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

Catalog Number	CON2006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 7975158
• Report Number: 1000306051-2018-00137
• Device Sequence Number: 1488436
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: CON2006
• Device Lot Number: SP100493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention