MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURE COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	TCM-330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2019
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.The reason for reoperation: rupture.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
A patient reported experiencing the events of ¿no energy¿, ¿feel ill¿, ¿rupture", "pain", "swelling" and ¿feeling tired¿.Additionally, the healthcare professional reported the events of ¿pain and swelling¿ are due to ¿rupture¿.The device was explanted.
Event or Problem Description
A patient reported experiencing the events of ¿no energy¿, ¿feel ill¿, ¿rupture", "pain", "swelling" and ¿feeling tired¿.Additionally, the healthcare professional reported the events of ¿pain and swelling¿ are due to ¿rupture¿.The device was explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified broken shell and others, brown particles on the shell, and flat crease.Weight measurement of the device identified device weight was within specification.A microscopic analysis was performed which identified: broken striated edge on the anterior.Based on the device analysis the final assessment was a broken striated edge due to surgical damage consistent in the use of some surgical tools.

• Brand Name: INSPIRA TEXTURE COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8964120
• Report Number: 9617229-2019-13503
• Device Sequence Number: 2041236
• Product Code: FTR
• UDI-Device Identifier: 10888628030886
• UDI-Public: 10888628030886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 09/10/2021
• Device Catalogue Number: TCM-330
• Device Lot Number: 2970522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/07/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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: 27 YR