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

Model Number	133MV-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
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.
Event or Problem Description
Company representative reported "partial shell tear was found" with a tissue expander.Patient contact was not made.Surgery was completed with a backup device.
Additional Manufacturer Narrative
Device analysis: visual analysis of the returned device identified: device appeared to have vulcanization mark in the internal part of the shell.A leak test was performed which did not identify any openings on the device.Microscopic analysis was performed which identified a vulcanization mark, it was cataloged as workmanship due to vulcanization mark.A further investigation was requested due to the workmanship found during the device analysis.The review of the documentation associated to the manufacturing process indicates that all devices were released in accordance with allergan medical¿s procedures, and no anomalies were found in the personnel training related to the reported event.According to the device analysis performed in the laboratory, a vulcanization mark was found on the inner surface which is related to the reported complaint.The issue with vulcanization mark will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Company representative reported "partial shell tear was found" with a tissue expander.Patient contact was not made.Surgery was completed with a backup device.

• Brand Name: STYLE 133MV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7073913
• Report Number: 9617229-2017-04830
• Device Sequence Number: 13706496
• Product Code: LCJ
• UDI-Device Identifier: 10888628004122
• UDI-Public: (01)10888628004122(10)3054403(11)170522(17)210422
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 04/22/2021
• Device Model Number: 133MV-13
• Device Catalogue Number: 133MV-13
• Device Lot Number: 3054403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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