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

Catalog Number	133FV-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.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reports a right side deflation of a tissue expander.The device has been explanted.The replacement device is a second tissue expander.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified white particles.A leak test was perform and two openings were found.A microscopic analysis identified: two curved striated openings on the patch assessed as surgical damage.Based on the device analysis the final assessment is: two curved striated openings assessed as surgical damage.
Event or Problem Description
Healthcare professional reports a right side deflation of a tissue expander.The device has been explanted.

• Brand Name: STYLE 133FV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8217665
• Report Number: 9617229-2018-10028
• Device Sequence Number: 1656643
• Product Code: LCJ
• UDI-Device Identifier: 10888628003941
• UDI-Public: 10888628003941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/22/2019

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: 04/27/2021
• Device Catalogue Number: 133FV-13
• Device Lot Number: 3057145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/22/2019
• 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