MAUDE Adverse Event Report: LIFECELL MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2); MESH, SURGICAL

Catalog Number CON2006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: based on limited information, including no identification of the relevant lot number, a relationship between the event and strattice could not be determined.Due to lack of information, strattice as a contributing factor cannot be ruled out.Lifecell reports the event in an abundance of caution.Attempts to obtain additional information are being made, including identification of the lot number.Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.

Event Description

This report is associated with the strattice mesh placement on the right side.Please refer to mdr 1000306051-2018-00074 for the event associated with the left side.It was reported that the female patient had bilateral breast augmentation revision surgery (b)(6) 2015 with strattice.On (b)(6) 2017, the patient had another augmentation revision on the right side due to an unspecified failure of the strattice.

Manufacturer Narrative

Our investigation of lot sp100184 includes: review of information as reported, review of the device history records, and review of the complaint history records associated with lot sp100184.Review of lot processing history and complaint history records for lot sp100184 was unremarkable.There were no processing deviations or nonconformance related to the nature of this complaint.The lot met qc criteria for release.As of 12 jun 2018, no similar complaints have been reported to lifecell against lot sp100184.As of 07 jun 2018, of the 495 devices released to finished goods for lot sp100184, 490 devices were distributed with 173 devices reported to be implanted.Conclusion: the device was not returned to lifecell for evaluation.As per our internal review of the device processing history, lot sp100184 met qc criteria for product release with no nonconformance or deviations related to the event.

Event Description

This report represents follow up report #1 and is associated with the strattice mesh placement on the right-side breast.Please refer to mdr 1000306051-2018-00074 for the event associated with the left side.On follow up, it was reported that the augmentation revision was performed because the strattice did not incorporate.There were no contributing patient conditions or co-morbidities.At some time in (b)(6) 2017, the patient presented with complications.The course of treatment involved surgery and the patient is reported to be in good condition.As initially reported, it was reported that the female patient had bilateral breast augmentation revision surgery (b)(6) 2015 with strattice.On (b)(6) 2017, the patient had another augmentation revision on the right side due to an unspecified failure of the strattice.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 7570962
• MDR Text Key: 110455027
• Report Number: 1000306051-2018-00075
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K082176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

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: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: CON2006
• Device Lot Number: SP100184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention