MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number	1151935
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no malfunction of the xenmatrix ab graft.The material degradation that presented was directly attributable to the environment in which the graft was placed.As reported the surgeon had not expected the graft to be as compromised as he found during the second procedure.However, based on the events as reported the patient had previously undergone a bowel resection with a bile leak and the surgeon reports that the implant site was "clearly contaminated" with a high level of contamination at the site and direct contact with bowel secretion, it is not unanticipated that the biologic graft could be compromised.The instructions-for-use state to, "place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date there have been no other reported complaints for this manufacturing lot of (b)(4) units released for distribution in august 2018.Remains implanted.
Event or Problem Description
As reported the patient underwent hernia repair on (b)(6) 2019 and was implanted with a bard/davol xenmatrix ab graft.Surgeon reports "this was a worse of the worse case and clearly contaminated." the abdomen was left open.As reported the patient was taken back into surgery two days later and the surgeon noted 30% of the graft was completely broken down and non existent.The surgeon did not expect the graft to have broken down to this extent after two days.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8709644
• Report Number: 1213643-2019-05179
• Device Sequence Number: 2073547
• Product Code: PIJ
• UDI-Device Identifier: 00801741074301
• UDI-Public: (01)00801741074301
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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 Expiration Date: 07/28/2020
• Device Catalogue Number: 1151935
• Device Lot Number: HUCS0220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention