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

Catalog Number	133MX-14-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-conformance noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation was due to a tear in the tissue expander.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported an unknown side "tear" in tissue expander.Device was explanted.
Additional Manufacturer Narrative
Further investigation (fi) results: the review of the documentation associated to the manufacturing process indicates that all devices with work order (b)(4) were released in accordance with allergan medical¿s procedures, and no anomalies were found in the documents or in the personnel training related to the reported event.According to the device analysis performed in the laboratory, observed void in insert (vi).Considering that there is not an adverse trend for this event, no additional actions are deemed required at this time.The issues with void in insert will continue to be monitored and a corrective action will take in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported a left side "tear" in tissue expander.Device was explanted.
Additional Manufacturer Narrative
A further investigation (fi) has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Device evaluation: visual analysis of the returned device identified a curved opening and brown particles.A leak test was performed which found one opening.A microscopic analysis identified a curved sharp opening on the stable base bond edge assessed as an unidentified tear opening.A dimension measurement in the shell was performed which identified the shell thickness within the specification.An air void measuring 2.3mm was observed between the shell and insert which is out of specification and is assessed as a workmanship.Based on the device analysis the final assessment is a sharp opening assessed as an unidentified tear opening.
Event or Problem Description
The events occurred on the left side.

• Brand Name: STYLE 133MX 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: 8736383
• Report Number: 9617229-2019-07171
• Device Sequence Number: 19358498
• Product Code: LCJ
• UDI-Device Identifier: 10888628004498
• UDI-Public: 10888628004498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K102806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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: 03/20/2021
• Device Catalogue Number: 133MX-14-T
• Device Lot Number: 3042187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/26/2019; 08/09/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/24/2019; 09/06/2019
• 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