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	Injury (2348)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusion can be made at this time.It is alleged that the xenmatrix ab broke one week post-implant and underwent an additional surgery.Patient condition prior to implant and type of procedure performed is unknown at this time.Multiple attempts have been made to obtain additional information.A review of manufacturing records indicate the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february 2020.The precautions section of the instructions-for-use states: place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling.When unable to close skin over the xenmatrix¿ ab surgical graft, ensure that the implant remains moist.Avoid drying of the implant through ¿continued suction devices¿ as this may negatively impact the performance of the implant.If/when additional information is provided, a supplemental emdr will be submitted.Note, the date of event is provided as (b)(6) 2020 as the best estimate, based on the date of implant.Device evaluated by manufacturer? remains implanted.
Event or Problem Description
As reported, the patient was implanted with xenmatrix ab on (b)(6) 2020.One week post-implant, xenmatrix ab had broke down and the patient was taken back to surgery.

• 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: 10276882
• Report Number: 1213643-2020-06674
• Device Sequence Number: 2496193
• Product Code: PIJ
• UDI-Device Identifier: 00801741074301
• UDI-Public: (01)00801741074301
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: 1151935
• Device Lot Number: HUDV1849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/15/2020
• 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