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

Catalog Number	133MV-13-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
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: avoiding damage during surgery.Extreme care should be taken to avoid damage to the tissue expander during surgery.Possible sources of damage include sharp surgical instruments such as scalpels and needles used during the initial surgery, subsequent filling, or hematoma/fluid evacuation.A sterile back-up tissue expander must be readily available at the time of surgery in the event that damage occurs.Products must be carefully inspected for leaks or nicks prior to use.Do not attempt to repair damaged products.
Event or Problem Description
Healthcare professional reported a "leak" with a tissue expander.Device was not implanted.Surgery was completed with a backup expander.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device not identified observations.A leak test was performed which did not identify openings on the device.Microscopic analysis was performed which did not identify any additional observations.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.No openings on the device and no damage on valve; broken device was not confirmed.
Event or Problem Description
Healthcare professional reported a "leak" with a tissue expander.Device was not implanted.Surgery was completed with a backup expander.

• Brand Name: STYLE 133MV 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: 7157598
• Report Number: 9617229-2017-05671
• Device Sequence Number: 13653468
• Product Code: LCJ
• UDI-Device Identifier: 10888628004429
• UDI-Public: 10888628004429
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: 133MV-13-T
• Device Lot Number: 3118794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 02/19/2018
• 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: Other