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

Model Number CON3006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Implant date is estimated based on the reported information.(b)(4).-qa investigation into lot sp100447 resulted in no remarkable findings including no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.- as of 6/5/2017, of the (b)(4) devices released to finished goods for lot sp100447, (b)(4) devices have been distributed.- lot sp100447 was terminally sterilized and met all qc release criteria.(b)(4).This event is being reported in an abundance of caution due to the planned surgical intervention to replace the strattice device and the lack of patient and procedure specific details that would affect incorporation.To date, the revision surgery has not been performed and the device remains implanted.Limited information was reported regarding the method in which the nonincorporation was discovered.Based on the limited information, a relationship between this event and the strattice cannot be conclusively determined.Qa investigation resulted in no remarkable findings.Lot sp100447 met all qc release criteria.No further actions are required as a nonconformance was not confirmed.Lifecell has made multiple attempts for additional patient and procedure specific information.If additional information is received, a follow up report will be submitted.Device remains implanted.

Event Description

It was reported that this is a healthy, thin female patient with a surgical history of a breast augmentation on (b)(6) 2006, a revision on (b)(6) 2015 and a second revision on (b)(6) 2016.Approximately two months ago (procedure date not reported), the patient underwent another breast revision surgery with strattice bps lot sp100447-056 implanted.Based on a clinical evaluation, the patient has visible signs of "window shadowing" and rippling.The assessment made by the doctor is that the strattice did not revascuralize and resulted in the clinical diagnosis.The surgeon planned to replace the non-revascularized tissue with another piece of strattice bps.As of (b)(6) 2017, the revision case had been rescheduled.

• Brand Name: STRATTICE BPS
• 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: 6622936
• MDR Text Key: 77016796
• Report Number: 1000306051-2017-00025
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082176
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: CON3006
• Device Catalogue Number: N/A
• Device Lot Number: SP100447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• 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
• Treatment: BREAST IMPLANTS
• Patient Outcome(s): Required Intervention