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

Catalog Number	133MX-14
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/27/2018
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: while tissue expansion may be a beneficial surgical alternative for many patients, it may not be appropriate for every patient, because it is a time and labor intensive process that may cause temporary discomfort and distortion.The surgeon is responsible for selecting appropriate candidates, and counseling those patients on the risk/benefit relationship.Before tissue expander placement, patients should fully understand the elective nature of the procedure, and be willing to comply with expansion process requirements to minimize the risk of complications.Allergan relies on the surgeon to advise the patient of all warnings, precautions, and adverse reactions before the decision to proceed with tissue expander placement and inflation.The surgeon should advise the patient that adverse reactions may interfere with the original surgical plan and that medical management may include premature explantation.Natrelle® 133 tissue expanders are temporary devices, and are not to be used for permanent implantation or beyond 6 months.Tissue expanders should be removed once adequate tissue has developed.Tissue expansion in breast reconstruction typically requires four to six months.The total expansion period will vary depending on patient tolerance, tissue tolerance, and desired tissue expansion.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 deflation of a tissue expander.Tissue expansion is not complete.Tissue expander implanted beyond six month timeframe.Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: opening, black and green particles, fluids.Leak test was performed and found an opening on the posterior.A microscopic analysis was performed which identified a sharp edge opening.Based on the device analysis the final assessment is: a sharp edge opening on the posterior due to an unidentified (tear) opening.
Event or Problem Description
Device has been explanted.

• Brand Name: STYLE 133MX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7899100
• Report Number: 9617229-2018-07174
• Device Sequence Number: 1552549
• Product Code: LCJ
• UDI-Device Identifier: 10888628004191
• UDI-Public: 10888628004191
• Combination Product (Y/N): N
• Initial Reporter State: LA
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 05/19/2021
• Device Catalogue Number: 133MX-14
• Device Lot Number: 3061029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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: 55 YR