MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number	1151015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medical records provided: the patient presented with symptoms of a core muscle injury and persistent groin pain.Per the operative details, the previous rectus abdominis left sided repair was intact."there were multiple other areas of scar tissue.This was mobilized up the entire rectus abdominis muscle above and below, cut through multiple bundles of scar tissue, and maneuvered the muscle to fill in the gap by doing so.Multiple 2-chromic sutures were used to approximate the muscle.Thus, the gap was replaced with intact muscle.A w-plasty was performed using a combination of sutures to decompress the compartment.A 10 x 15 cm piece of xenmatrix ab mesh was fitted and placed in an overlying fashion.This was also attached with ethibond at the pubic bone and along inguinal ligament.This was also secured at the external oblique and rectus abdominis muscles bilaterally." per contact since implant the graft had become "tighter and tighter in the abdomen and the patient is in significant pain.¿ contact reports that the patient had undergone three prior surgeries for ¿basically the same problem" and doctors now recommend aggressive dry needling of the rectus abdominis.
Additional Manufacturer Narrative
Based on the information provided, we are unable to determine to what extent, if any, the xenmatrix ab graft may be contributing to the patient¿s ongoing pain.As reported, the patient has a complex surgical history involving muscle/mesh repair and persistent groin pain prior to implant of the xenmatrix ab graft.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Remains implanted.

• Brand Name: XENMATRIX AB
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15991986
• Report Number: 1213643-2022-00800
• Device Sequence Number: 12193452
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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: 1151015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male