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

Catalog Number	133P-SX-16-T
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.Reason for reoperation due to deflation.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 reported a right side deflation.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: curved opening.A leak test was performed and was found one opening.A microscopic analysis identified: a curved sharp opening on stable base bond edge assessed as unidentified(tear) opening(a dimension measurement in the shell was performed which identify the thickness within specification) and two curved sharp openings on suture taps assessed as unidentified(tear) opening.Based on the device analysis the final assessment is: a sharp opening assessed as unidentified(tear) opening.
Event or Problem Description
Healthcare professional reported a right side deflation.Device has been explanted.

• Brand Name: STYLE 133PLUS SX TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8676919
• Report Number: 9617229-2019-05729
• Device Sequence Number: 10836975
• Product Code: LCJ
• UDI-Device Identifier: 10888628010475
• UDI-Public: 10888628010475
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: K143354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 10/23/2021
• Device Catalogue Number: 133P-SX-16-T
• Device Lot Number: 2993157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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