MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM; MESH, SURGICAL

Catalog Number 1620002

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Adhesion(s) (1695)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to lifecell for evaluation.The internal investigation into strattice lot sp100367 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no other medical complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, 244 devices were released to finished goods and 218 have been distributed.Of the 218 distributed, 83 have been reported as implanted.Based on our internal review with no remarkable findings, a relationship to the strattice device and this event could not be determined.Other surgical or patient factors could also contribute to this event.No further actions are required as a nonconformance could not be confirmed.

Event Description

Patient underwent parastomal hernia repair surgery and was implanted with strattice mesh (lot/batch: sp100367-164, catalog/serial: (b)(4)).Patient returned to the hospital 1.5 years later and there were several small bowel loops that were densely adherent to the partially intact strattice.A second strattice mesh was implanted to repair and revise the failed device.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ ; 9089471470
• MDR Report Key: 11352330
• MDR Text Key: 241671282
• Report Number: 1000306051-2021-00011
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00818410010010
• UDI-Public: 00818410010010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1620002
• Device Lot Number: SP100367
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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: 64 YR