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

Model Number 30012-31

Device Problems Degraded (1153); Torn Material (3024)

Patient Problems Wound Dehiscence (1154); Fistula (1862); Sepsis (2067)

Event Date 06/15/2016

Event Type  Injury  

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 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
• Type of Device: MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS
• Manufacturer (Section D): DSM BIOMEDICAL; 735 pennsylvania drive; exton PA 19341
• Manufacturer Contact: forde hansell ; 735 pennsylvania drive; exton, PA 19341 ; 4847132152
• MDR Report Key: 5775060
• MDR Text Key: 48946820
• Report Number: 2530154-2016-00010
• Device Sequence Number: 1
• Product Code: OXK
• UDI-Device Identifier: 00812337020312
• UDI-Public: 00812337020312
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NYLON SUTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR