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

Catalog Number	133SX-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2017
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: 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 right side "faulty implant" specified as "leaking (decreasing in size)." the device was implanted for over 6 months.The device has been explanted.The expansion process was not complete upon explantation.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: flat crease , brown particles in the shell, and two openings on the radius.A microscopic analysis was performed, which identified one sharp opening and one striated opening on the radius.A dimension measurement in the shell was performed, which identified the thickness within specification.Based on the device analysis the final assessment was: one sharp opening, due to an unidentified (tear) opening, on the radius and one striated opening on radius due to surgical damage, consistent with the use of some surgical tool.
Event or Problem Description
Healthcare professional reported right side "faulty implant" specified as "leaking (decreasing in size)." the device was implanted for over 6 months.The device has been explanted.The expansion process was not complete upon explantation.

• Brand Name: STYLE 133SX 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: 7845631
• Report Number: 9617229-2018-06708
• Device Sequence Number: 1574229
• Product Code: LCJ
• UDI-Device Identifier: 10888628004603
• UDI-Public: 10888628004603
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 11/05/2019
• Device Catalogue Number: 133SX-13-T
• Device Lot Number: 2839610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: 32 YR