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

Catalog Number	133FV-14-T
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
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: the following is a list of potential adverse events that may occur with breast implant surgery.The risks include: implant deflation/leakage, additional surgery, capsular contracture, infection, toxic shock syndrome, necrosis, hematoma, seroma, extrusion, breast pain, changes in nipple sensation, changes in breast sensation, dissatisfaction with cosmetic results (wrinkling, folding, displacement, asymmetry, palpability, visibility, ptosis, sloshing), calcific deposits, irritation/inflammation, delayed wound healing, hypertrophic scarring, breast tissue atrophy/chest wall deformity, difficulty/inability in breast feeding, and inability to adequately visualize breast lesions with mammography.In addition to these potential adverse events, there have been concerns with certain systemic diseases.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.Follow the recommended fill volume on the product data sheet; do not overfill or underfill the implant.One hundred and thirty-three 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
Healthcare professional reported right side tissue expander, "ruptured after chemoport maintenance." expander was implanted for 7 months.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: yellow particles, a curved opening, partial delamination of suture tap.A leak test was performed and found one opening.A microscopic analysis of the returned device identified: a curved sharp opening on posterior side assessed as an unidentified (tear) opening(a dimension measurement in the shell was performed which identified the thickness was within specification) and partial delamination of suture tap assessed as adhesive failure.Based on the device analysis the final assessment is: a sharp opening due to an unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported right side tissue expander, "ruptured after chemoport maintenance." expander was implanted for 7 months.Device has been explanted.

• Brand Name: STYLE 133FV 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: 7864611
• Report Number: 9617229-2018-06796
• Device Sequence Number: 13844639
• Product Code: LCJ
• UDI-Device Identifier: 10888628004252
• UDI-Public: 10888628004252
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K102806
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 03/04/2020
• Device Catalogue Number: 133FV-14-T
• Device Lot Number: 2895191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: 60 YR