MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	468-230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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.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: deflation.
Event or Problem Description
Healthcare professional reported left side deflation.Device remains implanted.
Additional Manufacturer Narrative
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.
Event or Problem Description
Healthcare professional additionally reported left side capsular contracture, baker grade unknown.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side deflation.Healthcare professional additionally reported left side capsular contracture, baker grade unknown.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: flat creases, brown particles in the shell, and a curved opening on posterior.A leak test and microscopic analysis were performed which identified: sharp opening on posterior and non-penetrating nicks.A dimension measurement of the shell was performed which identified the thickness to be within specification.The fill test inspection was performed and resulted in no blockage.Based on the device analysis, the final assessment is: a sharp opening on posterior assessed as an unidentified (tear) opening.

• Brand Name: STYLE 468 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9569551
• Report Number: 9617229-2019-23054
• Device Sequence Number: 438118
• Product Code: FWM
• UDI-Device Identifier: 10888628001091
• UDI-Public: 10888628001091
• Combination Product (Y/N): N
• Initial Reporter State: IN
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2020

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: 12/09/2020
• Device Model Number: 468-230
• Device Catalogue Number: 468-230
• Device Lot Number: 3005793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/30/2020; 05/15/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/22/2020; 06/12/2020
• 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