MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE; SURGICAL MESH

Model Number 3030002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Fistula (1862); Obstruction/Occlusion (2422)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This patient was returned to surgery 1 month post op for bowel entrapment, small bowel obstruction and fistula formation.Dense, fibrous bowel adhesions were removed and the nonincorporated strattice device was explanted.Fistula formation and adhesions are potential adverse events associated with surgical mesh materials and their implantation procedures as documented in the ifu.Patient factors can increase the risk of the formation of fistulas and adhesions.Multiple follow up attempts were made in an effort to obtain additional information including this patient's surgical history and surgical complications, but to date no additional information has been received.Due to the lack of information reported, a relationship between the strattice and the post-operative complications could not be determined.While it is unlikely that the strattice caused the fistula and adhesions, the device as a contributing factor could not be ruled out.If additional information is received, a follow up report will be filed.Qa investigation into lot sp100258 resulted in no remarkable findings.Lot sp100258 met all qc release criteria.

Event Description

Limited information was reported regarding a patient that underwent a hernia repair with a 30 x 30 strattice device on (b)(6) 2015.The patient returned to the operating room (o.R.) on (b)(6) 2015 (1 month post-op) with a bowel entrapment, sbo (small bowel obstruction) and fistula development.The strattice along with dense, fibrotic bowel adhesions and areas of non incorporation were explanted.Multiple follow up attempts were made in an effort to obtain additional information but to date no additional information has been received.

• 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: 5377363
• MDR Text Key: 36320353
• Report Number: 1000306051-2016-00004
• 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: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: 3030002
• Device Catalogue Number: N/A
• Device Lot Number: SP100258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2015
• 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