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

Catalog Number	TSF-415
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
¿subacute arterial bleeding after simultaneous mastopexy and breast augmentation with implants: case report,¿ by vik¿raitis, zacharevskij e., baranauskas g., published in acta chirurgiae plasticae, 29., no.2., 2017, pp.92-96.The events of bleeding and hematoma are physiological complications 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 will be requested.No additional information is available at this time.Device labeling: potential adverse events that may occur with silicone gel-filled breast implant surgery include: implant rupture, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Patients should be advised that capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.After breast implant surgery the following may occur and/or persist, with varying intensity and/or for a varying length of time: hematoma/seroma, implant extrusion, necrosis, delayed wound healing, and breast tissue atrophy/chest wall deformity.
Event or Problem Description
Reported events of right side ¿fluid accumulation,¿ and ¿subacute hematoma¿ for a patient implanted with a ¿round silicone¿ allergan tsf device were noted in ¿subacute arterial bleeding after simultaneous mastopexy and breast augmentation with implants: case report." during revision surgery, ¿a blood clot of 650 ml was removed,¿ and ¿bleeding from one of the internal mammary artery branches in the implant pocket between the rib cage and pectoral muscle lower pole was detected and stopped.¿ treatment of ¿vacuum drainage¿ was additionally provided, and the device remains implanted.

• Brand Name: INSPIRA TEXTURED 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: 7357784
• Report Number: 9617229-2018-01743
• Device Sequence Number: 1393416
• Product Code: FTR
• UDI-Device Identifier: 10888628034167
• UDI-Public: 10888628034167
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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 Catalogue Number: TSF-415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/21/2018
• 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: 27 YR