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

Catalog Number	133SX-12
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2018
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: 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
Healthcare professional reported a left side deflation of a tissue expander.The device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: a visual analysis of the returned device identified 3 curved openings on the anterior side.A leak test was performed which identified three openings on the device.The microscopic analysis was performed which identified one curved opening on the radius displaying striated edge consistent with the use of a surgical tool.Based on the device analysis the final assessment is: three openings due to surgical damage.
Event or Problem Description
Healthcare professional reported a left side deflation of a tissue expander.The device has been explanted.

• Brand Name: STYLE 133SX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; austin TX ; CS
• MDR Report Key: 7422043
• Report Number: 9617229-2018-02371
• Device Sequence Number: 84067
• Product Code: LCJ
• UDI-Device Identifier: 10888628004160
• UDI-Public: 10888628004160
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 04/24/2021
• Device Catalogue Number: 133SX-12
• Device Lot Number: 3054489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/30/2018
• 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: 62 YR