GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 3003910212-2018-00112
- Event Type
- Death
- Date Received
- November 13, 2018
- Date of Event
- December 18, 2015
- Report Date
- November 20, 2020
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601141
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS DATED (B)(6) 2009 STATE: ¿COMPLAINING OF LUMP IN ABDOMEN. SAYS THAT HE HAD ABDOMINAL AORTIC ANEURYSM SURGERY IN THE PAST, AND HE FEELS THAT HIS LUMP IS INCREASING IN SIZE.¿ RECORDS DATED (B)(6) 2010 STATE THE PATIENT WAS SEEN FOR A ONE MONTH POSTOPERATIVE FOLLOW UP. ¿¿PRESENTS FOR FOLLOW UP 1 MO S/P LAP VENTRAL HERNIA REPAIR W/ GORE-TEX MESH. PT DENIES PAIN, ABD PAIN, N/V/D/C, OR DIFFICULTY URINATING.¿ ¿ABDOMEN: OBESE, SOFT, NONDISTENDED; NO BULGING OVER OLD VERTICAL INCISION W/ INCREASED INTRAABDOMINAL PRESSURE; INCISION WOUNDS HEALING WELL, C/D/I.¿ RECORDS DATED (B)(6) 2010 INDICATE THE PATIENT WAS SEEN FOR FOLLOW UP ¿STATUS POST REPAIR OF VENTRAL HERNIA. PATIENT DOING WELL.¿ RECORDS DATED (B)(6) 2011 STATE THE PATIENT WAS SEEN FOR FOLLOW UP. ¿HE HAS HISTORY OF ASBESTOSIS/COPD. EARLIER THIS YEAR HE WAS SMOKING UP TO 3 PACKS A DAY, AND HE IS NOW DOWN TO ABOUT 6 CIGARETTES PER DAY. HE HAD A VERY EVENTFUL YEAR AROUND THE TIME OF REPAIR OF HIS ABDOMINAL HERNIA. HE WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT FOR SOMETIME WITH PULMONARY DIFFICULTIES. HE IS DOING OKAY RIGHT NOW, BUT DOES REPORT SOME DIZZINESS WHEN HE BENDS OVER AND THEN STANDS UP AGAIN.¿ ¿BLOOD SUGAR WAS 118.¿ PERTINENT RECORDS BETWEEN (B)(6) 2011 AND (B)(6) 2015 WERE NOT PROVIDED. 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.¿ 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 PATIENT CODES. H6: UPDATED DEVICE CODE. H6: UPDATED CONCLUSION CODES. PREVIOUS PATIENT CODE (1695) 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. THE FOLLOWING INFORMATION WAS DETERMINED FROM THE MEDICAL RECORDS. MEDICAL RECORDS: KNOWN MEDICAL RECORDS SPAN FEBRUARY 19, 2010 TO DECEMBER 20, 2015 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. RECORDS FROM FEBRUARY 4, 2011 THROUGH NOVEMBER 25, 2015 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: CHRONIC OBSTRUCTIVE PULMONARY DISEASE [COPD]. SEVERE RESTRICTIVE LUNG DISEASE. SMOKER. ON (B)(6) 2010: 65 PACK/YR SMOKER. ¿HE WAS COUNSELED [SIC] ON SMOKING CESSATION AND OFFERED A REFERRAL BUT REFUSED. IT WAS STRESSED THE IMPORTANCE SMOKING CESSATION ON THE OUTCOME OF HIS SURGERY.¿ ON (B)(6) 2010: SMOKER, SEVERE RESTRICTIVE LUNG DISEASE. ON (B)(6) 2011: ¿HE HAS HISTORY OF ASBESTOSIS / COPD. EARLIER THIS YEAR HE WAS SMOKING UP TO 3 PACKS A DAY, AND HE IS NOW DOWN TO ABOUT 6 CIGARETTES PER DAY.¿ ON (B)(6) 2015: SMOKES ½ PACK PER DAY. ON (B)(6) 2010: OBESITY, ON (B)(6) 2015: BMI 37, GASTROESOPHAGEAL REFLUX DISEASE, ASBESTOSIS, HYPERTENSION, HYPERLIPIDEMIA, TYPE II DIABETES. PRIOR SURGICAL PROCEDURES: UNKNOWN DATE: APPENDECTOMY. 2005: OPEN ABDOMINAL AORTIC ANEURYSM REPAIR WITH ¿POST OP WOUND DISTAL TO UMBILICUS THAT REQUIRED PACKING.¿ ON (B)(6) 2010: LAPAROSCOPIC VENTRAL HERNIA REPAIR. ON (B)(6) 2015: RIGHT TOTAL HIP ARTHROPLASTY, POSTERIOR APPROACH. ON (B)(6) 2015: EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, DIVERTICULAR DISEASE. ON (B)(6) 2015: EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, EXPLANTATION OF MESH. IMPLANT PREOPERATIVE COMPLAINTS: [5 MONTHS]. ON (B)(6) 2009: ¿COMPLAINING OF LUMP IN ABDOMEN. SAYS THAT HE HAD ABDOMINAL AORTIC ANEURYSM SURGERY IN THE PAST, AND HE FEELS THAT HIS LUMP IS INCREASING IN SIZE.¿ ON (B)(6) 2010: ¿SUSPECTED VENTRAL HERNIA. LUMP AT THE LEVEL OF THE UMBILICUS TO THE RIGHT OF HIS AAA INCISION 3 MONTHS AGO. SIZE VARIES FROM DAY TO DAY, NEVER COMPLETELY RESOLVES, LARGEST IN MORNING. PT CAN REDUCE IT BUT IT IMMEDIATELY RETURNS.¿ ¿VISIBLE 5 CM BULDGE [SIC] TO RIGHT OF UMBILICUS WHEN STANDING. BULDGE [SIC] WITH FASCIAL DEFECT IS PALPABLE IN SUPINE POSITION AND REDUCEABLE [SIC].¿ ¿HE WAS COUNSELED [SIC] ON SMOKING CESSATION AND OFFERED A REFERRAL BUT REFUSED. IT WAS STRESSED THE IMPORTANCE SMOKING CESSATION ON THE OUTCOME OF HIS SURGERY.¿ ON (B)(6) 2010: CT ABDOMEN ¿VENTRAL HERNIA WITH MESENTERY PRESENT.¿ ON (B)(6) 2010: ¿62 YEAR OLD MALE [WITH HISTORY OF HYPERTENSION, HYPERLIPIDEMIA], ASBESTOSIS, 5 [YEARS STATUS POST] AAA REPAIR, AND A 65 PACK YR HISTORY REFERRED TO CLINIC BY PCP FOR SUSPECTED VENTRAL HERNIA. HE FIRST NOTICED A ¿LUMP¿ AT THE LEVEL OF THE UMBILICUS TO THE RIGHT OF HIS AAA INCISION 3 MONTHS AGO BUT CAN NOT ASSOCIATE IT WITH A CERTAIN INCIDENCE. SIZE VARIES FROM DAY TO DAY BUT IT NEVER COMPLETELY RESOLVES AND IT SEEMS TO BE LARGEST IN THE MORNING. [PATIENT] CAN REDUCE IT BUT IMMEDIATELY RETURNS. PAIN FLUCTUATES FROM ON (B)(6). HE HAS VERY LITTLE PHYSICAL ACTIVITY AND NO ASSOCIATION OF SX'X [SIC] WITH COUGH OR STRAINING.¿ ON (B)(6) 2010: ¿PT HAS [HISTORY OF] OF COPD AND HAS BEEN TOLD THAT HE HAS ASBESTOSIS. OVER THE LAST 4-5 YEARS, HE HAS DEVELOPED PROGRESSIVE DYSPNEA ON EXERTION.¿ ¿HE HAS A LARGE AMOUNT OF SPUTUM PRODUCTION MOSTLY OF WHITE SPUTUM.¿ ¿HE IS CURRENTLY STILL SMOKING 1/2 [PACKS PER DAY] AND IS NOT INTERESTED IN QUITTING.¿ ¿GIVEN THE AMOUNT OF SPUTUM HE PRODUCES, THE PATIENT WILL NEED TO BE TAUGHT HOW TO EFFECTIVELY COUGH WHILE HOLDING HIS ABDOMEN TO PREVENT WOUND ISSUES WHILE STILL KEEPING AN EFFECTIVE COUGH.¿ IMPLANT PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH. GORE® DUALMESH® PLUS BIOMATERIAL 05828393/1DLMCP07 (20CM X 30CM). IMPLANT DATE: ON (B)(6) 2010 [HOSPITALIZATION FROM ON (B)(6) 2010]. DESCRIPTION OF HERNIA BEING TREATED: ¿THE ABDOMEN WAS ENTERED WITH A VERESS NEEDLE IN THE LEFT UPPER QUADRANT AND INSUFFLATED WITH CARBON DIOXIDE. THE INITIAL INSUFFLATION PRESSURES WERE LESS THAN 7 MMHG WITH GOOD FLOWS. THE ABDOMEN INSUFFLATED EASILY. AFTER INSUFFLATION TO 15 MMHG THE 5 MM PORT WAS PLACED IN THE LEFT UPPER QUADRANT THROUGH THE PREVIOUS VERESS NEEDLE INCISION. THE LAPAROSCOPE WAS INTRODUCED THROUGH THIS INCISION AND A SECOND 5 MM PORT WAS PLACED IN THE LEFT LOWER QUADRANT. A THIRD 5 MM PORT WAS PLACED INTERMEDIATE BETWEEN THESE TWO AND THE LEFT UPPER QUADRANT PORT WAS UPSIZED TO A 10 MM PORT.¿ ¿WE THEN EXPLORED THE ABDOMEN. WE IDENTIFIED SEVERAL VENTRAL HERNIA DEFECTS ON THE ANTERIOR ABDOMINAL WALL IN THE MIDLINE, WHICH CONTAINED OMENTAL FAT. WE DID NOT NOTE ANY BOWEL TO BE ASSOCIATED WITH THESE HERNIAS. THEY WERE REDUCED WITH A COMBINATION OF BLUNT AND SHARP DISSECTION. THE MESENTERIC FAT WAS EASILY REDUCED FROM THESE HERNIAS. AS THE HERNIATED FAT WAS BROUGHT DOWN FROM THE ANTERIOR ABDOMINAL WALL IT WAS EVIDENT THAT THERE WERE SEVERAL SMALL DISCRETE DEFECTS PRIMARILY IN THE MIDLINE EXTENDING FROM JUST BELOW THE FALCIFORM LIGAMENT DOWN TO THE LEVEL OF THE UMBILICUS. THERE WAS ALSO AN ADDITIONAL DEFECT TO THE RIGHT OF THE MIDLINE AT THE LEVEL OF THE UMBILICUS.¿ ¿WE CAREFULLY BROUGHT DOWN ALL OF THE MESENTERIC FAT, WHICH HAD BEEN ADHERENT OR HERNIATED THROUGH THESE DEFECTS. WE ALSO CLEARED SEVERAL SMALL FILMY ADHESIONS OF MESENTERIC FAT FROM THE ANTERIOR ABDOMINAL WALL. WE THEN MARKED THE BOUNDARIES OF THE HERNIA DEFECT USING A SPINAL NEEDLE, WHICH WAS PASSED THROUGH THE ANTERIOR ABDOMINAL WALL UNDER DIRECT VISUALIZATION SUCH THAT WE COULD DELINEATE THE SPECIFIC SUPERIOR, INFERIOR, AND LATERAL BOUNDARIES OF OUR HERNIA DEFECTS.¿ IMPLANT SIZE AND FIXATION: ¿WE FOUND THAT THE HERNIA DEFECTS COMPRISED AN AREA OF 10 X 15 CM IN THE ANTERIOR ABDOMINAL WALL. A 20 X 25 CM PIECE OF GORE-TEX DUAL MESH WAS THEN BROUGHT TO THE FIELD. 0 GORE-TEX SUTURES WERE PLACED IN THE TOP, BOTTOM, AND MIDPOINT OF THE SIDES OF THE MESH. THE MESH WAS LAYED OVER THE ANTERIOR ABDOMINAL WALL AND THE POSITION OF THE MESH AND THE PREVIOUSLY PLACED SUTURES WAS MARKED ON THE ANTERIOR ABDOMINAL WALL. WE THEN PLACED AN ADDITIONAL 5 MM LAPAROSCOPIC PORT IN THE RIGHT ABDOMEN LATERAL TO THE UMBILICUS. A GRASPER WAS PASSED THROUGH THIS RIGHT-SIDED PORT AND OUT THROUGH THE 10 MM PORT IN THE LEFT UPPER QUADRANT OF THE ABDOMEN.¿ ¿THE 10 MM PORT WAS REMOVED AND THE ROLLED GORE-TEX DUAL MESH WAS PASSED THROUGH THE 10 MM PORT INCISION WITH USING THE GRASPER PASSED FROM THE OPPOSITE SIDE. THE MESH WAS DELIVERED EASILY INTO THE ABDOMEN. THE 10 MM PORT WAS THEN REPLACED. INSIDE THE ABDOMEN THE MESH WAS UNROLLED AND USING A SUTURE PASSER DEVICE THE PREVIOUSLY PLACED SUTURES AT THE SUPERIOR, INFERIOR, AND THE MIDDLE OF THE LATERAL ASPECTS OF THE MESH WERE BROUGHT OUT TO THE SURFACE OF THE ANTERIOR ABDOMINAL WALL THROUGH 3 MM SKIN INCISIONS. THESE SUTURES WERE CAREFULLY TIED DOWN. ON INSPECTION OF THE ABDOMEN WITH THE LAPAROSCOPE WE COULD SEE THAT THE MESH WAS JUST TAUT IN BOTH THE ANTEROPOSTERIOR AND LATERAL DIRECTIONS. WE THEN BROUGHT AN AUTOSUTURE STAPLING DEVICE ONTO THE FIELD.¿ ¿WE PLACED STAPLES AT 1 CM INTERVALS ON THE ENTIRE PERIPHERY OF THE MESH TACKING IT TO THE POSTERIOR ASPECT OF THE ANTERIOR ABDOMINAL WALL. THEN USING THE SUTURE PASSER DEVICE WE PLACED 0 GORE-TEX INTERRUPTED SUTURES IN EACH CORNER OF THE MESH FOR A TOTAL OF FOUR ADDITIONAL TRANSFIXION SUTURES. AT THIS POINT THE MESH WAS WELL SECURED TO THE ANTERIOR ABDOMINAL WALL. THE ABDOMEN WAS CAREFULLY EXPLORED. THERE WAS NO SIGNIFICANT BLEEDING. THE MESH WAS WELL SECURED TO THE ANTERIOR ABDOMINAL WALL. WE THEN CLOSED THE 10 MM PORT SITE WITH A FIGURE-OF-8 SUTURE OF 0 VICRYL PLACED WITH THE SUTURE PASSER DEVICE.¿ ¿THE 10 PORT WAS REMOVED AND THIS SUTURE TIED DOWN UNDER DIRECT VISUALIZATION WITH THE LAPAROSCOPE. THE PORT SITE WAS WELL CLOSED. THE 5 MM PORTS WERE REMOVED AND THE SITES WERE CLOSED WITH SUBCUTICULAR SUTURES OF 4-0 MONOCRYL.¿ ONE DAY POST-OPERATIVE PERIOD: ON (B)(6) 2010: ¿FROM A RESPIRATORY STANDPOINT, THE PATIENT WAS INITIATED ON BIPAP, AS WELL AS INITIATED ON ALL OF HIS HOME MEDICATIONS INCLUDING TIOTROPIUM, ALBUTEROL NEBULIZERS, AND FLUTICASONE / SALMETEROL INHALERS. FROM A SURGERY STANDPOINT, THE PATIENT DEMONSTRATED EVIDENCE OF A POSTOPERATIVE ILEUS, WHICH WAS NOT UNEXPECTED GIVEN THE AMOUNT OF INTESTINES THAT WERE INVOLVED WITH THE INCISIONAL HERNIA, AS WELL AS WITH ADHESIONS.¿ RELEVANT MEDICAL INFORMATION: ON (B)(6) 2010: ¿INCISION WOUNDS HEALING WELL, C/D/I [CLEAN, DRY, INTACT].¿ ON (B)(6) 2010: ¿STATUS POST REPAIR OF VENTRAL HERNIA. PATIENT DOING WELL.¿ ON (B)(6) 2011: ¿HE HAD A VERY EVENTFUL YEAR AROUND THE TIME OF REPAIR OF HIS ABDOMINAL HERNIA. HE WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT FOR SOME TIME WITH PULMONARY DIFFICULTIES.¿ ON (B)(6) 2015: CT ABD / PELVIS ¿EITHER A REFLEX FOCAL ILEUS IN THE UPPER ABDOMEN OR PARTIAL SMALL BOWEL OBSTRUCTION. THERE APPEARS TO BE A TRANSITION ZONE IN THE PELVIS, SO THIS IS PROBABLY A PARTIAL OBSTRUCTION.¿ ON (B)(6) 2015: EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION. THE FASCIA/MESH IS APPROXIMATED WITH RUNNING NUMBER 1 PROLENE.¿ ¿A MIDLINE INCISION WAS MADE, DEEPENED DOWN THROUGH THE SUBCUTANEOUS TISSUE IN A MIDLINE FASHION. THE ABDOMEN ENTERED. WE DISSECTED DOWN THROUGH THE MESH, TAKING THE ADHESIONS OFF THE MESH, AND EVENTUALLY WE WERE ABLE TO EXTEND THE INCISION SUPERIORLY AND INFERIORLY. MOST OF THESE WERE OMENTAL ADHESIONS. THE SMALL BOWEL WAS RAN FROM THE LIGAMENT OF TREITZ DISTALLY. THE MAJORITY OF VERY SIGNIFICANT ADHESIONS WERE DOWN IN THE RIGHT LOWER QUADRANT. THE PATIENT HAS HAD A PREVIOUS APPENDECTOMY, AS WELL AS HIS THE AORTOBIFEMORAL BYPASS.¿ ¿THE LOOPS OF SMALL BOWEL WERE STUCK DOWN INTO THE OLD APPENDECTOMY SITE, AS WELL AS NEAR THE RIGHT LIMB OF THE AORTOBIFEMORAL BYPASS. WERE ABLE TO FREE ALL OF THESE UP. THE DISSECTION IS PERFORMED WITH SCISSORS AND CAUTERY. WE THEN RUN THE SMALL BOWEL X2. THERE ARE NO SEROSAL TEARS. THERE IS 1 TEAR IN THE MESENTERY THAT IS APPROXIMATED WITH 3-0 VICRYL. THE FASCIA/MESH IS APPROXIMATED WITH RUNNING NUMBER 1 PROLENE. IT IS ELECTED NOT TO DO THE CHOLECYSTECTOMY, BECAUSE THIS WOULD HAVE NECESSITATED EXTENDING THE ALREADY FAIRLY LARGE INCISION CEPHALAD. HE HAS HAD NO HISTORY OF GALLBLADDER DISEASE. SKIN EDGES APPROXIMATED WITH STAINLESS STEEL STAPLES. ¿SMALL BOWEL OBSTRUCTION SECONDARY TO ADHESIONS AND CHOLELITHIASIS.¿ ¿THE PATIENT HAS MARKED SMALL BOWEL ADHESIONS. THERE IS A DEFINITE TRANSITION POINT IN THE RIGHT LOWER QUADRANT, MARKEDLY DILATED PROXIMAL SMALL BOWEL, NORMAL SMALL BOWEL DISTAL. WE DISSECT EVERYTHING FROM THE LIGAMENT OF TREITZ ALL WAY TO THE ILEOCECAL VALVE. THE PATIENT HAS VERY DENSE ADHESIONS. THE PATIENT HAS PREVIOUS MESH IN PLACE. THE INCISION WAS STARTED AS A MIDLINE INCISION AND THEN HAD TO BE EXTENDED CAUDAD TODAY. IT WAS ELECTED NOT TO REMOVE HIS GALLBLADDER. THE GALLBLADDER WAS PALPATED. THERE WERE STONES ON ULTRASOUND. I DID NOT FEEL ANY STONES. IT WAS SOMEWHAT DISTENDED, CONSISTENT WITH HIS N.P.O. STATUS. LIVER WAS NORMAL. NO OTHER ABNORMALITIES WERE NOTED. THE SMALL BOWEL WAS RAN FROM THE ILEOCECAL VALVE TO THE LIGAMENT OF TREITZ. NO SMALL BOWEL ENTEROTOMIES WERE MADE. THE PATIENT HAD AIR IN THE BLADDER ON CT SCAN. THE PATIENT HAS SOME DIVERTICULAR DISEASE, SOMEWHAT OF A REDUNDANT SIGMOID COLON, BUT THERE IS NO CONNECTION BETWEEN THE COLON AND THE BLADDER.¿ EXPLANT PREOPERATIVE COMPLAINTS: ON (B)(6) 2015: ¿POST OP ILEUS WITH SMALL BOWEL OBSTRUCTION.¿ ON (B)(6) 2015: ABDOMEN XR. ¿ABNORMAL UPPER ABDOMEN SMALL BOWEL LOOPS. THIS SUGGESTS A HIGH-GRADE REFLEX ILEUS SUCH AS FROM PAIN OR INFLAMMATION.¿ ON (B)(6) 2015: ABDOMEN XR ¿DISTENDED GAS-FILLED LOOPS OF BOWEL BUT THIS APPEARS TO PROBABLY BE AN ILEUS.¿ ON (B)(6) 2015: CT ABD / PELVIS: ¿DESPITE THE RECENT SURGERY, THERE IS CONCERN FOR A PARTIAL SMALL BOWEL OBSTRUCTION. PRESUMED POSTSURGICAL CHANGES WITH STRAND DENSITY REMAINING IN THE MESENTERY IN THE RIGHT LOWER QUADRANT. THERE HAS BEEN PLACEMENT OF MESH IN THE ANTERIOR ABDOMINAL WALL ON THE RIGHT.¿ ON (B)(6) 2015: ¿FAIRLY MASSIVELY DILATED STOMACH AND PROXIMAL SMALL BOWEL. I THINK IT IS APPROPRIATE AT THIS TIME FOR THE PATIENT TO UNDERGO EXPLORATORY LAPAROTOMY. THE PATIENT IS AT SIGNIFICANT RISK BECAUSE OF ADHESIONS. RISKS INCLUDE FISTULA FORMATION, HOWEVER THE PATIENT IS NOT IMPROVING. HIS WHITE COUNT HAS GONE UP. THE PATIENT HAD VERY DENSE ADHESIONS AT THE TIME OF HIS INITIAL SURGERY. I EXPECT THIS TO BE A VERY DIFFICULT PROCEDURE AND THE PATIENT HAS BEEN SO INFORMED.¿ EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY WITH EXTENSIVE 45-MINUTE LYSIS OF ADHESIONS, SEGMENTAL SMALL BOWEL RESECTION, EXPLANTATION OF PREVIOUSLY PLACED KUGEL PATCH (RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL WAS PREVIOUSLY PLACED). THE REFERENCE TO "KUGEL PATCH" IS INCORRECTLY REFERENCED IN THE DICTATION. RECORDS INDICATE THE PATIENT¿S ONLY IMPLANTED DEVICE WAS A GORE® DUALMESH® PLUS BIOMATERIAL ON (B)(6) 2010. THE PATIENT THEN UNDERWENT A HIP REPLACEMENT ON (B)(6) 2015 AND DEVELOPED A SMALL BOWEL OBSTRUCTION FOLLOWING THAT SURGERY. THE PATIENT THEN HAD SURGERY ON (B)(6) 2015 FOR THE OBSTRUCTION WITH BOWEL RESECTION AT WHICH TIME THE GORE® DUALMESH® PLUS BIOMATERIAL (REFERENCED AS KUGEL) IS REMOVED. THE PATIENT THEN BECAME SEPTIC AND EXPIRED ON (B)(6) 2015. UNLESS THE PATIENT HAD SURGERY SOMETIME BETWEEN ON (B)(6) 2011 AND ON (B)(6) 2015 (NO RECORDS SUPPLIED FOR THAT TIME FRAME) THE REFERENCED "KUGEL" PATCH IS THE GORE® DUALMESH® PLUS BIOMATERIAL. EXPLANT DATE: ON (B)(6) 2015. ¿1. SMALL BOWEL RESECTION, OBSTRUCTION RECURRENT. 2. NECROTIC SMALL BOWEL.¿ ¿THE PATIENT HAS MARKEDLY DILATED PROXIMAL SMALL BOWEL. THE SMALL BOWEL IS GROWING INTO THE ANTERIOR ABDOMINAL WALL MESH AND IS VERY THIN WALLED. THERE WERE SOME AREAS OF ACTUAL MICROPERFORATION. THIS WAS ALL WALLED OFF. DURING THE MOBILIZATION OF THIS, WE SPILLED SOME SMALL BOWEL CONTENTS. THERE WAS A SMALL HEMATOMA IN THE ORIGINAL WOUND AT THE LOWER PORTION AND CULTURES WERE OBTAINED OF THIS. AGAIN, THE WOUND WAS LEFT OPEN. THERE WAS NO INTRAABDOMINAL INFECTION. THE ADHESIONS ARE VERY DENSE. THE STOMACH AND PROXIMAL SMALL BOWEL ARE MASSIVELY DISTENDED. THE DISTAL SMALL BOWEL IS GNARLED AND REQUIRED RESECTION.¿ ¿THE PREVIOUS INCISION WAS OPENED. CULTURES WERE OBTAINED OF THE AREA OF HEMATOMA IN THE INFERIOR PORTION OF THE INCISION. THE PROLENE SUTURES WERE REMOVED AND THE ABDOMEN ENTERED. VERY DENSE ADHESIONS WERE ENCOUNTERED FROM THE SMALL BOWEL TO THE MESH. THESE WERE TAKEN DOWN BY BLUNT AND SHARP DISSECTION. THE NECROTIC SMALL BOWEL WAS NOTED. GIA STAPLER IS FIRED PROXIMAL AND DISTAL TO THIS AND THE MESENTERY DIVIDED BETWEEN CLAMPS, TRANSECTED, AND LIGATED WITH 2-0 VICRYL TIES.¿ ¿WE CONTINUED THE DISSECTION. THE VERY DISTAL 2 FEET OF TERMINAL ILEUM IS BASICALLY A GNARLED MASS. THESE WERE VERY DIFFICULT ADHESIONS THE FIRST-TIME THROUGH AND THERE WAS SOME FIBROSIS AND FAT NECROSIS AND IT WAS FELT BEST TO RESECT THIS. THE TERMINAL ILEUM WAS DIVIDED WITH A GIA STAPLER. MESENTERY DIVIDED BETWEEN CLAMPS, TRANSECTED, AND LIGATED WITH 2-0 VICRYL TIES. WE THEN REMOVED THE KUGEL PATCH. THERE ARE MULTIPLE METAL SPIRAL TACKS THAT ARE REMOVED. THIS WAS VERY DIFFICULT. I FELT THAT THE MESH NEEDED TO BE REMOVED TO PREVENT #1 INFECTION BUT MORE SIGNIFICANTLY TO DECREASE THE CHANCE OF THE BOWEL WHICH IS VERY EDEMATOUS FROM ATTACHING TO THIS MESS.¿ ¿ABDOMEN WAS THEN COPIOUSLY IRRIGATED AND SUCTIONED DRY. WE WERE ON THE PROXIMAL SMALL BOWEL. THE NG TUBE WAS REPOSITIONED. AFTER IRRIGATING THE ABDOMEN, THE MESENTERY WAS APPROXIMATED WITH 3-0 VICRYL. THE FASCIA WAS APPROXIMATED WITH RUNNING #1 VICRYL AND INTERRUPTED 0 VICRYL SUTURES. THE WOUND WAS LEFT OPEN.¿ ¿RECEIVED IN FIXATIVE LABELED ¿SMALL BOWEL SEGMENTAL RESECTION¿ ARE 2 LARGE SEGMENTS OF SYNTHETIC MESH MATERIAL WITH IMBEDDED DENSE FIBROUS TISSUE. THE SEGMENTS OF MESH MEASURE APPROXIMATELY 14.0 X 14.0 X 0.8 CM IN AGGREGATE. ALSO SUBMITTED ARE 2 SEPARATE SEGMENTS OF SMALL BOWEL. THE FIRST SEGMENT OF BOWEL MEASURES APPROXIMATELY 60 CM IN LENGTH. THE SEROSAL ASPECT SHOWS ADHERENT CLOT AND DENSE FIBROUS ADHESIONS. THERE ARE FOCALLY DENSE ADHESIONS BETWEEN THE LOOPS OF BOWEL CAUSING A SLIGHT KINKING OF THE BOWEL. APPROXIMATELY 3 CM FROM ONE MARGIN IS A FULL-THICKNESS DEFECT IN THE BOWEL WALL MEASURING 5 CM IN LENGTH. SEPARATE 1 CM SURFACE DEFECT IS IDENTIFIED APPROXIMATELY 16 CM FROM THE SAME MARGIN. THE BOWEL MUCOSA IS PREDOMINANTLY INTACT WITH AN AVERAGE BOWEL WALL THICKNESS OF 0.4 CM. THERE ARE FOCAL AREAS OF MUCOSAL FLATTENING AND HEMORRHAGE. THE LARGEST AREA MEASURES 2 CM IN LENGTH. NO MASSES ARE PRESENT. THE SECOND SEGMENT OF BOWEL MEASURES APPROXIMATELY 40 CM IN LENGTH AND ALSO CONTAINS ADHERENT THROMBUS AND FIBROUS ADHESIONS ALONG THE EXTERNAL SURFACE. APPROXIMATELY 10 MM FROM ONE FROM ONE MARGIN IS A 4 CM SURFACE FULL-THICKNESS DEFECT (PERFORATION). OTHERWISE, THE BOWEL MUCOSA IS INTACT WITHOUT MASS LESION AND AVERAGES APPROXIMATELY 0.3 CM IN THICKNESS.¿ ¿DIAGNOSIS: SMALL BOWEL SEGMENTS, 2, AND SURGICAL MESH EXPLANT (RECURRENT OBSTRUCTION) DIFFUSE SEROSAL ADHESIONS, SEGMENTAL ISCHEMIC NECROSIS.¿ POST-OPERATIVE PERIOD [TWO DAYS]: ON (B)(6) 2015: ¿POSTOPERATIVE SEPSIS AND SEPTIC SHOCK. I AM VERY WORRIED THAT HE HAS ONGOING METABOLIC ALKALOSIS. HE MAY HAVE AN OVERWHELMING ABDOMINAL INFECTION AND SEPSIS OR RETURN OF HIS HEALTHCARE-ASSOCIATED PNEUMONIA. HIS PROGNOSIS AT THIS POINT IS VERY POOR. I WOULD NOT BE SURPRISED IF HE DID NOT SURVIVE THE DAY. I ASKED HIS WIFE ABOUT DNR / DNI ORDERS, AND SHE WANTS TO KEEP THOSE IN PLACE.¿ ON (B)(6) 2015: ¿ADMIT DIAGNOSIS: WAS LEFT HIP PAIN. DISCHARGE DIAGNOSES: S/P LEFT TOTAL HIP REPLACEMENT. S/P HEALTHCARE ASSOCIATED PNEUMONIA. S/P BOWEL OBSTRUCTION WITH LYSIS OF ADHESIONS AND EXPLORATORY LAPAROTOMY TIMES TWO. OVERWHELMING METABOLIC ACIDOSIS. DISTRIBUTIVE SHOCK. HPI: ADMITTED FOR TOTAL HIP ARTHROPLASTY. DEVELOPED A BOWEL OBSTRUCTION AND IT BECAME NECESSARY TO TAKE HIM TO SURGERY FOR EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS. AFTER THAT, HE DID HAVE A BOUT OF HEALTHCARE ASSOCIATED PNEUMONIA. THIS WAS TREATED WITH TRIPLE ANTIBIOTIC THERAPY AND RESOLVED. HAD A HIGH NG ASPIRATE FOR SEVERAL DAYS AFTER HIS SURGERY AND THOUGH HE HAD SMALL BOWEL MOVEMENTS, WAS FELT TO BE WORSENING FROM AN ABDOMINAL STANDPOINT. HE WAS TAKEN BACK FOR A REPEAT EXPLORATORY LAPAROTOMY, AND THEN HAD DECOMPENSATION AFTER THAT SURGERY. THROUGH THE LAST COUPLE OF DAYS, HE HAS REQUIRED HEROIC MEASURES, INCLUDING VASOPRESSORS, POSITIVE PRESSURE VENTILATION, AND REGULAR AMPS OF BICARBONATE TO COMBAT HIS WORSENING MEDICAL STATUS. TODAY, I MET WITH THE FAMILY REGARDING THE MEDICAL FUTILITY OF CONTINUING CARE. HIS BLOOD PRESSURE WAS 40 SYSTOLIC AT THE TIME AND HAD BEEN MOST OF THE NIGHT. THEY ELECTED TO MAKE HIM COMFORT CARE AND HE PASSED AWAY SHORTLY THEREAFTER.¿ CONCLUSION: THE PATIENT EXPERIENCED A SMALL BOWEL OBSTRUCTION AS A RESULT OF A POTENTIAL ILEUS FOLLOWING A R TOTAL HIP ARTHROPLASTY FOR WHICH THE PATIENT WAS ADMITTED ON (B)(6) 2015. THIS IS NOTED IN THE MEDICAL RECORD ON (B)(6) 2015 AND STATES ¿EITHER A REFLEX FOCAL ILEUS IN THE UPPER ABDOMEN OR PARTIAL SMALL BOWEL OBSTRUCTION. THERE APPEARS TO BE A TRANSITION ZONE IN THE PELVIS, SO THIS IS PROBABLY A PARTIAL OBSTRUCTION.¿ THIS OBSTRUCTION WAS ADDRESSED DURING AN EXPLORATORY LAPAROTOMY PERFORMED ON (B)(6) 2015. THE PATIENT CONTINUED TO HAVE OBSTRUCTIVE SYMPTOMS AS NOTED IN THE DIAGNOSTIC IMAGING STUDIES RECORDED ON (B)(6) 2015: ¿ABNORMAL UPPER ABDOMEN SMALL BOWEL LOOPS. THIS SUGGESTS A HIGH-GRADE REFLEX ILEUS SUCH AS FROM PAIN OR INFLAMMATION.¿; ON (B)(6) 2015: ¿DISTENDED GAS-FILLED LOOPS OF BOWEL BUT THIS APPEARS TO PROBABLY BE AN ILEUS.¿; AND ON (B)(6) 2015: ¿DESPITE THE RECENT SURGERY, THERE IS CONCERN FOR A PARTIAL SMALL BOWEL OBSTRUCTION¿. MEDICAL RECORDS MENTION THE IMPLANTED GORE DEVICE IN CONNECTION WITH THE PATIENT¿S SUBSEQUENT SMALL BOWEL OBSTRUCTION. AS STATED IN THE MEDICAL RECORD ON (B)(6) 2015, ¿THE PATIENT HAD MARKEDLY DILATED PROXIMAL SMALL BOWEL. THE SMALL BOWEL IS GROWING INTO THE ANTERIOR ABDOMINAL WALL MESH AND IS VERY THIN WALLED. THIS IS WALLED OFF THE ADHESIONS ARE VERY DENSE. THE STOMACH AND PROXIMAL SMALL BOWEL ARE MASSIVELY DISTENDED. VERY DENSE ADHESIONS WERE ENCOUNTERED FROM THE SMALL BOWEL TO THE MESH. THESE WERE TAKEN DOWN BY BLUNT AND SHARP DISSECTION. THE NECROTIC SMALL BOWEL WAS NOTED.¿ THE MEDICAL RECORD GOES ON TO STATE THAT DUE TO THE PATIENT¿S WORSENING CONDITION A DISCUSSION WAS HELD WITH THE FAMILY REGARDING FUTILITY OF CARE AND THE PATIENT WAS MADE ¿COMFORT CARE¿. THE PATIENT EXPIRED SHORTLY AFTER AS A RESULT OF COMPLICATIONS FROM SURGERY, ¿POSTOPERATIVE SEPSIS AND SEPTIC SHOCK¿, ¿OVERWHELMING METABOLIC ACIDOSIS¿ AND ¿DISTRIBUTIVE SHOCK¿. HOWEVER, THE PROVIDED DEATH CERTIFICATE SPECIFIES THE PRIMARY CAUSE OF DEATH AS ¿SMALL BOWEL OBSTRUCTION¿ WITH HCAP [HEALTH-CARE ASSOCIATED PNEUMONIA] AS A ¿SIGNIFICANT CONDITION CONTRIBUTING TO DEATH¿. GIVEN THE AVAILABLE INFORMATION AND IN AN ABUNDANCE OF CAUTION, THE PATIENT¿S DEATH IS BEING REPORTED. 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.¿ 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 RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE FOR USE IN PRODUCT SURVEILLANCE TRACKING, TRENDING AND FOLLOW-UP. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING MANUFACTURER / COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 05828393. 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.
B7: ADDED PATIENT MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. SEE ATTACHMENT FOR CONTINUATION OF RECORDS. ADDITIONAL DETAILS REGARDING THE PATIENT¿S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2010: CONSULTATION. ¿SUSPECTED VENTRAL HERNIA. LUMP AT THE LEVEL OF THE UMBILICUS TO THE RIGHT OF HIS AAA INCISION 3 MONTHS AGO. SIZE VARIES FROM DAY TO DAY, NEVER COMPLETELY RESOLVES, LARGEST IN MORNING. PT CAN REDUCE IT BUT IT IMMEDIATELY RETURNS. PSH: NONEMERGENT AAA REPAIR 2005. IT WAS C/B POST D/C POSTOP WOUND DISTAL TO UMBILICUS THAT REQUIRED PACKING. EXAM: ABDOMEN: OBESE NT. VISIBLE 5 CM BULDGE [SIC] TO RIGHT OF UMBILICUS WHEN STANDING. BULDGE [SIC] WITH FASCIAL DEFECT IS PALPABLE IN SUPINE POSITION AND REDUCEABLE [SIC]. ASSESSMENT/PLAN: VENTRAL INCISIONAL HERNIA. PT WAS PRESENTED WITH OBSERVATION OR LAP VS OPEN REPAIR. HE WAS COUNCILED [SIC] ON SMOKING CESSATION AND OFFERED A REFERRAL BUT REFUSED. IT WAS STRESSED THE IMPORTANCE SMOKING CESSATION ON THE OUTCOME OF HIS SURGERY.¿ (B)(6) 2010: CT ABDOMEN W/O CON. ¿IMPRESSION: VENTRAL HERNIA WITH MESENTERY PRESENT.¿ (B)(6) 2015: CT ABDOMEN, PELVIS W/ CONTRAST. ¿REASON FOR EXAM: SBO, EVALUATE ABDOMEN ILEUS OR OBSTRUCTION, ABD DISTENTION. READ: HAS ABDOMEN DISTENTION, SO AN ILEUS OR OBSTRUCTION IS SUSPECTED. EXTENSIVE DIVERTICULOSIS IN THE COLON EVEN IN THE RIGHT COLON. DENSE MATERIAL ANTERIORLY IN THE MID AND RIGHT ABDOMEN APPARENTLY REPRESENTING HERNIA REPAIR. THERE ARE DILATED SMALL BOWEL LOOPS SUPERIORLY AND PROXIMALLY BUT DISTALLY THE SMALL BOWEL IS NORMAL SO THAT CERTAINLY SUGGESTS A TRANSITION ZONE. IMPRESSION: EITHER A REFLEX FOCAL ILEUS IN THE UPPER ABDOMEN OR PARTIAL SMALL BOWEL OBSTRUCTION. THERE APPEARS TO BE A TRANSITION ZONE IN THE PELVIS, SO THIS IS PROBABLY A PARTIAL OBSTRUCTION.¿ (B)(6) 2015: PROGRESS NOTES. ¿POST OP ILEUS WITH SMALL BOWEL OBSTRUCTION.¿ (B)(6) 2015: ABDOMEN ACUTE SERIES. ¿IMPRESSION: ABNORMAL UPPER ABDOMEN SMALL BOWEL LOOPS. THIS SUGGESTS A HIGH-GRADE REFLEX ILEUS SUCH AS FROM PAIN OR INFLAMMATION.¿ (B)(6) 2015: ABDOMEN COMP W/ ERECT. ¿REASON FOR EXAM: ILEUS. IMPRESSION: DISTENDED GAS-FILLED LOOPS OF BOWEL BUT THIS APPEARS TO PROBABLY BE AN ILEUS.¿ (B)(6) 2015: CT ABDOMEN, PELVIS W/ CONTRAST. ¿IMPRESSION: DESPITE THE RECENT SURGERY, THERE IS CONCERN FOR A PARTIAL SMALL BOWEL OBSTRUCTION. PRESUMED POSTSURGICAL CHANGES WITH STRAND DENSITY REMAINING IN THE MESENTERY IN THE RIGHT LOWER QUADRANT. THERE HAS BEEN PLACEMENT OF MESH IN THE ANTERIOR ABDOMINAL WALL ON THE RIGHT.¿ (B)(6) 2015: PROGRESS NOTES. ¿FAIRLY MASSIVELY DILATED STOMACH AND PROXIMAL SMALL BOWEL. I THINK IT IS APPROPRIATE AT THIS TIME FOR THE PATIENT TO UNDERGO EXPLORATORY LAPAROTOMY. THE PATIENT IS AT SIGNIFICANT RISK BECAUSE OF ADHESIONS. RISKS INCLUDE FISTULA FORMATION, HOWEVER THE PATIENT IS NOT IMPROVING. HIS WHITE COUNT HAS GONE UP. THE PATIENT HAD VERY DENSE ADHESIONS AT THE TIME OF HIS INITIAL SURGERY. I EXPECT THIS TO BE A VERY DIFFICULT PROCEDURE AND THE PATIENT HAS BEEN SO INFORMED.¿ (B)(6) 2015: PROGRESS NOTES. ¿CC: S/P ABDOMINAL SURGERY. ASSESSMENT: POSTOPERATIVE SEPSIS AND SEPTIC SHOCK. PLAN: I AM VERY WORRIED THAT HE HAS ONGOING METABOLIC ALKALOSIS. HE MAY HAVE AN OVERWHELMING ABDOMINAL INFECTION AND SEPSIS OR RETURN OF HIS HEALTHCARE-ASSOCIATED PNEUMONIA. HIS PROGNOSIS AT THIS POINT IS VERY POOR. I WOULD NOT BE SURPRISED IF HE DID NOT SURVIVE THE DAY. I ASKED HIS WIFE ABOUT DNR/DNI ORDERS, AND SHE WANTS TO KEEP THOSE IN PLACE.¿ 12/20/15: DISCHARGE SUMMARY. ¿ADMIT DIAGNOSIS: WAS LEFT HIP PAIN. DISCHARGE DIAGNOSES: S/P LEFT TOTAL HIP REPLACEMENT. S/P HEALTHCARE ASSOCIATED PNEUMONIA. S/P BOWEL OBSTRUCTION WITH LYSIS OF ADHESIONS AND EXPLORATORY LAPAROTOMY TIMES TWO. OVERWHELMING METABOLIC ACIDOSIS. DISTRIBUTIVE SHOCK. HPI: ADMITTED FOR TOTAL HIP ARTHROPLASTY. DEVELOPED A BOWEL OBSTRUCTION AND IT BECAME NECESSARY TO TAKE HIM TO SURGERY FOR EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS. AFTER THAT, HE DID HAVE A BOUT OF HEALTHCARE ASSOCIATED PNEUMONIA. THIS WAS TREATED WITH TRIPLE ANTIBIOTIC THERAPY AND RESOLVED. HAD A HIGH NG ASPIRATE FOR SEVERAL DAYS AFTER HIS SURGERY AND THOUGH HE HAD SMALL BOWEL MOVEMENTS, WAS FELT TO BE WORSENING FROM AN ABDOMINAL STANDPOINT. HE WAS TAKEN BACK FOR A REPEAT EXPLORATORY LAPAROTOMY, AND THEN HAD DECOMPENSATION AFTER THAT SURGERY. THROUGH THE LAST COUPLE OF DAYS, HE HAS REQUIRED HEROIC MEASURES, INCLUDING VASOPRESSORS, POSITIVE PRESSURE VENTILATION, REGULAR AMPS OF BICARBONATE TO COMBAT HIS WORSENING MEDICAL STATUS. TODAY, I MET WITH THE FAMILY REGARDING THE MEDICAL FUTILITY OF CONTINUING CARE. HIS BLOOD PRESSURE WAS 40 SYSTOLIC AT THE TIME AND HAD BEEN MOST OF THE NIGHT. THEY ELECTED TO MAKE HIM COMFORT CARE AND HE PASSED AWAY SHORTLY THEREAFTER.¿ 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.¿ 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.
PLEASE NOTE THE INITIAL MEDWATCH INDICATES AN INCORRECT DATE GORE AWARE OF 11/12/2018. THE DATE GORE AWARE OF INFORMATION FOR THE INITIAL REPORT IS 11/10/2018. B7: ADDED MEDICAL HISTORY. H6: 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: RECORDS PRIOR TO (B)(6) 2010, INCLUDING RECORDS FOR THE OPEN ABDOMINAL AORTIC ANEURYSM REPAIR IN 2005 AND APPENDECTOMY WERE NOT PROVIDED. RECORDS DATED (B)(6) 2010 STATE: ¿62 YEAR OLD MALE [WITH HISTORY OF HYPERTENSION, HYPERLIPIDEMIA], ASBESTOSIS, 5 [YEARS STATUS POST] AAA REPAIR, AND A 65 PACK YR HISTORY REFERRED TO CLINIC BY PCP FOR SUSPECTED VENTRAL HERNIA. HE FIRST NOTICED A "LUMP" AT THE LEVEL OF THE UMBILICUS TO THE RIGHT OF HIS AAA INCISION 3 MONTHS AGO BUT CAN NOT ASSOCIATE IT WITH A CERTAIN INCIDENCE. SIZE VARIES FROM DAY TO DAY BUT IT NEVER COMPLETELY RESOLVES AND IT SEEMS TO BE LARGEST IN THE MORNING. [PATIENT] CAN REDUCE IT BUT IMMEDIATELY RETURNS. PAIN FLUCTUATES FROM 3/10 TO 9/10. HE HAS VERY LITTLE PHYSICAL ACTIVITY AND NO ASSOCIATION OF SX'X [SIC] WITH COUGH OR STRAINING. HE DENIES ANY [NAUSEA/VOMITING/DIARRHEA/COUGHING],HEMATOCHEZIA, MELENA, TRAUMA, CHANGE IN SLEEP, ENERGY, OR WEIGHT. PAST SURGICAL [HISTORY]: NONEMERGENT AAA REPAIR 2005 IN (B)(6). 5 DAYS INPATIENT. IT WAS [COMPLICATED BY] POST [DISCHARGE] POST OP WOUND DISTAL TO UMBILICUS THAT REQUIRED PACKING.¿ PULMONARY CONSULATION NOTES DATED (B)(6) 2010 STATE: ¿PT HAS [HISTORY OF] OF COPD AND HAS BEEN TOLD THAT HE HAS ASBESTOSIS. OVER THE LAST 4-5 YEARS, HE HAS DEVELOPED PROGRESSIVE DYSPNEA ON EXERTION.¿ ¿HE HAS A LARGE AMOUNT OF SPUTUM PRODUCTION MOSTLY OF WHITE SPUTUM.¿ ¿HE IS CURRENTLY STILL SMOKING 1/2 [PACKS PER DAY] AND IS NOT INTERESTED IN QUITTING.¿ RECOMMENDATIONS FROM THE PULMONARY CONSULTATION STATE: ¿GIVEN THE AMOUNT OF SPUTUM HE PRODUCES, THE PATIENT WILL NEED TO BE TAUGHT HOW TO EFFECTIVELY COUGH WHILE HOLDING HIS ABDOMEN TO PREVENT WOUND ISSUES WHILE STILL KEEPING AN EFFECTIVE COUGH.¿ OPERATIVE RECORDS DATED (B)(6) 2010 STATE THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH THE PATIENT ¿IS A 62-YEAR-OLD MAN WITH A PAST SURGICAL HISTORY OF ABDOMINAL AORTIC ANEURYSM. HE HAS HAD A BULGE IN HIS ANTERIOR ABDOMINAL WALL, WHICH IS PAINFUL AND ENLARGING FOR SEVERAL YEARS. ON EXAMINATION IT IS CONSISTENT WITH A VENTRAL HERNIA.¿ THE OPERATIVE RECORDS DATED (B)(6) 2010 STATE: ¿THE ABDOMEN WAS ENTERED WITH A VERESS NEEDLE IN THE LEFT UPPER QUADRANT AND INSUFFLATED WITH CARBON DIOXIDE. THE INITIAL INSUFFLATION PRESSURES WERE LESS THAN 7 MMHG WITH GOOD FLOWS. THE ABDOMEN INSUFFLATED EASILY. AFTER INSUFFLATION TO 15 MMHG THE 5 MM PORT WAS PLACED IN THE LEFT UPPER QUADRANT THROUGH THE PREVIOUS VERESS NEEDLE INCISION. THE LAPAROSCOPE WAS INTRODUCED THROUGH THIS INCISION AND A SECOND 5 MM PORT WAS PLACED IN THE LEFT LOWER QUADRANT. A THIRD 5 MM PORT WAS PLACED INTERMEDIATE BETWEEN THESE TWO AND THE LEFT UPPER QUADRANT PORT WAS UPSIZED TO A 10 MM PORT.¿ OPERATIVE RECORDS DATED (B)(6) 2010 CONTINUE: ¿WE THEN EXPLORED THE ABDOMEN. WE IDENTIFIED SEVERAL VENTRAL HERNIA DEFECTS ON THE ANTERIOR ABDOMINAL WALL IN THE MIDLINE, WHICH CONTAINED OMENTAL FAT. WE DID NOT NOTE ANY BOWEL TO BE ASSOCIATED WITH THESE HERNIAS. THEY WERE REDUCED WITH A COMBINATION OF BLUNT AND SHARP DISSECTION. THE MESENTERIC FAT WAS EASILY REDUCED FROM THESE HERNIAS. AS THE HERNIATED FAT WAS BROUGHT DOWN FROM THE ANTERIOR ABDOMINAL WALL IT WAS EVIDENT THAT THERE WERE SEVERAL SMALL DISCRETE DEFECTS PRIMARILY IN THE MIDLINE EXTENDING FROM JUST BELOW THE FALCIFORM LIGAMENT DOWN TO THE LEVEL OF THE UMBILICUS. THERE WAS ALSO AN ADDITIONAL DEFECT TO THE RIGHT OF THE MIDLINE AT THE LEVEL OF THE UMBILICUS.¿ RECORDS DATED (B)(6) 2010 CONTINUE: ¿WE CAREFULLY BROUGHT DOWN ALL OF THE MESENTERIC FAT, WHICH HAD BEEN ADHERENT OR HERNIATED THROUGH THESE DEFECTS. WE ALSO CLEARED SEVERAL SMALL FILMY ADHESIONS OF MESENTERIC FAT FROM THE ANTERIOR ABDOMINAL WALL. WE THEN MARKED THE BOUNDARIES OF THE HERNIA DEFECT USING A SPINAL NEEDLE, WHICH WAS PASSED THROUGH THE ANTERIOR ABDOMINAL WALL UNDER DIRECT VISUALIZATION SUCH THAT WE COULD DELINEATE THE SPECIFIC SUPERIOR, INFERIOR, AND LATERAL BOUNDARIES OF OUR HERNIA DEFECTS.¿ THE RECORDS DATED (B)(6) 2010 STATE: ¿WE FOUND THAT THE HERNIA DEFECTS COMPRISED AN AREA OF 10 X 15 CM IN THE ANTERIOR ABDOMINAL WALL. A 20 X 25 CM PIECE OF GORE-TEX DUAL MESH WAS THEN BROUGHT TO THE FIELD. 0 GORE-TEX SUTURES WERE PLACED IN THE TOP, BOTTOM, AND MIDPOINT OF THE SIDES OF THE MESH. THE MESH WAS LAYED OVER THE ANTERIOR ABDOMINAL WALL AND THE POSITION OF THE MESH AND THE PREVIOUSLY PLACED SUTURES WAS MARKED ON THE ANTERIOR ABDOMINAL WALL. WE THEN PLACED AN ADDITIONAL 5 MM LAPAROSCOPIC PORT IN THE RIGHT ABDOMEN LATERAL TO THE UMBILICUS. A GRASPER WAS PASSED THROUGH THIS RIGHT-SIDED PORT AND OUT THROUGH THE 10 MM PORT IN THE LEFT UPPER QUADRANT OF THE ABDOMEN.¿ OPERATIVE RECORDS DATED (B)(6) 2010 CONTINUE: ¿THE 10 MM PORT WAS REMOVED AND THE ROLLED GORE-TEX DUAL MESH WAS PASSED THROUGH THE 10 MM PORT INCISION WITH USING THE GRASPER PASSED FROM THE OPPOSITE SIDE. THE MESH WAS DELIVERED EASILY INTO THE ABDOMEN. THE 10 MM PORT WAS THEN REPLACED. INSIDE THE ABDOMEN THE MESH WAS UNROLLED AND USING A SUTURE PASSER DEVICE THE PREVIOUSLY PLACED SUTURES AT THE SUPERIOR, INFERIOR, AND THE MIDDLE OF THE LATERAL ASPECTS OF THE MESH WERE BROUGHT OUT TO THE SURFACE OF THE ANTERIOR ABDOMINAL WALL THROUGH 3 MM SKIN INCISIONS. THESE SUTURES WERE CAREFULLY TIED DOWN. ON INSPECTION OF THE ABDOMEN WITH THE LAPAROSCOPE WE COULD SEE THAT THE MESH WAS JUST TAUT IN BOTH THE ANTEROPOSTERIOR AND LATERAL DIRECTIONS. WE THEN BROUGHT AN AUTOSUTURE STAPLING DEVICE ONTO THE FIELD.¿ RECORDS DATED (B)(6) 2010 STATE: ¿WE PLACED STAPLES AT 1 CM INTERVALS ON THE ENTIRE PERIPHERY OF THE MESH TACKING IT TO THE POSTERIOR ASPECT OF THE ANTERIOR ABDOMINAL WALL. THEN USING THE SUTURE PASSER DEVICE WE PLACED 0 GORE-TEX INTERRUPTED SUTURES IN EACH CORNER OF THE MESH FOR A TOTAL OF FOUR ADDITIONAL TRANSFIXION SUTURES. AT THIS POINT THE MESH WAS WELL SECURED TO THE ANTERIOR ABDOMINAL WALL. THE ABDOMEN WAS CAREFULLY EXPLORED. THERE WAS NO SIGNIFICANT BLEEDING. THE MESH WAS WELL SECURED TO THE ANTERIOR ABDOMINAL WALL. WE THEN CLOSED THE 10 MM PORT SITE WITH A FIGURE-OF-8 SUTURE OF 0 VICRYL PLACED WITH THE SUTURE PASSER DEVICE.¿ THE OPERATIVE RECORD DATED (B)(6) 2010 CONTINUES: ¿THE 10 PORT WAS REMOVED AND THIS SUTURE TIED DOWN UNDER DIRECT VISUALIZATION WITH THE LAPAROSCOPE. THE PORT SITE WAS WELL CLOSED. THE 5 MM PORTS WERE REMOVED AND THE SITES WERE CLOSED WITH SUBCUTICULAR SUTURES OF 4-0 MONOCRYL. THE WOUNDS WERE THEN DRESSED WITH STERI-STRIPS AND BAND-AIDS.¿ THE RECORDS CONFIRM A GORE DUALMESH®PLUS BIOMATERIAL (1DLMC078/05828393) WAS USED DURING THE PROCEDURE . DISCHARGE SUMMARY RECORDS DATED (B)(6) 2010 STATE: ¿THE PATIENT IS A 62-YEAR-OLD WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR OPEN ABDOMINAL AORTIC ANEURYSM REPAIR 5 YEARS PRIOR TO PRESENTATION, SEVERE RESTRICTIVE LUNG DISEASE WITH A 65 PACK-YEAR HISTORY, AND OBESITY, WHO PRESENTED IN FEBRUARY OF THIS YEAR FOR EVALUATION OF SYMPTOMATIC VENTRAL INCISIONAL HERNIA.¿ ¿GIVEN THE SYMPTOMATIC NATURE OF HIS INCISIONAL VENTRAL HERNIA, THE RECOMMENDATION WAS MADE FOR THE PATIENT TO PROCEED WITH VENTRAL HERNIA REPAIR, LAPAROSCOPIC VERSUS OPEN.¿ THE (B)(6) 2010 DISCHARGE SUMMARY CONTINUES: ¿THE PATIENT WAS DEEMED TO BE AN APPROPRIATE SURGICAL CANDIDATE, ALTHOUGH INTERMEDIATE RISK GIVEN COMORBIDITIES. THE PATIENT PROCEEDED TO THE OPERATING ROOM ON (B)(6) 2010 FOR A LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH. SIGNIFICANT PHYSICAL EXAMINATION FINDINGS PRIOR TO SURGERY INCLUDED AN OBESE ABDOMEN, NONTENDER, NONDISTENDED, WITH A MIDLINE ABDOMINAL SCAR BEGINNING 2 CM BELOW THE XYPHOID AND EXTENDING DISTALLY IN THE BILATERAL GROIN, A VISIBLE 5 CM HERNIA NOTED TO THE RIGHT OF THE UMBILICUS, ESPECIALLY WITH STANDING, EASILY REDUCIBLE AND PALPABLE FASCIAL DEFECT.¿ THE (B)(6) 2010 DISCHARGE SUMMARY STATES: ¿POSTOPERATIVELY, THE PATIENT WAS QUICKLY EXTUBATED IN THE OPERATING ROOM AND TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT FOR FURTHER MONITORING AND CARE.¿ ¿FROM A RESPIRATORY STANDPOINT, THE PATIENT WAS INITIATED ON BIPAP, AS WELL AS INITIATED ON ALL OF HIS HOME MEDICATIONS INCLUDING TIOTROPIUM, ALBUTEROL NEBULIZERS, AND FLUTICASONE/SALMETEROL INHALERS. FROM A SURGERY STANDPOINT, THE PATIENT DEMONSTRATED EVIDENCE OF A POSTOPERATIVE ILEUS, WHICH WAS NOT UNEXPECTED GIVEN THE AMOUNT OF INTESTINES THAT WERE INVOLVED WITH THE INCISIONAL HERNIA, AS WELL AS WITH ADHESIONS. THE PATIENT'S PULMONARY STATUS WAS STABLE THROUGHOUT THE HOSPITALIZATION.¿ ¿ON POSTOPERATIVE DAY #4, THE PATIENT DEMONSTRATED RETURN OF BOWEL FUNCTION AS EVIDENCED BY THE PASSAGE OF FLATUS AND HIS DIET WAS SUBSEQUENTLY ADVANCED WITHOUT SIGNIFICANT ISSUE. ON POSTOPERATIVE DAY #5, THE PATIENT REPORTED PASSAGE OF BOWEL MOVEMENTS AND TOLERATING A REGULAR DIET WITHOUT ANY NAUSEA OR VOMITING.¿ OPERATIVE RECORDS DATED (B)(6) 2015 STATE THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY THROUGH A POSTERIOR APPROACH. THERE IS NO MENTION OF GORE DUALMESH®PLUS BIOMATERIAL IN THE RECORDS . OPERATIVE RECORDS DATED (B)(6) 2015 STATE THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS. POSTOPERATIVE DIAGNOSIS STATES: ¿SMALL BOWEL OBSTRUCTION SECONDARY TO ADHESIONS AND CHOLELITHIASIS.¿ FINDINGS FROM THE PROCEDURE STATE: THE PATIENT HAS MARKED SMALL BOWEL ADHESIONS. THERE IS A DEFINITE TRANSITION POINT IN THE RIGHT LOWER QUADRANT, MARKEDLY DILATED PROXIMAL SMALL BOWEL, NORMAL SMALL BOWEL DISTAL. WE DISSECT EVERYTHING FROM THE LIGAMENT OF TREITZ ALL WAY TO THE ILEOCECAL VALVE. THE PATIENT HAS VERY DENSE ADHESIONS. THE PATIENT HAS PREVIOUS MESH IN PLACE. THE INCISION WAS STARTED AS A MIDLINE INCISION AND THEN HAD TO BE EXTENDED CAUDAD TODAY. IT WAS ELECTED NOT TO REMOVE HIS GALLBLADDER. THE GALLBLADDER WAS PALPATED. THERE WERE STONES ON ULTRASOUND. I DID NOT FEEL ANY STONES. IT WAS SOMEWHAT DISTENDED, CONSISTENT WITH HIS N.P.O. STATUS. LIVER WAS NORMAL. NO OTHER ABNORMALITIES WERE NOTED. THE SMALL BOWEL WAS RAN FROM THE ILEOCECAL VALVE TO THE LIGAMENT OF TREITZ. NO SMALL BOWEL ENTEROTOMIES WERE MADE. THE PATIENT HAD AIR IN THE BLADDER ON CT SCAN. THE PATIENT HAS SOME DIVERTICULAR DISEASE, SOMEWHAT OF A REDUNDANT SIGMOID COLON, BUT THERE IS NO CONNECTION BETWEEN THE COLON AND THE BLADDER.¿ THE (B)(6) 2015 OPERATIVE REPORT STATES: ¿A MIDLINE INCISION WAS MADE, DEEPENED DOWN THROUGH THE SUBCUTANEOUS TISSUE IN A MIDLINE FASHION. THE ABDOMEN ENTERED. WE DISSECTED DOWN THROUGH THE MESH, TAKING THE ADHESIONS OFF THE MESH, AND EVENTUALLY WE WERE ABLE TO EXTEND THE INCISION SUPERIORLY AND INFERIORLY. MOST OF THESE WERE OMENTAL ADHESIONS. THE SMALL BOWEL WAS RAN FROM THE LIGAMENT OF TREITZ DISTALLY. THE MAJORITY OF VERY SIGNIFICANT ADHESIONS WERE DOWN IN THE RIGHT LOWER QUADRANT. THE PATIENT HAS HAD A PREVIOUS APPENDECTOMY, AS WELL AS HIS THE AORTOBIFEMORAL BYPASS.¿ RECORDS DATED (B)(6) 2015 STATES: ¿THE LOOPS OF SMALL BOWEL WERE STUCK DOWN INTO THE OLD APPENDECTOMY SITE, AS WELL AS NEAR THE RIGHT LIMB OF THE AORTOBIFEMORAL BYPASS. WERE ABLE TO FREE ALL OF THESE UP. THE DISSECTION IS PERFORMED WITH SCISSORS AND CAUTERY. WE THEN RUN THE SMALL BOWEL X2. THERE ARE NO SEROSAL TEARS. THERE IS 1 TEAR IN THE MESENTERY THAT IS APPROXIMATED WITH 3-0 VICRYL. THE FASCIA/MESH IS APPROXIMATED WITH RUNNING NUMBER 1 PROLENE . IT IS ELECTED NOT TO DO THE CHOLECYSTECTOMY, BECAUSE THIS WOULD HAVE NECESSITATED EXTENDING THE ALREADY FAIRLY LARGE INCISION CEPHALAD. HE HAS HAD NO HISTORY OF GALLBLADDER DISEASE. SKIN EDGES APPROXIMATED WITH STAINLESS STEEL STAPLES. OPERATIVE RECORDS DATED (B)(6) 2015 STATE THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE 45-MINUTE LYSIS OF ADHESIONS, SEGMENTAL SMALL BOWEL RESECTION, EXPLANTATION OF PREVIOUSLY PLACED KUGEL PATCH. POSTOPERATIVE DIAGNOSES ARE NOTED AS ¿1. SMALL BOWEL RESECTION, OBSTRUCTION RECURRENT. 2. NECROTIC SMALL BOWEL.¿ FINDINGS FROM THE (B)(6) 2015 PROCEDURE STATE: ¿THE PATIENT HAS MARKEDLY DILATED PROXIMAL SMALL BOWEL. THE SMALL BOWEL IS GROWING INTO THE ANTERIOR ABDOMINAL WALL MESH AND IS VERY THIN WALLED. THERE WERE SOME AREAS OF ACTUAL MICROPERFORATION. THIS WAS ALL WALLED OFF. DURING THE MOBILIZATION OF THIS, WE SPILLED SOME SMALL BOWEL CONTENTS. THERE WAS A SMALL HEMATOMA IN THE ORIGINAL WOUND AT THE LOWER PORTION AND CULTURES WERE OBTAINED OF THIS. AGAIN, THE WOUND WAS LEFT OPEN. THERE WAS NO INTRAABDOMINAL INFECTION. THE ADHESIONS ARE VERY DENSE. THE STOMACH AND PROXIMAL SMALL BOWEL ARE MASSIVELY DISTENDED. THE DISTAL SMALL BOWEL IS GNARLED AND REQUIRED RESECTION.¿ THE OPERATIVE RECORDS DATED (B)(6) 2015 STATE: ¿THE PREVIOUS INCISION WAS OPENED. CULTURES WERE OBTAINED OF THE AREA OF HEMATOMA IN THE INFERIOR PORTION OF THE INCISION. THE PROLENE SUTURES WERE REMOVED AND THE ABDOMEN ENTERED. VERY DENSE ADHESIONS WERE ENCOUNTERED FROM THE SMALL BOWEL TO THE MESH. THESE WERE TAKEN DOWN BY BLUNT AND SHARP DISSECTION. THE NECROTIC SMALL BOWEL WAS NOTED. GIA STAPLER IS FIRED PROXIMAL AND DISTAL TO THIS AND THE MESENTERY DIVIDED BETWEEN CLAMPS, TRANSECTED, AND LIGATED WITH 2-0 VICRYL TIES.¿ THE RECORDS DATED (B)(6) 2015 CONTINUE: ¿WE CONTINUED THE DISSECTION. THE VERY DISTAL 2 FEET OF TERMINAL ILEUM IS BASICALLY A GNARLED MASS. THESE WERE VERY DIFFICULT ADHESIONS THE FIRST-TIME THROUGH AND THERE WAS SOME FIBROSIS AND FAT NECROSIS AND IT WAS FELT BEST TO RESECT THIS. THE TERMINAL ILEUM WAS DIVIDED WITH A GIA STAPLER. MESENTERY DIVIDED BETWEEN CLAMPS, TRANSECTED, AND LIGATED WITH 2-0 VICRYL TIES. WE THEN REMOVED THE KUGEL PATCH. THERE ARE MULTIPLE METAL SPIRAL TACKS THAT ARE REMOVED. THIS WAS VERY DIFFICULT. I FELT THAT THE MESH NEEDED TO BE REMOVED TO PREVENT #1 INFECTION BUT MORE SIGNIFICANTLY TO DECREASE THE CHANCE OF THE BOWEL WHICH IS VERY EDEMATOUS FROM ATTACHING TO THIS MESS.¿ THE OPERATIVE RECORDS DATED (B)(6) 2015 STATE: ¿ABDOMEN WAS THEN COPIOUSLY IRRIGATED AND SUCTIONED DRY. WE WERE ON THE PROXIMAL SMALL BOWEL. THE NG TUBE WAS REPOSITIONED. AFTER IRRIGATING THE ABDOMEN, THE MESENTERY WAS APPROXIMATED WITH 3-0 VICRYL. THE FASCIA WAS APPROXIMATED WITH RUNNING #1 VICRYL AND INTERRUPTED 0 VICRYL SUTURES. THE WOUND WAS LEFT OPEN .¿ PATHOLOGY REPORT DATED (B)(6) 2015 STATES: ¿RECEIVED IN FIXATIVE LABELED "SMALL BOWEL SEGMENTAL RESECTION" ARE 2 LARGE SEGMENTS OF SYNTHETIC MESH MATERIAL WITH IMBEDDED DENSE FIBROUS TISSUE. THE SEGMENTS OF MESH MEASURE APPROXIMATELY 14.0 X 14.0 X 0.8 CM IN AGGREGATE. ALSO SUBMITTED ARE 2 SEPARATE SEGMENTS OF SMALL BOWEL. THE FIRST SEGMENT OF BOWEL MEASURES APPROXIMATELY 60 CM IN LENGTH. THE SEROSAL ASPECT SHOWS ADHERENT CLOT AND DENSE FIBROUS ADHESIONS. THERE ARE FOCALLY DENSE ADHESIONS BETWEEN THE LOOPS OF BOWEL CAUSING A SLIGHT KINKING OF THE BOWEL. APPROXIMATELY 3 CM FROM ONE MARGIN IS A FULL-THICKNESS DEFECT IN THE BOWEL WALL MEASURING 5 CM IN LENGTH. SEPARATE 1 CM SURFACE DEFECT IS IDENTIFIED APPROXIMATELY 16 CM FROM THE SAME MARGIN. THE BOWEL MUCOSA IS PREDOMINANTLY INTACT WITH AN AVERAGE BOWEL WALL THICKNESS OF 0.4 CM. THERE ARE FOCAL AREAS OF MUCOSAL FLATTENING AND HEMORRHAGE. THE LARGEST AREA MEASURES 2 CM IN LENGTH. NO MASSES ARE PRESENT. THE SECOND SEGMENT OF BOWEL MEASURES APPROXIMATELY 40 CM IN LENGTH AND ALSO CONTAINS ADHERENT THROMBUS AND FIBROUS ADHESIONS ALONG THE EXTERNAL SURFACE. APPROXIMATELY 10 MM FROM ONE FROM ONE MARGIN IS A 4 CM SURFACE FULL-THICKNESS DEFECT (PERFORATION). OTHERWISE, THE BOWEL MUCOSA IS INTACT WITHOUT MASS LESION AND AVERAGES APPROXIMATELY 0.3 CM IN THICKNESS.¿ ¿DIAGNOSIS: SMALL BOWEL SEGMENTS, 2, AND SURGICAL MESH EXPLANT (RECURRENT OBSTRUCTION) -- DIFFUSE SEROSAL ADHESIONS, -- SEGMENTAL ISCHEMIC NECROSIS.¿ A CULTURE REPORT OF THE SWABS TAKEN IN THE AREA OF THE HEMATOMA DURING THE (B)(6) 2015 PROCEDURE WERE NOT PROVIDED. 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.¿ 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: 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: (B)(6) 2015: (B)(6) RECORDS. CERTIFICATE OF DEATH. DEATH AT AGE 68 YEARS. PLACE OF DEATH: (B)(6) MEDICAL CENTER. IMMEDIATE CAUSE: SMALL BOWEL OBSTRUCTION. MANNER OF DEATH: NATURAL. AUTOPSY: NO. DID TOBACCO USE CONTRIBUTE TO DEATH: UNKNOWN. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING. ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE." 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.
H6: UPDATED RESULT CODE. CONCLUSION CODE REMAINS UNCHANGED.
(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.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2010, WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL DEVICE WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES, SMALL BOWEL OBSTRUCTION, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 904226 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP07 | 05828393 | 00733132601141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |