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

Catalog Number	133MV-14-T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Device labeling addresses: 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: opening curve, yellow particles, and yellow biological tissue.Leak test was performed and found opening on anterior.A microscopic analysis was performed which identified sharp edge opening assessed as unidentified tear opening, opening striated in the anterior side, also a striated break in the suture tabs and missing piece of the suture tab.A dimension measurement of the shell was performed which identified the thickness within specification.The fill test inspection was performed, with the result of no blockage.Based on the device analysis the final assessment is: a sharp opening in the anterior side due to an unidentified (tear) opening, a striated edge opening on anterior side due to surgical damage, a striated break in the suture tab, and a missing suture tab due to inconclusive.Device labeling: 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.
Event or Problem Description
Device was implanted for more than 6 months.

• 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: 7725692
• Report Number: 9617229-2018-05475
• Device Sequence Number: 11080091
• Product Code: LCJ
• UDI-Device Identifier: 10888628004436
• UDI-Public: 10888628004436
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2021
• Device Catalogue Number: 133MV-14-T
• Device Lot Number: 3044461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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; Required Intervention