MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE LAPAROSCOPIC MESH; SURGICAL MESH

Model Number 1620005

Device Problem Material Fragmentation (1261)

Patient Problem Abdominal Pain (1685)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method of evaluation: manufacturing review: review of information as reported, review of the device history records, and review of complaint history records associated with lot sp100274; pathological examination.Results of evaluation: no failure detected.Review of lot processing history and complaint history records for lot sp100274 was unremarkable.There were no processing deviations or nonconformance issues related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results; as per pathological assessment of the explanted specimen, the microscopic diagnostic revealed strips of partially incorporated strattice graft with acellular strattice material showing irregular fibrous septations and adjacent native fibrocollagenous tissue at the edges.Foci of chronic inflammation, focally in florid aggregates, are seen within the strattice graft collagen.Special stains for bacteria (b&b) and fungi (gridley) show no organisms; as of 03/07/2017, one other non-reportable complaint involving re-herniation was reported to lifecell against lot sp100274.As per the surgeon, the graft size selected was not adequate to cover the defect completely, thus a larger strattice graft was used to cover the existing defect.This was an incidental finding during surgery and no failure of the device was detected; as of 02/17/2017, of the (b)(4) devices released to finished goods for lot sp100274, (b)(4) devices were distributed.Evaluation conclusion: device failure related to patient condition.The repair was completed with a replacement strattice mesh and the patient was reported to be recovering well with minimal pain.The re-herniation is unlikely related to strattice laparoscopic and is likely due to the patient's condition, including prior history of hernia, obesity, and asthma.Nonincorporation was an incidental finding, secondary to reherniation.Based on our internal review of the device processing history, lot sp100274 met qc criteria for release, including mechanical testing.No deviations were encountered in association with the event.One other complaint, unrelated to the device, was related to a surgeon's piece size election.

Event Description

It was reported to lifecell that a (b)(6) male patient underwent an initial hernia repair with a strattice laparoscopic mesh on (b)(6) 2016.On (b)(6) 2017, the patient was received in the er complaining of abdominal pain.The surgeon performed a diagnostic scan and found that the patient reherniated.On (b)(6) 2017, the patient was returned to surgery where the surgeon found that the hernia occurred through the middle of the strattice laparoscopic mesh.The mesh was fragmented and unincorporated.No infection was seen.The surgeon then removed the mesh and replaced it with another strattice mesh.Primary closure was obtained to complete the repair.The patient's medical history also includes obesity and asthma with prescription of albuterol.

• Brand Name: STRATTICE LAPAROSCOPIC MESH
• 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: 6397261
• MDR Text Key: 69738662
• Report Number: 1000306051-2017-00012
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130817
• 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: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: 1620005
• Device Catalogue Number: N/A
• Device Lot Number: SP100274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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