MAUDE Adverse Event Report: ALLERGAN (AUSTIN) STYLE 133MX TISSUE EXPANDER WITH SUTURE TAB; EXPANDER, SKIN, INFLATABLE

Catalog Number	133MX-15-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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: deflation- 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 a left side deflation.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: brown particles, linear opening, fold creases.A leak test was perform and was found one opening.A microscopic analysis of the returned device identified: a linear sharp opening on posterior side assessed as unidentified(tear) opening(a dimension measurement in the shell was performed which identify the thickness within specification), partial delamination of suture tap assessed as adhesive failure and tree curved sharp openings on suture tap assessed as unidentified(tear) opening.Based on the device analysis the final assessment is: a sharp opening due to unidentified(tear) opening.
Event or Problem Description
Healthcare professional reported a left side deflation.Device has been explanted.

• Brand Name: STYLE 133MX TISSUE EXPANDER WITH SUTURE TAB
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (AUSTIN); 301 w howard lane; suite 100; austin TX 78753
• MDR Report Key: 7510890
• Report Number: 9617229-2018-03527
• Device Sequence Number: 1624025
• Product Code: LCJ
• UDI-Device Identifier: 10888628004504
• UDI-Public: 10888628004504
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: health professional
• 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: 06/26/2021
• Device Catalogue Number: 133MX-15-T
• Device Lot Number: 3083627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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