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

Catalog Number	133P-MV-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.Device labeling: extreme care should be taken to avoid needle puncture or other damage to the tissue expander or the injection site during the expansion process.To minimize the risk of tissue expander damage during expansion, fill the expander only with sterile saline for injection and use the appropriate location methods and instruments, as described in instructions for use.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 reports right side deflation of a tissue expander.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: biological tissue white particles on the outer surface and one curved opening on the insert assembly.Leak test and microscopic analysis was performed which identified; sharp opening on the insert bond edge and punctured openings.A dimension measurement in the shell was performed which identified the shell thickness within specification.Based on the device analysis the final assessment is: a sharp opening on the insert bond edge due to an unidentified (tear) opening and punctured openings assessed as surgical damage.
Event or Problem Description
Healthcare professional reports right side deflation of a tissue expander.The device has been explanted.

• Brand Name: STYLE 133PLUS MV TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7999646
• Report Number: 9617229-2018-08002
• Device Sequence Number: 288541
• Product Code: LCJ
• UDI-Device Identifier: 10888628010048
• UDI-Public: 10888628010048
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 05/01/2022
• Device Catalogue Number: 133P-MV-13
• Device Lot Number: 3061011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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