MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 133LV TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	133LV-15
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: research continues to address the various hypothetical long-term effects of silicone implants, primarily silicone-filled breast implants.To the extent that such research applies to the safety of silicone in general for implantation, it is relevant to tissue expanders.However, given the intended temporary use of tissue expanders, and the fact that tissue expanders consist primarily of a silicone elastomer shell filled with sterile saline for injection, the research has not been directly concerned with tissue expander use.The following is a list of potential adverse events that may occur with breast implant surgery.The risks 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.
Event or Problem Description
Healthcare professional reported a right side deflation.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified openings and crease/fold.A leak test was performed which identified openings on the radius.A microscopic analysis was performed which identified one striated curved opening on the anterior side assessed as surgical damage, curved punctured openings on the radius side consistent with the use of some surgical tools, and non-penetrating nicks around the punctures.
Event or Problem Description
Healthcare professional reported "creases associated with hole".Device was explanted.

• Brand Name: STYLE 133LV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7974009
• Report Number: 9617229-2018-07852
• Device Sequence Number: 19243756
• Product Code: LCJ
• UDI-Device Identifier: 10888628004085
• UDI-Public: 10888628004085
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 03/30/2022
• Device Catalogue Number: 133LV-15
• Device Lot Number: 3194603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 47 YR