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

Catalog Number	133SV-13-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.The reason for reoperation: 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
Company representative reported a left side deflation of a tissue expander.Device has been explanted.
Event or Problem Description
Patient reported a right side deflation of a tissue expander.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: one opening curved on the stable base-shell and device appearance (the device has a black circle in anterior side).Leak test and microscopic analysis was performed which identified: two openings striated on the anterior and one opening sharp on the stable base-shell.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis the final assessment is: a sharp opening due to an unidentified (tear) opening.Two striated openings due to surgical damage consist in the use of some surgical tool.

• Brand Name: STYLE 133SV 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: 8614237
• Report Number: 9617229-2019-03272
• Device Sequence Number: 16609368
• Product Code: LCJ
• UDI-Device Identifier: 10888628004542
• UDI-Public: 10888628004542
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K102806
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 04/16/2020
• Device Catalogue Number: 133SV-13-T
• Device Lot Number: 2911417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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