MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 2025002

Device Problems Hole In Material (1293); Torn Material (3024)

Patient Problems Adhesion(s) (1695); Hernia (2240); Therapeutic Response, Decreased (2271)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is unlikely related to the strattice mesh and likely related to the patient's condition.As noted in the histological evaluation, partial incorporation of the device is seen is at the edges of the device.The central portion of the device is largely unincorporated in areas affected with chronic inflammatory infiltrate.Extensive destruction of the device collagen is seen in areas with adjacent foreign body granulomatous reaction.Special stains for fungi and bacteria are negative for organisms.Based on our internal review of the lot processing history, the lot met qc criteria for product release.No deviations were encountered in association with the event.No other complaints were reported to lifecell against the lot.Should additional relevant clinical details be received, a follow up mdr will be submitted.

Event Description

It was reported to lifecell that a strattice mesh was used in an underlay fashion to repair a ventral hernia on (b)(6) 2014.The patient developed a recurrence of hernia.Upon exploration of the second post operative ventral hernia repair, (b)(6) 2015, the strattice mesh ripped down the middle resulting in exposure of the bowel under the abdominal wall.The strattice mesh was found to be well adhered and incorporated on the lateral sides of the abdomen.One dime-sized hole was seen in the strattice on the lower left side.To repair the defect, another strattice mesh was placed in the retro rectus space after performing lysis of adhesions (which were minimal).The previous strattice mesh was removed as best as possible.Phasix was used as an onlay.

• Brand Name: STRATTICE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): LIFECELL CORPORATION; one millennium way; branchburg NJ 08876
• Manufacturer Contact: stanley dube ; one millennium way; branchburg, NJ 08876 ; 9089471575
• MDR Report Key: 5367928
• MDR Text Key: 35999647
• Report Number: 1000306051-2016-00003
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: 2025002
• Device Catalogue Number: N/A
• Device Lot Number: SP100123
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• 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