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

Catalog Number	C-HYB-10X15
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Graft was explanted the week of (b)(6) 2016.A review of the device history records indicated the product was manufactured to specifications.The root cause of the adhesions is inconclusive.However, many factors can influence and contribute to adhesion formation including, but not limited to a patient's tendency to form adhesions, an abdominal procedure, any damage to the bowel during the initial surgery, excessive tissue incisions, history of prior surgeries, excessive handling of viscera, post-operative activities, nutrition, and the overall state of health of the patient.Adhesion formation is listed as a potential complication in the ifu.
Event or Problem Description
The patient had a few small midline incision hernias.On (b)(6) 2016, dr.(b)(6) placed a c-hyb-10x15 and a peritoneal dialysis catheter.The operation was performed laparoscopically.The graft was placed intraperitoneally (underlay), it was not cut or trimmed and absorba-tacks were used to fixate the graft.The graft was placed with the according to sidedness recommendations.Extensive adhesions were not noted during this operation.The following week, the patient was urgently taken to the operating room due to concern for a closed loop bowel obstruction.The patient had not had any peritoneal dialysis treatments at this point.Upon reoperation, a bowel obstruction was not discovered, but the patient did have extensive adhesions to the mesh.This operation was performed in an open manner by dr.(b)(6).The zenapro was removed and a primary closure of the midline was performed.

• 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: 5529371
• Report Number: 1835959-2016-00036
• Device Sequence Number: 494529
• Product Code: FTL
• UDI-Device Identifier: 10827002354774
• UDI-Public: (01)10827002354774(17)160430(10)LB771275
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2016

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 Catalogue Number: C-HYB-10X15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2016
• Initial Report FDA Received Date: 03/28/2016
• 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: ABSORBA-TACKS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention