BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH PLUS BIOMATERIAL

    MDR report key: 8372492 · Received February 26, 2019

    Report

    Report Number
    3003910212-2019-00031
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    March 13, 2017
    Report Date
    March 19, 2021
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    UDI-DI
    00733132601110
    PMA / PMN Number
    K063435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: UPDATED HEALTH EFFECT- CLINICAL CODE. H6: UPDATED INVESTIGATION FINDINGS . H6: UPDATED INVESTIGATION CONCLUSIONS. H6: HEALTH EFFECT IMPACT CODE: F1903: DEVICE EXPLANTATION. PREVIOUS PATIENT CODE (1930) WAS REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2011 THROUGH (B)(6) 2018 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. RECORDS FROM (B)(6) 2012 THROUGH (B)(6) 2016 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: SMOKER ­ (B)(6) 2016: 1 PACK/DAY ­ (B)(6) 2016: 1 PACK/DAY X 17 YEARS ­ (B)(6) 2016: [PATIENT] ¿CONTINUES TO SMOKE¿ ASTHMA HEPATITIS C DIVERTICULOSIS OF COLON WITHOUT DIVERTICULITIS OBESITY ­ (B)(6) 2016: 87.7 KG; BMI 33.83 .­ (B)(6) 2016: 198.7 LBS; BMI 34.11. ­ (B)(6) 2017: 88 KG; BMI 33.3. PRIOR SURGICAL PROCEDURES: 2011: LAPAROSCOPIC CHOLECYSTECTOMY. VENTRAL HERNIA REPAIR [UNKNOWN DATE]. RELEVANT MEDICAL INFORMATION: (B)(6) 2012: CT ABDOMEN: ¿IMPRESSION: 1. HEPATOMEGALY. 2. STATUS POST CHOLECYSTECTOMY.3. DEFECT WITHIN THE ANTERIOR ABDOMINAL WALL CONSISTENT WITH A HERNIA. THE HERNIA CONTAINS OMENTAL FAT AS WELL AS A PORTION OF THE TRANSVERSE PORTION OF THE COLON. THERE IS NO EVIDENCE OF BOWEL WALL THICKENING OR OBSTRUCTION.¿ (B)(6) 12: ¿THIS PATIENT IS A 28-YEAR-OLD FEMALE WHO ORIGINALLY PRESENTED IN (B)(6) 2011 WITH A PAINFUL VENTRAL HERNIA WHILE PREGNANT. THE PATIENT RECENTLY DELIVERED AND HAS CONTINUED TO HAVE SYMPTOMATIC VENTRAL HERNIA. SHE REQUESTS SURGICAL REPAIR AT THIS TIME.¿ ¿ABDOMEN: SOFT, NONDISTENDED. THERE IS A MODERATE SIZE TENDER BUT REDUCIBLE MIDLINE SUPRAUMBILICAL HERNIA PRESENT.¿ ¿ASSESSMENT AND PLAN: THIS IS A 28-YEAR-OLD WITH KNOWN SYMPTOMATIC SUPRAUMBILICAL VENTRAL HERNIA. SHE IS TO UNDERGO OPERATIVE REPAIR AT THIS TIME.¿ RECORDS PERTAINING TO ABDOMINAL PROCEDURES PERFORMED PRIOR TO OCTOBER 2016 WERE NOT PROVIDED. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2016: ¿C/O [COMPLAINS OF] HERNIA. ONSET VARIABLE AND OCCURRING INTERMITTENT (PT [PATIENT] STATES IN LAST WEEK IT HAS GOTTEN WORSE AND THINKS SHE MAY HAVE 2) [SIC] PATTERN FOR 4 YEARS. HERNIA DESCRIBED AS SEVERE.¿ ¿PMH [PAST MEDICAL HISTORY]: CELLULITIS; OPEN WOUND, POST-SURGICAL NON-HEALING. ASTHMA. ABDOMINAL HERNIA.¿ (B)(6) 2016: CT ABDOMEN/PELVIS: ¿THERE IS A ROUGHLY A 3CM VENTRAL WALL DEFECT ABOVE THE UMBILICUS IN THE MIDLINE WITH ASSOCIATED HERNIATED OMENTAL FAT.¿ (B)(6) 2016: ¿HERNIA, DURATION 5 YEARS. PROBLEM IS WORSE. OCCURS RECURRINGLY, AND PERIUMBILICAL. RADIATION TO BACK, ACHING AND SHARP. CONTEXT INCLUDES PREGNANCY. AGGRAVATED BY COUGH AND A LOT OF MOVING. RELIEVING FACTORS INCLUDE LYING DOWN AND IBUPROFEN. PT STATES ON AND OFF PAIN. HX [HISTORY] OF INTERMITTENT MASS ABOVE HER UMBILICUS. IT CAN BE 10/10 PAINFUL WHICH IS WORSE W/ ACTIVITY AND BOTHERS HER LESS WHEN SHE IS AT REST. DENIES N/V [NAUSEA/VOMITING] OR OBSTRUCTIVE SYMPTOMS. CT SCAN CONFIRMS VENTRAL HERNIA ABOVE UMBILICUS CONTAINING ONLY OMENTUM.¿ (B)(6) 2016: ¿PATIENT IS A 33-YEAR-OLD WHITE FEMALE WHO IS STATUS POST A PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY WHO HAD BEEN COMPLAINING OF A PAINFUL LUMP ABOVE HER UMBILICUS. HER LAPAROSCOPIC CHOLECYSTECTOMY SCAR WAS BELOW THE UMBILICUS. THE HERNIA WAS CONFIRMED ON CT SCAN.¿ IMPLANT PROCEDURE: VENTRAL HERNIORRHAPHY AND VENTRAL INCISIONAL HERNIORRHAPHY WITH MESH. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL (14385766/1DLMCP04) 15 X 19 CM. IMPLANT DATE: (B)(6) 2016. DESCRIPTION OF HERNIA BEING TREATED: ¿A SCALPEL WAS USED TO MAKE A SMALL INCISION ABOVE THE UMBILICUS. ELECTROCAUTERY WAS USED TO CARRY THE INCISION DOWN TO THE HERNIA SAC. THE HERNIA SAC WAS DISSECTED DOWN AROUND ITS NECK AND THE HERNIA SAC WAS OPENED AT ITS NECK. IT WAS FOUND TO CONTAIN ONLY OMENTUM. A PORTION OF THE OMENTUM WAS SENT WITH THE SAC AND THE REST OF THE OMENTUM WAS REDUCED BACK INTO THE ABDOMEN AFTER BEING DIVIDED WITH THE LIGATURE. THE SURGEON'S FINGER WAS THEN PLACED BENEATH THE FASCIA TO BE SURE THAT THERE WERE NO ADHESIONS TO IT AND CHECKED FOR OTHER DEFECTS. THERE WAS A SECOND FASCIAL DEFECT NOTED JUST BENEATH THE UMBILICUS. THEREFORE, A SCALPEL WAS USED TO LENGTHEN THE INCISION INFERIORLY TO GO AROUND THE UMBILICUS TO APPROXIMATELY 3 CM INFERIOR TO THE UMBILICUS. ELECTROCAUTERY WAS USED TO CARRY THE INCISION DOWN TO THE FASCIA AND THE 2 FASCIAL DEFECTS WERE JOINED USING ELECTROCAUTERY INTO 1 LARGE DEFECT. THE DEFECT WAS 8 CM IN LENGTH.¿ IMPLANT SIZE AND FIXATION: ¿A GORE-TEX DUAL MESH PLUS WAS TRIMMED TO SIZE IN AN OVAL SHAPE SUCH THAT THERE WAS APPROXIMATELY 4 CM OF OVERLAP IN ALL DIRECTIONS AROUND THE DEFECT. INTERRUPTED GORE-TEX SUTURES WERE PLACED BACK FROM THE FASCIAL OPENING AND THE ENTIRE PERIPHERY OF THE HERNIA AND WAS SUTURED TO THE PERIPHERY OF THE DUAL MESH PLUS. THESE WERE TIED DOWN WITH THE DUAL MESH PLUS IN PLACE. THE AREA BETWEEN THE STITCHES WAS PROBED WITH THE SURGEON'S GLOVED FINGER TO BE SURE THAT THERE WAS NO HERNIATION OF FAT OR BOWEL BETWEEN THE STITCHES. THERE WAS NOT AND THERE WERE NO OPEN DEFECTS TO ALLOW AN INTERNAL HERNIA. THEREFORE, THE WOUND WAS COPIOUSLY IRRIGATED WITH SALINE AND #1 LOOPED PDS WAS USED TO REAPPROXIMATE THE FASCIA IN THE MIDLINE ON TOP OF THE MESH. THE WOUND WAS ONCE AGAIN IRRIGATED WITH SALINE. INTERRUPTED 3-0 VICRYL SUTURES WERE USED TO REAPPROXIMATE THE FAT SUCH AS TO ALLOW ANY DEAD SPACES, AND THE SKIN WAS CLOSED WITH STAPLES.¿ POST-OPERATIVE PERIOD: [0 DAYS] ­ (B)(6) 2016: ¿D/C [DISCHARGE] HOME. NO LIFTING > 5 POUNDS FOR 6 WEEKS.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2016: EMERGENCY ROOM: HAD HERNIA REPAIR 3 DAYS AGO, YESTERDAY BEGAN WITH VOMITING, UNABLE TO EAT/DRINK.¿ (B)(6) 2016: CT ABDOMEN/PELVIS: ¿1. RECENT VENTRAL HERNIORRHAPHY WITH SUBCUTANEOUS FLUID COLLECTIONS AND GAS WHICH MAY BE POSTSURGICAL SEROMA/HEMATOMA OR ABSCESS. CORRELATE AS TO WHEN THE SURGERY WAS PERFORMED. CORRELATE WITH PHYSICAL FINDINGS AT THE SURGICAL SITE. 2. PROBABLE PARTIAL SMALL BOWEL OBSTRUCTION WITH APPARENT TRANSITION AT THE DISTAL ILEUM LIKELY RELATED TO ADHESIONS. THE TERMINAL ILEUM AND COLON ARE DECOMPRESSED. GASTRIC DECOMPRESSION BY NG TUBE PLACEMENT IS LIKELY INDICATED.¿ (B)(6) 2016: (B)(6) 2016 UNDERWENT A VENTRAL HERNIORRHAPHY W/ MESH PER DR. (B)(6) . PT D/C HOME SAME AFTERNOON FOLLOWING PROCEDURE AND STATES SHE WAS DOING WELL THAT EVENING. SHE STATES BY LATE SATURDAY AFTERNOON INTO THE EVENING SHE DEVELOPED NAUSEA W/ ONE EPISODE OF VOMITING. THIS SUBSIDED BUT RECURRED ON SUNDAY AND SINCE SHE HAS HAD INTERMITTENT NAUSEA AND VOMITING W/ INCREASING ABDOMINAL PAIN. PRESENTED TO MANSFIELD MEDCENTRAL EMERGENCY DEPARTMENT FOR EVALUATION. FOUND TO HAVE ELEVATED WHITE BLOOD CELL COUNT AT 14,000. CT SCAN OF ABDOMEN AND PELVIS REVEALED SUBCUTANEOUS FLUID COLLECTIONS AND GAS WHICH BE R/T [RELATED TO] POSTSURGICAL SEROMA, HEMATOMA, OR AN ABSCESS. ALSO FOUND TO HAVE A PARTIAL SMALL BOWEL OBSTRUCTION W/ APPARENT TRANSITION AT THE DISTAL ILEUM, LIKELY R/T TO ADHESIONS. FINDINGS DISCUSSED W/ DR. (B)(6) , PT TRANSFERRED TO BUCYRUS HOSPITAL. NG [NASOGASTRIC] TUBE PLACE TO LOW WALL SUCTION LAST EVENING. PT STATES SHE HAS HAD IMMENSE IMPROVEMENT IN HER ABDOMINAL DISCOMFORT, HAS PASSED GAS AND HAD ONE BOWEL MOVEMENT THIS EVENING. DENIES ANY RECENT FEVERS, CHILLS OR CHEST PAIN. ADMITS TO NAUSEA AND VOMITING. NO DIARRHEA. PRESENTLY RESTING COMFORTABLY IN BED IN NO ACUTE DISTRESS. SHE IS AWAKE, ALERT, AND ORIENTED X 4 W/ CLEAR SPEECH AND CONVERSATION. PAIN 0/10.¿ (B)(6) 2016: ¿NG-TUBE REMOVED, STARTED ON CLEAR LIQUID DIET, ADVANCED TO REGULAR. TODAY FOLLOWING REGULAR DIET, MOVING BOWELS, PASSING FLATUS, NO FURTHER NAUSEA, VOMITING, DENYING ABDOMINAL PAIN. INCISION CLEAN, DRY AND INTACT. D/C HOME. D/C DX [DISCHARGE DIAGNOSIS]: OBSTIPATION S/P [STATUS POST] VENTRAL HERNIORRHAPHY.¿ (B)(6) 2016: ¿PT CALLED STATING SHE THINKS HER STAPLES ARE INFECTED FROM RECENT VENTRAL HERNIA SURGERY W/ DR. (B)(6) . PT FEELS LIKE ¿THE STAPLES CAME APART.¿ SHE STATED THAT THE INCISION SITE IS VERY RED AND THERE IS FLUID SEEPING OUT. I THEN ASKED HER IF HER SKIN WAS WARM TO TOUCH, PT STATED YED [SIC]. I ASKED ABOUT FEVERS, SHE STATED ¿TO THE BEST OF MY KNOWLEDGE I HAVE NOT HAD ONE.¿ I INFORMED PT IF SHE STILL WAS NOT FEELING WELL, SHE NEEDED TO GO BACK TO THE HOSPITAL TO BE SEEN. PT STATED SHE WOULD KEEP HER ORIGINAL P/O [POST-OPERATIVE] APPT (B)(6) W/ DR. (B)(6) . (B)(6) 2016: ¿STATES WENT TO ER [EMERGENCY ROOM] ON (B)(6) D/T [DUE TO] N/V. STATES WAS TOLD HAD BROKEN BLOOD VESSEL IN STOMACH. RELEASED (B)(6) . STARTING TO HAVE A LOT OF DRAINAGE ON (B)(6) , HAS A LOT OF RIGHT-SIDE PAIN, LOWER BACK AND UPPER INCISION SITE PAIN . PAIN SCALE 9/10, ABDOMEN. IMPRESSION/PLAN: S/P REPAIR VENTRAL HERNIA AND INCISIONAL HERNIA W/ MESH. NO EVIDENCE OF RECURRENCE. SOME SEROSANG [SEROSANGUINOUS] DRAINAGE FROM INCISION (PT CONTINUES TO SMOKE). STAPLES D/C¿D [DISCONTINUED], KEEP COVERED.¿ (B)(6) 2016: ¿POSTOP, S/P VENTRAL HERNIA W/ MESH. PT REPORTING INCISION STILL DRAINING DAILY COVERING GAUZE PADS.¿ ¿S/P OPEN VENTRAL HERNIORRHAPHY X 2 DEFECTS. DRAINAGE FROM UMBILICUS; NO EVIDENCE OF CELLULITIS. KEEP COVERED.¿ (B)(6) 2016: ¿STILL LITTLE PAIN ABDOMINAL AREA, INCISION STILL DRAINING. MEDS: AUGMENTIN, KEFLEX. STILL HAVING DRAINAGE FROM NEAR UMBILICUS, DECREASING. KEEP COVERED.¿ (B)(6) 2016: ¿RECHECK OF HERNIA. ONSET OF HERNIA OCCURRING FOR 4 YEARS. HERNIA REPAIR W/ DR. (B)(6) APPROX. A MONTH AGO. STILL HAS PAIN, STATES HAS A SMALL HOLE IN ABDOMEN. DR. (B)(6) TOLD HER HE MAY HAVE TO REPAIR. SHE STATES WOUND IS SLOWLY CLOSING.¿ ¿DRAINING WOUND ABDOMEN, CLEAN. IMPRESSION/PLAN: CELLULITIS; ANAEROBIC AND AEROBIC CULTURE. REFERRAL TO WOUND CLINIC.¿ (B)(6) 2016: WOUND CULTURE: ¿STAPHYLOCOCCUS AUREUS.¿ (B)(6) 2016: ¿S/P VENTRAL ABDOMINAL HERNIA W/ MESH. EXAM: UNREMARKABLE EXCEPT SEROUS DRAINAGE FROM UMBILICUS. ABDOMINAL WOUND MEASUREMENT 1.8 X 1.5 X 3 CM. IMPRESSION: S/P VENTRAL HERNIA REPAIR W/ MESH AND DISRUPTION OF SURGICAL WOUND. PLAN: RINSE ABDOMINAL SITE W/ STERILE SALINE 2-3 TIMES PER DAY. CULTURES WILL BE OBTAINED.¿ (B)(6) 2016: WOUND CULTURE: ¿ESCHERICHIA COLI, SERRATIA MARCESCENS¿ (B)(6) 2017: ¿ABDOMEN SOFT, SEROUS DRAINAGE FROM UMBILICAL INCISION. WOUND MEASURES 1.7 X 1 BUT DEPTH EXTENDS DEEP INTO SUBCUTANEOUS TISSUE PLANE. STATES HAS A FEW DAYS OF ANTIBIOTICS REMAINING AND APPOINTMENT W/ DR. (B)(6) TOMORROW. DRAINAGE IS NOT PURULENT AND HAS NO ODOR.¿ ¿I BELIEVE THE WOUND MOST LIKELY WILL NOT HEAL UNLESS MESH IS REMOVED. F/U [FOLLOW UP] W/ DR. (B)(6) TO DETERMINE WHETHER ADDITIONAL SURGERY IS RECOMMENDED AT THIS TIME. CONTINUE W/ AQUACEL AG AND GAUZE, DRESSING, CHANGE DAILY.¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2017: ¿PCP [PRIMARY CARE PHYSICIAN] REFERRED HER TO WOUND CLINIC FOR SECOND OPINION. PT STATES WOUND CLINIC TOLD HER TO HAVE SURGERY AGAIN D/T MESH. PT STATES THE HOLE IN HER STOMACH IS GETTING DEEPER, HAVING DRAINAGE, AND SHARP PAIN. CLINIC PRESCRIBED HER BACTRIM. IMPRESSION/PLAN: STILL HAVING DRAINAGE NEAR UMBILICUS, HAS NOT CHANGED IN QUANTITY. THERE IS NO ERYTHEMA OR SIGN OF CELLULITIS. I OFFERED THE OPTIONS OF REMOVING THE MESH VS CONT [CONTINUE] TO OBSERVE. SHE IS CURRENTLY ON A COURSE OF BACTRIM RX BY BAKENHASTER. PT WISHES TO WAIT AT THIS TIME.¿ (B)(6) 2017: ¿F/U VENTRAL HERNIA. INCISION STILL OPEN, NOT HAVING PAIN. CLEAR ODORLESS DRAINAGE. MEDS: BACTRIM. IMPRESSION/PLAN: SCHEDULE REMOVAL OF MESH W/ PRIMARY CLOSURE.¿ (B)(6) 2017: ¿THIS IS A 34 YEAR OLD FEMALE WHO PREVIOUSLY HAD UNDERGONE A LAPAROSCOPIC CHOLECYSTECTOMY WITH THE GALLBLADDER REMOVAL SITE BEING PERIUMBILICAL WHO SUBSEQUENTLY DEVELOPED AN INCISIONAL HERNIA AT THIS SITE AND UNDERWENT A VENTRAL HERNIORRHAPHY WITH A GORE-TEX MESH. THE GORE-TEX MESH SUBSEQUENTLY GOT INFECTED AND, DESPITE ATTEMPTS AT ANTIBIOTIC TREATMENT, THE INFECTION DID NOT RESOLVE, SO THE PATIENT PRESENTS NOW FOR REMOVAL OF AN INFECTED HERNIA MESH.¿ EXPLANT PROCEDURE: DRAINAGE OF ABDOMINAL WALL ABSCESS. REMOVAL OF VENTRAL HERNIA MESH. PRIMARY VENTRAL HERNIORRHAPHY. EXPLANT DATE: (B)(6) 2017. ¿FINDINGS: INFECTED HERNIA MESH WITH A SINUS TRACT JUST NEXT TO THE UMBILICUS AND A POCKET OF PUS SURROUNDING THE HERNIA MESH.¿ ¿A SCALPEL WAS USED TO MAKE AN ELLIPTICAL INCISION AROUND THE SCAR, THE SINUS TRACT, AND THE UMBILICUS. ELECTROCAUTERY WAS USED TO TAKE THIS DOWN AROUND THE UMBILICUS DOWN TO THE LEVEL OF THE FASCIA UNTIL THE HERNIA MESH WAS IDENTIFIED. THE HERNIA MESH WAS THEN REMOVED WITH A COMBINATION OF ELECTROCAUTERY AND BLUNT DISSECTION . ALL THE GORE-TEX SUTURES WERE ALSO REMOVED. THERE WAS A DENSE LAYER JUST POSTERIOR TO THE HERNIA MESH KEEPING THE AREA SEPARATE FROM THE ABDOMEN. THIS WAS THEN IRRIGATED WITH 50:50 SALINE AND PEROXIDE MIX. ELECTROCAUTERY WAS USED FOR HEMOSTASIS. A JACKSON-PRATT DRAIN WAS THEN PLACED BETWEEN THIS LAYER AND THE FASCIA AND WAS EXITED JUST TO THE LEFT OF THE INCISION THROUGH A STAB WOUND. THE FASCIA WAS THEN CLOSED OVER TOP OF THE DRAIN WITH #2 FIGURE-OF-EIGHT SUTURES. THE SUBCUTANEOUS TISSUE WAS THEN IRRIGATED AND EXAMINED FOR HEMOSTASIS AND THE SKIN WAS CLOSED WITH STAPLES. A 2-0 NYLON DRAIN STITCH WAS PLACED AND STERILE DRESSINGS WERE APPLIED.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2017: ¿PREVIOUSLY UNDERGONE LAPAROSCOPIC CHOLECYSTECTOMY, TO WHICH DEVELOPED INCISIONAL HERNIA, UNDERWENT VENTRAL HERNIORRHAPHY. FOUND TO HAVE INFECTED MESH DESPITE USE OF ANTIBIOTICS. INFECTION DID NOT RESOLVE AND RECOMMENDED SURGICAL INTERVENTION. PROCEDURE COMPLETED UNEVENTFULLY.¿ (B)(6) 2017: PATHOLOGY: ¿SPECIMENS RECEIVED -SKIN, SOFT TISSUE AND MESH. GROSS DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN, AND LABELED ¿SKIN SOFT TISSUE AND MESH¿ WITH PATIENT'S NAME AND SECOND IDENTIFIER. THE SPECIMEN CONSISTS OF TWO FRAGMENTS OF PINK TAN SOFT TISSUE, ONE OF WHICH CONTAINS SKIN MEASURING 7 X 3 X 2 CM AND 5 X 4.5 X 3CM. ALSO INCLUDED IS A SYNTHETIC MESH MEASURING 7 X 3 X 1CM. SECTIONING REVEALS GROSSLY UNREMARKABLE TISSUE. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES.¿ CONCLUSIONS: 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 GORE® DUALMESH® PLUS BIOMATERIAL IS PROVIDED STERILE. THE INSTRUCTIONS FOR USE FURTHER WARNS: ¿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 MATERIAL.¿ THE IFU FURTHER WARNS ¿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 WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. 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, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. 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. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER 14385766. 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.

    Additional Manufacturer Narrative · 0

    ADDED MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: ON (B)(6) 2016: (B)(6). OFFICE NOTES. HPI: C/O HERNIA. ONSET VARIABLE AND OCCURRING INTERMITTENT (PT STATES IN LAST WEEK IT HAS GOTTEN WORSE AND THINKS SHE MAY HAVE 2) PATTERN FOR 4 YEARS. HERNIA DESCRIBED AS SEVERE. RECHECK F/U FOR ASTHMA, CHRONIC HEPATITIS C. PMH: CELLULITIS; OPEN WOUND, POST-SURGICAL NON-HEALING. ASTHMA. ABDOMINAL HERNIA. PSH: GALLBLADDER SURGERY (B)(6). SOCIAL HX: TOBACCO: SMOKES 1 PPD. WT 87.7 KG, BMI 33.83. IMPRESSION/PLAN: ABDOMINAL HERNIA; CAT SCAN OF ABDOMEN AND PELVIS W/ AND W/OUT CONTRAST. CELLULITIS; OPEN WOUND, POST-SURGICAL NON-HEALING. ON (B)(6) 2016: (B)(6). OFFICE NOTES. HPI: HERNIA, DURATION 5 YEARS. PROBLEM IS WORSE. OCCURS RECURRINGLY, AND PERIUMBILICAL. RADIATION TO BACK, ACHING AND SHARP. CONTEXT INCLUDES PREGNANCY. AGGRAVATED BY COUGH AND A LOT OF MOVING. RELIEVING FACTORS INCLUDE LYING DOWN AND IBUPROFEN. PT STATES ON AND OFF PAIN. HX OF INTERMITTENT MASS ABOVE HER UMBILICUS. IT CAN BE 10/10 PAINFUL WHICH IS WORSE W/ ACTIVITY AND BOTHERS HER LESS WHEN SHE IS AT REST. DENIES N/V OR OBSTRUCTIVE SYMPTOMS. CT SCAN CONFIRMS VENTRAL HERNIA ABOVE UMBILICUS CONTAINING ONLY OMENTUM. EXAM: UNREMARKABLE EXCEPT POSITIVE FOR VENTRAL HERNIA SUPRAUMBILICAL. OBESE. WT 198.7 LBS, BMI 34.11. IMPRESSION/PLAN: VENTRAL HERNIA SUPRAUMBILICAL FOR HERNIORRHAPHY W/ MESH. ANCEF OCOR. RISKS/BENEFITS DISCUSSED W/ PT. ON (B)(6) 2016: (B)(6) HOSPITAL. DISCHARGE INSTRUCTIONS. D/C HOME. NO LIFTING > 5 POUNDS FOR 6 WEEKS. ON (B)(6) 2016. (B)(6) HOSPITAL. (B)(6) DO. CONSULTATION. REASON FOR CONSULT: MEDICAL MANAGEMENT W/ PARTIAL SMALL BOWEL OBSTRUCTION. HPI: ON (B)(6) 2016 UNDERWENT A VENTRAL HERNIORRHAPHY W/ MESH PER DR. (B)(6). PT D/C HOME SAME AFTERNOON FOLLOWING PROCEDURE AND STATES SHE WAS DOING WELL THAT EVENING. SHE STATES BY LATE SATURDAY AFTERNOON INTO THE EVENING SHE DEVELOPED NAUSEA W/ ONE EPISODE OF VOMITING. THIS SUBSIDED BUT RECURRED ON SUNDAY AND SINCE SHE HAS HAD INTERMITTENT NAUSEA AND VOMITING W/ INCREASING ABDOMINAL PAIN. PRESENTED TO (B)(6) EMERGENCY DEPARTMENT FOR EVALUATION. FOUND TO HAVE ELEVATED WHITE BLOOD CELL COUNT AT 14,000. CT SCAN OF ABDOMEN AND PELVIS REVEALED SUBCUTANEOUS FLUID COLLECTIONS AND GAS WHICH BE R/T POSTSURGICAL SEROMA, HEMATOMA, OR AN ABSCESS. ALSO FOUND TO HAVE A PARTIAL SMALL BOWEL OBSTRUCTION W/ APPARENT TRANSITION AT THE DISTAL ILEUM, LIKELY R/T TO ADHESIONS. FINDINGS DISCUSSED W/ DR. (B)(6), PT TRANSFERRED TO (B)(6) HOSPITAL. NG TUBE PLACE TO LOW WALL SUCTION LAST EVENING. PT STATES SHE HAS HAD IMMENSE IMPROVEMENT IN HER ABDOMINAL DISCOMFORT, HAS PASSED GAS AND HAD ONE BOWEL MOVEMENT THIS EVENING. DENIES ANY RECENT FEVERS, CHILLS OR CHEST PAIN. ADMITS TO NAUSEA AND VOMITING. NO DIARRHEA. PRESENTLY RESTING COMFORTABLY IN BED IN NO ACUTE DISTRESS. SHE IS AWAKE, ALERT, AND ORIENTED X 4 W/ CLEAR SPEECH AND CONVERSATION. PAIN 0/10. SOCIAL HX: SMOKES ONE PACK A DAY FOR 17 YEARS . EXAM: UNREMARKABLE EXCEPT ABDOMEN SLIGHTLY TENDER. MIDLINE SURGICAL DRESSING INTACT W/ OLD DRAINAGE. IMPRESSION/PLAN: ABDOMINAL PAIN; D/T PARTIAL SMALL BOWEL OBSTRUCTION W/ QUESTIONABLE HEMATOMA VS. ABSCESS. ADMITTED. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD. HISTORY AND PHYSICAL. HPI: POSTOP DAY 4 FROM UNDERGOING REPAIR OF VENTRAL HERNIA AND UMBILICAL HERNIA W/ MESH DONE IN OPEN FASHION. IMPRESSION/PLAN: NAUSEA, VOMITING AND OBSTIPATION S/P VENTRAL HERNIORRHAPHY W/ MESH, APPEARS TO BE RESOLVING. ON (B)(6) 2016: (B)(6) HOSPITAL. ON (B)(6), MD. DISCHARGE SUMMARY. NG-TUBE REMOVED, STARTED ON CLEAR LIQUID DIET, ADVANCED TO REGULAR. TODAY FOLLOWING REGULAR DIET, MOVING BOWELS, PASSING FLATUS, NO FURTHER NAUSEA, VOMITING, DENYING ABDOMINAL PAIN. INCISION CLEAN, DRY AND INTACT. D/C HOME. D/C DX: OBSTIPATION S/P VENTRAL HERNIORRHAPHY . ON (B)(6) 2016: (B)(6). TELEPHONE MESSAGE. PT CALLED STATING SHE THINKS HER STAPLES ARE INFECTED FROM RECENT VENTRAL HERNIA SURGERY W/ DR. (B)(6). PT FEELS LIKE ¿THE STAPLES CAME APART.¿ SHE STATED THAT THE INCISION SITE IS VERY RED AND THERE IS FLUID SEEPING OUT. I THEN ASKED HER IF HER SKIN WAS WARM TO TOUCH, PT STATED YED [SIC]. I ASKED ABOUT FEVERS, SHE STATED ¿TO THE BEST OF MY KNOWLEDGE I HAVE NOT HAD ONE.¿ I INFORMED PT IF SHE STILL WAS NOT FEELING WELL, SHE NEEDED TO GO BACK TO THE HOSPITAL TO BE SEEN. PT STATED SHE WOULD KEEP HER ORIGINAL P/O APPT ON (B)(6) W/ DR. ON (B)(6). ON (B)(6) 2016: (B)(6). OFFICE NOTES. STATES WENT TO ER ON (B)(6) D/T N/V. STATES WAS TOLD HAD BROKEN BLOOD VESSEL IN STOMACH. RELEASED ON (B)(6). STARTING TO HAVE A LOT OF DRAINAGE ON (B)(6), HAS A LOT OF RIGHT-SIDE PAIN, LOWER BACK AND UPPER INCISION SITE PAIN. PAIN SCALE 9/10, ABDOMEN. IMPRESSION/PLAN: S/P REPAIR VENTRAL HERNIA AND INCISIONAL HERNIA W/ MESH. NO EVIDENCE OF RECURRENCE. SOME SEROSANG DRAINAGE FROM INCISION (PT CONTINUES TO SMOKE). STAPLES D/C¿D, KEEP COVERED. RX AUGMENTIN 500 BID X 10 DAYS. F/U 1 WEEK. ON (B)(6) 2016: (B)(6). OFFICE NOTES. HPI: POSTOP, S/P VENTRAL HERNIA W/ MESH. PT REPORTING INCISION STILL DRAINING DAILY COVERING GAUZE PADS. MEDS: AUGMENTIN. IMPRESSION/PLAN: S/P OPEN VENTRAL HERNIORRHAPHY X 2 DEFECTS. DRAINAGE FROM UMBILICUS; NO EVIDENCE OF CELLULITIS. KEEP COVERED. RX KEFLEX X 2 WKS. F/U 1 WEEK. ON (B)(6) 2016: (B)(6). OFFICE NOTES. HPI: STILL LITTLE PAIN ABDOMINAL AREA, INCISION STILL DRAINING. MEDS: AUGMENTIN, KEFLEX. STILL HAVING DRAINAGE FROM NEAR UMBILICUS, DECREASING. KEEP COVERED. F/U 2 WEEKS. ON (B)(6) 2016: (B)(6). OFFICE NOTES. HPI: RECHECK OF HERNIA. ONSET OF HERNIA OCCURRING FOR 4 YEARS. HERNIA REPAIR W/ DR. (B)(6) APPROX. A MONTH AGO. STILL HAS PAIN, STATES HAS A SMALL HOLE IN ABDOMEN. DR. (B)(6) TOLD HER HE MAY HAVE TO REPAIR. SHE STATES WOUND IS SLOWLY CLOSING. PMH: CELLULITIS; OPEN WOUND, POST-SURGICAL NON-HEALING. ABDOMINAL HERNIA. EXAM: DRAINING WOUND ABDOMEN, CLEAN. IMPRESSION/PLAN: CELLULITIS; ANAEROBIC AND AEROBIC CULTURE. REFERRAL TO WOUND CLINIC. ON (B)(6) 2016: (B)(6) HOSPITAL. WOUND CULTURE. SPECIMEN: SKIN. GRAM STAIN: FEW WBC¿S SEEN. RARE GRAM-POSITIVE COCCI. FINAL: STAPHYLOCOCCUS AUREUS. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), DO. WOUND CLINIC NOTES. HX: S/P VENTRAL ABDOMINAL HERNIA W/ MESH. EXAM: UNREMARKABLE EXCEPT SEROUS DRAINAGE FROM UMBILICUS. ABDOMINAL WOUND MEASUREMENT 1.8 X 1.5 X 3 CM. IMPRESSION: S/P VENTRAL HERNIA REPAIR W/ MESH AND DISRUPTION OF SURGICAL WOUND. PLAN: RINSE ABDOMINAL SITE W/ STERILE SALINE 2-3 TIMES PER DAY. CULTURES WILL BE OBTAINED. F/U W/ DR. (B)(6). WILL APPLY AQUACEL AG TO DECREASE WOUND DRAINAGE. (B)(6) 2016: (B)(6) HOSPITAL. WOUND CULTURE. SPECIMEN: UMBILICUS. GRAM STAIN: RARE WBC¿S SEEN. FEW GRAM-NEGATIVE RODS. FINAL: MODERATE GROWTH ORGANISM: ESCHERICHIA COLI, SERRATIA MARCESCENS, ESCHERICHIA COLI MIC, SERRATIA MARCESCENS MIC. (B)(6) 2017: (B)(6)HOSPITAL. (B)(6), DO. WOUND CLINIC NOTES. ABDOMEN SOFT, SEROUS DRAINAGE FROM UMBILICAL INCISION. WOUND MEASURES 1.7 X 1 BUT DEPTH EXTENDS DEEP INTO SUBCUTANEOUS TISSUE PLANE. STATES HAS A FEW DAYS OF ANTIBIOTICS REMAINING AND APPOINTMENT W/ DR. (B)(6) TOMORROW. DRAINAGE IS NOT PURULENT AND HAS NO ODOR. IMPRESSION: ABDOMINAL WOUND, S/P VENTRAL HERNIA REPAIR W/ MESH. PLAN: I BELIEVE THE WOUND MOST LIKELY WILL NOT HEAL UNLESS MESH IS REMOVED. F/U W/ DR. (B)(6) TO DETERMINE WHETHER ADDITIONAL SURGERY IS RECOMMENDED AT THIS TIME. CONTINUE W/ AQUACEL AG AND GAUZE, DRESSING, CHANGE DAILY. (B)(6) 2017: (B)(6). OFFICE NOTES. HPI: PCP REFERRED HER TO WOUND CLINIC FOR SECOND OPINION. PT STATES WOUND CLINIC TOLD HER TO HAVE SURGERY AGAIN D/T MESH. PT STATES THE HOLE IN HER STOMACH IS GETTING DEEPER, HAVING DRAINAGE, AND SHARP PAIN. CLINIC PRESCRIBED HER BACTRIM. IMPRESSION/PLAN: STILL HAVING DRAINAGE NEAR UMBILICUS, HAS NOT CHANGED IN QUANTITY. THERE IS NO ERYTHEMA OR SIGN OF CELLULITIS. I OFFERED THE OPTIONS OF REMOVING THE MESH VS CONT TO OBSERVE. SHE IS CURRENTLY ON A COURSE OF BACTRIM RX BY (B)(6). PT WISHES TO WAIT AT THIS TIME. F/U 2 WEEKS. (B)(6) 2017: (B)(6). OFFICE NOTES. HPI: F/U VENTRAL HERNIA. INCISION STILL OPEN, NOT HAVING PAIN. CLEAR ODORLESS DRAINAGE. MEDS: BACTRIM. IMPRESSION/PLAN: SCHEDULE REMOVAL OF MESH W/ PRIMARY CLOSURE. ANCEF OCOR. (B)(6) 2017 (B)(6) HOSPITAL. MRSA SCREENING. SPECIMEN: NASAL. POSITIVE. STAPH AUREUS SCREENING: POSITIVE. (B)(6) 2017: (B)(6). [ILLEGIBLE]. ANESTHESIA RECORD. ASA 3, WT 88 KG. (B)(6) 2017: (B)(6). OPERATIVE REPORT. ANESTHESIA: GENERAL ENDOTRACHEAL. PROCEDURE: DRAINAGE OF ABDOMINAL WALL ABSCESS. REMOVAL OF VENTRAL HERNIA MESH. PRIMARY VENTRAL HERNIORRHAPHY. PRE/POSTOP DIAGNOSIS: INFECTED HERNIA MESH. INDICATION: ¿THIS IS A 34 YEAR OLD FEMALE WHO PREVIOUSLY HAD UNDERGONE A LAPAROSCOPIC CHOLECYSTECTOMY WITH THE GALLBLADDER REMOVAL SITE BEING PERIUMBILICAL WHO SUBSEQUENTLY DEVELOPED AN INCISIONAL HERNIA AT THIS SITE AND UNDERWENT A VENTRAL HERNIORRHAPHY WITH A GORE-TEX MESH. THE GORE-TEX MESH SUBSEQUENTLY GOT INFECTED AND, DESPITE ATTEMPTS AT ANTIBIOTIC TREATMENT, THE INFECTION DID NOT RESOLVE, SO THE PATIENT PRESENTS NOW FOR REMOVAL OF AN INFECTED HERNIA MESH.¿ FINDINGS: INFECTED HERNIA MESH WITH A SINUS TRACT JUST NEXT TO THE UMBILICUS AND A POCKET OF PUS SURROUNDING THE HERNIA MESH. SPECIMEN: SKIN, SOFT TISSUE, AND HERNIA MESH. SUMMARY: ¿THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM AND PLACED ON THE OPERATIVE TABLE IN THE SUPINE POSITION. AFTER GENERAL ANESTHESIA HAD BEEN ESTABLISHED, THE PATIENT¿S ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A SCALPEL WAS USED TO MAKE AN ELLIPTICAL INCISION AROUND THE SCAR, THE SINUS TRACT, AND THE UMBILICUS. ELECTROCAUTERY WAS USED TO TAKE THIS DOWN AROUND THE UMBILICUS DOWN TO THE LEVEL OF THE FASCIA UNTIL THE HERNIA MESH WAS IDENTIFIED. THE HERNIA MESH WAS THEN REMOVED WITH A COMBINATION OF ELECTROCAUTERY AND BLUNT DISSECTION. ALL THE GORE-TEX SUTURES WERE ALSO REMOVED. THERE WAS A DENSE LAYER JUST POSTERIOR TO THE HERNIA MESH KEEPING THE AREA SEPARATE FROM THE ABDOMEN. THIS WAS THEN IRRIGATED WITH 50:50 SALINE AND PEROXIDE MIX. ELECTROCAUTERY WAS USED FOR HEMOSTASIS. A JACKSON-PRATT DRAIN WAS THEN PLACED BETWEEN THIS LAYER AND THE FASCIA AND WAS EXITED JUST TO THE LEFT OF THE INCISION THROUGH A STAB WOUND. THE FASCIA WAS THEN CLOSED OVER TOP OF THE DRAIN WITH #2 FIGURE-OF-EIGHT SUTURES. THE SUBCUTANEOUS TISSUE WAS THEN IRRIGATED AND EXAMINED FOR HEMOSTASIS AND THE SKIN WAS CLOSED WITH STAPLES. A 2-0 NYLON DRAIN STITCH WAS PLACED AND STERILE DRESSINGS WERE APPLIED. ALL INSTRUMENT AND SPONGE COUNTS WERE REPORTED AS CORRECT. THE PATIENT WAS AWOKEN FROM ANESTHESIA WITHOUT INCIDENT AND TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.¿ (B)(6) 2017: (B)(6). CONSULTATION. REASON FOR CONSULT: MEDICAL MANAGEMENT, S/P DRAINAGE OF ABDOMINAL WALL ABSCESS W/ REMOVAL OF VENTRAL HERNIA MESH. HPI: PREVIOUSLY UNDERGONE LAPAROSCOPIC CHOLECYSTECTOMY, TO WHICH DEVELOPED INCISIONAL HERNIA, UNDERWENT VENTRAL HERNIORRHAPHY. FOUND TO HAVE INFECTED MESH DESPITE USE OF ANTIBIOTICS. INFECTION DID NOT RESOLVE AND RECOMMENDED SURGICAL INTERVENTION. PROCEDURE COMPLETED UNEVENTFULLY. RECOVERED ADEQUATELY POSTOP. IMPRESSION/PLAN: ABDOMINAL ABSCESS W/ INFECTED MESH-S/P DRAINAGE W/ MESH REMOVAL. PT WILL CONTINUE ON ANTIBIOTICS W/ LEVAQUIN, WILL ADD ADDITIONAL COVERAGE W/ FLAGYL. DIET ADVANCED PER SURGEON¿S RECOMMENDATIONS. (B)(6) 2017: (B)(6). OFFICE NOTES. CC: ABDOMEN MASS; STATES WHEN COUGHS WILL HAVE A SHARP PAIN AND WILL SEE SOME BULGING IN UPPER MIDDLE ABDOMEN AND LOWER LEFT QUADRANT, FEELS 2 BULGES. EXAM: W 88.8 KG (195 LB 12.8 OZ.). ABDOMINAL; SOFT, BOWEL SOUNDS NORMAL, EXHIBITS MASS (BULHES [SIC]-NO DEFINITE HERNIAS), NO TENDERNESS, NO GUARDING. REFERRAL GENERAL SURGERY. (B)(6) 2018: (B)(6). EMERGENCY DEPARTMENT. CC: FLANK PAIN, SENT FROM URGENT CARE W/ C/O FLANK PAIN, TENDER TO TOUCH. ONSET ONE WEEK AGO. HPI: ONE-WEEK HX OF RIGHT UPPER QUADRANT ABDOMINAL DISCOMFORT, RADIATES AROUND TO RIGHT FLANK. SEEN AT (B)(6) EARLIER TODAY, ADVISED TO COME TO EMERGENCY DEPARTMENT. SAW DR. (B)(6) YESTERDAY FOR F/U FOR HERNIA REPAIR, STATED EVERYTHING LOOKED GOOD, IT WAS HEALING WELL, NO DISCHARGE, HAS NOT HAD ANY FEVERS. REPORTS NAUSEA NOT VOMITING. MULTIPLE HERNIA REPAIRS ON HER ABDOMEN IN PAST. MEDS: MOMETASONE FURO FORMOTEROL FUM. EXAM: UNREMARKABLE EXCEPT TENDERNESS RIGHT UPPER QUADRANT, GUARDING. CT ABDOMEN/PELVIS SHOWS MODERATE INFLAMMATORY CHANGES W/ IN VENTRAL ABDOMINAL WALL WHICH IS NEW SINCE SURGERY WHICH THE RADIOLOGIST STATES IS LIKELY D/T VENTRAL HERNIA REPAIR W/ MESH. STABLE FOR D/C. F/U WITH PRIMARY CARE DOCTOR. IMPRESSION: NO DX FOUND. (B)(6) 2018: (B)(6). RADIOLOGY-CT ABDOMEN/PELVIS WITH CONTRAST. CLINICAL INFORMATION: RIGHT UPPER QUADRANT PAIN AND NAUSEA FOR ONE WEEK. FINDINGS: AT LEAST 2 MIDLINE UPPER VENTRAL ABDOMINAL WALL HERNIA CONTAINING FAT. THEY MEASURE UP TO 4.2 AND 5.2 CM IN SIZE EACH. THERE IS ASSOCIATED INDURATION OF SUBCUTANEOUS FAT IN THE VICINITY ADJACENT TO THE HERNIAS. ADDITIONAL DIFFUSE THICKENING AND SUBCUTANEOUS EDEMA INVOLVING THE VENTRAL ABDOMINAL WALL MUSCULATURE FASCIA PROBABLY POSTOPERATIVE IN ETIOLOGY. MODERATE PERIUMBILICAL. 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® PLUS 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

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    B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULT CODE. CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. RECORDS FOR THE LAPAROSCOPIC CHOLECYSTECTOMY IN 2011 WERE NOT PROVIDED. ULTRASOUND OF ABDOMEN RECORDS DATED (B)(6) 2011 STATE: ¿CLINICAL HISTORY: RIGHT UPPER QUADRANT PAIN. VOMITING. HISTORY OF HEPATITIS C. STATUS POST CHOLECYSTECTOMY.¿ RECORDS STATE: ¿IMPRESSION: L. STATUS POST CHOLECYSTECTOMY. 2. THERE ARE SOME APPARENT DILATED SMALL BOWEL SEGMENTS. THIS IS NON-SPECIFIC IN ETIOLOGY AND SIGNIFICANCE ON AN ULTRASOUND EXAMINATION. CORRELATE WITH THE CLINICAL FINDINGS IS RECOMMENDED. DEPENDING UPON THIS, FOLLOW-UP STUDIES MAY BE HELPFUL. 3. OTHERWISE, UNREMARKABLE EXAMINATION.¿ CT ABDOMEN DATED (B)(6) 2012 STATES: ¿IMPRESSION: 1.HEPATOMEGALY. 2. STATUS POST CHOLECYSTECTOMY. 3. DEFECT WITHIN THE ANTERIOR ABDOMINAL WALL CONSISTENT WITH A HERNIA. THE HERNIA CONTAINS OMENTAL FAT AS WELL AS A PORTION OF THE TRANSVERSE PORTION OF THE COLON. THERE IS NO EVIDENCE OF BOWEL WALL THICKENING OR OBSTRUCTION.¿ MEDICAL RECORDS DATED (B)(6) 2012 STATE: ¿CHIEF COMPLAINT: HERNIA¿ RECORDS STATE: ¿THIS PATIENT IS A 28-YEAR-OLD FEMALE WHO ORIGINALLY PRESENTED IN (B)(6) 2011 WITH A PAINFUL VENTRAL HERNIA WHILE PREGNANT. THE PATIENT RECENTLY DELIVERED AND HAS CONTINUED TO HAVE SYMPTOMATIC VENTRAL HERNIA. SHE REQUESTS SURGICAL REPAIR AT THIS TIME.¿ THE RECORDS STATE: ¿ABDOMEN: SOFT, NONDISTENDED. THERE IS A MODERATE SIZE TENDER BUT REDUCIBLE MIDLINE SUPRAUMBILICAL HERNIA PRESENT.¿ THE RECORDS ALSO STATE: ¿ASSESSMENT AND PLAN: THIS IS A 28-YEAR-OLD WITH KNOWN SYMPTOMATIC SUPRAUMBILICAL VENTRAL HERNIA. SHE IS TO UNDERGO OPERATIVE REPAIR AT THIS TIME.¿ RECORDS BETWEEN (B)(6) 2012 AND (B)(6) 2016, PERTAINING TO ABDOMINAL PROCEDURES, WERE NOT PROVIDED. CT ABDOMEN/PELVIS DATED (B)(6) 2016 STATES: ¿IMPRESSION: 1. THERE IS A ROUGHLY A 3CM VENTRAL WALL DEFECT ABOVE THE UMBILICUS IN THE MIDLINE WITH ASSOCIATED HERNIATED OMENTAL FAT. NO BOWEL ASSOCIATED. 2. STATUS POST CHOLECYSTECTOMY. 3. NO OTHER ACUTE PERI-INTRAABDOMINAL AND PELVIC FINDINGS SEEN.¿ OPERATIVE RECORDS DATED (B)(6) 2016 INDICATE THE PATIENT UNDERWENT VENTRAL HERNIORRHAPHY AND VENTRAL INCISIONAL HERNIORRHAPHY WITH MESH. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: VENTRAL HERNIA. THE RECORDS STATE: ¿PATIENT IS A 33-YEAR-OLD WHITE FEMALE WHO IS STATUS POST A PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY WHO HAD BEEN COMPLAINING OF A PAINFUL LUMP ABOVE HER UMBILICUS. HER LAPAROSCOPIC CHOLECYSTECTOMY SCAR WAS BELOW THE UMBILICUS. THE HERNIA WAS CONFIRMED ON CT SCAN.¿ OPERATIVE RECORDS DATED (B)(6) 2016 STATE: ¿FINDINGS: MODERATE-SIZED HERNIA ABOVE THE UMBILICUS AND SMALL INCISIONAL HERNIA BENEATH THE UMBILICUS.¿ THE RECORDS STATE: ¿A SCALPEL WAS USED TO MAKE A SMALL INCISION ABOVE THE UMBILICUS. ELECTROCAUTERY WAS USED TO CARRY THE INCISION DOWN TO THE HERNIA SAC. THE HERNIA SAC WAS DISSECTED DOWN AROUND ITS NECK AND THE HERNIA SAC WAS OPENED AT ITS NECK. IT WAS FOUND TO CONTAIN ONLY OMENTUM. A PORTION OF THE OMENTUM WAS SENT WITH THE SAC AND THE REST OF THE OMENTUM WAS REDUCED BACK INTO THE ABDOMEN AFTER BEING DIVIDED WITH THE LIGATURE.¿ OPERATIVE RECORDS DATED (B)(6) 2016 CONTINUE: ¿THE SURGEON'S FINGER WAS THEN PLACED BENEATH THE FASCIA TO BE SURE THAT THERE WERE NO ADHESIONS TO IT AND CHECKED FOR OTHER DEFECTS. THERE WAS A SECOND FASCIAL DEFECT NOTED JUST BENEATH THE UMBILICUS. THEREFORE, A SCALPEL WAS USED TO LENGTHEN THE INCISION INFERIORLY TO GO AROUND THE UMBILICUS TO APPROXIMATELY 3 CM INFERIOR TO THE UMBILICUS. ELECTROCAUTERY WAS USED TO CARRY THE INCISION DOWN TO THE FASCIA AND THE 2 FASCIAL DEFECTS WERE JOINED USING ELECTROCAUTERY INTO 1 LARGE DEFECT.¿ OPERATIVE RECORDS DATED (B)(6) 2016STATE: ¿THE DEFECT WAS 8 CM IN LENGTH. A GORE-TEX DUAL MESH PLUS WAS TRIMMED TO SIZE IN AN OVAL SHAPE SUCH THAT THERE WAS APPROXIMATELY 4 CM OF OVERLAP IN ALL DIRECTIONS AROUND THE DEFECT. INTERRUPTED GORE-TEX SUTURES WERE PLACED BACK FROM THE FASCIAL OPENING AND THE ENTIRE PERIPHERY OF THE HERNIA AND WAS SUTURED TO THE PERIPHERY OF THE DUAL MESH PLUS. THESE WERE TIED DOWN WITH THE DUAL MESH PLUS IN PLACE. THE AREA BETWEEN THE STITCHES WAS PROBED WITH THE SURGEON'S GLOVED FINGER TO BE SURE THAT THERE WAS NO HERNIATION OF FAT OR BOWEL BETWEEN THE STITCHES.¿ OPERATIVE RECORDS DATED (B)(6) 2016STATE: ¿THERE WAS NOT AND THERE WERE NO OPEN DEFECTS TO ALLOW AN INTERNAL HERNIA. THEREFORE, THE WOUND WAS COPIOUSLY IRRIGATED WITH SALINE AND #1 LOOPED PDS WAS USED TO REAPPROXIMATE THE FASCIA IN THE MIDLINE ON TOP OF THE MESH. THE WOUND WAS ONCE AGAIN IRRIGATED WITH SALINE. INTERRUPTED 3-0 VICRYL SUTURES WERE USED TO REAPPROXIMATE THE FAT SUCH AS TO ALLOW ANY DEAD SPACES, AND THE SKIN WAS CLOSED WITH STAPLES. STERILE DRESSINGS APPLIED.¿ THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/14385766) WAS USED DURING THE PROCEDURE. EMERGENCY ROOM RECORDS DATED (B)(6) 2016 STATE: ¿HAD HERNIA REPAIR 3 DAYS AGO, YESTERDAY BEGAN WITH VOMITING, UNABLE TO EAT/DRINK.¿ CT ABDOMEN/PELVIS DATED (B)(6) 2016 STATES: ¿CLINICAL HISTORY: MID ABDOMINAL AND PELVIS PAIN AND DISTENTION. RECENT ABDOMINAL HERNIORRHAPHY.¿ THE RECORDS ALSO STATE: ¿FINDINGS: POSTSURGICAL SEQUELA FROM RECENT ABDOMINAL HERNIORRAPHY INCLUDES FLUID COLLECTIONS AND SMALL COLLECTION OF GAS IN THE SUBCUTANEOUS TISSUES DEEP TO SURGICAL SKIN CLOSURE STAPLES, THE MORE INFERIOR COLLECTIONS MEASURING 24 X 37 MM, THE MORE SUPERIOR SUPERFICIAL COLLECTION MEASURING 39 X 41 MM. MULTIFOCAL DILATED SMALL BOWEL LOOPS ARE DEMONSTRATED WITH TRANSITION IN THE RIGHT MID PELVIS PROBABLY AT THE DISTAL ILEUM.¿ CT ABDOMEN/PELVIS DATED (B)(6) 2016 STATES: ¿THE TERMINAL ILEUM AND COLON ARE DECOMPRESSED. NO PNEUMOPERITONEUM IS SEEN. THE UTERUS AND ADNEXAL STRUCTURES ARE UNREMARKABLE WITHIN THE PELVIS. URINARY BLADDER IS DECOMPRESSED. THE LIVER, SPLEEN, ADRENAL GLANDS, PANCREAS, AORTA, INFERIOR VENA CAVA AND KIDNEYS APPEAR UNREMARKABLE. NO ABDOMINAL OR PELVIC ADENOPATHY OR FREE FLUID IS SEEN. THERE ARE FEW DIVERTICULA INVOLVING THE SIGMOID COLON. ¿IMPRESSION: 1. RECENT VENTRAL HERNIORRHAPHY WITH SUBCUTANEOUS FLUID COLLECTIONS AND GAS WHICH MAY BE POSTSURGICAL SEROMA/HEMATOMA OR ABSCESS. CORRELATE AS TO WHEN THE SURGERY WAS PERFORMED. CORRELATE WITH PHYSICAL FINDINGS AT THE SURGICAL SITE. 2. PROBABLE PARTIAL SMALL BOWEL OBSTRUCTION WITH APPARENT TRANSITION AT THE DISTAL ILEUM LIKELY RELATED TO ADHESIONS. THE TERMINAL ILEUM AND COLON ARE DECOMPRESSED. GASTRIC DECOMPRESSION BY NG TUBE PLACEMENT IS LIKELY INDICATED.3. BIBASILAR SUBSEGMENTAL ATELECTASIS. 4. CHOLECYSTECTOMY.¿ SURGICAL RECORDS DATED (B)(6) 2017 INDICATE THE PATIENT UNDERWENT REMOVAL OF HERNIA MESH WITH PRIMARY VENTRAL HERNIORRHAPHY. CLINICAL/PREOPERATIVE DIAGNOSIS ¿DRAINAGE¿. OPERATIVE RECORDS DETAILING THE (B)(6) 2017 PROCEDURE WERE NOT PROVIDED. SURGICAL RECORDS DATED (B)(6) 2017STATE: ¿SPECIMENS RECEIVED - SKIN, SOFT TISSUE AND MESH. GROSS DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN, AND LABELED "SKIN SOFT TISSUE AND MESH" WITH PATIENT'S NAME AND SECOND IDENTIFIER. THE SPECIMEN CONSISTS OF TWO FRAGMENTS OF PINK TAN SOFT TISSUE, ONE OF WHICH CONTAINS SKIN MEASURING 7 X 3 X 2 CM AND 5 X 4.5 X 3CM. ALSO INCLUDED IS A SYNTHETIC MESH MEASURING 7 X 3 X 1CM. SECTIONING REVEALS GROSSLY UNREMARKABLE TISSUE. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES.¿ PATHOLOGY RECORDS FOR THE SPECIMEN DATED (B)(6) 2017WERE NOT PROVIDED. MEDICAL RECORDS STATE: ¿MRSA SCREENING DATED (B)(6) 2017 STATES: POSITIVE.¿ CT ABDOMEN/PELVIS DATED (B)(6) 2017 STATES: ¿IMPRESSION: 1. ANTERIOR ABDOMINAL WALL HERNIA WITH EVIDENCE OF INTERVAL SURGERY. LOW-DENSITY FLUID AT THE SURGICAL SITE IS PROBABLY DUE TO A POST-OPERATIVE SEROMA ALTHOUGH A SMALL ABSCESS AT THIS LOCATION CANNOT BE EXCLUDED BASED ON THIS EXAMINATION ALONE. CLINICAL CORRELATION IS REQUIRED.2. RIGHT MIDDLE LOBE AND LINGULAR ATELECTASIS. 3. HEPATIC STEATOSIS. 4. STATUS POST CHOLECYSTECTOMY. 5. DIVERTICULOSIS BUT NO EVIDENCE OF DIVERTICULITIS. OPERATIVE REPORT DATED (B)(6) 2017 INDICATES THE PATIENT UNDERWENT 1. OPEN REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. 2. BILATERAL MYOFASCIAL FLAP CLOSURE (COMPONENT SEPARATION), BILATERAL. 3. IMPLANT BIOLOGICAL MESH FOR REINFORCEMENT OF THE ABDOMINAL CLOSURE. THE RECORDS STATE PREOPERATIVE/POSTOPERATIVE DIAGNOSIS ¿1. RECURRENT INCARCERATED INCISIONAL HERNIA. 2. HISTORY OF PREVIOUS MESH INFECTION REQUIRING EXPLANTATION.¿ OPERATIVE RECORDS DATED (B)(6) 2017 STATE: ¿PATIENT IS A 34-YEAR-OLD FEMALE WHO PRESENTED TO THE OFFICE FOR EVALUATION OF AN INCISIONAL HERNIA. SHE HAD A PREVIOUS CHOLECYSTECTOMY FOLLOWED BY AN INCISIONAL HERNIA REPAIR. SHE SUBSEQUENTLY DEVELOPED A MESH INFECTION REQUIRING MESH EXPLANTATION. SHE HAS HAD PERSISTENT ABDOMINAL PAIN SINCE THAT TIME, AND NOW PRESENTED FOR EVALUATION FOR POSSIBLE HERNIA. HER SURGERIES WERE DONE BY AN OUTSIDE SURGEON IN THE HOSPITAL. I OBTAINED A CAT SCAN TO DEFINE HER ANATOMY AND SHE DID HAVE A LARGE MIDLINE VENTRAL HERNIA COMPLEX IN NATURE WITH LOSS OF DOMAIN. AS SUCH, I MET WITH HER AND DISCUSSED PROCEEDING WITH A COMPONENT SEPARATION WITH POSSIBLE BIOLOGIC MESH IMPLANTATION. WE DISCUSSED DETAILS OF THE PROCEDURE, RATIONALE, POTENTIAL RISKS AND BENEFITS, AND SHE WAS AGREEABLE TO PROCEED.¿ OPERATIVE RECORDS DATED (B)(6) 2017 STATE: ¿A MIDLINE LAPAROTOMY INCISION WAS MADE AND I EXCISED THE PATIENT'S PREVIOUS MIDLINE SCAR USING A #10 BLADE SCALPEL. I DISSECTED THROUGH THE SUBCUTANEOUS TISSUE USING ELECTROCAUTERY. I CAME DOWN TO THE LEVEL OF THE PATIENT'S HERNIA DEFECT AND HERNIA SAC. I BLUNTLY DISSECTED THE SURROUNDING SUBCUTANEOUS TISSUE OFF THE HERNIA SAC. ULTIMATELY THEN, AT THE SUPERIOR ASPECT I OPENED THE HERNIA SAC SHARPLY USING METZENBAUM SCISSORS. THERE WERE OMENTAL ADHESIONS TO THE INNER ASPECT OF THIS HERNIA SAC. THESE WERE ALL TAKEN DOWN USING ELECTROCAUTERY.¿ OPERATIVE RECORDS DATED (B)(6) 2017 STATE: ¿THE PERITONEAL CAVITY WAS ACTUALLY RELATIVELY FREE OF ADHESIONS. ULTIMATELY, I WAS ABLE TO COMPLETELY DISSECT OUT THE PATIENT'S HERNIA SAC BACK TO THE LEVEL OF THE ABDOMINAL MUSCULATURE AND FASCIA. ALL THE INTERNAL ADHESIONS HAD BEEN LYSED USING ELECTROCAUTERY AND BLUNT DISSECTION. IT WAS AT THIS POINT THAT I COMPLETELY EXCISED THE OVERLYING HERNIA SAC AND SUBCUTANEOUS TISSUE. SHE DID HAVE 1 AREA OF THICK CHRONIC SCARRED TISSUE IN THE CENTRAL PORTION OF THE INCISION AND THIS WAS EXCISED AS WELL. THE HERNIA SAC WAS THEN SENT OFF AS A SPECIMEN. THE SUPERIOR AND INFERIOR ASPECT OF THE INCISION WERE THEN GRASPED USING KOCHER'S.¿ OPERATIVE RECORDS DATED (B)(6) 2017 STATE: ¿THE HERNIA DEFECT WAS MEASURED TO BE 15 CM IN LENGTH. THERE WAS STILL TENSION IN ORDER TO CLOSE THE FASCIA IN THE MIDLINE, AND SO THEN I PROCEEDED WITH MY BILATERAL COMPONENT SEPARATION. ON BOTH THE LEFT AND RIGHT SIDE OF THE ABDOMINAL WALL, THE UNDERLYING FASCIA WAS DISSECTED FREE FROM THE OVERLYING SKIN AND SUBCUTANEOUS TISSUE. THIS WAS TAKEN OUT WELL LATERALLY BEYOND TO THE LEVEL OF THE ASIS BEYOND THE EDGE OF THE RECTUS MUSCLE. THIS WAS DONE ON BOTH SIDES, AND THEN I CHOSE A POINT TO PERFORM THE FASCIAL RELEASE LATERAL TO THE RECTUS MUSCLES. AN INCISION WAS MADE THROUGH THE FASCIA USING ELECTROCAUTERY AND THEN THIS WAS EXTENDED FROM THE LEVEL FROM THE INFERIOR ASPECT OF THE RIBS ALL THE WAY DOWN TO THE LEVEL OF THE ASIS DIVIDING THE FASCIA TO ALLOW FOR REAPPROXIMATION IN THE MIDLINE.¿ OPERATIVE RECORDS DATED (B)(6) 2017 CONTINUE: ¿WHEN BOTH SIDES WERE RELEASED USING ELECTROCAUTERY, THIS GAVE ME SEVERAL CENTIMETERS OF REAPPROXIMATION IN THE MIDLINE AND I FELT COMFORTABLE NOW AT THIS POINT THAT I WOULD BE ABLE TO CLOSE THE MIDLINE FASCIA WITHOUT EXCESS TENSION. IT WAS AT THIS POINT THEN THAT THE XENMATRIX GRAFT WAS BROUGHT INTO THE FIELD. IT MEASURED 19 X 28 CM. IT WAS CUT DOWN TO THE APPROPRIATE LENGTH TO HAVE AT LEAST 3 CM OF OVERLAP BETWEEN THE EDGES OF THE FASCIAL DEFECT AND THE MESH. THE MESH WAS THEN PLACED INTO THE ABDOMINAL CAVITY AND IT WAS CIRCUMFERENTIALLY TACKED TO THE ABDOMINAL WALL. THIS WAS DONE BY PLACING #1 PROLENE SUTURES FULL-THICKNESS THROUGH THE ABDOMINAL WALL AND TACKING IT TO THE XENMATRIX MESH.¿ OPERATIVE RECORDS DATED (B)(6) 2017 STATE: ¿INTERRUPTED SUTURES WERE PLACED, AND ONCE THEY WERE ALL PLACED, THEY WERE SEQUENTIALLY TIED DOWN. THIS ALLOWED THE MESH TO LAY VERY NICELY IN THE HERNIA DEFECT AND THERE WERE NO SPACES BETWEEN SUTURES WHERE ABDOMINAL CONTENTS WOULD BE ABLE TO SNEAK BETWEEN THE ABDOMINAL WALL AND THE MESH. OVERALL, I WAS EXTREMELY HAPPY WITH HOW THE MESH LAID. FOLLOWING THIS POINT, THE MIDLINE FASCIA DEFECT WAS THEN CLOSED USING INTERRUPTED #1 PROLENE SUTURES PLACED IN A FIGURE-OF-EIGHT FASHION. ONCE ALL THESE WERE PLACED, THEY WERE SEQUENTIALLY TIED DOWN. TWO STAB INCISIONS WERE THEN MADE IN THE LOWER QUADRANTS OF THE ABDOMEN AND 10 MM FLAT JACKSON-PRATT DRAINS WERE BROUGHT OUT THROUGH THESE SITES. THE DRAINS WERE CROSSING IN THE MIDLINE SO THAT THE DRAIN EXITING ON THE LEFT LAID IN THE RIGHT GUTTER AND THE DRAIN EXITING ON THE RIGHT LAID IN THE LEFT GUTTER.¿ OPERATIVE RECORDS DATED (B)(6) 2017 STATE: ¿THEY WERE SECURED IN PLACE USING 2-0 NYLON SUTURE. EVERYTHING WAS RENDERED HEMOSTATIC. THE SUBCUTANEOUS TISSUE WAS THEN REAPPROXIMATED USING 3-0 VICRYL SUTURES AND THE MIDLINE INCISION WAS CLOSED USING SKIN STAPLES. COUNTS HAD BEEN CORRECT X3 PRIOR TO THE COMPLETION OF THE PROCEDURE. SHE TOLERATED THE PROCEDURE WELL WITHOUT ANY APPARENT COMPLICATIONS. STERILE DRESSINGS WERE PLACED.¿ RECORDS CONFIRM A NON GORE DEVICE WAS USED DURING THE PROCEDURE. PATHOLOGY RECORDS DATED (B)(6) 2017 FOR SPECIMEN OBTAINED DURING PROCEDURE ON 7/20/2017 STATES: ¿SOURCE-HERNIA SAC. DIAGNOSIS- SEROSAL-LINED FIBROADIPOSE TISSUE, CONSISTENT WITH HERNIA SAC. GROSS DESCRIPTION:RECEIVED IN FORMALIN LABELED "HERNIA SAC" IS A PORTION OF SEROSAL-LINED FIBROADIPOSE TISSUE WHICH MEASURES APPROXIMATELY 29 X 6 X 4 CM. THE SPECIMEN IS SERIALLY SECTIONED. NO DISTINCT NODULES OR MASS LESIONS ARE IDENTIFIED. REPRESENTATIVE SECTIONS ARE SUBMITTED IN 2 CASSETTES.¿ MEDICAL RECORDS DATED (B)(6) 2017 STATE: ¿[PATIENT] IS A 34-YEAR-OLD FEMALE PATIENT WHO WAS JUST RECENTLY DISCHARGED FROM THE HOSPITAL AFTER UNDERGOING AN OPEN REPAIR OF A RECURRENT INCARCERATED INCISIONAL HERNIA WITH A BILATERAL MYOFASCIAL FLAP CLOSURE AND IMPLANTATION OF BIOLOGICAL MESH FOR REINFORCEMENT OF THE ABDOMINAL CLOSURE. THE PATIENT STATES THAT SHE WENT HOME AND WAS DOING FAIRLY WELL BUT ON SATURDAY DEVELOPED SOME NAUSEA AND VOMITING, AND THEN ON SUNDAY DEVELOPED SOME DIARRHEA. THE PATIENT STATES SHE DID NOT TAKE HER TEMPERATURE ALTHOUGH SHE DID FEEL FEVERISH TO HERSELF. SHE HAS HAD ABDOMINAL PAIN. SHE STATES THAT IT WAS A 10/10 AT ITS WORST AND IS CURRENTLY 7/10 WITH MEDICATIONS. THE PATIENT ALSO HAS A HISTORY OF ASTHMA AND STATES THAT SHE IS HAVING AN EXACERBATION OF THIS ASTHMA AND HAS BEEN SHORT OF BREATH FOR SOME TIME.¿ MEDICAL RECORDS DATED (B)(6) 2017ALSO STATE: ¿¿CAME IN WITH PROGRESSIVELY WORSENING SHORTNESS OF BREATH FOR 2 DAYS ASSOCIATED WITH THE MILD WHEEZING. SHE DENIES ANY COUGH, ABDOMINAL PAIN BUT COMPLAINTS OF VOMITINGS [SIC] NAUSEA AND DIARRHEA. SHE DESCRIBES DIARRHEA AS LOOSE STOOLS. SHE DENIES ANY FEVER, LEG SWELLING, CHEST PAIN, HEADACHE, BLURRY VISION, BLEEDING. WHEN SHE CAME TO EMERGENCY ROOM CT OF THE CHEST DID NOT SHOW ANY ACUTE PE BUT SHOWED POSSIBLE SMALL BOWEL OBSTRUCTION/ILEUS.¿ KUB AD UPRIGHT KUB RECORDS DATED (B)(6) 2017STATE: ¿34-YEAR-OLD FEMALE WITH ABDOMINAL PAIN AND DIARRHEA STATUS POST HERNIORRHAPHY FIVE DAYS AGO.¿ ¿FINDINGS: THERE ARE LINEAR DENSITIES AT THE LUNG BASES. THERE IS BLUNTING OF THE LEFT COSTOPHRENIC SULCUS. BOWEL GAS IS SEEN THROUGHOUT THE COLON HOWEVER THERE ARE MULTIPLE DILATED LOOPS OF SMALL BOWEL CENTRALLY NO DEFINITE FREE PERITONEAL AIR ALTHOUGH THERE ARE MULTIPLE AIR-FLUID LEVELS WITHIN THE DILATED SMALL BOWEL. NO OBVIOUS ABDOMINAL MASSES OR ORGANOMEGALY. THERE ARE JP DRAINS OVERLYING THE RIGHT AND LEFT LATERAL ABDOMEN. THERE ARE SURGICAL CLIPS IN THE RIGHT UPPER QUADRANT. THERE ARE MIDLINE SKIN STAPLES. IMPRESSION 1. LIEUS VERSUS PARTIAL SMALL BOWEL OBSTRUCTION. 2. BILATERAL LOWER LOBE ATELECTASIS AND SMALL LEFT PLEURAL EFFUSION. 3. EVIDENCE OF RECENT ABDOMINAL SURGERY.¿ DISCHARGE DIAGNOSIS (B)(6) 2017 STATES: ¿INTESTINAL OBSTRUCTION, PARALYTIC LIEUS [SIC], DETAILS PRESENT ON ADMIT-YES, CLINICAL STATUS NEW, PLAN PT[PATIENT] LEAVING AMA BECAUSE SHE IS UPSET GS DOES NOT WANT TO GIVE HER A DIET TODAY- KUB THIS MORNING STILL SHOWING ILEUS VS SBO, PT [PATIENT] STATES SHE IS PASSING GAS AND MOVING HER BOWELS- NO BM HAS BEEN WITNESSED. GS AWARE OF PT [PATIENT] WANTING TO LEAVE AMA AND STATES THEY HAVE HAD COMPLIANCE ISSUES WITH HER IN THE PAST, THEIR POC IS NOT CHANGING, NO DIET TODAY PT WISHES TO LEAVE. NURSING EDU[CATE] PT [PATIENT ]ON JP DRAINS INTACT TO HER ABDOMEN FROM RECENT HERNIA REPAIR SURGERY- TO FOLLOW UP WITH DR. (B)(6) IN THE OFFICE.¿ OPERATIVE RECORDS DATED (B)(6) 2018 INDICATE THE PATIENT UNDERWENT 1. DEBRIDEMENT OF ABDOMINAL WALL 7 X 10 CM. 2. EXCISION OF SUTURE GRANULOMAS X 2. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS ¿SUTURE GRANULOMAS, CHRONIC ABDOMINAL WOUND.¿ OPERATIVE RECORDS DATED (B)(6) 2018 STATE: ¿PATIENT IS A 35- YEAR- OLD FEMALE KNOWN TO ME FROM A PREVIOUS COMPONENT SEPARATION WITH PLACEMENT OF A BIOLOGIC MESH. SHE HAD A POSTOPERATIVE SEROMA THAT REQUIRED SECONDARY INTENTION HEALING. SHE HAS HAD A PERSISTENT OPEN AREA OF THE ABDOMINAL WALL THAT HAS FAILED TO HEAL. ADDITIONALLY, SHE RECENTLY PRESENTED FOR KNOTS IN THE ABDOMINAL WALL THAT ARE PAINFUL. THESE ARE FELT TO BE CONSISTENT WITH SUTURE GRANULOMA. I RECOMMENDED EXCISION AND ALSO BECAUSE OF THE CHRONIC ABDOMINAL WOUND, RECOMMENDED EXPLORATION AND DEBRIDEMENT OF THIS.¿ OPERATIVE RECORDS DATED (B)(6) 2018 STATE: ¿MADE AN ELLIPTICAL INCISION OVER THE PALPABLE SUTURE GRANULOMA, DISSECTED THROUGH THE SUBCUTANEOUS TISSUE USING ELECTROCAUTERY. THIS WAS INDEED AREA OF CHRONIC INDURATION AND INFLAMMATION AND FIBROSIS SECONDARY TO AN UNDERLYING SUTURE. THE SUTURES WERE REMOVED. THIS WOUND WAS PACKED. THERE IS A MORE INFERIOR AND MEDIAL SUTURE GRANULOMA IN A LIKEWISE FASHION. THE SKIN OVER LYING IS EXCISED USING A 15 BLADE AN ELLIPSE DISSECTED DOWN THROUGH THE SUBCUTANEOUS TISSUE EXCISING OUT THIS GRANULOMA AND THERE IS A SUTURE ENCOUNTERED IN THIS SITE. THIS WOUND IS THEN PACKED. ATTENTION WAS THEN TURNED TO THE MIDLINE ABDOMINAL WALL. I EXCISED AN ELLIPSE OF SKIN, 10 CM IN LENGTH FROM THIS SITE AND THEN BEGAN DISSECTING DOWN THROUGH THE SUBCUTANEOUS TISSUE.¿ OPERATIVE RECORDS DATED (B)(6) 2018 STATE: ¿FOLLOWING THE TRACT, IT WAS PROBED. THERE IS CHRONIC INDURATION ALL ALONG THE MIDLINE AND EXCISING THE CHRONICALLY INDURATED TISSUE. MULTIPLE MIDLINE SUTURES WERE IDENTIFIED. THESE WERE ALL REMOVED. UNFORTUNATELY, THIS WOUND IS FOUND TO TRACK SIGNIFICANTLY TO THE LEFT LATERAL ASPECT WHERE A LARGE SEROMA CAVITY IS IN COUNTERED. IT IS EVACUATED. CHRONIC GRANULATION TISSUE IS REMOVED AS WELL AS MULTIPLE SUTURES FROM THIS SITE. ALONG THE RIGHT SIDE OF THE ABDOMEN, THE TRACT IS MUCH SHORTER AND IT TERMINATES AT A AGAIN, SUTURE. ALL OF THE SUTURE MATERIAL IS IDENTIFIED, IT REMOVED. I REMOVED THE ABDOMINAL WALL AND CHRONIC INDURATED TISSUE AND INFLAMMATION AND FIBROSIS FROM THE ABDOMINAL WALL WITH AN AREA MEASURING 7 X 10 CM. EVERYTHING WAS RENDERED HEMOSTATIC. THIS WOUND WAS THEN PACKED WITH A SALINE MOISTENED KERLIX ROLL AND THE 2 SUTURE GRANULOMA SITES ARE CLOSED USING SKIN STAPLES.¿ PATHOLOGY RECORDS DATED (B)(6) 2018 FOR SPECIMEN OBTAINED DURING (B)(6) 2018 PROCEDURE STATE: ¿SOURCE: A. SOFT TISSUE DEBRIDEMENT, SUTURE GRANULOMA B. SOFT TISSUE DEBRIDEMENT, SECOND SUTURE GRANULOMA C. SOFT TISSUE DEBRIDEMENT, CHRONIC ABDOMINAL WOUND. CLINICAL HISTORY:ABDOMINAL WOUND CHRONIC¿ GROSS DESCRIPTION: A. ¿THE SPECIMEN RECEIVED IN FORMALIN LABELED "SUTURE GRANULOMA" IS A PORTION OF SKIN AND UNDERLYING SOFT TISSUE WHICH MEASURES 4 X 4 X 2 CM. THERE ARE ALSO SEVERAL DETACHED FRAGMENTS OF ADIPOSE TISSUE WHICH AGGREGATE TO 5.5 X 3.5 X 2.0 CM. THERE IS ALSO A PORTION OF BLUE SUTURE-LIKE MATERIAL WHICH MEASURES 2.5 CM IN GREATEST DIMENSION. THE SPECIMEN IS SECTIONED, AND REPRESENTATIVE SECTIONS ARE SUBMITTED IN CASSETTE AL.¿ B. ¿THE SPECIMEN RECEIVED IN FORMALIN LABELED "SECOND SUTURE GRANULOMA" IS A PORTION OF SKIN AND UNDERLYING SOFT TISSUE WHICH MEASURES 3.5 X 3.0 X 2.0 CM. THERE IS A DETACHED SUTURE WHICH MEASURES APPROXIMATELY 4.5 CM IN GREATEST DIMENSION. THE SPECIMEN IS SERIALLY SECTIONED AND TO REVEAL A PREDOMINANTLY FATTY CUT SURFACE WITH FOCAL AREAS OF FIBROSIS. A REPRESENTATIVE SECTION IS SUBMITTED IN CASSETTE B 1.¿ C. ¿THE SPECIMEN RECEIVED IN FORMALIN LABELED "CHRONIC ABDOMINAL WOUND" IS A SEGMENT OF SKIN AND UNDERLYING SOFT TISSUE WHICH MEASURES 6.8 X 3.0 X 3.5 CM. THERE ARE ALSO MULTIPLE DETACHED FRAGMENTS OF SOFT TISSUE AND SUTURE MATERIAL WHICH AGGREGATE TO 6.5 X 4.0 X 2.0 CM. THE SPECIMENS ARE SECTIONED TO REVEAL A FATTY CUT SURFACE WITH MULTIPLE AREAS OF ERYTHEMA AND DEGENERATIVE-APPEARING SON TISSUE. REPRESENTATIVE SECTIONS ARE SUBMITTED IN CASSETTE CL.¿ 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® PLUS 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    (B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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". THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL".

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2016, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, INFECTION, ADDITIONAL SURGERY, ABDOMINAL WALL ABSCESS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162945 GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES 1DLMCP04 14385766 00733132601110

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R