MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2030002

Device Problem Split (2537)

Patient Problem Wound Dehiscence (1154)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

Method of evaluation: 3263: actual device not evaluated; 3317: manufacturing review; review of information as reported, review of the device history records and complaint history records associated with lot sp100450.Results of evaluation: no failure detected.Review of lot processing history and complaint history records for lot sp100450 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 (b)(6) 2017, no other complaints were reported to lifecell against lot sp100450.As of (b)(6) 2017, of the 103 devices released to finished goods for lot sp100450, 75 devices were distributed with 5 devices reported to be implanted.Evaluation conclusion: device not returned.Device failure related to patient condition.The event is unlikely related to strattice and likely due to the patient's condition.As per the surgeon, the tear was caused by increased intra-abdominal pressure when the patient coughed.Based on our internal review of the device processing history, the lot met qc criteria for product release, including mechanical testing.No deviations were encountered in association with the event.No other complaints were reported to lifecell against the lot.

Event Description

It was reported to lifecell that on (b)(6) 2016, a patient underwent open ventral hernia repair where strattice was placed as a bridge inlay.There were no signs of infection or gi/abdominal contaminations at the time strattice was implanted.Ten days post operatively, the patient coughed and it was observed that the incision spontaneously dehisced and exposed the strattice.On (b)(6) 2017, the patient was taken back to the or.The mesh was repaired after it was found that the strattice had split in the middle.On follow up, the surgeon explained that the cause of contributing factor to the tear was increased intra-abdominal pressure when the patient coughed.The surgeon removed the wound vac.The patient is in long term acute care (ltac) and stable.Patient's pre-existing conditions and morbidities include chronic respiratory failure, sepsis, parastomal hernia, loss of abdominal domain, and history of colectomy and ileostomy.

• 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: 6296606
• MDR Text Key: 66377794
• Report Number: 1000306051-2017-00004
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: 2030002
• Device Catalogue Number: N/A
• Device Lot Number: SP100450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• 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