MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 363 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	363LF-560
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2017
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: potential adverse events that may occur with saline-filled breast implant surgery include: reoperation, pain, wrinkling, asymmetry, implant palpability/visibility, implant removal, capsular contracture, changes in nipple and breast sensation, implant displacement/migration, implant deflation, scarring, infection, hematoma/seroma, breastfeeding complications, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Deflation ¿ breast implants are not lifetime devices.Saline breast implants deflate when the shell develops a tear or hole.Deflation can occur at any time after implantation, but they are more likely to occur the longer the implant is implanted.The following things may cause implants to deflate: damage by surgical instruments; folding or wrinkling of the implant shell; excessive force to the chest (e.G., during closed capsulotomy, which is contraindicated); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.Laboratory studies have identified some of the causes of deflation for allergan¿s product; however, it is not conclusively known whether these tests have identified all causes of deflation.
Event or Problem Description
Healthcare professional reported a right side deflation.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis was performed which identified: an opening on anterior, wear abrasion, and fold creases.Unable to perform leak test due to extended opening.Microanalysis identified an opening on anterior with striated edge consistent with the used of a surgical tool like scalpels, surgical scissors, or a surgical needle assessed as surgical damage.Fill inspection was performed and identified no blockage in the valve.Based on the device analysis the final assessment is: opening due to surgical damage.
Event or Problem Description
Healthcare professional reported a right side deflation.The device has been explanted.

• Brand Name: STYLE 363 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: 7201559
• Report Number: 9617229-2018-00164
• Device Sequence Number: 11134258
• Product Code: FWM
• UDI-Device Identifier: 10888628001053
• UDI-Public: 10888628001053
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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: 10/17/2019
• Device Catalogue Number: 363LF-560
• Device Lot Number: 2833153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/20/2018
• 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: 55 YR