BIODESIGN HIATAL HERNIA GRAFT

Report

Report Number: 1835959-2022-00006
Event Type: Injury
Date Received: October 11, 2022
Date of Event: April 29, 2020
Report Date: October 5, 2022
Manufacturer: COOK BIOTECH
Product Code: OWV
UDI-DI: 10827002314556
PMA / PMN Number: K133011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION: EVALUATION: INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE FEEDBACK DETAILS, A REVIEW OF THE DEVICE LOT HISTORY RECORD, A REVIEW OF THE CBI COMPLAINT DATABASE, AND A REVIEW OF THE BIODESIGN HIATAL HERNIA GRAFT IFU FP0032-03J. UPDATE: ADDITIONAL INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF MEDICAL RECORDS. UPDATE: ADDITIONAL INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE PRODUCT LIABILITY CLAIM DETAILS. ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. SUMMARY OF INVESTIGATION FINDINGS: A REVIEW OF THE DEVICE LOT HISTORY RECORD INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE NONCONFORMANCE AND DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE OCCURRENCE. THE LOT PRODUCED A TOTAL OF 6 DEVICES. THE DEVICE LOT HISTORY RECORDS INDICATE THAT THE 6 DEVICES THAT WERE RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. PER THE IFU, THE FOLLOWING COMPLICATIONS ARE POSSIBLE WITH THE USE OF SURGICAL GRAFT MATERIALS: INFECTION, ACUTE OR CHRONIC INFLAMMATION (INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION.), ALLERGIC REACTION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE OF TISSUE DEFECT. THE FOLLOWING COMPLICATIONS ARE ASSOCIATED WITH USE OF GRAFT MATERIALS IN HIATAL HERNIA REPAIR: ESOPHAGEAL EROSION, STRICTURE FORMATION, PERFORATION, AND DYSPHAGIA. BASED ON THE AVAILABLE DETAILS, A SPECIFIC CORRELATION BETWEEN THE DEVICE'S PERFORMANCE AND THE PATIENT'S OUTCOME ARE UNKNOWN. A ROOT CAUSE OF THE PATIENT'S EXPERIENCE IS INCONCLUSIVE DUE TO A LACK OF DETAILS. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED, THAN THE COMPLAINT WILL BE REOPENED. UPDATE: BASED ON THE REVIEW OF MEDICAL RECORDS, THE PATIENT EXPERIENCED A HIATAL HERNIA RECURRENCE. THE ROOT CAUSE OF THE RECURRENCE IS LIKELY DUE TO THE PATIENT'S CONDITION AT THE TIME OF IMPLANT AND SURGICAL TECHNIQUE. THE HERNIA REPAIR TOOK PLACE ON (B)(6) 2019 AND IMAGING RESULTS FROM (B)(6) 2019 STATED A SMALL SLIDING HERNIA REMAINS. IN RELATION TO THE DEVICE BEING NOTED TO HAVE AN INFECTED APPEARANCE AND PARTIALLY SHRIVELED AWAY FROM THE HERNIA SITE, THE DEVICE IS SUPPLIED TO THE END USER AS A STERILE DEVICE. THE DEVICE WOULD NOT HAVE CAUSED OR CONTRIBUTED TO AN INFECTION. THE DEVICE PERFORMANCE WAS LIKELY AFFECTED BY THE PATIENT'S UNDERLYING CONDITION BEING TREATED AND SURGICAL TECHNIQUE. UPDATE: BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN HERNIA MESH'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE. HOWEVER, THE PRIOR ROOT CAUSE ANALYSIS (BASED ON THE REVIEW OF THE PATIENT'S MEDICAL RECORDS SUBMITTED TO CBI), REMAINS UNCHANGED AT THIS TIME. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED THE COMPLAINT WILL BE REOPENED.

Description of Event or Problem · 0

A LAWYER CONTACTED COOK MEDICAL TO INFORM THEM OF A POTENTIAL PRODUCT LIABILITY CLAIM. PATIENT: (B)(6), LOT #: LB1143478, CATALOG #: G31455. (B)(6) 2022: COOK LEGAL INDICATED NO ADDITIONAL DETAILS RECEIVED. (B)(6) 2022: COOK LEGAL INDICATED STILL NO ADDITIONAL DETAILS RECEIVED. UPDATE: PATIENT MEDICAL RECORDS RECEIVED ON (B)(6) 2022. ON (B)(6) 2019, THE PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF HIATAL HERNIA WITH MESH; 2. UPPER ENDOSCOPY; AND 3. WEDGE RESECTION OF THE GASTRIC FUNDUS. PER THE OPERATIVE NOTE, THE PATIENT HAD SEVERE ESOPHAGITIS. LARGE AMOUNT OF RETAINED FOOD DEBRIS WITHIN THE STOMACH. MUCOSAL CHANGES WERE NOT VISIBLE DUE TO THE SHEER AMOUNT OF FOOD WITHIN THE STOMACH. ENTIRE STOMACH WAS INTRATHORACIC. VISIBLE WAS WHAT APPEARED TO BE A DEVITALIZED GASTRIC BODY ALONG THE LEFT CRUS AND ANTERIORLY THE STOMACH GOING UP INTO THE CHEST CAVITY APPEARED TO BE VIABLE. THE HIATAL DEFECT WAS QUITE LARGE. THE OMENTUM GOING UP INTO THE CHEST CAVITY ALSO APPEARED TO BE VIABLE. A VERY THICK AND INFLAMED HIATAL HERNIA SAC WAS COMPLETELY EXCISED AND BROUGHT BACK INTO THE ABDOMINAL CAVITY. CAREFUL INSPECTION OF THE STOMACH REVEALED THAT A GOOD PORTION OF THE GREATER CURVE OF THE STOMACH WAS FAIRLY ISCHEMIC, ESPECIALLY ONE AREA NEAR THE FUNDUS, WHICH APPEARED TO BE VERY THINNED OUT AND NECROTIC. THIS WAS ABOUT A 2 CM AREA. BARIATRIC SURGERY WAS CONSULTED. A LARGE PORTION OF THE GASTRIC FOOD DEBRIS WAS CLEANED OUT. THEN THE GE JUNCTION WAS IDENTIFIED AS VIABLE ABOUT 3 TO 4 CM DISTAL TO IT, ABOUT 6 TO 7 CM OF THE GASTRIC FUNDUS AND GREATER CURVE WERE NOT VIABLE. BARIATRIC SURGEON PERFORMED A PARTIAL GASTRECTOMY WITH REINFORCED STAPLES. THE STAPLE LINE WAS THEN COVERED WITH OMENTUM AND A JP DRAIN WAS LEFT IN PLACE THERE. ESOPHAGEAL HIATUS WAS THEN CLOSED WITH 4 POSTERIOR 0 ETHIBOND SUTURES. THERE WAS A GOOD BIT OF TENSION ON THE TOP 2 SUTURES. SURGISIS MESH IN A U-SHAPED FASHION WAS PLACED AND ANCHORED TO THE RIGHT AND LEFT CRURA AND THE LEFT HEMIDIAPHRAGM. NG TUBE WAS PLACED. IT APPEARED THAT THE ENTIRE STAPLE LINE ON THE STOMACH AT THE END OF PROCEDURE ON ENDOSCOPY WAS ON VIABLE STOMACH WITHOUT ANY FRANK FOOD DEBRIS LEFT WITHIN THE STOMACH. LITTLE BIT OF FOOD DEBRIS WAS LEFT ALL THE WAY DOWN AT THE LEVEL OF THE PYLORUS. ON (B)(6) 2019, AN UPPER GI IMAGING REVEALED 1. REPAIR OF A MASSIVE HIATAL HERNIA WITH STOMACH NOW POSITIONED BELOW THE DIAPHRAGM. SMALL SLIDING HERNIA REMAINS. 2. MARKED GASTROESOPHAGEAL REFLUX. POOR ESOPHAGEAL EMPTYING AND DYSMOTILITY. 3. WEDGE RESECTION GASTRIC WALL ALONG GREATER CURVATURE OF FUNDUS AND UPPER BODY WITH POSTOPERATIVE DEFECT. NO EVIDENCE OF LEAK. ABSENCE OF GASTRIC MOTILITY. MAY BE RELATED TO PAIN MEDICATION. NO EVIDENCE OF GASTRIC OUTLET OBSTRUCTION. ON (B)(6) 2020, THE PATIENT UNDERWENT XI ROBOTIC ASSISTED EXTENSIVE LYSIS OF ADHESIONS, TAKE DOWN GASTRIC CUTANEOUS FISTULA, DRAINAGE AND WASHOUT INTRA-ABDOMINAL ABSCESS, REPAIR RECURRENT DIAPHRAGMATIC HERNIA WITH MESH, GASTRIC EXCLUSION PROCEDURE VIA ROUX EN Y GASTRIC BYPASS. THE SURGERY WAS FOR COMPLICATIONS AFTER EMERGENT PARAESOPHAGEAL HERNIA REPAIR WITH RECURRENCE OF THE HERNIA AND A CHRONICALLY DRAINING WOUND AS WELL AS GASTROPARESIS AND SEVERE GASTRIC REFLUX. EXTENSIVE UPPER ABDOMINAL ADHESIONS WERE NOTED WITH COLON AND BOWEL ADHERENT TO THE ANTERIOR ABDOMINAL WALL. TEDIOUS LYSIS OF ADHESIONS WAS OF UNUSUAL DIFFICULTY AND ADDED SIGNIFICANT TIME TO THE CASE. THE OMENTUM, COLON, STOMACH, LIVER, SPLEEN, AND DIAPHRAGM WERE ALL FOUND TO BE INVOLVED IN THESE ADHESIONS. PATIENT WAS FOUND TO HAVE GASTROCUTANEOUS FISTULAS ARISING FROM THE ANTRUM OF THE STOMACH TO WHAT APPEARED TO BE PRIOR PORT SITES AND THE ANTERIOR ABDOMINAL WALL. THESE CORRELATED ON CAT SCAN WITH THE LOCATION OF THE INTRA-ABDOMINAL WALL ABSCESS WHICH HAD BEEN INTERMITTENTLY DRAINING THROUGH HER LEFT SUBCOSTAL DRAIN SITE. THE STOMACH END OF THE GASTROCUTANEOUS FISTULA WAS TAKEN DOWN BY STAPLING ACROSS THE STOMACH AT A HEALTHY MARGIN IN 2 SEPARATE LOCATIONS. THE FISTULA TRACT WAS THEN CARVED OUT FROM THE PERITONEUM AND POSTERIOR RECTUS SHEATH. PUS WAS IDENTIFIED AND CULTURED. THE AREA WAS WASHED OUT, AND BOTH SECTIONS SENT FOR PATHOLOGY AS GASTROCUTANEOUS FISTULA. NEXT THE PARAESOPHAGEAL HERNIA WAS EXAMINED. THE GREATER CURVE OF THE STOMACH HAD ALREADY BEEN TAKEN DOWN, BUT THE SCAR TISSUE HAD RECURRED AND THIS WAS CAREFULLY DISSECTED. PATIENT WAS FOUND TO HAVE WHAT APPEARED TO BE INFECTED MESH WHICH HAD PARTIALLY SHRIVELED AWAY FROM THE HIATAL HERNIA SITE. BILATERAL CRURA WERE IDENTIFIED BUT WERE VERY FRIABLE. MULTIPLE ETHIBOND SUTURES AND 1 METAL TACK WERE NOTED ADJACENT TO THE MESH. THE MESH WAS CAREFULLY REMOVED AND SENT FOR SPECIMEN. HERNIA DEFECT MEASURED AT 4X3 CM IN SIZE. AN ATTEMPT WAS MADE TO REDUCE THE PREVIOUSLY RETAINED HERNIA SAC HOWEVER THIS WAS ABANDONED AS IT BECAME CLEAR THAT FURTHER DISSECTION WOULD LEAD TO UNACCEPTABLE BLOOD LOSS. HERNIA WAS REPAIRED USING RUNNING LOOPED 0V LOCK IN A POSTERIOR LOCATION REDUCING THE DEFECT TO 2X2 CM. PHASIC¿S MESH WAS PLACED. ENTIRE ABDOMEN WASHED OUT. SMALL REMNANT OF THE BODY OF THE STOMACH PROXIMAL TO THE ANTRUM WAS RESECTED AS IT HAD A UNHEALTHY APPEARANCE WITH QUESTIONABLE PERFUSION. THE COLON WAS FOUND TO BE DENSELY SCARRED WITHIN THE OMENTUM, AND WAS INADVERTENTLY BURNED DURING THE TAKEDOWN OF THE GREATER OMENTUM. THIS WAS RECOGNIZED IMMEDIATELY, AND THE INJURED SEGMENT OF COLON WAS STAPLED OFF AND REMOVED AS SPECIMEN ¿COLOTOMY¿. UPDATE: THIS UPDATE IS IN RELATION DETAILS PROVIDED IN A PRODUCT LIABILITY CLAIM PRESENTED TO CBI ON (B)(6) 2022. THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN HERNIA MESH DEVICE, ON OR ABOUT (B)(6) 2019, AT (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE CLAIM REPORTS THAT AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2020, FOR A REVISION OPERATION WHEREIN THE BIODESIGN HERNIA MESH WAS FOUND TO BE CAUSING AND/OR CASUALLY CONTRIBUTING TO AN ABSCESS/FISTULA. ADDITIONALLY, THE CLAIM ALLEGES THAT THE BIODESIGN MESH HAD PARTIALLY SHRIVELED AWAY FROM THE HERNIA SITE AND CAUSED A SEVERE INFLAMMATORY AND INFECTIOUS RESPONSE WHICH NECESSITATED A MESH REMOVAL SURGERY ALONG WITH REMOVAL AND DRAINAGE OF AN ABSCESS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
287894	BIODESIGN HIATAL HERNIA GRAFT	HIATAL HERNIA GRAFT	OWV	COOK BIOTECH	G31455	LB1143478	10827002314556

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR	Female	Hospitalization