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	Bacterial Infection (1735)
Date of Event	11/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation of lot sp100311 includes: method of evaluation: actual device not evaluated.Manufacturing review.Review of information as reported, review of the device history records and complaint history.Records associated with lot sp100311.Results of evaluation: no failure detected.- review of lot processing history and complaint history records for lot sp100311 was unremarkable.There was no processing deviation or nonconformance related to the nature of this complaint and the lot met qc criteria for release, including mechanical testing results.- as of 29 jan 2018, no similar complaint has been reported to lifecell against lot sp100311.- as of 29 jan 2018, of the (b)(4) devices released to finished goods for lot sp100311, (b)(4) devices were distributed with 145 devices reported to be implanted.No deviations or nonconformance related to labeling were revealed.Evaluation conclusion: device not returned.- based on the limited information, a relationship between the event and the strattice mesh could not be determined.As per our internal review of the device processing history, the lot met qc criteria for product release.Lot sp100311 was aseptically processed and terminally sterilized within process parameters.No deviation was encountered in association with the reported event.No similar complaint has been reported to lifecell against lot sp100311.The event is unlikely related to strattice.Multiple attempts were made to retrieve additional clinical information concerning the event including contributing patient conditions, co-morbidities, medical and surgical history, results of culture testing and source, if any, course of treatment, and patient outcome.Should additional information be received, a follow up report will be submitted.
Event or Problem Description
It was reported by the doctor that a (b)(6) y.O.Female patient underwent breast augmentation and mastopexy in 2015.Status post operatively, the patient presented with left capsular contracture.The patient underwent left partial capsulectomy/capsulotomy with strattice interposition, jp drain placement, and right capsulorrhaphy/capsulotomy and bilateral mastopexy.A second, unspecified procedure occurred (b)(6) 2017.On (b)(6) 2017, the patient underwent explantation of bilateral implants and the left placed strattice, as the left side only was infected.
Additional Manufacturer Narrative
Conclusion: based on updated information from the surgeon, expired product use occurred.Lifecell informed the surgeon that we do not support the use of expired product, and as labeled, the expiration date for lot sp100311 was september 2017.As per our internal review of the device processing history, the lot met qc criteria for product release.Lot sp100311 was aseptically processed and terminally sterilized within process parameters.No deviation was encountered in association with the reported event.No similar complaint has been reported to lifecell against lot sp100311.The event is unlikely related to strattice.This concludes our investigation.
Event or Problem Description
This report represents follow up report #1 which includes feedback from the surgeon.On (b)(4) 2018, the surgeon provided additional follow up information.The surgeon clarified that he performed a unilateral breast reconstruction with strattice mesh (b)(4) on (b)(6) 2017.Based on this statement, lifecell informed the surgeon that the lot has an expiration date of 30 sep 2017.The surgeon continued and stated that the patient has a history of capsular contracture episodes.Jp drain was used no more than a week after the procedure.Culture of the drain showed no growth, but since antibiotics were given to the patient, this [antibiotic treatment] may have influenced the results.The loose, unincorporated portion of strattice was removed and the part that incorporated was left in place.The patient has since recovered.As initially reported, a (b)(6) y.O.Female patient underwent breast augmentation and mastopexy in 2015.Status post operatively, the patient presented with left capsular contracture.The patient underwent left partial capsulectomy/capsulotomy with strattice interposition, jp drain placement, and right capsulorrhaphy/capsulotomy and bilateral mastopexy.A second, unspecified procedure occurred (b)(6) 2017.On (b)(6) 2017, the patient underwent explantation of bilateral implants and the left placed strattice, as the left side only was infected.

• 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: 7230894
• Report Number: 1000306051-2018-00013
• Device Sequence Number: 1274538
• Product Code: FTM
• UDI-Device Identifier: 00818410010270
• UDI-Public: 00818410010270
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CON2006
• Device Lot Number: SP100311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/27/2018
• 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
• Patient Age: 51 YR