MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN HERNIA GRAFT

Catalog Number C-SLH-8H-20X30

Device Problems Hole In Material (1293); Torn Material (3024)

Patient Problems Death (1802); Fistula (1862); Necrosis (1971); Respiratory Failure (2484)

Event Type  Injury  

Manufacturer Narrative

Date of death not reported by complainant, but device did not cause or contribute.Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Implant date - (b)(6) 2014.Product manufacture date unknown; lot number unknown.The root cause of the pinhole enterotomy, which was suspected to lead to the enterocutaneous fistula, is inconclusive.Dr.(b)(6) suspected that the biodesign or the quilting sutures in the biodesign adhered to the bowel, then tore away and created the enterotomy.Many factors could contribute to adhesions, an enterotomy, or a fistula.Such factors include, but are not limited to, the underlying health conditions of the patient, the integrity of the bowel, and surgical technique to name a few.This patient was notably quite ill and had multiple underlying health conditions.The ifu notes adhesion and fistula formation of some of the possible adverse reactions with the use of any prosthesis.Additionally, the ifu states, "the need for re-operation should be reasonable expected in patients who are critically ill or who have severely contaminated abdomens.".

Event Description

In (b)(6) 2014, dr.(b)(6) placed a biodesign 20x30 cm sheet in an intraperitoneal onlay placement for a complex repair of a para-urostomy hernia with urostomy relocation and abdominoplasty in an (b)(6) caucasian male patient.The patient was noted to have multiple medical problems.Blake drains were placed.On post op day 23, the patient had greenish drainage from the inferior portion of the midline incision.There was some skin necrosis at the quadrafecta where the skin incision came together.This required debridement and resulted in an enterocutaneous fistula that could not be controlled.The patient went back to the operating room on post op day 28.The biodesign was found to be densely adherent to underlying bowel in multiple places.The graft was largely degraded into multiple fragments.A very tiny pinhole enterotomy was found at an area where vicryl stitching in the graft seemed to be densely adherent like it had torn away during movement.Dr.(b)(6) was able to bring up the proximal and distal stomas and close the abdomen.The patient required continued intubation post op due to poor pulmonary function and respiratory failure.The patient eventually requested withdrawal of care and expired within hours of his decision.Dr.(b)(6) indicated that he could have gotten the patient through this situation.The use of the biodesign device was not alleged to have caused or contributed to the patient's death.

• Brand Name: BIODESIGN HERNIA GRAFT
• Type of Device: HERNIA GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 5408245
• MDR Text Key: 37425702
• Report Number: 1835959-2016-00007
• Device Sequence Number: 1
• Product Code: OXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-SLH-8H-20X30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR