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 Capsular Contracture (1761)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

Our investigation of lot sp100493 includes: manufacturing review; review of information as reported; review of the device history records and complaint history records associated with lot sp100493. Results of review: review of processing history records for lot sp100493 was unremarkable. There were no processing deviations or nonconformance related to the nature of this complaint and the lot met qc criteria for release. As of 16 oct 2018, review of the complaint history records for lot sp100493 revealed one similar complaint that resulted in no serious injury. As of 16 oct 2018, of the (b)(4) devices released to finished goods for lot sp100493, (b)(4) have been distributed and (b)(4) devices were reported as implanted. Conclusion: based on our internal review of the device processing history, the lot met qc criteria for product release. Lot sp100493 was aseptically processed and terminally sterilized within process parameters. No deviation was encountered in association with the reported event. One similar complaint has been reported to allergan against lot sp100493 that resulted in no serious injury. This concludes our investigation.

Event Description

It was reported that a patient who underwent bilateral breast reconstruction with strattice on (b)(6) 2017 postoperatively presented with capsular contractures bilaterally. The left-side contracture is at baker grade iii and the right-side contracture is at baker grade ii. The explant surgery was scheduled for the left side on (b)(6) 2018. The patient is not having "right" the right-side mesh explanted. The strattice lot number for the left-side mesh is sp100493-154. The strattice lot number for the right-side mesh is sp100493-107. As per clinical feedback reported by the surgeon on 15 october 2018: the patient underwent submuscular implant exchange with no comorbidities. Onset of capsular contracture was three weeks post implant exchange with placement of strattice bilaterally (approximately (b)(6) 2017). The patient's course of treatment involved antibiotic placement on doxycycline, singulair and vitamin e for several months. The surgeon took the patient back to the operating room on (b)(6) 2018 for right implant exchange, complete capsulectomy and removal of old strattice with placement of new strattice (just the left strattice mesh was replaced. The right strattice mesh remains in place). The intervention was to treat the capsular contracture. The patient has no history of x ray therapy. The surgeon attributes strattice as the cause of the event. The patient is currently reported to be doing well so far with no recurrence.

• Brand Name: MEDIUM CURVED SHAPE FOR STRATTICE, BPS (CONTOUR2)
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471100
• MDR Report Key: 7975158
• MDR Text Key: 124089354
• Report Number: 1000306051-2018-00137
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2018
• Device Catalogue Number: CON2006
• Device Lot Number: SP100493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/17/2018 Patient Sequence Number: 1