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 Codes	Inflammation (1932); Irritation (1941)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qa investigation into lot sp100528 resulted in no remarkable findings including 441 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 the patient did well after the first procedure (b)(6) 2017.They had mild inferior descent of the implants and was going to the or for facial surgery under the care of doctor's partner.Doctor opened the vertical incision and performed b inferior capsulorrhaphy with a good aesthetic on table result.The strattice appeared to be will incorporated at that time.Non-incorporated strattice was removed with breast implant on (b)(6) 2018.Patient returned to or on (b)(6) 2019 for further debridement of incorporated strattice and products of degradation of strattice due to u/s evidence of fluid collection which was the sterile, murky appearing breakdown of the residual strattice.Doctor indicated that around this time the patient developed join swelling in their hand, and it looked like raynaud's syndrome.Doctor stated it seems to be that the strattice ¿melted¿ and caused an inflammatory response leading to the loss of breast implant.Affected breast is left.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: 10025081
• Report Number: 1000306051-2020-00023
• Device Sequence Number: 14131826
• 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: 2018
• 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