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

Catalog Number 133P-FX-16

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: capsular contracture.

Event Description

Healthcare professional reported left side capsular contracture baker grade unknown.The device has been explanted.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: the device related to the reported event of deflation was received on january 13, 2020 with lot number 2974662.Visual analysis of the returned device identified: one curved opening, black particles in device inner surface and creases.Leak test and microscopic analysis was performed which identified: more than three openings striated.Based on the device analysis the final assessment is: - more than three openings striated assessed as surgical damage.Reason for reoperation: use error.Capsular contractureis a known potential adverse event addressed in the product labeling.

Event Description

Additional information received confirmed that the device is a tissue expander which was implanted for longer than 6 months.

Manufacturer Narrative

Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.

Event Description

Healthcare professional reported capsular contracture baker grade iii on left side, device was a tissue expander implanted for more than 6 months.The device has been explanted.

• Brand Name: STYLE 133PLUS FX TISSUE EXPANDER
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9454525
• MDR Text Key: 170861107
• Report Number: 9617229-2019-20060
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• PMA/PMN Number: K143354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• Device Catalogue Number: 133P-FX-16
• Device Lot Number: 2974662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention