MAUDE Adverse Event Report: DSM BIOMEDICAL XCM BIOLOGIC TISSUE MATRIX; MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS

Model Number	30012-31
Medical Device Problem Codes	Degraded (1153); Torn Material (3024)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fistula (1862); Sepsis (2067)
Date of Event	06/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the lot history records revealed no deviations that would contribute to suture tear.Given the use of the mesh to bridge a gap in the rectus muscles, excessive forces on the abdominal wall post-operatively may have contributed to the mesh detachment.In addition, presence of bowel contents in the abdominal cavity is known to degrade biologic mesh.
Event or Problem Description
The patient was female with a significant surgical history consisting of colectomy, stoma, stoma reversal, fistula, and hernia repair.On (b)(6) 2016, another abdominal surgery was performed that involved significant adhesiolysis, fistula debridement and closure, and resection of previously placed mesh.The surgical site was considered to be contaminated.The surgeon was not able to re-approximate the rectus muscles.Therefore, xcm biologic was implanted to bridge the gap in the abdominal wall.Approximately 2 weeks later, the patient presented with wound dehiscence and a small bowel fistula.Upon reoperation, the surgeon reported that the mesh had detached from the right side and was bunched up on the left side of the abdomen.The mesh was described as jelly-like in appearance.The surgeon removed the xcm biologic mesh and implanted vicryl mesh to cover the defect.The patient was still in the hospital one week later, but was no longer septic.

• Brand Name: XCM BIOLOGIC TISSUE MATRIX
• Common Device Name: MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS
• Manufacturer (Section D): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• MDR Report Key: 5775060
• Report Number: 2530154-2016-00010
• Device Sequence Number: 18967514
• Product Code: OXK
• UDI-Device Identifier: 00812337020312
• UDI-Public: 00812337020312
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K091499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2016

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: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: 30012-31
• Device Lot Number: C1026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NYLON SUTURE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR