GORE DUALMESH BIOMATERIAL
Report
- Report Number
- 2017233-2019-00568
- Event Type
- Injury
- Date Received
- July 26, 2019
- Report Date
- October 27, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON GORE¿S INVESTIGATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES (1994 AND 3191 APPROPRIATE TERM/CODE NOT AVAILABLE FOR: "MESH DETACHED FROM LEFT RECTUS.") WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2008 THROUGH (B)(6) 2018 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. MEDICAL RECORDS FROM (B)(6) 2011 THROUGH (B)(6) 2014 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: MORBID OBESITY 1992: 323 LBS., BMI 45.7. (B)(6) 2008: 301 LBS., BMI 42.6. (B)(6) 2009: 293 LBS., BMI 41.6. (B)(6) 2010: 320 LBS., BMI 45.71. (B)(6) 2014: 269 LBS., BMI 38.8. (B)(6) 2016: ¿HAS LOST APPROXIMATELY 130 POUNDS AND CONTINUES TO TRY TO LOSE MORE WEIGHT¿ (B)(6) 2018: ¿GRADUAL PROGRESSIVE WEIGHT GAIN OF 65 POUNDS.¿ (B)(6) 2010: HISTORY GASTROESOPHAGEAL REFLUX DISEASE [GERD]. (B)(6) 2010: CHRONIC INFECTION IN ABDOMEN. (B)(6) 2011: AUTO ACCIDENT: HIT FROM BEHIND, SUFFERED ABDOMINAL TRAUMA; ABDOMEN HIT STEERING WHEEL, BRUISING LEFT LOWER QUADRANT. (B)(6) 2014: POLYPECTOMIES, DIVERTICULOSIS SIGMOID COLON. SURGICAL PROCEDURES: 1984: GASTRIC STAPLING. 2005: LAPAROSCOPIC CHOLECYSTECTOMY. (B)(6) 2008: IMPLANTATION OF HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE [VAD] AS BRIDGE THERAPY TO HEART TRANSPLANTATION AND CLOSURE OF PATENT FORAMEN OVALE WITH MESH. (B)(6) 2008: RE-EXPLORATION SURGERY FOR BLEEDING. (B)(6) 2009: IRRIGATION AND DEBRIDEMENT OF CHEST WOUND WITH SHARP DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, DEEP FASCIA, AS WELL AS REMOVAL OF INFECTED ¿GORE-TEX MESH.¿ A PEDICLED RIGHT VERTICAL RECTUS ABDOMINIS MUSCLE FLAP TO THE CHEST. PEDICLED OMENTAL FLAP TO THE CHEST. REPAIR OF BOTH UMBILICAL AND VENTRAL INCISIONAL HERNIAS WITH ALLODERM. (B)(6) 2009: RENAL ASPIRATION FOR PHLEGMON OR ABSCESS. (B)(6) 2014: OPEN VENTRAL HERNIA REPAIR WITH MESH. REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH MESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL. (B)(6) 2015: REDO STERNOTOMY. EXTENSIVE MEDIASTINAL LYSIS OF ADHESIONS IN EXCESS OF 1 HOUR. ORTHOTOPIC HEART TRANSPLANT USING BICAVAL ANASTOMOTIC TECHNIQUE. REMOVAL OF HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE AND DRIVELINE. REMOVAL OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR GENERATOR AND LEADS. (B)(6) 2017: OPEN REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH 23CM X 20CM POLYPROPYLENE MESH. (B)(6) 2017: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH 16 X 18 CM GORE-TEX DUALMESH. IMPLANT: GORE® DUALMESH® BIOMATERIAL RELEVANT MEDICAL INFORMATION: (B)(6) 2008: ¿PLANNED FOR IMPLANTATION OF HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE TODAY AS BRIDGE THERAPY TO HEART TRANSPLANTATION. NO CONTRAINDICATIONS TO HEART TRANSPLANT EXCEPT UNDERLYING OBESITY.¿ [OPERATIVE NOTE FOR IMPLANTATION OF VENTRICULAR ASSIST DEVICE AND CLOSURE OF PATENT FORAMEN OVALE WITH MESH NOT PROVIDED.]. (B)(6) 2009: INPATIENT HOSPITALIZATION. (B)(6) 2009: CT ABDOMEN. ¿SMALL PARAUMBILICAL FAT-CONTAINING HERNIA.¿ (B)(6) 2009: ¿POSTOP DIAGNOSES: OPEN CHEST WOUND WITH INFECTION OF LEFT VENTRICULAR ASSIST DEVICE, AS WELL AS THE ¿GORE-TEX MESH¿ AROUND THE DEVICE . UMBILICAL HERNIA. VENTRAL INCISIONAL HERNIA. PROCEDURE: IRRIGATION AND DEBRIDEMENT OF CHEST WOUND WITH SHARP DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, DEEP FASCIA, AS WELL AS REMOVAL OF INFECTED GORE-TEX MESH. A PEDICLED RIGHT VERTICAL RECTUS ABDOMINIS MUSCLE FLAP TO THE CHEST. PEDICLED OMENTAL FLAP TO THE CHEST. REPAIR OF BOTH UMBILICAL AND VENTRAL INCISIONAL HERNIAS WITH ALLODERM.¿ [NO PRIOR MEDICAL RECORDS PROVIDED TO INDICATE PRODUCT ID] ¿THERE WAS GROSS PURULENCE AROUND THE GORE-TEX THAT SURROUNDED THE DEVICE ITSELF. ALL OF THE GORE-TEX WAS THEN REMOVED INCLUDING THE STAPLES AND PROLENE SUTURES THAT ANCHORED IT IN PLACE. AFTER ALL THE GRANULATION TISSUE AND EDEMATOUS-LOOKING TISSUE AROUND THE DEVICE WAS REMOVED, THE WOUND WAS IRRIGATED WITH 3 L OF ANTIBIOTIC IRRIGATION. THIS LEFT A RELATIVELY LARGE CAVITY AROUND THE DEVICE AS WELL AS THE MEDIAL 10 CM OF THE DRIVELINE.¿ (B)(6) 2009: DISCHARGE SUMMARY. ¿ANAEROBIC VENTRICULAR ASSIST DEVICE POCKET INFECTION WITH BACTEREMIA, STATUS POST DEBRIDEMENT WITH RECTUS AND OMENTAL FLAPS ON (B)(6) 2009. FOLLOW-UP BLOOD CULTURE SERIES WERE NEGATIVE.¿ (B)(6) 2010: ¿VENTRAL HERNIA APPRECIATED.¿ (B)(6) 2010: CT ABDOMEN/PELVIS. ¿22.0 CM LARGE VENTRAL WALL HERNIA PROTRUDES THROUGH FASCIAL DEFECT OF 11.0 CM. MUCH LARGER IN COMPARISON TO PRIOR EXAM (B)(6) 2009. HERNIA CONTAINS MULTIPLE SMALL BOWEL LOOPS WITH NO EVIDENCE OF OBSTRUCTION. INFERIOR EDGE OF VENTRICULAR ASSIST DEVICE ABUTS THE HERNIA.¿ (B)(6) 2010: ¿NOT A SURGICAL CANDIDATE AT THIS TIME.¿ IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2014: CT ABDOMEN/PELVIS. ¿LARGE MIDLINE ANTERIOR ABDOMINAL WALL HERNIA CONTAINING LOOPS OF SMALL BOWEL AND COLON. NO EVIDENCE FOR OBSTRUCTION OR INCARCERATION.¿ (B)(6) 2014: ¿HERNIA BECOMING LARGER, MORE SYMPTOMATIC. PLAN: HE SHOULD PROBABLY HAVE THIS REPAIRED, ALTHOUGH RISKS SIGNIFICANT. DRIVELINE AND VENTRICULAR ASSIST DEVICE IN VERY CLOSE PROXIMITY IF NOT INVOLVED IN THE HERNIA ITSELF. THIS CANNOT BE DONE LAPAROSCOPICALLY BY MY ESTIMATION DUE TO PREVIOUS OMENTAL FLAP IN LOWER CHEST. WILL NEED OPEN REPAIR WITH SOME TYPE OF MESH, EITHER MORE BIOLOGIC OR PROLENE MESH DEPENDING ON THE ANATOMY OF HIS DEFECT . THIS WOULD PROBABLY BE A 4-HOUR OR SO OPERATION, SO HE WILL NEED TO BE OFF COUMADIN AT LEAST DURING TIME OF SURGERY IF NOT FOR A PERIOD BEYOND THIS.¿ (B)(6) 2014: ¿PATIENT RECENTLY HAD SUBTHERAPEUTIC INR IN WHICH HE COMPLETED APPROXIMATELY 8 DOSES OF LOVENOX SUBCUTANEOUSLY. SCHEDULED TO UNDERGO VENTRAL HERNIA REPAIR (B)(6) 2014. WILL HAVE PATIENT ADMITTED FOR HEPARIN BRIDGING ON (B)(6) 2014. IN REGARDS TO HERNIA, PATIENT STILL HAS SOME NAUSEA, NO VOMITING OR ACUTE PAIN TO THE SITE.¿ (B)(6) 2014: INDICATION: ¿HISTORY OF HEART FAILURE REQUIRING A VENTRICULAR ASSIST DEVICE. THE PATIENT HAD DEVELOPED COMPLICATIONS OF THE IMPLANTATION OF THE VENTRICULAR ASSIST DEVICE INCLUDING INFECTED HARDWARE. THE PATIENT HAD A PRIOR EXPLORATORY LAPAROTOMY WITH MOBILIZATION OF THE RECTUS MUSCLE AND THE INTRAABDOMINAL OMENTUM WITH TRANSPLANTATION AND OVERLAPPING OF THE HARDWARE TO ASSIST IN RIDDING OF THE INFECTION. FROM THIS OPERATION, THE PATIENT DEVELOPED A LARGE VENTRAL INCISIONAL HERNIA.¿ IMPLANT #1 PROCEDURE: OPEN VENTRAL HERNIA REPAIR WITH MESH. REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH MESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC04/11195996, 15CM X 19CM X 1MM THICK, OVAL]. IMPLANT #1 DATE: (B)(6), 2014 [HOSPITALIZATION DATES (B)(6) 2014 THROUGH (B)(6) 2014]. DESCRIPTION OF HERNIA BEING TREATED: [DRS. B. & C.] ¿THE PREVIOUS MIDLINE INCISION WAS THEN EXCISED USING SHARP DISSECTION. THE MIDLINE WAS ENTERED INFERIOR TO THE AREA OF THE HERNIA WHERE WE ENCOUNTERED THE MIDLINE RECTUS APONEUROSIS. WE IDENTIFIED THE HERNIA SAC WITH THE HERNIATING BOWEL CONTENTS. WE DISSECTED THIS FREE FROM THE SKIN FLAPS AND DELINEATED THE OPENING IN THE FASCIA MEASURED TO BE ABOUT 12 CM ACROSS X 15 CM CRANIOCAUDAL. WE DISSECTED THE PREVIOUSLY PLACED OMENTUM FREE FROM THE HERNIA AND REPLACED IT INTO THE ABDOMEN. WE ENTERED THE SAC AND PARTIALLY EXCISED THE SAC LEAVING SOME REMNANT ATTACHED TO ALLOW US TO COVER THE MESH. WE THEN PERFORMED A DISSECTION OF THE FASCIA IN TWO LAYERS BY ISOLATING THE POSTERIOR RECTUS SHEATH.¿ IMPLANT SIZE AND FIXATION: ¿THIS ALLOWED US TO PLACE A 15 X 19 GORE-TEX DUALMESH AND ATTACH IT TO THE POSTERIOR SHEATH IN A BRIDGING FASHION USING INTERRUPTED 0-PROLENE SUTURES. THE ANTERIOR SHEATH WHICH HAD REMNANTS OF THE HERNIA SAC WAS THEN USED TO COVER THE ANTERIOR PORTION OF THE SHEATH. TWO #19 ROUND J-P DRAINS WERE PLACED IN THE OPERATIVE BED, ONE IN THE SKIN FLAP ON THE LEFT LATERAL ASPECT OF THE PATIENT, AND ONE IMMEDIATELY ADJACENT TO THE MESH. THESE WERE SECURED TO THE ABDOMINAL WALL USING 3-0 PROLENE SUTURES. THE SKIN CLOSURE WAS PERFORMED BY OUR PLASTIC SURGERY COLLEAGUES. ALL HEMOSTASIS WAS CONTROLLED WITH ELECTROCAUTERY AND WAS ADEQUATE AT THE END OF THE OPERATION.¿ DR. J: ¿HIS PRIOR MIDLINE INCISION HAD A WIDENED SCAR. THE SCAR WAS EXCISED. THE SUBCUTANEOUS TISSUE WAS THEN DISSECTED, FIRST DISTALLY AND ON THE LEFT SIDE. THE HERNIA SAC WAS IDENTIFIED. THIS WAS A FAIRLY EXTENSIVE HERNIA SAC THAT DID EXTEND UP TOWARDS THE LEFT VENTRICULAR ASSIST DEVICE AS WELL AS LATERAL TO THE LEFT RECTUS ABDOMINIS MUSCLE. DR. J. AND DR. B. WERE ABLE TO DISSECT THE HERNIA SAC AWAY FROM THE SUBCUTANEOUS TISSUE AND IDENTIFY THE FASCIAL EDGES, FIRST ON THE LEFT SIDE. THE HERNIA SAC WAS ENTERED. THE HERNIA SAC DID EXTEND UP TOWARDS THE LEFT VENTRICULAR ASSIST DEVICE AS WELL AS THE DRIVELINE. THERE WAS EXCELLENT INCORPORATION OF THE DRIVELINE AS WELL AS THE DEVICE. THE OMENTAL FLAP HAD COVERED OVER THE MAJORITY OF THE VENTRICULAR ASSIST DEVICE. WE WERE ABLE TO DISSECT THE HERNIA SAC AWAY WITHOUT EXPOSURE OF THE DEVICE ITSELF OR THE DRIVELINE. AFTER THE HERNIA SAC WAS ENTERED, THE HERNIA SAC ON THE LEFT SIDE HAD BEEN EXCISED. THE HERNIA SAC ON THE RIGHT SIDE WAS LEFT ATTACHED TO THE RESIDUAL DEEP FASCIA. DR. J. THEN DEVELOPED A PLANE AROUND THE POSTERIOR RECTUS SHEATH CIRCUMFERENTIALLY AND PLACED A PIECE OF DUALMESH. AT THIS POINT, THE PROCEDURE WAS AGAIN TURNED OVER TO MYSELF. AFTER THE ASSURANCE OF HEMOSTASIS, A 19-FRENCH ROUND BLAKE DRAIN WAS THEN PLACED SUBCUTANEOUSLY AND THEN PLACED JUST ON TOP OF THE DUALMESH. THE HERNIA SAC PERITONEUM WAS THEN CLOSED OVER THE DUALMESH FOR COMPLETE SOFT TISSUE COVERAGE AND TACKED ON THE LEFT SIDE OF THE ABDOMEN DOWN TO THE DEEP FASCIA USING INTERRUPTED 2-0 VICRYL SUTURE. AN ADDITIONAL 19-FRENCH ROUND BLAKE DRAIN WAS PLACED SUBCUTANEOUSLY. THERE WAS A FAIRLY EXTENSIVE DEAD SPACE LATERALLY ON THE LEFT SIDE. AFTER THE ASSURANCE OF HEMOSTASIS, A SMALL AMOUNT OF REDUNDANT SKIN WAS EXCISED. SCARPA¿S LAYER WAS THEN CLOSED VERTICALLY WITH INTERRUPTED 2-0 VICRYL SUTURE. THE DEEP DERMIS WAS CLOSED WITH INTERRUPTED 3-0 VICRYL AND THE SKIN CLOSED WITH RUNNING 4-0 MONOCRYL SUBCUTICULAR SUTURE AS WELL AS WITH STAPLES. STERILE DRESSING WAS APPLIED IN ADDITION TO ABDOMINAL BINDER.¿ (B)(6) 2014: PATHOLOGY. ¿ABDOMINAL HERNIA SAC. GROSS: A PIECE OF THICKENED MEMBRANOUS GLISTENING PINK-TAN TISSUE WITH ATTACHED FAT. ONE SURFACE IS SLIGHTLY IRREGULAR AND FIBROTIC. THE OTHER IS FATTY. THERE IS NO EVIDENCE OF LESIONS GROSSLY.¿ (B)(6) 2014: DISCHARGE SUMMARY. ABDOMINAL BINDER ON WITH CLEAN, DRY, DRESSING UNDERNEATH. HAS NOT BEEN ON ANY PAIN MEDICATIONS FOR LAST 72 HOURS, ALERT & ORIENTED X3.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2014: ¿WAS DISCHARGED HOME WITH STAPLES INTACT AS WELL AS JACKSON-PRATT BULB DRAIN TO BULB SUCTION. MIDLINE INCISION INTACT WITHOUT EXUDATES OR DRAINAGE. STAPLES INTACT AND WELL-APPROXIMATED. JACKSON-PRATT DRAIN TO LEFT UPPER QUADRANT DRAINING SEROUS DRAINAGE WITH MAROON DRAINAGE AS WELL. BULB INTACT. NO LONGER HAS ABDOMINAL HERNIA. DRAIN PUTTING OUT APPROXIMATELY 10 TO 20 ML SEROUS FLUID SINCE DISCHARGE. DRAIN WITH SEROSANGUINEOUS IN LEFT HEMI-ABDOMEN, LESS THAN 5 ML FLUID. REMOVED AT BEDSIDE WITHOUT ANY COMPLICATIONS. STAPLES LEFT IN PLACE. HAS EXTENSIVE ABDOMINAL BRUISING; HOWEVER, NO EVIDENCE OF INFECTION.¿ (B)(6) 2014: ¿INCISION HEALED STAPLES REMOVED, NO FLUID COLLECTIONS, ERYTHEMA OR EVIDENCE OF ANY RECURRENCE OF HERNIA. WILL LIMIT ACTIVITY FOR NEXT 2 TO 3 WEEKS, THEN SLOWLY INCREASE LIFTING.¿ (B)(6) 2014: ¿WELL-HEALED SCAR ABDOMINAL MIDLINE, NO EVIDENCE OF DEHISCENCE, ALTHOUGH I CAN NOW FEEL THE PUMP [SIC] AND HE WAS CONCERNED THAT MAYBE THE HERNIA RECURRED, ALTHOUGH I DO NOT FEEL DEFECT IN INCISION, NOR IN MESH REPAIR.¿ (B)(6) 2014: ¿CHEST REVEALS WELL-HEALED STERNOTOMY SCAR EXTENDING ALL THE WAY DOWN INTO THE ABDOMEN. THERE IS SOME FULLNESS AND A MASS-LIKE DENSITY WHERE HE PREVIOUSLY HAD HIS MESH AND HERNIA REPAIR.¿ (B)(6) 2014: CT COLONOGRAPHY. ¿VENTRAL ABDOMINAL WALL HERNIA REPAIR WITH MESH WITH LEFT LATERAL WALL HERNIA SEEN LATERAL TO THE END OF THE MESH.¿ (B)(6) 2015: REDO STERNOTOMY. EXTENSIVE MEDIASTINAL LYSIS OF ADHESIONS IN EXCESS OF 1 HOUR. ORTHOTOPIC HEART TRANSPLANT USING BICAVAL ANASTOMOTIC TECHNIQUE. REMOVAL OF HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE AND DRIVELINE. REMOVAL OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR GENERATOR AND LEADS. FINDINGS AT SURGERY: ¿IT APPEARED PART OF THE LOWER ASPECT OF THE STERNUM HAD BEEN REMOVED AS PART OF THE PATIENT¿S TREATMENT FOR INFECTION. THERE WAS VERY LITTLE FASCIAL TISSUE LEFT IN THIS AREA, AND AS PART OF CLOSURE WE DID CLOSE THIS AREA CAREFULLY GRABBING THE FASCIA WITH INTERRUPTED FIGURE-OF-EIGHT #2 ETHIBOND PERMANENT SUTURES TO TRY AND PREVENT THE PATIENT FROM HAVING A FASCIAL DEHISCENCE .¿ (B)(6) 2016: ¿SUSPECTED RECURRENCE OF VENTRAL HERNIA. RECENTLY PATIENT STARTED TO NOTICE INCREASED UPPER GI SYMPTOMS, MAINLY IN FORM OF REFLUX WITH SOME NAUSEA AND ABDOMINAL DISCOMFORT UPPER ABDOMEN, MAINLY ON LEFT AT SITE OF HERNIA. HAS CONSTANT SENSATION OF GURGLING IN AREA OF PREVIOUS HERNIA, WITH LOOSE BOWEL MOVEMENTS AND DIARRHEA. HAS LOST APPROXIMATELY 130 POUNDS AND CONTINUES TO TRY TO LOSE MORE WEIGHT . EXAM: PROTUBERANT ABDOMEN, MAINLY IN UPPER PART, CONSISTENT WITH LARGE VENTRAL HERNIA. HAS LONG MIDLINE INCISION. HAS POSITIVE COUGH IMPULSE IN THE MASS. NO CLEAR DEFECT COULD BE IDENTIFIED; HOWEVER, THE MESH COULD BE PALPATED . INGUINAL HERNIA ORIFICES ARE NORMAL. IMAGING: LAST CROSS-SECTIONAL IMAGING WAS DONE 10/14. HOWEVER, THERE IS NO CROSS-SECTIONAL IMAGING SINCE THEN. THIS DOES SHOW PRESENCE OF A HERNIA AND SMALL DEFECT IN UPPER PART OF THE WOUND . PATIENT WITH SIGNS AND SYMPTOMS SUGGESTIVE RECURRENCE OF VENTRAL HERNIA. HAS CONCOMITANT AND PROGRESSIVELY WORSENING UPPER GI SYMPTOMS, MAINLY IN FORM OF REFLUX. WILL NEED TO RESTUDY THE CURRENT ANATOMY OF THE PATIENT¿S ANTERIOR ABDOMINAL WALL SINCE HE HAD A LONG TIME SINCE THE LAST SURGICAL INTERVENTION AND LAST CROSS-SECTIONAL IMAGING. SOME OF THE GI COMPLAINT COMPONENTS NOT DIRECTLY RELATED TO HIS HERNIA, AND THESE CAN BE BETTER ADDRESSED BY FORMAL GI CONSULTATION AND POSSIBLE UPPER GI.¿ (B)(6) 2016: ¿UPPER ABDOMINAL WALL EVENTRATION WITH POSSIBLE HERNIA. WILL OBTAIN CT ABDOMEN AND PELVIS. NEED TO EVALUATE INTEGRITY OF UPPER ABDOMINAL WALL. I BELIEVE GI SYMPTOMS ARE EXACERBATING ABDOMINAL WALL DEFECT AND NOT VICE VERSA.¿ (B)(6) 2016: CT ABDOMEN/PELVIS. ¿LARGE RECURRENT ABDOMINAL WALL VENTRAL HERNIA WITH DETACHED MESH, EXTENDING FROM THE XIPHOID PROCESS FOR DISTANCE OF APPROXIMATELY 24 CM. HERNIA CONTAINS UNOBSTRUCTED AND NON-INCARCERATED LOOPS OF SMALL BOWEL AND COLON. THERE ARE 2 ADDITIONAL SMALL VENTRAL HERNIAS ABOVE AND BELOW THE AREA OF THE MESH REPAIR.¿ (B)(6) 2016: ¿ATTEMPT AT RECONSTRUCTION AND PLACEMENT OF MESH WAS UNSUCCESSFUL, NOW HAS HERNIA AND ABDOMINAL PAIN EXCLUSIVELY RELATED TO HERNIA AREA. HAS PAIN IN THE AREA, PRESENT ALL DAY . HOLDS THE AREA, NOTES IT¿S BLOATED AND SWOLLEN, FEELS LIKE IT¿S GOING TO BURST, FEELS DISTENDED AND HE HAS A LOT OF GAS. EXAM: A LEFT UPPER QUADRANT LARGE VENTRAL HERNIA IS NOTED . BOWEL COULD BE PALPABLE THROUGH THE HERNIA. NO SPECIFIC ABDOMINAL WALL OPENING AND EXIT COULD BE PALPATED, BUT THERE ARE CLEARLY LOOPS OF BOWEL JUST BENEATH THE HERNIA. PATIENT UNDOUBTEDLY WILL NEED SURGERY FOR HERNIA. I INDICATED TO PATIENT THE REAL QUESTION IS IF ANYTHING ELSE IS PRESENT BESIDES THE HERNIA WHICH WILL NEED TO BE ADDRESSED.¿ (B)(6) 2016: ¿HAS BEEN HAVING RECURRENT NAUSEA AND VOMITING. STATES HE VOMITS AT LEAST ONCE A WEEK, SOMETIMES TWICE. HAS BEEN SUFFERING FROM DIARRHEA AND CONSTIPATION, ABDOMEN PROTRUDES QUITE SIGNIFICANTLY. HE STATES THAT THIS IS REDUCIBLE AND HAS NO SYMPTOMS OF STRANGULATION. WEIGHT HAS STAYED THE SAME FOR APPROXIMATELY PAST 3 MONTHS. EXAM: QUITE NOTICEABLE ABDOMINAL PROTRUSION IN UPPER ABDOMEN, AS WELL AS SOME SMALLER HERNIAS THAT CAN BE PALPATED ON EXAM IN LOWER ABDOMEN. ABDOMEN SOFT, NO TENDERNESS TO PALPATION. ON IMAGING, IT LOOKS LIKE HE HAS A LARGE AREA OF DOMAIN LOSS, AND WE WOULD LIKE TO DISCUSS WITH PLASTIC SURGERY ABOUT POSSIBLE OPTIONS FOR RECONSTRUCTION. ENCOURAGED PATIENT TO CONTINUE TO LOSE WEIGHT.¿ REVISION #1 PREOPERATIVE COMPLAINTS: (B)(6) 2017: ¿PATIENT¿S INTESTINAL CONTINUITY IS INTACT BUT HE DOES HAVE SOME ISSUES WITH SOME BLOATING, REFLUX AND MILD GENERAL ABDOMINAL PAIN. CT SCAN SHOWS VERY LARGE HERNIA. THE PIECE OF GORE-TEX MESH IS FREE FLOATING IN THE MIDST OF THIS. IT STARTS AT HIS COSTAL MARGIN WHERE THE GREATEST AMOUNT OF HERNIA IS LOCATED, BUT DOES EXTEND DOWN BELOW THE UMBILICUS. EXAM: STERNAL SCAR IS WIDENED AND MILDLY THICKENED. HAS VERY LARGE HERNIA BEGINNING AT COSTAL MARGIN AND EXTENDING DOWN BELOW UMBILICUS. IT¿S ONE LARGE HERNIA AND DOES APPEAR AS THOUGH THERE IS SOME LOSS OF DOMAIN. NO EVIDENCE OF ANY INCARCERATION OR STRANGULATION; HOWEVER, THE HERNIA BASE WIDTH IS LARGE ENOUGH THAT THIS IS UNLIKELY TO OCCUR. RIGHT RECTUS MUSCLE IS GONE. THE GORE-TEX MESH IS STILL FREE FLOATING IN THE MIDST OF THIS HERNIA. THERE IS SIGNIFICANT SHORTENING OF THE OBLIQUES. PLACING A TISSUE EXPANDER IN THE OBLIQUES WOULD NOT HELP THE COMPONENT AT THE COSTAL MARGIN. UNFORTUNATELY WITH THE SIZE OF THIS HERNIA AND ITS LOCATION AS WELL AS HIS PRIOR SURGERY LIMITING THINGS SUCH AS COMPONENT SEPARATION, I THINK THAT THE ONLY GOOD WAY WILL BE A LARGE OPEN PROCEDURE TO BRIDGE THIS GAP. FIXATION AROUND THE COSTAL MARGIN CAN BE CHALLENGING BUT I THINK WITH SOME SUTURES AROUND THE COSTAL MARGIN AND RIBS ITSELF WE CAN ANCHOR THIS APPROPRIATELY. (B)(6) 2017: INDICATION: ¿HISTORY OF PRIOR ORTHOTOPIC HEART TRANSPLANT AS WELL AS RECURRENT VENTRAL INCISIONAL HERNIAS. HIS PRIOR MESH REPAIR HAD FAILED WITH THE DEVELOPMENT OF A LARGE EPIGASTRIC MIDLINE HERNIA. THE RISKS, BENEFITS, AND ALTERNATIVES OF AN OPEN REPAIR WITH MESH WERE DISCUSSED WITH THE PATIENT AND HE ELECTED TO PROCEED. WRITTEN INFORMED CONSENT WAS OBTAINED.¿ REVISION #1 PROCEDURE: OPEN REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH 23CM X 20CM POLYPROPYLENE MESH. REVISION #1 DATE: (B)(6) 2017 [HOSPITALIZATION DATES (B)(6) 2017]. ¿THEN A PORTION OF THE PATIENT¿S MIDLINE WOUND WAS REOPENED. HIS WIDE MIDLINE SCAR WAS EXCISED FROM THE AREA OF HIS SUBXIPHOID REGION DOWN TO HIS LOWER ABDOMEN. ELECTROCAUTERY WAS USED TO DISSECT DOWN THROUGH THE SUBCUTANEOUS TISSUES AND THROUGH THE ABDOMINAL WALL SCAR. THE MIDLINE INCISIONAL HERNIA WAS LARGE AND WE ENCOUNTERED THE HERNIA SAC. THIS WAS EVENTUALLY OPENED. THERE WAS NO INJURY TO THE BOWEL DURING THIS PROCESS. THE BOWEL ITSELF WAS NOT ADHERENT TO THE HERNIA SAC; HOWEVER, THE THICK SAC WAS CIRCUMFERENTIALLY DISSECTED FREE FROM THE EDGES OF THE LEFT RECTUS. A PIECE OF GORE MESH WAS NOTED TO BE ADHERENT TO THE MUSCULATURE OF THE RIGHT ABDOMINAL WALL. THIS HAD CLEARLY DETACHED FROM THE LEFT RECTUS. THIS PATIENT ADDITIONAL HAD A HISTORY OF PRIOR RIGHT RECTUS FLAP FOR THE TREATMENT AN OLD DRIVELINE INFECTION AND THEREFORE HIS RIGHT RECTUS HAD BEEN PREVIOUSLY MOBILIZED TO THE EPIGASTRIUM. THE HERNIA SAC WAS DETACHED FROM THE MEDIAL EDGE OF THE GORE MESH. LATERALLY, THIS MESH WAS FOUND TO BE WELL-INCORPORATED AND WELL FIXED IN PLACE TO THE MUSCULATURE OF THE LEFT ABDOMINAL WALL LATERALLY AT THE RIGHT OBLIQUES. THE HERNIA SAC WAS DISSECTED INFERIORLY AS WELL AND EXCISED CIRCUMFERENTIALLY. GIVEN THAT THE RIGHT RECTUS WAS NO LONGER PRESENT FOR CLOSURE OF THE ABDOMINAL WALL GIVEN ITS PRIOR MOBILIZATION FOR USE AS A FLAP, A RETRORECTUS PLANE WAS CREATED POSTERIOR TO THE LEFT RECTUS. THIS ALLOWED FOR ADDITIONAL MOBILIZATION OF THE LEFT POSTERIOR SHEATH. ONCE THIS WAS MOBILIZED, IT WAS SEEN TO APPROXIMATE WELL WITH THE TISSUES IN THE LAYER WHICH INCLUDED THE PREVIOUSLY PLACED AND NOW INCORPORATED GORE MESH. THIS LAYER WAS THEN CLOSED USING RUNNING 0 PROLENE CREATING CLOSURE OF THE ABDOMINAL CAVITY WITHOUT TENSION. ONCE THIS LAYER WAS CLOSED, A PIECE OF 23 X 20 CM STANDARD WEIGHT POLYPROPYLENE MESH WAS CUT AND PLACED WITHIN THE ABDOMINAL WALL. IT WAS MATTRESSED IN A RETROMUSCULAR PLANE CIRCUMFERENTIALLY USING 0 PROLENE SUTURES. PRIOR TO CLOSURE OF EACH LAYER, HEMOSTASIS WAS CHECKED AND ASSURED USING ELECTROCAUTERY. PRIOR TO CLOSURE AS WELL THE ABDOMEN WAS IRRIGATED AND CHECKED FOR HEMOSTASIS. ANTIBIOTIC IRRIGATION WAS USED IN THE RETROMUSCULAR PLANE. THE EFFLUENT WAS REMOVED WITH SUCTION. PRIOR TO PLACEMENT OF THE POLYPROPYLENE MESH, IT WAS ENSURED THAT THE POSTERIOR LAYER WAS CLOSED COMPLETELY, THUS PREVENTING ANY CONTACT OF THE VISCERA WITH THE MESH. THEN THE MUSCULAR LAYER OVERLYING THE MESH WAS PRIMARILY CLOSED USING 0 VICRYL. A 19-FRENCH FLUTED J-P DRAIN WAS THEN INSERTED INTO THE SUBCUTANEOUS SPACE. THE SUBCUTANEOUS TISSUES WERE SUTURED DOWN TO THE CLOSED MUSCULAR LAYER IN ORDER TO CLOSE ANY DEAD SPACE BENEATH THE SUBCUTANEOUS TISSUES. THIS WAS DONE USING 2-0 VICRYL SUTURES IN INTERRUPTED FASHION. THEN 3-0 VICRYL SUTURES WERE USED TO REAPPROXIMATE THE SUBCUTANEOUS TISSUES AND THE DERMIS FOR A DEEP DERMAL CLOSURE. ONCE THE DERMIS WAS CLOSED, THE SKIN WAS CLOSED WITH RUNNING 4-0 MONOCRYL. THE ABDOMEN WAS THEN WASHED, DRIED, AND STERILE DRESSINGS WERE PLACED. A 4-0 PROLENE SUTURE WAS USED TO SECURE THE J-P DRAIN TUBING IN PLACE.¿ (B)(6) 2017: DISCHARGE SUMMARY. ¿JACKSON-PRATT DRAIN WAS LEFT IN PLACE PER PLASTIC SURGERY RECOMMENDATIONS AND CONTINUED SEROSANGUINEOUS OUTPUT.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2017: ¿DRAIN PUTTING OUT LESS THAN 10 CC PER DAY. STAPLES INTACT MIDLINE. FAINT, SMALL HEME CRUST PRESENT OVER MIDLINE INCISION. AT INFERIOR ASPECT OF ABDOMEN HAS JACKSON-PRATT DRAIN THAT IS SUTURED AND TACKED. THERE IS FIBROUS AND SEROSANGUINEOUS MATERIAL LESS THAN 5 TO 8 CC IN BULB. VERY FAINT ERYTHEMA SURROUNDING DRAIN SITE. STAPLES AND JACKSON-PRATT DRAIN REMOVED TODAY.¿ (B)(6) 2017: ¿PATIENT HAD SOME CONCERNS JUST BELOW XIPHOID AND LEFT COSTAL MARGIN THAT THERE MAY BE A RECURRENCE OF HIS HERNIA . ON EXAM INCISION IS HEALED. VAST MAJORITY SHOWS GOOD CONTINUITY OF THE FASCIA AND ANTERIOR ABDOMINAL WALL. BELOW THE LEFT COSTAL MARGIN AND XIPHOID, HOWEVER, THERE IS AN AREA OF APPROXIMATELY 5 X 9 CM WHERE THERE APPEARS TO BE A RECURRENT HERNIA. THERE IS A FAIRLY WELL-DEFINED FASCIAL RING, EASILY REDUCIBLE, NO OVERLYING SKIN CHANGES. I DO THINK HE HAS A RECURRENT HERNIA, QUESTION IS WHAT TO DO WITH THIS. I DO THINK ULTIMATELY IT WILL REQUIRE REPAIR, THE QUESTIONS IS HOW. I ALSO THINK IT¿S BEST TO WAIT A LITTLE BIT LONGER TO ALLOW ALL THE INFLAMMATORY CHANGE FROM THE RECENT PROCEDURE TO RESOLVE AND ALSO ALLOW HIM TO REGAIN SOME OF HIS STRENGTH. THE QUESTION IS WHETHER THIS COULD POTENTIALLY BE DONE EITHER LAPAROSCOPICALLY OR IF WE SHOULD DO THIS OPEN.¿ (B)(6) 2017: CT ABDOMEN/PELVIS. ¿NEW/RECURRENT VENTRAL HERNIA WITH FASCIAL DEFECT BELOW THE XIPHOID, MOSTLY TO THE LEFT OF MIDLINE. NEW POSTOPERATIVE CHANGES FOLLOWING INTERVAL HERNIA REPAIR.¿ (B)(6) 2017: ¿LOOKS AS THOUGH THERE IS A RECURRENT HERNIA LEFT UPPER QUADRANT. NO EVIDENCE OF OBSTRUCTION, NO SIGNS OF FLUID COLLECTIONS. ON EXAM NO ERYTHEMA, SKIN REMAINS HEALED. DOES APPEAR TO HAVE A HERNIA THAT IS REDUCIBLE. FORTUNATELY AT THIS TIME THERE ARE NO SIGNS OF OBSTRUCTION AND I THINK THAT CHANCE IS FAIRLY LOW.¿ IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2017: INDICATION: ¿HISTORY OF ORTHOTOPIC HEART TRANSPLANT AS WELL AS RECURRENT INCISIONAL HERNIAS. AFTER HIS MOST RECENT REPAIR ON (B)(6) 2017, HE DEVELOPED EPIGASTRIC BULGE AND WAS SHOWN TO HAVE A NEW HERNIA. THE RISKS, BENEFITS, AND ALTERNATIVES TO LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH WERE DISCUSSED WITH THE PATIENT AND HE DID WISH TO PROCEED WITH SURGERY AND AN INFORMED CONSENT WAS SIGNED.¿ IMPLANT #2 PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH 16 X 18 CM GORE-TEX DUALMESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC06/15977199, 18CM X 24CM X 1MM THICK] [NO ALLEGATIONS FOR THIS DEVICE, NOT ADDED TO THE COMPLAINT]. IMPLANT #2 DATE: (B)(6) 2017 (HOSPITALIZATION (B)(6) 2017). DESCRIPTION OF HERNIA BEING TREATED: ¿IN THE RIGHT UPPER QUADRANT, BELOW THE COSTAL MARGIN, SKIN INCISION WAS MADE OF APPROXIMATELY 5 MM AND VERESS NEEDLE WAS INSERTED. THE ABDOMEN WAS INSUFFLATED WITHOUT DIFFICULTY AND AN OPTIVIEW TROCAR WAS USED TO INSERT A 5 MM PORT INTO THE RIGHT UPPER QUADRANT. TWO ADDITIONAL 5 MM PORTS WERE INSERTED ALONG THE RIGHT SIDE OF THE ABDOMEN AND ONE 5 MM PORT WAS INSERTED IN THE LEFT UPPER QUADRANT OF THE ABDOMEN. ON SURVEYING THE ABDOMEN, THERE WERE SOME ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WHICH INVOLVED BOTH SMALL AND LARGE INTESTINE. THE COLON WAS WITHIN THE EPIGASTRIC HERNIA SAC ITSELF. WE PROCEEDED TO TAKE THESE ADHESIONS DOWN WITH A COMBINATION OF COLD SCISSORS, HOT SCISSORS, AND THE HARMONIC SCALPEL. THERE WERE NO INJURIES NOTED TO ANY OF THE BOWEL DURING THIS DISSECTION.¿ IMPLANT SIZE AND FIXATION: ¿WE THEN PLACED SPINAL NEEDLES APPROXIMATELY 5 CM FROM ALL FASCIAL EDGES OF THE VENTRAL HERNIA AND MEASURED THIS INTERNALLY USING A TAPE MEASURE AND IT WAS SHOWN TO BE 16 X 18 CM MESH REQUIRED FOR COVERAGE OF 5 CM OVERLAP IN ALL DIRECTIONS ON THE HERNIA. WE USED A 24 X 18 CM GORE-TEX DUALMESH WHICH WE CUT DOWN TO THE APPROPRIATE SIZE AND ROUNDED THE CORNERS. THE GORE-TEX SUTURES WERE USED IN ALL FOUR QUADRANTS OF THE MESH. THE MESH WAS THEN ROLLED UP AND INSERTED INTO THE ABDOMEN THROUGH THE LEFT UPPER QUADRANT PORT SITE. SMALL INCISIONS WERE MADE NEXT TO EACH SPINAL NEEDLE AND A TRANSFASCIAL SUTURE DEVICE WAS USED ALONG WITH MARYLAND GRASPERS IN ORDER TO ELEVATE THE TRANSFASCIAL SUTURES THROUGH THE ABDOMEN ON ALL SIDES EXCEPT THE SUPERIOR PORTION OF THE MESH. THESE WERE TIED DOWN ABOVE THE LEVEL OF THE SKIN AND THE SUPERIOR GORE-TEX SUTURES WERE CUT OFF OF THE MESH AS THEY WOULD HAVE BEEN IMPOSSIBLE TO SECURE AS THEY WOULD HAVE REQUIRED CHEST FIXATION. WE THEN USED THE PROTACK TO SECURE THE MESH CIRCUMFERENTIALLY AND PLACED FIVE ADDITIONAL TRANSFASCIAL GORE-TEX SUTURES, U-STITCHES IN ORDER TO FURTHER FIXATE THE MESH INTO PLACE . AT THE END OF THE PROCEDURE, WE DID HAVE A GOOD COVERAGE ON ALL OF VENTRAL HERNIA. THE PORTS WERE REMOVED UNDER DIRECT VISUALIZATION.¿ (B)(6) 2017: DISCHARGE SUMMARY. ¿DO NOT LIFT GREATER THAN 15 POUNDS FOR 6 WEEKS.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2017: ¿HAVING OCCASIONAL PAIN WITH MOVEMENT. FEELS PRESSURE-LIKE SENSATION UPPER ABDOMINAL REGION, WORSE WHEN GETTING UP FROM LYING POSITION. EXAM: WELL-HEALING SCARS BOTH UPPER CHEST AND ACROSS UPPER MIDLINE OF ABDOMEN, PORT SITES HEALING UNREMARKABLY, NO ERYTHEMA, ECCHYMOSIS OR WARMTH. QUESTIONABLE AREA OF SEROMA BUT AGAIN NO WARMTH OR DISCOLORATION OF SKIN NOTED. ASSESSMENT: STATUS POST LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH GORE-TEX DUAL MESH. CONTINUE NO HEAVY LIFTING, PUSHING, PULLING GREATER THAN 15 POUNDS FOR 6 WEEKS FROM SURGERY. (B)(6) 2018: ¿POSTTRANSPLANT COURSE, GRADUAL PROGRESSIVE WEIGHT GAIN OF 65 POUNDS.¿ (B)(6) 2018: ¿HAS NOT BEEN EXERCISING OR TAKING VERY GOOD CARE OF HIMSELF AS OF LATE BECAUSE HE HAS BEEN EXTREMELY BUSY WITH HIS OCCUPATION .¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE 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. BASED UPON THE INFORMATION RECEIVED, THE DEVICE REMAINS IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE MANUFACTURING 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.
D4: ADDED LOT #, EXPIRATION DATE, DI #. H4: ADDED DEVICE MANUFACTURE DATE. H6: CONCLUSION CODE REMAINS UNCHANGED.
B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: NO RECORDS PRIOR TO 9/2/08; INCLUDING STOMACH STAPLING, PACEMAKER AND LAPAROSCOPIC CHOLECYSTECTOMY. (B)(6) 2008: MAYO CLINIC ROCHESTER. LAWRENCE J. SINAK, MD. TRANSFER SUMMARY. PLANNED FOR IMPLANTATION OF HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE TODAY AS BRIDGE THERAPY TO HEART TRANSPLANTATION. NO CONTRAINDICATIONS TO HEART TRANSPLANT EXCEPT UNDERLYING OBESITY. [MISSING RECORDS: OPERATIVE NOTE FOR IMPLANTATION OF VENTRICULAR ASSIST DEVICE AND CLOSURE OF PATENT FORAMEN OVALE ON 09/02/08 WITH MESH NOT PROVIDED.] PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿GORE-TEX MESH¿ WERE NOT PROVIDED. (B)(6) 2009: MAYO CLINIC ARIZONA. MICHAEL MARRANCA, PA-C. HISTORY & PHYSICAL. HAS BOIL OR PIMPLE TYPE LESION ON LOWER POLE OF STERNAL INCISION WHERE HAS LARGE DENSE KELOID. OVER LAST 48 HOURS IT STARTED TO BECOME ERYTHEMATOUS AND EXPRESSED PUS. IMMEDIATELY ADMITTED, WORKED UP FOR POSSIBLE DEVICE INFECTION. EXAM: WELL-HEALED STERNOTOMY SCAR COVERED WITH KELOID MOST NOTICEABLE IN LOWER POLE OF INCISION. AT VERY LOWER POLE OF INCISION WHERE KELOID IS MOST DENSE HAS AREA OF ERYTHEMA APPROXIMATELY 3 X 3 CM WITH FLUCTUANCE EXTENDING OUT APPROXIMATELY 4 CM. WAS ABLE TO EXPRESS FRANK SEROSANGUINEOUS PUS FROM THE WOUND. WOUND WAS PROBED, FOUND TO BE HITTING THE DEVICE THROUGH SMALL PINHOLE THAT IS EXPRESSING THE PURULENCE. WHITE COUNT 10.6. (B)(6) 2009: MAYO CLINIC ARIZONA. J. KUJAK, MD. RADIOLOGY-CT THORAX WITH CONTRAST. INDICATION: ASSESS FOR SUBCUTANEOUS OR INTRA-ABDOMINAL EXTENSION. IMPRESSION: LOCULATED FLUID SURROUND HARDWARE WITHIN THE CUTANEOUS AND SUBCUTANEOUS TISSUES OF THE VENTRAL UPPER ABDOMEN WITHOUT EXTENSION INTO THE INTRAPERITONEAL CAVITY OR CHEST. DIFFERENTIAL CONSIDERATIONS INCLUDE POSTOPERATIVE SEROMA OR POSSIBLY ABSCESS. (B)(6) 2009: MAYO CLINIC ARIZONA. JENNIFER KUJAK, MD. RADIOLOGY-CT ABDOMEN WITH CONTRAST. STREAK ARTIFACT FROM LEFT VENTRICULAR ASSIST DEVICE, MILDLY LIMITED VISUALIZATION OF UPPER ABDOMEN. IMPRESSION: LIKELY BILATERAL RENAL CYSTS AND 0.8 CM LEFT RENAL ANGIOMYOLIPOMA. SMALL PARAUMBILICAL FAT-CONTAINING HERNIA. (B)(6) 2009: MAYO CLINIC ARIZONA. JANIS BLAIR, MD. CONSULTATION-INFECTIOUS DISEASE. DR. ARABIA EVALUATED WOUND, AREA PROBED AND FOUND TO BE IN COMMUNICATION WITH HARDWARE. PATIENT HAS NOT HAD ANY SYSTEMIC SYMPTOMS OF FEVERS, CHILLS, OR SWEATS. NO CHANGE IN ENERGY. HAS NOT HAD ANY OTHER ISSUES WITH DRIVELINE SITE NOR PREVIOUS SURGICAL SITE. ABDOMINAL EXAM: NO OBVIOUS CELLULITIS, NO PALPABLE TENDERNESS ALONG PATHWAY OF DRIVELINE SITE. BLOOD CULTURES NEGATIVE TO DATE. CULTURE OF FLUID COMING FROM CHEST INCISION NO GROWTH TO DATE. ADDENDUM 02/04/09: PT HAS HAD SURGICAL DEBRIDEMENT AND IS DOING WELL. NONE OF THE CULTURES HAVE COME BACK POSITIVE. NOW WE ARE EXTENDING CULTURING TECHNIQUE TO LOOK FOR UNUSUAL ORGANISMS AS WELL. (B)(6) 2009: MAYO CLINIC ARIZONA. WILLIAM CASEY, MD. CONSULTATION-PLASTIC SURGERY. PHYSICAL EXAM: STERNAL WOUND SLIGHTLY HYPERTROPHIC, WELL-HEALED. AT AROUND LEVEL OF XIPHOID THERE IS 3 TO 5-MM SINUS TRACT DRAINING SMALL AMOUNT OF CLEAR SEROUS FLUID. NO SURROUNDING ERYTHEMA. MILD FLUCTUANCE BENEATH THIS. ABDOMEN: WELL-HEALED MIDLINE INCISION FROM PREVIOUS GASTRIC STAPLING PROCEDURE. NO EVIDENCE OF ANY HERNIAS. DRIVELINE IS ON RIGHT SIDE OF ABDOMEN WHICH APPEARS CLEAN WITH NO EVIDENCE OF ANY SURROUNDING INFECTION. IMPRESSION: HAS FLUID AROUND HIS DEVICE AND AN OVERLYING WOUND. PRESENTS A SERIOUS PROBLEM, AS A POTENTIAL INFECTION OF THIS DEVICE WOULD BE DEVASTATING. BASED ON ELEVATED WHITE BLOOD CELL COUNT, THE FACT THAT HE HAD ERYTHEMA AT TIME OF ADMISSION, AND BASED ON CT FINDINGS, I THINK THE BEST OPTION WOULD BE TO OPEN & DEBRIDE THE WOUND. I THINK A RIGHT VERTICAL RECTUS ABDOMINUS MUSCLE FLAP FOR COVERAGE WOULD BE THE IDEAL. UNDERSTANDS THERE IS CHANCE OF HERNIA FORMATION. WE WOULD USE ALLODERM TO RECREATE THE ABDOMINAL WALL, AND MINIMIZE CHANCE OF HERNIA. (B)(6) 2009: MAYO CLINIC ARIZONA. WILLIAM CASEY, MD; F. A. ARABIA, MD. OPERATIVE REPORT. PREOP DIAGNOSIS/INDICATION: OPEN CHEST WOUND WITH PROBABLE INFECTION OF LEFT VENTRICULAR ASSIST DEVICE. ASSISTANT: B. J. HEMMINGER, PA-C. POSTOP DIAGNOSES: OPEN CHEST WOUND WITH INFECTION OF LEFT VENTRICULAR ASSIST DEVICE, AS WELL AS THE GORE-TEX MESH AROUND THE DEVICE. UMBILICAL HERNIA. VENTRAL INCISIONAL HERNIA. PROCEDURE: IRRIGATION AND DEBRIDEMENT OF CHEST WOUND WITH SHARP DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, DEEP FASCIA, AS WELL AS REMOVAL OF INFECTED GORE-TEX MESH. A PEDICLED RIGHT VERTICAL RECTUS ABDOMINIS MUSCLE FLAP TO THE CHEST. PEDICLED OMENTAL FLAP TO THE CHEST. REPAIR OF BOTH UMBILICAL AND VENTRAL INCISIONAL HERNIAS WITH ALLODERM (8 X 16-CM SHEET OF EXTRA THICK ALLODERM UNDERLAY, AS WELL AS 8 X 16-CM SHEET OVERLAY AROUND THE POSTERIOR RECUTS SHEATH). ANESTHESIA: GENERAL VIA ENDOTRACHEAL TUBE. ESTIMATED BLOOD LOSS FOR THE PROCEDURE: 400 ML. COMPLICATIONS: NONE. SPECIMENS: TISSUE CULTURES WERE TAKEN AS WELL AS SWABS. DISPOSITION: THE PATIENT WAS TRANSFERRED IN A STABLE CONDITION TO THE INTENSIVE CARE UNIT. DESCRIPTION OF PROCEDURE: ¿I SAW THE PATIENT IN THE PREOPERATIVE HOLDING ROOM AND AGAIN DISCUSSED DEBRIDEMENT OF HIS CHEST WOUND. WE TALKED ABOUT A PEDICLED RIGHT VERTICAL RECTUS ABDOMINIS MUSCLE FLAP IN ADDITION TO THE OVERLYING SKIN AND/OR THE POSSIBILITY OF USING AN OMENTAL FLAP. WE TALKED ABOUT THE POSSIBILITY OF BLEEDING, INFECTION, ONGOING INFECTION AROUND THE DEVICE, WOUND HEALING ISSUES, HERNIAS, INJURY TO UNDERLYING STRUCTURES, ETC. HE UNDERSTOOD AND ASKED THAT WE PROCEED. HE WAS BROUGHT TO OPERATING ROOM 8, PLACED SUPINE, AND GIVEN A GENERAL ANESTHETIC. HIS CHEST AND ABDOMEN WERE PREPPED AND DRAPED IN A STERILE FASHION. WITH THE ASSISTANCE OF DR. ARABIA, THE LOWER PORTION OF THIS PREVIOUS STERNOTOMY INCISION WAS REOPENED. THE SINUS TRACT WAS FOLLOWED DOWN TO THE UNDERLYING SOURCE. THIS EXTENDED TO THE MEDIAL ASPECT OF THE DRIVELINE FOR THE LEFT VENTRICULAR ASSIST DEVICE. THIS THEN TRACKED ALONG THE SMOOTH PORTION TO THE DEVICE ITSELF. THE GRANULATION TISSUE AROUND THE DEVICE WAS THEN SHARPLY EXCISED. THERE WAS GROSS PURULENCE AROUND PREDOMINANTLY THE DEVICE ITSELF. BOTH TISSUE CULTURES AND WOUND CULTURES WITH SWABS WERE TAKEN AND SENT TO MICROBIOLOGY. THERE WAS GROSS PURULENCE AROUND THE GORE-TEX THAT SURROUNDED THE DEVICE ITSELF. ALL OF THE GORE-TEX WAS THEN REMOVED INCLUDING THE STAPLES AND PROLENE SUTURES THAT ANCHORED IT IN PLACE. AFTER ALL THE GRANULATION TISSUE AND EDEMATOUS-LOOKING TISSUE AROUND THE DEVICE WAS REMOVED, THE WOUND WAS IRRIGATED WITH 3 L OF ANTIBIOTIC IRRIGATION. THIS LEFT A RELATIVELY LARGE CAVITY AROUND THE DEVICE AS WELL AS THE MEDIAL 10 CM OF THE DRIVELINE. THE WOUND WAS THEN TEMPORARILY PACKED. AT THIS POINT, A 20-CM LONG X 10-CM WIDE SKIN PADDLE WAS DESIGNED OVERLYING THE CENTRAL RIGHT RECTUS ABDOMINIS MUSCLE. THE PREVIOUSLY MIDLINE INCISION WAS REOPENED, CARRIED AROUND THE UMBILICAL STALK, AND DOWN TOWARDS THE SYMPHYSIS PUBIS MEDIALLY. IT WAS NOTED AT THIS POINT THAT THERE WAS A LARGE REDUCIBLE UMBILICAL HERNIA WITH THE OMENTUM WITHIN THIS PRESENT. THERE WAS ALSO A 5-CM VENTRAL INCISIONAL HERNIA IN THE EPIGASTRIC AREA WITH SOME INCARCERATED OMENTUM. THE MEDIAL ASPECT OF THE RIGHT ANTERIOR RECTUS SHEATH WAS THEN OPENED. THE MUSCLE WAS THEN DEVELOPED AWAY FROM THE POSTERIOR RECTUS SHEATH. THE DISSECTION WAS CARRIED CAUDALLY. THE FASCIA AROUND THE SKIN PADDLE WAS INCISED AROUND THE CENTRAL 12 X 10-CM PORTION OF THE PERIUMBILICAL RECTUS MUSCLE. THE DEEP INFERIOR EPIGASTRIC ARTERY AND VEIN WERE THEN IDENTIFIED. IT SHOULD BE NOTED THAT THE DEEP INFERIOR EPIGASTRIC SYSTEM WAS EXTRAORDINARILY LARGE. THIS SENT SEVERAL PERFORATORS IN THE PERIUMBILICAL AREA TO THE OVERLYING SKIN PADDLE. THE DEEP INFERIOR EPIGASTRIC SYSTEM WAS TEMPORARILY OCCLUDED WITH ATRAUMATIC VASCULAR CLAMPS. THE FLAP WAS THEN ELEVATED FROM AROUND THE POSTERIOR RECTUS SHEATH. THE DEEP SUPERIOR EPIGASTRIC ARTERY WAS RELATIVELY SMALL. MANY OF THE INTERCOSTAL VESSELS ALONG THE LATERAL BORDER OF THE RIGHT RECTUS MUSCLE WERE DIVIDED WITH BIPOLAR CAUTERY OR HEMOCLIPS. THE SUPERIOR TWO INTERCOSTAL VESSELS THAT ENTERED INTO THE LATERAL PORTION OF THE SUPERIOR RIGHT RECTUS MUSCLE WERE PRESERVED SO THAT NOT ONLY THE DEEP SUPERIOR EPIGASTRIC SYSTEM SUPPLIED THE FLAP, BUT ALSO THESE TWO INTERCOSTAL VESSELS. IT APPEARED AS THOUGH THE FLAP HAD ADEQUATE PERFUSION BASED ON THE SUPERIOR SYSTEM, AS WELL AS THESE INTERCOSTALS. THE DEEP INFERIOR EPIGASTRIC VESSELS WERE THEREFORE CLIPPED AND DIVIDED. THE FLAP WAS THEN ELEVATED AWAY FROM THE POSTERIOR RECTUS SHEATH. THROUGHOUT THE REMAINDER OF THE PROCEDURE; HOWEVER, THE SKIN PADDLE BECAME PROGRESSIVELY MORE CONGESTED BASED ON THE SUPERIOR SYSTEM AND THE DEEP INFERIOR EPIGASTRIC VESSELS, PREDOMINANTLY THE VEINS WERE SOMEWHAT ENGORGED. THE MUSCLE ITSELF, HOWEVER, APPEARED TO HAVE EXCELLENT PERFUSION. THE SKIN PADDLE WAS THEREFORE REMOVED AND THE FLAP WAS TRANSFERRED AS A MUSCLE FLAP ALONE. DUE TO THE FACT THAT THERE WAS SUCH A LARGE CAVITY AND THE FACT THAT THE OMENTUM APPEARED FREELY MOBILE THROUGH THE VISUALIZED UMBILICAL HERNIA DEFECT, WE OPTED TO ALSO PERFORM AN OMENTAL FLAP. THEREFORE, THE POSTERIOR RECUTS SHEATH WAS INCISED LONGITUDINALLY TO ENCOMPASS THE AREA AROUND THE UMBILICAL HERNIA. THE UMBILICAL STALK HAD BEEN EXCISED. THE OMENTUM WAS FREELY MOBILE. THERE WERE NO SIGNIFICANT INTRA-ABDOMINAL ADHESIONS. THE OMENTUM WAS FREED FROM THE TRANSVERSE COLON USING ELECTROCAUTERY, AS WELL AS LIGATURE DIVISION. THE OMENTUM WAS DIVIDED LATERALLY TOWARDS THE SPLENIC FLEXURE, LEAVING THE FLAP SUPPLIED PREDOMINANTLY FROM THE RIGHT GASTROEPIPLOIC SYSTEM WITH THE LATERAL PORTION MOBILIZED USING 0 VICRYL TIES. THE OMENTAL FLAP WAS THEN TRANSFERRED TOWARDS THE CHEST. AN 8 X 16-CM SHEATH OF EXTRA THICK ALLODERM WAS THEN REHYDRATED. THIS WAS THEN TACKED IN PLACE AS AN UNDERLAY USING INTERRUPTED 0 ETHIBOND HORIZONTAL MATTRESS SUTURES TACKED TO THE FULL-THICKNESS LEFT RECTUS SHEATH AND RECTUS MUSCLE, AS WELL AS THE RIGHT OBLIQUE FASCIA. THE POSTERIOR RECTUS SHEATH WAS THEN REAPPROXIMATED USING RUNNING 2-0 VICRYL SUTURE. ALTHOUGH THE FASCIA APPEARED TO HAVE RELATIVELY GOOD CONTINUITY EXCEPT FOR THE AREA WHERE THE OMENTAL FLAP WAS TRANSPOSED, THERE WAS STILL SOME MILD LAXITY. THEREFORE, AN ADDITIONAL 8 X 16-CM SHEET OF EXTRA THICK ALLODERM WAS AGAIN RECONSTITUTED AND THIS WAS PLACED AS AN ONLAY TACKED FROM THE LEFT ANTERIOR RECTUS SHEATH TO THE RESIDUAL PORTION OF THE LATERAL RIGHT ANTERIOR RECTUS SHEATH WITH INTERRUPTED AND RUNNING 0 ETHIBOND SUTURES. THE RIGHT RECTUS MUSCLE STILL WAS PINK AND WELL PERFUSED. AT THIS POINT, VANCOMYCIN ANTIBIOTIC-IMPREGNATED BEATS WERE THEN CREATED. THESE WERE ZIMMER PALACOS LV RADIOPAQUE BONE CEMENT BEADS. THESE WERE LOT #65014019. SEVEN OF THESE ANTIBIOTIC BEADS WERE THEN PLACED AROUND THE LEFT VENTRICULAR ASSIST DEVICE. THE OMENTAL FLAP WAS THEN WRAPPED AROUND THE ENTIRETY, BOTH ANTERIORLY, AS WELL AS POSTERIORLY OF THE LEFT VENTRICULAR ASSIST DEVICE. THIS WAS TACKED IN PLACE CIRCUMFERENTIALLY WITH A FEW INTERRUPTED 2-0 VICRYL SUTURES. THE RIGHT VERTICAL RECTUS MUSCLE WAS THEN ALSO PLACED ALONG THE CENTRAL PORTION OF THE DEVICE, AS WELL AS OVER THE DRIVELINE, PARTICULARLY THE PORTION OVERLYING THE FELT-COATED PORTION OF THE DRIVELINE. THIS WAS ALSO TACKED IN CIRCUMFERENTIALLY WITH INTERRUPTED 2-0 VICRYL SUTURES. TWO 19-FRENCH ROUND BLAKE DRAINS WERE THEN PLACED IN THE ABDOMEN THROUGH SEPARATE LATERAL STAB INCISIONS AND SECURED IN PLACE AT THE LEVEL OF THE SKIN WITH PROLENE SUTURES. SCARPA¿S FASCIA WAS THEN CLOSED AS A LONGITUDINAL INCISION WITH INTERRUPTED 2-0 VICRYL SUTURES. THE SUBCUTANEOUS TISSUE AND DERMIS OF THE INCISION WERE CLOSED WITH INTERRUPTED 3-0 VICRYL AND THE SKIN WAS CLOSED RUNNING 4-0 MONOCRYL SUBCUTICULAR SUTURE. IN THE STERNAL AREA, SEVERAL INTERRUPTED 0 PROLENE VERTICAL MATTRESS SUTURES WERE ALSO PLACED. STERILE DRESSINGS WERE APPLIED. HE TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE INTENSIVE CARE UNIT INTUBATED, BUT STABLE POSTOPERATIVELY.¿ [MISSING RECORDS: PATHOLOGY AND CULTURE REPORTS DETAILING ANALYSIS OF SPECIMENS REMOVED DURING THE 02/02/09 PROCEDURE WERE NOT PROVIDED.] (B)(6) 2009: MAYO CLINIC ARIZONA. MEAGHAN KHAN, MD. CONSULTATION-CRITICAL CARE SERVICE. PATIENT AT RISK FOR BACTEREMIA WITH RISK FOR SEPSIS. PANCULTURES ORIGINALLY NO GROWTH TO DATE. HOWEVER, REPEAT CULTURES AND WOUND/TISSUE CULTURES WERE SENT TODAY, STATUS POST OPERATION. WILL CONTINUE IV ANTIBIOTICS, INCLUDING VANCOMYCIN, RIFAMPIN, CIPROFLOXACIN AND ZOSYN. WILL MONITOR LEUKOCYTOSIS. MILDLY ELEVATED POSTOPERATIVELY, LIKELY SECONDARY TO STRESS REACTION, BUT WILL CONTINUE TO MONITOR. PERCUTANEOUS DRAIN FROM WOUND INTACT. (B)(6) 2009: MAYO CLINIC ARIZONA. JOHN VOYTEK, PA-C. DISCHARGE SUMMARY. PRINCIPLE DIAGNOSIS: STERNAL WOUND AND LEFT VENTRICULAR ASSIST DEVICE POCKET INFECTION WITH PROPIONIBACTERIUM ACNES. HOSPITAL COURSE: WBCS 16,000 HOSPITAL DAY #2. ANTIMICROBIAL THERAPY EXPANDED TO INCLUDE ZOSYN AND RIFAMPIN. 02/06/09, MICROBIOLOGY RESULTS SHOWED EARLY EVIDENCE OF GROWTH OF GRAM-POSITIVE BACILLUS. PATIENT CONTINUED TO HAVE INTERMITTENT LOW-GRADE FEVERS AND MILD LEUKOCYTOSIS. 02/08/09, WBCS DOWN TO 10,000. EMPIRIC FLUCONAZOLE WAS ADDED PER INFECTIOUS DISEASE RECOMMENDATION. MICROBIOLOGY RESULTS LATER SHOWED ADMISSION BLOOD CULTURES AND SEVERAL WOUND CULTURES FROM SURGERY, AND, ALSO, WOUND CULTURE FROM TIME OF ADMISSION, WERE GROWING PROPIONIBACTERIUM ACNES. SUBSEQUENTLY, VANCOMYCIN, ZOSYN, RIFAMPIN, AND FLUCONAZOLE WERE DISCONTINUED, AND UNASYN IV WAS STARTED PER INFECTIOUS DISEASE RECOMMENDATION. DR. ARABIA SPOKE WITH THE APPROPRIATE PHYSICIANS AT MAYO CLINIC ROCHESTER TO CONSIDER AND ARRANGE FOLLOW-UP CARE AT THEIR FACILITY. PATIENT CONTINUED TO IMPROVE, WAS RECUPERATING ON TELEMETRY FLOOR. DIET & ACTIVITY WERE ADVANCED. COUMADIN THERAPY WAS RESUMED. ASPIRIN THERAPY WAS CONTINUED. JACKSON-PRATT TUBES REMAINED INTACT PER RECOMMENDATION OF PLASTIC SURGERY. ON DATE OF DISCHARGE, PATIENT WAS TOLERATING CARDIAC DIET WELL, AFEBRILE, WBCS 11.5. PATIENT CONTINUED ON IV UNASYN. RECOMMENDED COURSE OF THERAPY IS 6 WEEKS, FOLLOW-UP SUPPRESSIVE THERAPY WITH ORAL AUGMENTIN AFTER THAT. PATIENT DISCHARGED WITH HOME HEALTH CARE FOR IV ANTIBIOTIC THERAPY AND WOUND CARE. PATIENT INSTRUCTED TO WALK DAILY FOR 5 TO 10 MINUTES FOUR TIMES A DAY AND AVOID TUB BATHS, SWIMMING, AND SPAS. ARRANGEMENTS HAVE BEEN MADE FOR ADMISSION TO MAYO CLINIC ROCHESTER FOR FURTHER MEDICAL MANAGEMENT. (B)(6) 2009: MAYO CLINIC ROCHESTER. KARI A. DESSNER, APRN, CNP. HOSPITAL ADMISSION NOTE. CONTINUES TO HAVE 2 JACKSON-PRATT DRAINS IN SITU. LEFT LOWER QUADRANT DRAIN CONTINUES TO DRAIN 30-40 CC OF SEROSANGUINEOUS FLUID EVERY DAY. RIGHT ONE ONLY DRAINS 10 CC OR LESS A DAY. HAS HAD NO FURTHER ISSUES WITH INFECTIOUS SYMPTOMS SINCE SURGERY. INCISIONS CLEAN AND DRY. DRIVELINE HAS REMAINED CLEAN AND WITHOUT EXUDATE THROUGH THIS ENTIRE SITUATION. CONTINUE IV ANTIBIOTICS. (B)(6) 2009: MAYO CLINIC ROCHESTER. GEOFFREY TSARAS, MD. CONSULTATION-INFECTIOUS DISEASE. AGREE WITH 6 WEEKS IV THERAPY DUE TO BACTEREMIA AND PRESENCE OF OTHER (AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR) DEVICE. WILL NEED LONG-TERM SUPPRESSIVE THERAPY ON COMPLETION OF UNASYN. IDEAL DRUG WOULD BE PEN V-K. BLOOD CULTURES NEGATIVE. PRE-TRANSPLANT EVALUATION: EPSTEIN-BARR VIRUS POSITIVE, CYTOMEGALOVIRUS POSITIVE, TOXOPLASMOSIS NEGATIVE. FROM ID PERSPECTIVE, AFTER COMPLETION OF IV THERAPY, SHOULD BE OK TO PROCEED TO TRANSPLANT ONCE OTHER ISSUES RESOLVED. (B)(6) 2009: MAYO CLINIC ROCHESTER. BARRY A. BOILSON, MD. PROGRESS NOTE-HEART & LUNG TRANSPLANT HOSPITAL SERVICE. CULTURE OF FLUID FROM JACKSON-PRATT DRAINS STERILE TO DATE. NEGATIVE GRAM¿S STAINS AND FUNGAL SMEARS. REPEAT CENTRAL & PERIPHERAL BLOOD CULTURES 02/19 STERILE SO FAR. CT BODY TODAY SHOWS NEW POSTOPERATIVE CHANGES OF IRRIGATION AND DEBRIDEMENT OF INFECTED LEFT VENTRICULAR ASSIST DEVICE. IMPRESSION/PLAN: POSSIBLE LEFT RENAL ABSCESS. PATIENT, FORTUNATELY, REMAINS AFEBRILE WITH NO EVIDENCE OF LEUKOCYTOSIS. CLINICALLY WELL. [MISSING RECORDS: RECORDS FOR THE CT SCAN SHOWING ¿NEW POSTOPERATIVE CHANGES¿ WERE NOT PROVIDED.] (B)(6) 2009: MAYO CLINIC ROCHESTER. GEOFFREY TSARAS, MD. PROGRESS NOTE-INFECTIOUS DISEASE. HAS BLOOD CULTURES IN 1 OF 3 BOTTLES FROM PICC WITH STAPH SPECIES ON 02/18/09 AFTER 37 HOURS. PERIPHERAL LINE WAS NEGATIVE AND SUBSEQUENT REPEAT BLOOD CULTURES NEGATIVE. LAB YET TO PERFORM COAGULASE TEST, BUT I SUSPECT IT IS A CONTAMINANT (STAPHYLOCOCCUS COAGULASE NEGATIVE) VS. PICC COLONIZATION. WAS GIVEN 2 GRAM DOSE OF VANCOMYCIN AND PICC REMOVED YESTERDAY AND REPLACED. PICC SITE CLEAN. NEW CYSTIC LESION IN KIDNEY: CONCERNS FOR ABSCESS, BUT CLINICALLY LOOKS WELL, NOT FEBRILE, NO LEUKOCYTOSIS. WILL UNDERGO CT GUIDED NEEDLE ASPIRATION POSSIBLY MONDAY. SEND SAMPLES FOR BACTERIAL, FUNGAL AND MYCOBACTERIAL SMEARS AND CULTURES. FOR NOW UNASYN PROVIDES BROAD COVERAGE. STAPH SP [SAPROPHYTICUS] BACTEREMIA 1 OF 3 FROM PICC, AWAITING SPECIATION. LIKELY CONTAMINANT VS PICC COLONIZATION, BUT IN PRESENCE OF AUTOMATED IMPLANTABLE CARDIAC DEFIBRILLATOR/ LEFT VENTRICULAR ASSIST DEVICE, THERE IS A SMALL, BUT NOT INCONSEQUENTIAL RISK OF DEVICE INFECTION. WILL GIVE REPEAT DOSE OF VANCOMYCIN WHILE AWAITING SPECIATION TODAY. IF A COAGULASE NEGATIVE STAPH, THEN WILL DISCONTINUE VANCOMYCIN. (B)(6) 2009: MAYO CLINIC ROCHESTER. MICHAEL A. CHILDS, MD. CONSULTATION-UROLOGY. CT SCANS REVIEWED, APPEARS THERE IS SOME CONFLICTION IN THE REPORTS THAT WERE GENERATED BOTH BY OUR RADIOLOGISTS AND THE OUTSIDE RADIOLOGIST. APPEARS ABSCESS WAS PRESENT ON IMAGING FROM 01/31 IN MID PORTION OF LEFT KIDNEY. SLIGHT PROGRESSION NOTICED OVER 3-WEEK INTERVAL ON REPEAT IMAGING DESPITE CONTINUOUS IV ANTIBIOTICS. IT WAS THE OPINION OF OUR RADIOLOGISTS THAT THE OTHER LESION SEEN IN THE KIDNEY LIKELY REPRESENTS A SIMPLE CYST. HOWEVER, THESE MAY ALSO BE CONSISTENT WITH POSSIBLE SMALL ABSCESSES. IMPRESSION: LEFT RENAL ABSCESS. THE MOST LIKELY EXPLANATION OF THIS RENAL ABSCESS GIVEN HIS HISTORY IS SECONDARY TO BACTERIAL SEEDING WITH THE MOST LIKELY PRIMARY SOURCE BEING HIS INFECTED LEFT VENTRICULAR ASSIST DEVICE OR POSSIBLY AN UNKNOWN SOURCE THAT ALSO SEEDED HIS VENTRICULAR DEVICE. UNLIKELY THAT GU SYSTEM WAS THE PRIMARY GIVEN THE ORGANISM AND GIVEN THE PATIENT¿S LACK OF GU SYMPTOMATOLOGY OR HISTORY. PATIENT CLINICALLY STABLE, AND ABSCESS PROGRESSION HAS LIKELY BEEN SUPPRESSED BY ONGOING IV ANTIBIOTICS. ABSCESS WILL NOT CLEAR WITHOUT APPROPRIATE DRAINAGE AS DEMONSTRATED BY INTERVAL ABSCESS GROWTH OVER 3 WEEKS IN THE SETTING OF IV ANTIBIOTICS. AFTER REVIEW WITH THE ON-CALL RADIOLOGIST, OUR RECOMMENDATION IS FOR ULTRASOUND EXAMINATION THIS WEEKEND WITH SUBSEQUENT DRAINAGE VS. ASPIRATION AT THE DISCRETION OF OUR INTERVENTIONAL RADIOLOGISTS. WILL LEAVE IT TO THE EXPERTISE OF THE INTERVENTIONALISTS TO LEAVE A PIGTAIL CATHETER DRAIN VS. PROCEED WITH ASPIRATION. ABSCESS CULTURES WILL LIKELY SHOW NO GROWTH BUT ARE LIKELY CONSISTENT WITH HIS PREVIOUS BLOOD AND WOUND CULTURES SHOWING PROPIONIBACTERIUM ACNES. THIS ORGANISM WOULD ALSO BE CONSISTENT WITH A GRAM-POSITIVE COCCI SEEN ON BLOOD CULTURES FROM HIS PICC LINE ON ADMISSION. HOWEVER, OTHER ORGANISMS SUCH AS STAPH ARE WELL KNOWN TO SEED TO THE KIDNEY AND SHOULD BE CONSIDERED. [MISSING RECORDS: PROCEDURE NOTE FROM RENAL ASPIRATION WAS NOT PROVIDED.] (B)(6) 2009: MAYO CLINIC ROCHESTER. GEOFFREY TSARAS, MD. PROGRESS NOTE-INFECTIOUS DISEASE. HAD ASPIRATION OF RENAL FLUID YESTERDAY. PRELIMINARY REPORT INDICATES 2-3 CC OF PHLEGMON OR ABSCESS. GRAM STAIN POSITIVE FOR GRAM POSITIVE COCCI. (B)(6) 2009: MAYO CLINIC ROCHESTER. LUIS F. PULIDO SIERRA, MD. CONSULTATION-PLASTIC SURGERY. WOUND LOOKS WELL. NO ACTIVE SIGNS OF INFECTIONS. CONTINUE WITH DRAINS UNTIL COMPLETELY DRY. CONTINUE ERTAPENEM AND VANCOMYCIN. (B)(6) 2009: MAYO CLINIC ROCHESTER. RICHARD C. DALY, MD. CARDIOVASCULAR SURGERY PROGRESS NOTE. ASKED PLASTIC SURGERY TO REVIEW PUMP POCKET INFECTION AND WHETHER WE SHOULD REEXPLORE THIS WITH THEM. WOUND LOOKS GOOD; HOWEVER, WE HAVE BEEN CONCERNED ABOUT PERSISTENT MATERIAL IN POCKET AREA ON CT SCAN. 02/25/09: MAYO CLINIC ROCHESTER. BARRY A. BOILSON, MD. PROGRESS NOTE-HEART & LUNG TRANSPLANT HOSPITAL SERVICE. CYTOLOGY HAS RETURNED ON THE FLUID FROM THE RENAL CYST. SHOWED HISTORY OF CYTOMA LEAK. WILL REINSTITUTE COUMADIN THERAPY AT THIS TIME. (B)(6) 2009: MAYO CLINIC ROCHESTER. BETTINA M. KNOLL, MD, PHD. PROGRESS NOTE-INFECTIOUS DISEASE. DISCONTINUE VANCOMYCIN AND ERTAPENEM. INITIATED CEFTRIAXONE. START PEN VK 500 MG PO THREE TIMES DAILY ON 03/19/09 FOR LIFELONG SUPPRESSION. (B)(6) 2009: MAYO CLINIC ROCHESTER. KARI A. DESSNER, APRN, CNP. DISCHARGE SUMMARY. FINAL PRIMARY DIAGNOSIS: ANAEROBIC VENTRICULAR ASSIST DEVICE POCKET INFECTION WITH BACTEREMIA, STATUS POST DEBRIDEMENT WITH RECTUS AND OMENTAL FLAPS ON 02/02/09. UNITED NETWORK FOR ORGAN SHARING STATUS 7. LEFT RENAL ABSCESS, STATUS POST CT-GUIDED ASPIRATION ON 02/23/09. PATIENT WAS ADMITTED FOR PRE-TRANSPLANT REASSESSMENT UNDER THE NEW CIRCUMSTANCES, POSTOPERATIVE REEVALUATION, AND BARIATRIC SURGERY CONSULTATION AND WORKUP IF INDICATED. HOSPITAL COURSE: BLOOD CULTURES AND JP DRAINS EFFLUENTS WERE NEGATIVE. BLOOD CULTURE VIA PICC WAS ONLY POSITIVE FOR OXACILLIN-RESISTANT COAGULASE-NEGATIVE STAPH IN 2 OF 3 BOTTLES, BUT CONCOMITANTLY DRAWN CULTURES FROM STICK WERE NEGATIVE. THE STAPH WAS FELT TO BE A COLONIZER UNDER THE CIRCUMSTANCES. THE PICC WAS EXCHANGED (02/20/09). FOLLOW-UP BLOOD CULTURE SERIES WERE NEGATIVE. RIGHT JACKSON-PRATT DRAIN REMOVED 02/26/09. LEFT DRAIN REMOVED 02/27/09. ABDOMINAL CT DEMONSTRATED A 2-CM CYSTIC MASS IN THE MID LEFT KIDNEY SUSPICIOUS FOR ABSCESS. UNDER CT GUIDANCE THIS WAS ASPIRATED AND 2-3 CC BLOODY FLUID WAS OBTAINED. CYTOLOGY OF THIS WAS NEGATIVE FOR MALIGNANCY, MOSTLY HISTIOCYTES WERE SEEN, CONSISTENT WITH CYST CONTENTS. GRAM STAIN IDENTIFIED A FEW GRAM-POSITIVE COCCI, AEROBIC CULTURE WAS NEGATIVE, ANAEROBIC CULTURE WAS HELD FOR EXTENDED INCUBATION. UNDER TRANSPLANT ID CONSULTING SERVICE GUIDANCE, THIS WAS COVERED WITH VANCOMYCIN AND ERTAPENEM, AWAITING CULTURE RESULTS. THE PATIENT REMAINED AFEBRILE AND FREE OF LEUKOCYTOSIS AND CONSTITUTIONAL SYMPTOMS. UROLOGY CONSULTATION WAS OBTAINED AND FOUND NO PLACE FOR SURGICAL INTERVENTION UNDER THE CIRCUMSTANCES. FOLLOW-UP RECOMMENDATIONS: VENTRICULAR ASSIST DEVICE POCKET INFECTION ON IV ANTIBIOTICS. TO BE PROVIDED BY HOME AGENCY. CONTINUE CEFTRIAXONE 2 GRAMS IV VIA PICC EVERY 24 HOURS. STOP DATE: 03/19/09. DISCONTINUE PICC ACCESS AT THE COMPLETION OF IV ANTIBIOTIC THERAPY. 03/19/09 START PEN VK 500 MG BY MOUTH THREE TIMES DAILY AND CONTINUE LIFELONG. (DO NOT DISCONTINUE). (B)(6) 2009: MAYO CLINIC ARIZONA. JANIS BLAIR, MD. OFFICE NOTE. INCISION HAS HEALED UP BEAUTIFULLY WITHOUT PAIN, TENDERNESS OR DRAINAGE. STATUS POST IRRIGATION AND DEBRIDEMENT OF CHEST WOUND, SUBCUTANEOUS TISSUE, DEEP FASCIA, AND REMOVAL OF AN INFECTED GORE-TEX MESH, PEDICLED RIGHT VERTICAL RECTUS ABDOMINIS MUSCLE FLAP TO THE CHEST, AND PEDICLED OMENTAL FLAP TO THE CHEST, REPAIR OF UMBILICAL AND VENTRAL INCISIONAL HERNIAS WITH ALLODERM 02/02/09 FOR INFECTED DEVICE POCKET. ORGANISM PROPIONIBACTERIUM ACNES. STATUS POST 1 MONTH OF IV ANTIBIOTICS AND IS CURRENTLY ON ONGOING SUPPRESSIVE ANTIMICROBIAL THERAPY. 01/08/10: MAYO CLINIC ARIZONA. AMY TANGEMAN, NP. OFFICE NOTE. REMAINS AFEBRILE; HOWEVER, CALLED EARLIER CONCERNED HE MIGHT HAVE SMALL ABSCESSES ON HIS SKIN. WENT TO LOCAL PCP AND HAD LABS DRAWN. STATES AREA ON ABDOMINAL INCISION-LOOKED LIKE 2 WHITEHEADS WHICH POPPED WITH NO FURTHER ISSUES. COMPLAINS OF SOME ABDOMINAL PAIN HE DESCRIBES AS BURNING, MORE PRONOUNCED AT NIGHT WHEN HE LAYS DOWN. THIS HAS NOT CHANGED SINCE ABDOMINAL SURGERY. ABDOMINAL EXAM: STERILE DRESSING CHANGE PER PROTOCOL. ABDOMINAL BINDER REMOVED. NO REDNESS OR DRAINAGE AROUND HIS DRIVELINE, ALTHOUGH HE DOES HAVE SOME PINK SCAR TISSUE. DID HAVE 2 SMALL WHITEHEADS FROM HIS LOWER STERNAL WOUND WHICH WERE EXAMINED BY MYSELF AS WELL AS DR. ARABIA. NO CHANGES WERE MADE. (B)(6) 2010: MAYO CLINIC ROCHESTER. ALFREDO L. CLAVELL, MD. CONSULTATION-HEART & LUNG TRANSPLANT-CARDIOLOGY. RETURNS TO PURSUE BARIATRIC SURGERY EVALUATION. HAS MADE LITTLE PROGRESS IN WEIGHT LOSS PROGRAM SINCE DEVICE IMPLANT. HASN¿T HAD ANY RECENT ISSUES WITH DRIVELINE DRAINAGE. NO FEVER OR OTHER CONSTITUTIONAL SYMPTOMS REPORTED. MAINTAINS GOOD LEVEL OF PHYSICAL ACTIVITY, AND MAJOR DOWNFALL WITH REGARDS TO WEIGHT LOSS RELATES TO EXCESSIVE FOOD INTAKE. WEIGHT 145.50 KG, BMI 45.717. ABDOMINAL EXAM: LARGE AND RATHER PROTUBERANT. VENTRAL HERNIA IS APPRECIATED. (B)(6) 2010: MAYO CLINIC ROCHESTER. BROOKS S. EDWARDS, MD. CONSULTATION-HEART & LUNG TRANSPLANT-CARDIOLOGY. PENDING GASTRIC BYPASS SURGERY, AWAITING CARDIAC TRANSPLANT. FAILED MULTIPLE ATTEMPTS AT WEIGHT LOSS AND NOW WEIGHS 152.9 KG. HE IS CLEARLY WAY TOO HEAVY FOR CANDIDACY FOR CARDIAC TRANSPLANT. HAS BEEN TURNED DOWN FOR LAPAROSCOPIC SLEEVE GASTRIC SURGERY AND IS BEING CONSIDERED NOW BY DR. SARR FOR OPEN GASTRIC BYPASS. OVERALL, I BELIEVE HE IS A GOOD CANDIDATE FOR GASTRIC BYPASS SURGERY. 06/15/10: MAYO CLINIC ROCHESTER. IRINA E. PENEV, PA-C. CONSULTATION-HEART & LUNG TRANSPLANT-CARDIOLOGY. DOES NOT WEAR A DRIVE LINE IMMOBILIZATION BINDER, AS IT IS NOT FEASIBLE DUE TO OBESITY. 08/31/10: MAYO CLINIC ARIZONA. LINDA STALEY, MSN, CNP, NP. OFFICE NOTE-SURGERY. PATIENT SEEN TODAY FOR FEVERS OF 100.3 AND INCREASING ABDOMINAL DISCOMFORT TO LEFT UPPER QUADRANT. OVER LAST MONTH PATIENT HAS NOTED SOME GRADUAL PROMINENCE OF HIS LEFT UPPER QUADRANT OF HIS ABDOMEN WITH INCREASING AMOUNTS OF DULL ACHING PAIN IN THIS AREA. HE IS WITHOUT ANY NAUSEA, VOMITING, ANY BOWEL PROBLEMS OR OBSTRUCTIVE-TYPE SYMPTOMS. ALSO HAS INCREASING DISCOMFORT WHEN HE GOES FROM LYING ON HIS BACK AND USING HIS ABDOMEN TO SIT UP, HAS INCREASING PAIN. DENIES REDNESS TO DRIVELINE SITE. WIFE PERFORMS DAILY DRESSING CHANGES TO DRIVELINE WITHOUT ANY REDNESS OR ANY DRAINAGE OF DRIVELINE, WHICH EXITS RIGHT UPPER QUADRANT. WEIGHT HAS GRADUALLY INCREASED. NOW UP TO 155 KG. WAS 140 KG 01/10. PHYSICAL EXAM: STERNOTOMY INCISION HEALED WITH KELOID SCARS. NO AREAS OF REDNESS OR ANY ABSCESS FORMATION SEEN. ABDOMINAL BINDER REMOVED. NO REDNESS. TISSUE GRANULATING TO DRIVELINE SITE. NO DRAINAGE, TENDERNESS NOTED. DRESSING REAPPLIED PER PROTOCOL. ON PALPATION, PATENT HAS A BULGE TO LEFT UPPER ABDOMEN WITHOUT DEFINED EDGES, WITHOUT TENDERNESS WITH DEEP PALPATION. NEGATIVE FOR ANY REBOUNDING. WHITE COUNT 9.3. PATIENT WILL GO FOR CT SCAN OF ABDOMEN WITHOUT CONTRAST TODAY. WILL LOOK FOR ANY ABSCESSES AND FOR RECURRENT HERNIA. CONTINUED ON ATTACHMENT. - ATTACHMENT: [EVENT 41475 CONTINUATION H10.11.PDF].
PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. (B)(4). (B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH DETACHED FROM LEFT RECTUS, ADDITIONAL SURGERY, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623596 | GORE DUALMESH BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 11195996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |