MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2030002ET

Device Problem Material Deformation (2976)

Patient Problems Fever (1858); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

Method of evaluation: review of information as reported, review of the device history records and complaint history records associated with lot sp100446.Results of evaluation: - review of lot processing history and complaint history records for lot sp100446 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results.- as of 06/26/2017, no other complaint has been reported to lifecell in association with lot sp100446.- as of 06/26/2017, of the (b)(4) devices released to finished goods for lot sp100446, (b)(4) devices were distributed with (b)(4) devices reported to be implanted.Evaluation conclusion: - as the surgeon expressed, the strattice "was not a fault for this event, as it involved a very complex patient, and that the patient is "doing ok, not great." the event is likely related to the patient's condition, however, lifecell could not obtain clarification on which strattice device was referenced as being unrelated to the event.Therefore, lifecell reports this event in an abundance of caution.Based on our internal review of the device processing history, the lot met qc criteria for product release, including mechanical testing.No other complaint was reported against the lot.The lot was aseptically processed and terminally sterilized within process parameters.There was no nonconformance or deviations encountered in association with the event.Device not returned for evaluation.

Event Description

As documented in mdr1000306051-2017-00035 (referencing device #1, sp100480-008), it was initially reported that a patient underwent an open abdomen hernia repair with strattice on (b)(6) 2017.On (b)(6) 2017, the strattice mesh was removed because the mesh "fell apart" at the edges.This report refers to device #2, sp100446-076, which is associated with the same patient.It was reported that on (b)(6) 2017 the patient was brought back to or for placement of a replacement strattice mesh.The patient underwent a bridged ventral hernia repair with strattice 20x30 extra thick (sp100446-076) and a 10x16 piece of acell for a parastomal hernia repair on (b)(6) 2017.As per the surgeon, the midline wound has been seeping fluid, that is the mesh breaking down.The patient currently has a fever.Acell powder was sprinkled along the rectus/wound edges.The surgeon stated that she did not believe strattice was at fault for this event, this was a very complex patient, and it may have been too soon to try to reconstruct him the first time.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; one millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 6668833
• MDR Text Key: 78447953
• Report Number: 1000306051-2017-00038
• Device Sequence Number: 1
• Product Code: FTM
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: 2030002ET
• Device Catalogue Number: N/A
• Device Lot Number: SP100446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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: 47 YR