MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Model Number	133MV-16-T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: wear abrasion, opening, flat creases and brown and yellow particles on the device outer surface.Leak test was performed and found an opening on the posterior side.A microscopic analysis was performed which identified delamination and also identified a sharp edge opening, assessed as an unidentified tear opening.No shell thickness was measured due to the opening is under a suture tab.Based on the device analysis the final assessment is: - delamination of the suture tab assessed as adhesive failure.- a sharp opening on posterior (suture tab ) due to an unidentified (tear) opening.A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: potential adverse events that may occur with breast implant surgery include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.Deflation ¿ tissue expanders may deflate, and require replacement surgery.Deflation occurs when saline leaks through a damaged injection site or a damaged tissue expander envelope.
Event or Problem Description
Healthcare professional reported a left side deflation of a tissue expander and that the "medial tabs were torn".Device was implanted for more than 6 months.Device has been explanted and replaced with breast implants.

• Brand Name: STYLE 133MV TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 6815853
• Report Number: 9617229-2017-01159
• Device Sequence Number: 13896304
• Product Code: LCJ
• UDI-Device Identifier: 10888628004450
• UDI-Public: (01)10888628004450(10)2690197(11)150103(17)181203
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: 12/03/2018
• Device Model Number: 133MV-16-T
• Device Catalogue Number: 133MV-16-T
• Device Lot Number: 2690197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/23/2017
• 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: 50 YR