MAUDE Adverse Event Report: DSM BIOMEDICAL XCM BIOLOGIC TISSUE MATRIX

Model Number 30010-31

Device Problem Split (2537)

Patient Problem Hernia (2240)

Event Date 05/20/2015

Event Type  Injury  

Event Description

It was reported that xcm biologic was implanted in a patient to address a large abdominal wall hernia.The surgeon performed a component separation.The xcm biologic mesh was cut to a 25/25 cm dimension.The mesh was placed in the underlay position and sutured in place with interrupted, trans-fascial, prolene sutures.The rectus muscle was fully closed at the midline with figure 8 pds sutures.A small pledget ws placed to reinforce the suture line.The next day, the patient had a large mass in the area of a surgical drain.Upon inspection, it was determined that the patient's small bowel had eviscerated.The sutures had torn through the mesh along with one edge, appearing as a cheese-wiring from the suture holes to the edge of the device.The rectus muscle closure hade also failed.Subsequently, the surgeon removed the xcm biologic and repaired the defect again.The patient was discharged one week later.

Manufacturer Narrative

The biologic mesh was returned to the manufacturer approximately 3 weeks after explantation.However, the biologic mesh had substantially degraded making physical evaluation impossible.Review of the lot history records revealed no deviations tht would contribute to suture tear.Given the concurrent failure of the midline rectus muscle closure, excessive forces on the abdominal wall post-operatively may have contributed to the sutures tearing through the mesh.

• Brand Name: XCM BIOLOGIC TISSUE MATRIX
• Manufacturer (Section D): DSM BIOMEDICAL; exton PA
• Manufacturer Contact: forde hansell ; 735 pennsylvania drive; exton, PA 19341 ; 4847132152
• MDR Report Key: 4855498
• MDR Text Key: 5875095
• Report Number: 2530154-2015-00002
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 30010-31
• Device Lot Number: C0473
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR