOST LIKELY CAUSED BY METAL STAPLES THAT WERE APPLIED TO THE MESH ON THE PREVIOUS REPAIR. THE FISTULA TRACT WAS EXCISED AND THE OPENING IN THE BOWEL WAS CLOSED WITH INTERRUPTED 3-0 VICRYL SUTURES IN THE SEROSEROUS LAYER. THEN, EXTENSIVE LYSIS OF ADHESION WAS PERFORMED TO RELEASE THE BOWEL FROM THE ADHESIONS OF THE ANTERIOR ABDOMINAL WALL. DURING THE EXAMINATION OF THE SMALL BOWEL, A MECKEL DIVERTICULUM WAS FOUND IN APPROXIMATELY 2 FEET FROM THE ILEOCECAL VALVE AND THAT DIVERTICULUM WAS RESECTED USING GIA STAPLER DEVICE IN TRANSVERSE POSITION TO THE BOWEL. THE STAPLE LINE WAS COVERED WITH SEROSEROUS RUNNING 3-0 VICRYL SUTURE. AT THIS POINT, THE HERNIA AND THE INCISION ON THE ANTERIOR ABDOMINAL WALL WAS REPAIRED WITH 2 RUNNING #1 LOOPED PDS SUTURES. THE SKIN WAS APPROXIMATED WITH STAPLES AND PREVENA VACUUM DRESSING WAS APPLIED TO THE INCISION SITE. DURING THE PROCEDURE, THERE WAS [SIC] NO COMPLICATIONS. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION .¿ 11/25/20: (B)(6) MEDICAL CENTER . PATHOLOGY REPORT. FINAL DIAGNOSIS: A. MESH: ABDOMINAL MESH. GROSS ONLY. B. FISTULA: FIBROUS TISSUE WITH MIXED ACUTE AND CHRONIC INFLAMMATION AND FOREIGN BODY GRANULOMAS. C. SMALL BOWEL, RESECTION: SEGMENT OF SMALL INTESTINE WITH DIVERTICULUM. NO EVIDENCE FOR MALIGNANCY. SPECIMENS RECEIVED: A. MESH. B. FISTULA. C. SMALL BOWEL, RESECTION, NOT TUMOR. CLINICAL INFORMATION: PRE-OP: SUPRAUMBILICAL HERNIA ABDOMINAL PAIN. GROSS DESCRIPTION: THREE SPECIMENS ARE RECEIVED IN FORMALIN IN CONTAINERS LABELED WITH THE PATIENT¿S NAME ¿(B)(6)¿ AND DATE OF BIRTH. SPECIMEN A IS LABELED ¿MESH,¿ AND CONSISTS OF A 16.0 X 9.5 X 1.5 CM FLAT IRREGULAR PORTION OF WHITE SYNTHETIC MESH. THE MESH IS MOSTLY COVERED WITH A STRONGLY ADHERENT YELLOW-PINK MEMBRANOUS ADIPOSE TISSUE. REPRESENTATIVE SECTIONS OF THE SOFT TISSUE COMPONENT IS SUBMITTED IN CASSETTE A. SPECIMEN B IS LABELED "FISTULA TRACT," AND CONSISTS OF A 5.5 X 1.5 X 0.8 CM IRREGULAR PORTION OF YELLOW-RED FATTY SOFT TISSUE. SECTIONING SHOWS AN UNREMARKABLE YELLOW LOBULATED SURFACE. THE ENTIRE SECTIONED SPECIMEN IS SUBMITTED IN CASSETTES B1 THROUGH B3. SPECIMEN C IS LABELED "MECKEL'S DIVERTICULUM" AND CONSISTS OF A 3.0 CM IN LENGTH X 2.0 CM IN DIAMETER OBTUSE PORTION OF SOFT TISSUE. THE SEROSAL SURFACE IS MOSTLY SMOOTH AND PINK. SECTIONING SHOWS A PATENT LUMEN LINED WITH AN UNREMARKABLE PINK CONVOLUTED MUCOSA. REPRESENTATIVE SECTIONS SUBMITTED AS FOLLOWS: NO FURTHER INFO. 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.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT ANOTHER LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A SECOND GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016 AND (B)(6) 2020, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: CHRONIC PAIN, REMOVAL, ADDITIONAL SURGERIES, ADHESIONS, EXPULSION OF MESH, HERNIA RECURRENCE, REMOVAL, FISTULA, INFECTION, WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1792558 | GORE® DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC. | 00733132601134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Hospitalization| R |