MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 XenMatrix; Porcine Surgical Mesh

Catalog Number	1161015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic repair with implant of composix kugel patch (device 1).Per operative notes, ¿a left upper quadrant incision was made.The hernia sac was dissected out.A circular composix kugel patch (device 1) was placed into the abdominal wall and secured it with sutures.¿ (b)(6) 2013 - patient was diagnosed with recurrent ventral/umbilical hernia, infected mesh, adhesion thereby underwent open repair with implant of xenmatrix graft (device 2) and explant of composix kugel patch (device 1).Per operative notes, ¿an incision was made around the periumbilical region.A large ventral hernia sac was dissected out.Some of the dense adhesions which were taken down sharply.On the inferior edge of the hernia defect there was a hard firm abdominal wall composix kugel patch (device 1) which had previously been placed.The old mesh becomes balled up and incarcerated in the inferior aspect of the hernia defect.Previously placed composix kugel patch (device 1) was excised entirely.A xenmatrix graft (device 2) was placed into the abdominal cavity and secured it with sutures.¿ (b)(6) 2016 - patient was diagnosed with incarcerated recurrent ventral hernia, small bowel obstruction, adhesion, inflammation, scar tissue thereby underwent open repair with explant of xenmatrix graft (device 2) and implant of biological mesh.Per operative notes, ¿a left upper quadrant incision was made into the abdominal cavity.The hernia sac was dissected out.Multiple adhesions were noticed.All adhesions were taken down.Multiple loops of small bowel obstructions were removed.Previously placed xenmatrix graft (device 2) had torn in multiple areas.All the scar tissues were taken down.Xenmatrix graft (device 2) was totally excised.All the inflammatory omentum was removed from the hernia defect.A biological mesh was placed into the abdominal cavity and secured it with sutures.¿.
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 mdr represents the xenmatrix graft (device 2).An additional supplemental emdr was submitted to represent the composix kugel patch (device 1).Note, the manufacturing date (15-jul-2012) is considered to be a best estimate.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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50436579
• Report Number: 1213643-2026-01094
• Device Sequence Number: 9167921
• Product Code: FTM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 07/28/2014
• Device Catalogue Number: 1161015
• Device Lot Number: HUWG0403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2012
• 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 Sex: Male