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

Catalog Number	133FX-13
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2017
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: 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.
Event or Problem Description
Healthcare professional reported a left side deflation of a tissue expander.Device was explanted and replaced with another tissue expander.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified curved openings and black mold like appearance.A leak test was performed and two openings were found.A microscopic analysis identified: a curved striated opening, which was assessed as surgical damage, and a curved sharp opening on posterior side assessed as unidentified (tear) opening.A dimension measurement in the shell was performed which identified the thickness within specification.Air was observed entrapped between the insert bond (vi of approx.3.5 mm).It is out of specification and assessed as workmanship.A further investigation has been initiated due to the workmanship found during device evaluation.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Event or Problem Description
Healthcare professional additionally reported a "stress fold fracture.".
Additional Manufacturer Narrative
Further investigation results: the review of the documentation associated to the manufacturing process indicates that all devices 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, it was found air entrapped between the insert bond, which is not related to the reported complaint.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with void in insert in the valve will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported a left side deflation of a tissue expander and "stress fold fracture." device was explanted and replaced with another tissue expander.

• Brand Name: STYLE 133FX TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7158602
• Report Number: 9617229-2017-05408
• Device Sequence Number: 13487840
• Product Code: LCJ
• UDI-Device Identifier: 10888628004009
• UDI-Public: 10888628004009
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K862203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2018

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: 10/13/2019
• Device Catalogue Number: 133FX-13
• Device Lot Number: 2829988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 02/01/2018; 03/09/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 02/27/2018; 04/06/2018
• 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: 43 YR