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

Catalog Number	1161935
Medical Device Problem Codes	Material Disintegration (1177); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no malfunction of the xenmatrix device.The material degradation that presented was directly attributable to the environment in which the graft was subjected.As reported the surgeon had not expected the graft to be as compromised as he found during the revision procedure.However based on the reported level of contamination at the site and direct contact with bowel secretion, it is not unanticipated that the biologic graft would be significantly 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." additionally, regarding infection the instructions-for-use states, "if an infection develops, it should be treated aggressively." discarded.
Event or Problem Description
As reported the patient was admitted to the hospital on (b)(6) 2019 and after the relevant medical checks, was submitted to a rehabilitation surgery for a pre-6-month severe gravid necrotizing pancreatitis, which was successfully treated.On (b)(6) 2019 a restoration the continuity of the digestive system, i.E.Reunion (anastomosis) of the right with the left large intestine and closure of its ileostomy convergence.As well as a restoration of the abdominal wall gap that was left in the "open belly" technique from the pancreatitis phase, with a biological mesh (xenmatrix graft).After a smooth post-operative period, on the day of release from the hospital, a leak was identified from the bowel anastomosis.Two days later, after being evaluated by special examinations, underwent an operation where the bowel outlet was treated with the guided fistula technique to avoid new enterostomy.The xenmatrix graft was removed at that time because it was eroded by the leakage of the intestinal content.The patient was subjected to a total parenteral nutrition and antibiotic administration.On (b)(6) 2019 because the escape of intestinal contents continued, although embedded, the patient underwent a new operation where the escape was closed, and the doctor reset the temporary ileostomy to lead to the healing of the escape.The patient was released in good condition and on regular feeding.The doctors plan the closure of the ileostomy in 4-6 weeks depending on its course and after scanning of the transverse colon which had escaped, with gastro-intestinal administration.Doctor stated that the leakage was related to opening of the bowel anastomosis, this did not derive from the xenmatrix graft.

• Brand Name: XENMATRIX
• 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: 8705608
• Report Number: 1213643-2019-05108
• Device Sequence Number: 2073362
• Product Code: FTM
• UDI-Device Identifier: 00801741031441
• UDI-Public: (01)00801741031441
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 08/28/2020
• Device Catalogue Number: 1161935
• Device Lot Number: HUCV2778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/17/2019
• 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
• Patient Age: 40 YR
• Patient Weight: 75