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

Model Number	133SX-13
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
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: 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.Deflation - patients should be advised that the 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
Health professional reported a right side deflation of a tissue expander.During explant surgery, "creases" were noted on the device.
Additional Manufacturer Narrative
Device evaluation: visual analysis was performed which identified: opening, brown particles outer surface the device, and wear abrasion.Leak test was performed and found openings on anterior side a microscopic analysis was performed which identified punctured openings consistent in the use of some surgical tools.Based on the device analysis the final assessment is: a puncture opening on anterior side due to surgical damage-like.The creases folding conditional was observed, nevertheless is not related to the manufacturing process, due to the device was received out of their primary packaging and is an explanted device.
Event or Problem Description
Health professional reported a right side deflation of a tissue expander.During explant surgery, "creases" were noted on the device.

• Brand Name: STYLE 133SX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 6914014
• Report Number: 9617229-2017-02648
• Device Sequence Number: 13762802
• Product Code: LCJ
• UDI-Device Identifier: 10888628003828
• UDI-Public: (01)10888628003828(10)2686154(11)141224(17)181124
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 11/01/2017

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: 06/24/2018
• Device Model Number: 133SX-13
• Device Catalogue Number: 133SX-13
• Device Lot Number: 2638667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 11/01/2017
• 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