MAUDE Adverse Event Report: LIFECELL LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3); MESH, SURGICAL

Catalog Number	CON3006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	04/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation into lot sp100528 resulted in no remarkable findings including (b)(4) devices distributed with no other complaints and no related processing deviations or nonconformances revealed.Lot sp100528 was processed aseptically, terminally sterilized and met all qc release criteria.Device evaluation: acellular collagen graft layers are seen microscopically, consistent with unincorporated collagenous tissue.Many of the cut sections are flanked on one surface by dense eosinophilic fibrotic capsule, separated from the graft collagen by linear infiltrate of lymphocytes with rare polymorphonuclear leukocytes.The appearance suggests some low-grade host reactivity to the graft.Special stains for trichrome (connective tissue) are densely positive, consistent with collagen and not muscular tissue.Fungal (gridley) and bacterial (b&b) stains are negative for organisms.Elastin stain (vvg) shows minimal elastin fibers, consistent with unincorporated porcine collagen.
Event or Problem Description
It was reported that in (b)(6) 2020, patient's right breast became firm.Doctor saw the patient and determined that they had an impending extrusion.Doctor reported that the patient had swelling and erythema of both hands which appeared to resemble raynaud¿s with swelling of the joints of the hand.Rheumatology work up was negative.With this most recent right side explant the patient noted a recurrence of hand swelling within two weeks of the development of the impending extrusion.When the doctor opened the incision there was a non-odorous creamy fluid, no doubt, broken down strattice.They removed the implant and removed as much of the residual intact strattice along the fold.Strattice did not integrate with the patient was noted to be integrated at capsulorrhaphy procedure on (b)(6) 2018.Doctor reported that it seems to be that the strattice "melted" and caused an inflammatory response leading to the loss of breast implant.Affected side is right breast.Affected lot is sp100528.

• Brand Name: LARGE CURVED SHAPE FOR STRATTICE, BPS (CONTOUR3)
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 10025066
• Report Number: 1000306051-2020-00024
• Device Sequence Number: 2714770
• Product Code: FTM
• UDI-Device Identifier: 00818410010294
• UDI-Public: 00818410010294
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: K082176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 03/31/2019
• Device Catalogue Number: CON3006
• Device Lot Number: SP100528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 05/05/2020
• 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: 67 YR