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

Catalog Number	1161520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This emdr represents the xenmatrix (device 2).An additional supplemental emdr was submitted to represent the ventralex mesh (device 1) and additional emdr was submitted to represent the ventralight st mesh (device 3).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per information provided: (b)(6) 2006 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, "a ventralex mesh (device 1) was placed into the abdominal wall using prolene sutures." (b)(6) 2018 - patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with removal of mesh (device 1) and implant of xenmatrix (device 2).Per op notes, "a midline incision was made.Adhesiolysis was performed, the old mesh (device 1) was excised.A xenmatrix (device 2) was placed into rectro rectus space using prolene sutures." (b)(6) 2018 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with implant of ventralight st mesh (device 3).Per op notes, "the previously placed biologic mesh (device 2) had torn in half and retracted.Dense adhesions to the mesh were cleared.A ventralight st mesh (device 3) was placed above the level of the biologic mesh (device 2) and below he peritoneum." (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of ventralight st mesh using echo ps (device 4).Per op notes, "dense adhesions to the anterior abdominal wall.A ventralight st mesh using echo ps (device 4) was placed into the abdominal wall and a synthetic mesh also placed.".

• Brand Name: XENMATRIX
• 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: 22901737
• Report Number: 1213643-2025-00791
• Device Sequence Number: 15686410
• Product Code: FTM
• UDI-Device Identifier: 00801741031410
• UDI-Public: (01)00801741031410
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 1161520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 54 YR
• Patient Sex: Male