MAUDE Adverse Event Report: COOK BIOTECH ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT; HYBRID GRAFT

Model Number	G23770
Health Effect - Clinical Codes	Pain (1994); Seroma (2069); Discharge (2225)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the patient¿s infection was determined to be the seroma which required drainage.The seroma was the likely precursor to the course of events.A seroma is a known potential complication with the use of zenapro.Therefore, the device contributed to the need for reoperation due to the development of a seroma which required percutaneous drainage which likely led to an infection.The reoperation was also determined to have been performed to preclude serious injury as the zenapro device is contraindicated for use in infected fields.
Event or Problem Description
On (b)(6) 2017, dr.(b)(6) placed a c-hyb-20x30 to repair a recurrent hernia.The previously placed zenapro was not explanted.The new zenapro was placed in the onlay space with the 2-layer side down and the 4-layer side up.Many (30+) prolene sutures were used in a running stitch with a few interrupted stitches.Two drains were placed.The drains were left in place for two months and were removed in (b)(6).Within a week, the patient returned with complaints of pain.A large seroma was identified.The seroma was drained by interventional radiology via a percutaneous drainage.The patient was seen by dr.(b)(6) the week of (b)(6) 2017 and was draining questionable fluid.A culture of the fluid was positive for an unspecified infection.On (b)(6) 2017, dr.(b)(6) reoperated on the patient.The 2-layer side of the zenapro, which was the posterior side, was not incorporated and it was slimy.The 4-layer side of the zenapro was fully incorporated.The zenapro was not explanted, but a debridement of the 2-layer side was performed.A wound vac was placed on the patient.

• Brand Name: ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT
• Common Device Name: HYBRID GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• MDR Report Key: 6831529
• Report Number: 1835959-2017-00004
• Device Sequence Number: 44724
• Product Code: FTL
• UDI-Device Identifier: 10827002237701
• UDI-Public: (01)10827002237701(17)180112(10)LB928156
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K111695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G23770
• Device Catalogue Number: C-HYB-20X30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED BY THE COMPLAINANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69