GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL
Report
- Report Number
- 3003910212-2020-01100
- Event Type
- Injury
- Date Received
- September 28, 2020
- Date of Event
- September 29, 2017
- Report Date
- May 4, 2023
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- FTL
- UDI-DI
- 00733132635368
- PMA / PMN Number
- K152609
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
H6: CONCLUSION CODE REMAINS UNCHANGED. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RELEVANT MEDICAL INFORMATION: (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. EMERGENCY ROOM VISIT. HISTORY OF UTI, COMPLAINT OF DYSURIA, FREQUENCY, NAUSEA, VOMITING, DIARRHEA. WAS STARTED ON MACROBID APPROXIMATELY ONE WEEK AGO, HAD 2 BACTERIA IN URINE, STATES SHE STOPPED IT 4 DAYS AGO BECAUSE OF NAUSEA, SHE THEN RESUMED IT, AND AGAIN HAD NAUSEA WITH SOME DIARRHEA. IS URINATING FREQUENTLY, SMALL AMOUNTS. WAS TOLD TO FOLLOW UP WITH OB/GYN SECONDARY TO CONCERN FOR BLADDER PROLAPSE. SCHEDULED HERNIA SURGERY FOR AUGUST OF THIS YEAR. TRYING TO TAKE PROBIOTICS AS WELL AS HER USUAL PREVACID, BUT ANTIBIOTICS ARE TEARING UP HER STOMACH. DRINKING DECREASED AMOUNTS SECONDARY TO INTOLERANCE BY MOUTH. STATES SHE DOES NOT TOLERATE CIPRO OR SULFA DRUGS. HISTORY OF GALLBLADDER REMOVAL (B)(6) 2005, HYSTERECTOMY (B)(6) 1979, GASTROESOPHAGEAL REFLUX DISEASE, HYPERTENSION, HERNIA. FORMER SMOKER, QUIT AUGUST 2014 USING E-CIG. EXAM: WT 71.82 KG. GASTROINTESTINAL; SOFT, NONDISTENDED, MILD DIFFUSE LOWER DULL TENDERNESS TO PALPATION WITHOUT REBOUND, GUARDING OR MASSES. IMPRESSION/PLAN: URINALYSIS DOES NOT REVEAL URINARY TRACT INFECTION AT PRESENT. NAUSEA AND VOMITING, DIARRHEA, MEDICATION REACTION. CONTINUE PROBIOTIC, DRINK PLENTY OF FLUIDS, CONTINUE OMEPRAZOLE, USE MAALOX OR MYLANTA. IMPROVED, STABLE. DISCHARGED HOME. (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. HISTORY AND PHYSICAL. HAD LAPAROSCOPIC CONVERTED TO OPEN CHOLECYSTECTOMY APPROXIMATELY 9 YEARS AGO. THE CIRCUMSTANCES OF SURGERY AND WHY IT WAS CONVERTED TO OPEN ARE UNKNOWN TO HER, CAUSING HER MUCH DISTRESS. SIX MONTHS AGO NOTICED PAIN AND BULGING IN AREA OF MIDLINE INCISION. AREA REMAINED SOFT BUT DOES HAVE NAUSEA AND OCCASIONAL DIARRHEA. HISTORY: GALLBLADDER REMOVED (B)(6) 2005, HYSTERECTOMY (B)(6) 1979. EXAM: GASTROINTESTINAL; SOFT, NON-DISTENDED, WELL-HEALED LAPAROSCOPIC INCISIONS BARELY VISIBLE, WELL-HEALED 8 CM VERTICAL MIDLINE INCISION, FASCIAL DEFECT FELT AT SUPERIOR PORTION OF THE INCISION, SOME BULGING AND TENDERNESS TO PALPATION LATERAL TO INFERIOR PORTION OF THE INCISION. IMPRESSION/PLAN: PAINFUL VENTRAL INCISIONAL HERNIA. ADVISED OF RISKS, POSSIBLE COMPLICATIONS, AND OUTCOMES OF BOTH LAPAROSCOPIC AND OPEN REPAIRS, DISCUSSED AT LENGTH. PATIENT DESIRES OPEN OPERATION. IMPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, LEFT SIDED TRANSVERSUS ABDOMINIS RELEASE WITH MYOFASCIAL ADVANCEMENT, RIGHT-SIDED PERITONEAL DISSECTION WITH REPAIR OF VENTRAL HERNIA WITH MESH, INCARCERATED HERNIA WITH MESH. IMPLANT: GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL [GKFR2030/15310273, 20X30X0.5CM]. IMPLANT DATE: (B)(6) 2016 (HOSPITALIZATION (B)(6) 2016) (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: VENTRAL HERNIA. POSTOPERATIVE DIAGNOSIS: VENTRAL HERNIA. PROCEDURE PERFORMED: EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, LEFT SIDED TRANSVERSUS ABDOMINIS RELEASE WITH MYOFASCIAL ADVANCEMENT, RIGHT-SIDED PERITONEAL DISSECTION WITH REPAIR OF VENTRAL HERNIA WITH MESH, INCARCERATED HERNIA WITH MESH. ASSISTANT: DR. (B)(6). COMPLICATIONS: NONE. SPECIMENS: NONE. INDICATION FOR PROCEDURE: THE PATIENT PRESENTS WITH A SYMPTOMATIC VENTRAL HERNIA. I HAD A DETAILED CONVERSATION WITH THE PATIENT CONCERNING HER MEDICAL AND SURGICAL OPTIONS, THE RISKS, THE POSSIBLE COMPLICATIONS AND POSSIBLE OUTCOMES. SHE WANTED TO PROCEED WITH SURGERY. WE DISCUSSED IN DETAIL THE SURGICAL OPTIONS AND SHE CHOSE THE DAY OF SURGERY TO HAVE IT DONE OPEN. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED IN SUPINE POSITION ON THE OPERATING TABLE. AFTER GENERAL ENDOTRACHEAL ANESTHESIA WAS ESTABLISHED, SHE WAS PREPPED AND DRAPED IN STERILE FASHION. AN INCISION THROUGH HER OLD INCISION ENCOMPASSING PORTIONS OF HER WIDE SCAR WERE TAKEN DOWN SHARPLY THROUGH THE SKIN AND SUBCUTANEOUS TISSUES. I OPENED THE HERNIA SAC AND WALKED UPWARD AS I OPENED THE NUMEROUS HERNIAS COMPLETELY. THROUGHOUT HER INCISION, SHE HAD 6 HERNIAS, WHICH COMBINED TOGETHER MEASURED 14 X 9 CM. THERE WAS TENSION ON THIS ONCE I CLEARED THE FASCIAL EDGES OF STRETCHED OUT AND THINNED FASCIA. I BEGAN BY TAKING DOWN THE PERITONEUM ON THE PATIENT¿S RIGHT SIDE, CONSIDERING THAT WE WOULD ONLY NEED ONE SIDE FOR COMPONENT SEPARATION TO GET HER BACK TOGETHER AGAIN. THE PERITONEUM CAME DOWN BEAUTIFULLY AND I STAYED IN THE PREPERITONEAL SPACE ESSENTIALLY THROUGHOUT THE ENTIRE RIGHT SIDE OF HER ABDOMEN. I GOT INTO THE SPACE OF RETZIUS AND MOBILIZED HER BLADDER FULLY BACK AND FORTH, EXPOSING THE EPIGASTRIC VESSELS AND KEEPING THEM INTACT. I SUBSEQUENTLY THEN TOOK DOWN THE FALCIFORM LIGAMENT TO THE XIPHOID AND CONNECTED THE DOTS BETWEEN THE PREPERITONEAL DISSECTION ABOVE AND BELOW ON THE RIGHT SIDE THERE. I PERFORMED A COMPONENT SEPARATION ON THE PATIENT¿S LEFT SIDE, PERFORMING A TRANSVERSUS ABDOMINIS RELEASE SO THAT I COULD CLOSE THE FASCIA WITHOUT UNDUE TENSION. WE CUT THE POSTERIOR RECTUS SHEATH A DISTANCE APPROXIMATELY 19 CM AND FULLY MOBILIZED THE RECTUS MUSCLE. WE PRESERVED THE EPIGASTRIC VESSELS AS WELL AS THE NEUROVASCULAR BUNDLES, WHICH PENETRATED THROUGH THE POSTERIOR LAMELLA OF THE INTERNAL OBLIQUE AND INTO THE RECTUS MUSCLE. WE CUT THE POSTERIOR LAMELLA OF THE INTERNAL OBLIQUE JUST MEDIAL TO THESE NEUROVASCULAR BUNDLES AND THEN TRANSECTED THE TRANSVERSALIS MUSCLE AND WALKED THE LENGTH OF THE POSTERIOR RECTUS SHEATH TRANSECTING THE POSTERIOR LAMELLA OF THE INTERNAL OBLIQUE AS WELL AS THE TRANSVERSALIS. THIS GAVE US A WONDERFUL MUSCULOFASCIAL RELEASE AND WE WERE ABLE TO PULL THE ABDOMINAL WALL TOGETHER VERY NICELY. WE CONNECTED THE DOTS IN THE PREPERITONEAL DISSECTION ABOVE AND BELOW AND THEN MADE SURE THAT THERE WERE NO HOLES IN THE PERITONEUM AND CLOSED THE POSTERIOR RECTUS SHEATH TO THE PERITONEUM WITHOUT ANY ISSUES. THIS COMPLETELY SEPARATED THE INTESTINE. THERE WAS ONE SECTION WHERE THERE WAS OMENTUM. I FILLED THE GAP BETWEEN THE PERITONEUM ON THE RIGHT SIDE AND THE POSTERIOR RECTUS SHEATH ON THE LEFT SIDE. CONSIDERING HOW THIN THE PERITONEUM WAS, WE DID CHOOSE A PROTECTED MESH AND CHOSE A 20 X 30 CM SYNECOR MESH. THIS LAID BEAUTIFULLY IN THIS SPACE AND WE SUTURED IN WITH INTERRUPTED 0 PROLENE SUTURES. PRIOR TO PLACING THIS MESH, WE EXAMINED THE ENTIRE OPERATIVE FIELD AND FOUND NO BLEEDING AND NO PROBLEMS. WE LAID THIS MESH IN AND SUTURED IN MUCH AS DESCRIBED AND THEN PLACED A DRAIN ON TOP OF THE MESH. WE IRRIGATED WITH BACITRACIN IRRIGATION. WE SUTURED THE DRAIN AND PLACED IT OVER THE TOP OF THE MESH IN WITH A 2-0 PROLENES. WE CLOSED THE FASCIA WITH A RUNNING #1 PDS ENSURING WE DID NOT INCLUDE THE DRAIN IN MY STITCH. WE IRRIGATED THE SUBCUTANEOUS TISSUES AND FOUND NO BLEEDING OR OTHER ISSUES. WE CLOSED THE DEEP DERMAL TISSUES AFTER SUTURING DOWN THE UMBILICUS AND PLACING A DRAIN. THIS WAS SUTURED WITH 2-0 MONOCRYL AND THEN 4-0 MONOCRYL FOR THE SKIN AND DERMABOND. THE PATIENT TOLERATED ALL THIS VERY WELL. SHE WAS STABLE THROUGHOUT.¿ (B)(6) 2016: (B)(6) MEDICAL CENTER. IMPLANT RECORD. GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL. CATALOG NUMBER: GKFR2030. SERIAL NUMBER: (B)(6). EXPIRATION: 7/20/19. SIZE: 20CM X 30CM. W.L. GORE & ASSOCIATES. THE RECORDS CONFIRM A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL (GKFR2030/15310273) WAS IMPLANTED DURING THE PROCEDURE. RELEVANT MEDICAL INFORMATION: (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. DISCHARGE SUMMARY. DIAGNOSIS: VENTRAL HERNIA. COURSE: NO IMMEDIATE COMPLICATIONS, HAD ONE EPISODE OF POST-OP EMESIS ON POD#2 ASSOCIATED WITH DISTENTION. BY POD#3 WAS PASSING FLATUS, STARTED ON DIET, SLOWLY ADVANCED AS TOLERATED. AT TIME OF DISCHARGE HAD FULL RESUMPTION OF BOWEL FUNCTION, WAS AMBULATING WITHOUT DIFFICULTY, VOIDING WITHOUT DIFFICULTY, PAIN CONTROLLED WITH ORAL PAIN MEDICATION, TOLERATING DIET. DISCHARGE INSTRUCTIONS GIVEN IN DETAIL AND EXPLAINED TO PATIENT AT LENGTH. ALL QUESTIONS ANSWERED. PLAN: LIFTING LIMITS DO NOT LIFT MORE THAN 20 LBS FOR 6 WEEKS, NO LIFTING/PUSHING/PULLING MORE THAN 15-20 POUNDS FOR 6 WEEKS. NO STRENUOUS EXERCISES OR ABDOMINAL WALL EXERCISES FOR 6 WEEKS. SHOWER ONLY, NO BATHS OR SUBMERGING INCISIONS IN ANY WATER FOR ABOUT 3-4 WEEKS OR UNTIL FULLY HEALED. (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. EMERGENCY ROOM VISIT. MULTIPLE RECENT SURGERIES, INITIALLY FOR REPAIR OF INCISIONAL HERNIA, WITH MULTIPLE SUBSEQUENT COMPLICATIONS. WAS READMITTED WITH ABSCESS 09/12, DRAINS WERE PLACED. READMITTED 2 DAYS LATER FOR FAILURE TO THRIVE, DISCHARGED HOME ON ORAL ANTIBIOTICS. SHE TELLS ME SHE STOPPED TAKING THEM APPROXIMATELY 5 DAYS LATER, COMPLETED ONLY HALF OF THE SUGGESTED OUTPATIENT COURSE. COMPLAINS OF PERSISTENT ABDOMINAL PAIN, HYPERESTHESIA TO LEFT OF LOWER ASPECT OF INCISION. SHE IS CONCERNED BECAUSE WHEN SHE TAKES ANTIBIOTICS SHE IS SO NAUSEOUS THAT SHE CANNOT EAT, BUT KNOWS SHE NEEDS ANTIBIOTICS FOR RECURRENT INFECTIONS. NO FEVERS, NO SIGNIFICANT VOMITING TODAY. EXAM: GASTROINTESTINAL; SOFT, NONDISTENDED, MIDLINE VERTICAL INCISION CLEAN, DRY, INTACT. CENTRAL AREA WITHOUT SCAB OR DERMABOND AND GRANULATION TISSUE, BUT NO PUS COULD BE EXPRESSED. NO FOCAL AREAS OF ERYTHEMA. TENDERNESS; MODERATE, GENERALIZED. GUARDING; NEGATIVE. WBC 11.9 H (4.1-10.7). MEDICAL DECISION MAKING: ABDOMINAL PAIN AND NAUSEA IN THE POSTOPERATIVE SETTING CONCERNING FOR RECURRENT ABSCESS, SMALL BOWEL OBSTRUCTION, VOLVULUS. HIGHEST SUSPICION FOR ABSCESS BASED ON HISTORY OF ABSCESSES WITH RECURRENT DRAIN PLACEMENT, AND NONCOMPLIANCE WITH OUTPATIENT ANTIBIOTIC REGIMEN. CANNOT OBTAIN CT WITH CONTRAST SINCE CREATININE HAS BUMPED TO 2.2, UNCLEAR ETIOLOGY. PENDING CT WITHOUT. PAIN CONTROLLED WITH IV MORPHINE. IMPRESSION: CT CONSISTENT WITH INCREASED SIZE OF SUBCUTANEOUS ABSCESS. WILL BE TRANSFERRED TO CHARLOTTE VIA AMBULANCE. (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. RADIOLOGY - CT ABDOMEN/PELVIS WITHOUT INTRAVENOUS CONTRAST. INDICATION: RECENT SURGERY, RECURRENT ABSCESSES, ABDOMINAL PAIN. FINDINGS: INTERVAL INCREASE IN SIZE OF SUPRAUMBILICAL ANTERIOR ABDOMINAL WALL SUBCUTANEOUS GAS AND FLUID COLLECTION SUSPICIOUS FOR ABSCESS. MEASURES 6.5 X 2.5 X 5.0 CM IN MAXIMAL ORTHOGONAL DIMENSIONS. AGAIN SEEN ARE POSTOPERATIVE CHANGES OF ANTERIOR WALL ABDOMINOPLASTY WITH SURGICAL MESH PRESENT. THERE HAS BEEN INTERVAL DECREASE IN SIZE OF A GAS AND FLUID COLLECTION SUSPICIOUS OF ABSCESS ALONG THE DEEP MARGIN OF THE SURGICAL MESH WHICH MEASURES UP TO 15 X 1.5 X 20 CM IN MAXIMAL ORTHOGONAL DIMENSIONS. NO BOWEL OBSTRUCTION, PNEUMOPERITONEUM, OR FREE FLUID IS SEEN IN THE ABDOMEN OR PELVIS. NO OTHER LOCALIZED INTRAPERITONEAL FLUID COLLECTION IS IDENTIFIED. THE APPENDIX IS NORMAL. DIVERTICULOSIS COLI PRESENT WITHOUT EVIDENCE FOR ACUTE DIVERTICULITIS. GALLBLADDER SURGICALLY ABSENT OR CONTRACTED. NO BILIARY DUCTAL DILATATION. LIVER, PANCREAS, SPLEEN, ADRENAL GLANDS UNREMARKABLE. NON-OBSTRUCTING RENAL CALCULI BILATERALLY. LEFT RENAL CYST AGAIN SEEN, UNCHANGED. UTERUS ABSENT. NO ABDOMINOPELVIC LYMPHADENOPATHY. ATHEROSCLEROTIC CALCIFICATIONS PRESENT INVOLVING THE AORTA. ABDOMINAL AORTA NORMAL IN COURSE AND CALIBER. AORTIC DISSECTION IS NETHER INCLUDED OR EXCLUDED IN THE ABSENCE OF CONTRAST. AGAIN SEEN ARE BULLOUS/FIBROCYSTIC SCARRING INVOLVING THE LOWER LUNGS BILATERALLY. MILD ATELECTASIS IN LOWER LUNGS BILATERALLY. DEGENERATIVE CHANGES INVOLVING THE SPINE WITH GRADE 1 DEGENERATIVE ANTERIOR SPONDYLOLISTHESES AT L3 ON L4 AND L4 ON L5 AND AT LEAST MILD NARROWING OF THE CENTRAL SPINE CANAL AT THESE LEVELS. IMPRESSION: INTERVAL INCREASE IN SIZE OF SUPRAUMBILICAL AND INFRAUMBILICAL SUBCUTANEOUS FLUID COLLECTIONS SUSPICIOUS FOR ABSCESSES. INTERVAL DECREASED SIZE OF FLUID COLLECTION SUSPICIOUS FOR ABSCESS ALONG THE DEEP SURFACE OF ANTERIOR ABDOMINAL WALL SURGICAL MESH. DIVERTICULOSIS COLI. NON-OBSTRUCTING RENAL CALCULI BILATERALLY. LEFT RENAL CYST. (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. EMERGENCY ROOM VISIT. PRESENTS WITH DIARRHEA AND ABDOMINAL CRAMPING. WORSENING. EXACERBATING FACTOR, NONE. RELIEVING FACTOR, NONE. RECENT ANTIBIOTIC USE, RECENT SURGERY, RECENT HOSPITALIZATION. ASSOCIATED VOMITING AND CRAMPING. SENT BY PCP FOR VOMITING, ABDOMINAL PAIN AFTER LONG TERM ANTIBIOTICS. RECENT MESH SURGERY ABOUT 8 WEEKS AGO WITH MULTIPLE READMISSIONS. PICC LINE IN LEFT ARM. EXAM: GASTROINTESTINAL; SOFT, NONTENDER, NONDISTENDED, NORMAL BOWEL SOUNDS, NO ORGANOMEGALY. IMPRESSION: SEVERAL EXTENSIVE ADMISSIONS FOR C. DIFFICILE COLITIS. DEVELOPED VOMITING AND DIARRHEA PAST 48 HOURS, OTHERWISE WELL-APPEARING, TREATED WITH IV FLUIDS, LABS UNREMARKABLE. PATIENT IS ADAMANT THAT SHE DOES NOT WANT ADMITTED. VOMITING, DIARRHEA. IMPROVED, STABLE. DISCHARGED HOME. (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), PA; (B)(6), MD. EMERGENCY ROOM VISIT. STATUS POST OVHR WITH MESH PLACEMENT (B)(6) 2016 WITH SUBSEQUENT INTRA-ABDOMINAL FLUID COLLECTION REQUIRING MULTIPLE SURGICAL DRAINS STATUS POST REMOVAL, SUBSEQUENTLY DEVELOPING SUBCUTANEOUS ABSCESS DEVELOPMENT WITH MRSA ABDOMINAL WALL INFECTION REQUIRING 6 WEEKS OF IV ANTIBIOTICS, VANCOMYCIN VIA PICC LINE, HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE PRESENTS WITH CONTINUED NAUSEA. NO VOMITING. OCCASIONAL WATERY STOOLS, IMPROVES WITH IMODIUM. HAS BEEN TESTED FOR C. DIFFICILE RECENTLY, HAS BEEN FOLLOWED BY INFECTIOUS DISEASE. RECENTLY DISCONTINUED IV ANTIBIOTICS BUT DOES ENDORSE SOME NAUSEA AND EARLY SATIETY. DOES CONTINUE TO HAVE BOWEL MOVEMENTS, DOES NOT ENDORSE ANY SIGNIFICANT ABDOMINAL PAIN BUT IRRITATION AND KIND OF ¿RAWNESS¿ IN MIDEPIGASTRIC REGION. CONTINUES TO TAKE FAMOTIDINE AND PEPCID AC FOR ¿STOMACH TROUBLES¿. TRIED TO TAKE PROBIOTICS. FEELS DEHYDRATED. NAUSEA NOT WELL CONTROLLED WITH ZOFRAN, OCCASIONALLY TAKES HALF DOSE OF PHENERGAN WHICH DOES HELP ALTHOUGH TODAY DID NOT. ENDORSES DECREASED ORAL INTAKE DUE TO DECREASED APPETITE. EXAM: HT 5¿3¿, WT 59.2 KG, BMI 23.12. GASTROINTESTINAL; SOFT, NON-DISTENDED, TENDERNESS MILD, EPIGASTRIC, HYPOACTIVE BOWEL SOUNDS, PREVIOUS SURGICAL INCISIONS HEALED APPROPRIATELY. PALPABLE MESH STILL PRESENT. WBC 6.5. IMPRESSION/PLAN: EARLY SATIETY, NAUSEA. IMPROVED, STABLE. DISCHARGED HOME, PRESCRIBED REGLAN, DO NOT TAKE WITH ZOFRAN OR PHENERGAN. (B)(6) 2017: (B)(6) HOSPITAL. (B)(6). EMERGENCY ROOM VISIT. ABDOMINAL PAIN, LOWER ABDOMEN, BEGAN 2 DAYS AGO, WORSE THIS MORNING. DIARRHEA, VOMITING, ACHY, AT WORST PAIN WAS MODERATE, HAS NOT EXPERIENCED SIMILAR SYMPTOMS IN THE PAST. EXAM: ABDOMEN; MODERATE TENDERNESS. HT 5¿3¿, WT 65.32 KG, BMI 25.51. IMPRESSION/PLAN: DIVERTICULITIS OF INTESTINE WITH PERFORATION AND ABSCESS. ADMIT. (B)(6) 2017: (B)(6) HOSPITAL. NURSE NOTES. PATIENT STATES COUPLE WEEKS AGO FOUND OUT I HAD HEPATITIS C AND THEY STARTED ME ON A NEW MEDICINE CALLED MAVYRET WHICH BROKE ME OUT IN A RASH WHICH I AM TAKING BENADRYL FOR. THIS AM WOKE UP WITH SEVERE ABDOMINAL PAIN WITH DIARRHEA AND A LITTLE BIT OF NAUSEA, WENT TO MY FAMILY DOCTOR AND THEY TOLD ME TO COME STRAIGHT TO ER. (B)(6) 2017: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY - CT ABDOMEN/PELVIS WITHOUT CONTRAST. INDICATION: ABDOMINAL PAIN. PATIENT PROVIDES INFORMATION TO TECHNOLOGIST OF CHOLECYSTECTOMY, APPENDECTOMY, AND HERNIA SURGERY X 6. FINDINGS: A 3 MM AND 2 MM NONOBSTRUCTING RIGHT RENAL CALCULUS. A 7 MM AND 3 MM NONOBSTRUCTING LEFT RENAL CALCULUS. NO HYDRONEPHROSIS. INDETERMINATE SLIGHTLY GREATER THAN 2 CM LEFT RENAL LOW ATTENUATION MASS. NORMAL HEART SIZE. LOWER LUNG ZONE FINDINGS OF THE SCATTERED AIR CYSTIC SPACES, BRONCHIECTATIC CHANGES, AND INTERSTITIAL PROMINENCE THAT COULD RELATE TO CROWDING, ATELECTASIS OR FIBROSIS. LEFT POSTERIOR COSTOPHRENIC SULCUS RETICULONODULAR PATHOLOGY COULD RELATE TO PNEUMONITIS OR SCARRING. CLINICAL CORRELATION. MULTILEVEL DEGENERATIVE CHANGES IN THE SPINE. NO ACUTE FRACTURES. NO GROSS FINDINGS LIVER, SPLEEN, PANCREAS, OR ADRENAL GLANDS. CHOLECYSTECTOMY CHANGES. NO DUCTAL DILATATION. ABDOMINAL AORTIC ATHEROSCLEROTIC CHANGES. SMALL BOWEL UNREMARKABLE. IN THIS SETTING OF EXTENSIVE DIVERTICULOSIS, PARTICULAR THE DESCENDING COLON AND SIGMOID COLON, THERE IS A SEGMENT OF SIGMOID COLON INVOLVING THE LEFT SIDE OF PELVIS OVARY TOO CENTIMETER OR SO RANGE THAT DEMONSTRATES MUCOSAL THICKENING, PERICOLONIC MESENTERIC STRANDING CONSISTENT WITH ACUTE DIVERTICULITIS. SEEN LATERAL TO THE ABNORMAL SEGMENT, THERE IS ABNORMAL SOFT TISSUE DENSITY AND EXTRALUMINAL BUBBLES OF AIR OF CONCERN FOR ASSOCIATED DEFINED PERFORATION IN THIS REGION OF CONCERN FOR PHLEGMON PROCESS AND LIKELY DEVELOPING ABSCESS. SEEN SUPERIORLY TO THIS ALONG THE LEFT ANTERIOR SO AS REGION INFERIOR TO THE RENAL BED, ADDITIONAL AREAS OF PNEUMOPERITONEUM. THE COLONIC PATHOLOGY AT PRESENT IS NONOBSTRUCTING. THE APPENDIX IS NOT SEEN. HYSTERECTOMY CHANGES. THERE IS AREAS OF ABNORMAL SUBCUTANEOUS FAT SOFT TISSUE RETICULATION INVOLVING THE LEFT ABDOMINAL WALL BOTH BEFORE AT AND ABOVE THE LEVEL OF THE UMBILICUS FELT RELATED TO POSTSURGICAL CHANGES. A DEFINED HERNIA IN THIS REGION IS NOT DEMONSTRATED. MULTILEVEL DEGENERATIVE CHANGES IN THE SPINE. IMPRESSION: BILATERAL NONOBSTRUCTING RENAL CALCULI AND NO HYDRONEPHROSIS. INDETERMINATE PARTIALLY AXOPHYTIC SLIGHTLY GREATER THAN 2 CM LEFT RENAL MASS. FINDINGS INDICATIVE OF A 10 CM SEGMENT OF ACUTE SIGMOID DIVERTICULITIS COMPLICATED LOCALLY BY DEFINED COLLECTIONS OF EXTRALUMINAL AIR DASH MICROPERFORATION AS WELL AS A SOMEWHAT TUBULAR FOCUS OF SOFT TISSUE DENSITY MEASURING ABOUT 1 X 1 X 3 CM FELT INDICATIVE OF PHLEGMON AND DEVELOPING ABSCESS. THERE ARE HOWEVER ADDITIONAL AREAS OF PNEUMOPERITONEUM MORE CEPHALAD TO THE ACUTE DIVERTICULITIS PROCESS BELOW THE LEVEL OF THE RENAL BED REGIONS AND ANTERIOR TO THE LEFT SO AS MUSCULATURE. EXTENSIVE ABNORMALITIES IN THE SUBCUTANEOUS FAT OF THE LEFT ABDOMINAL WALL FELT LIKELY RELATED TO POSTSURGICAL CHANGES AND AREAS OF FAT NECROSIS WITHOUT DISCRETE UMBILICAL OR VENTRAL WALL ABSCESS. ADDITIONAL FINDINGS AS DETAILED ABOVE. EMERGENCY SURGICAL CONSULTATION RECOMMENDED.
H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE® SYNECOR® INTRAPERITONEAL 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. THE GORE® SYNECOR® INTRAPERITONEAL 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.
H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE® SYNECOR INTRAPERITONEAL 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, ADHESIONS AND RELATED HARMS, BOWEL OBSTRUCTION, CONTAMINATION, DEFECT RECURRENCE AND RELATED HARMS, DYSPHAGIA, EROSION OR EXTRUSIONS AND RELATED HARMS, EXPOSURE OR PROTRUSIONS AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, INFECTION, IRRITATION OR INFLAMMATION, MESH MIGRATION, MESH SHRINKAGE, PAIN, PARATHESIS, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY.¿ 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 MATERIAL.¿ 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. 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.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE® SYNECOR INTRAPERITONEAL 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, ADHESIONS AND RELATED HARMS, BOWEL OBSTRUCTION, CONTAMINATION, DEFECT RECURRENCE AND RELATED HARMS, DYSPHAGIA, EROSION OR EXTRUSIONS AND RELATED HARMS, EXPOSURE OR PROTRUSIONS AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, INFECTION, IRRITATION OR INFLAMMATION, MESH MIGRATION, MESH SHRINKAGE, PAIN, PARATHESIS, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY.¿ 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 MATERIAL.¿ 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. 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.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
IT SHOULD BE NOTED THAT THE GORE® SYNECOR INTRAPERITONEAL 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." THE GORE® SYNECOR INTRAPERITONEAL 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."
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL 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: HERNIA RECURRENCE, NECROSIS, INFECTION, SCARRING, INFLAMMATION, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057696 | GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W. L. GORE & ASSOCIATES, INC. | GKFR2030 | 00733132635368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Hospitalization| R |