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

Model Number	TRF-770
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930); Seroma (2069)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 15/oct/2018 and 22/jan/2019.Concomitant medical products: (b)(6) 2018: oxygen therapy.(b)(6) 2018: oxygen therapy.(b)(6) 2018: oxygen therapy.(b)(6) 2018: nebulizer treatment (respiratory).(b)(4).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.Device evaluation: analysis of the returned device identified: brown particles in the gel, broken shell, yellow particles in the shell and the weight the device within specification.A visual and microscopic analysis was performed which identified: striated broken on anterior, missing shell (0-25%) and sharp break on posterior.A dimension measurement in the shell was performed which identify the thickness within specification.Base on the device analysis the final assessment is: a sharp broken on posterior due to an unidentified (tear) opening.A striated broken due to surgical damage consist in the use of some surgical tool.Missing shell due to inconclusive.The events of seroma, infection (early onset), cellulitis, and wound dehiscence are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: rupture; seroma; infection (early onset); cellulitis; wound dehiscence.
Event or Problem Description
Healthcare professional reported left side rupture.Documentation received from patient representative notes that the patient contacted the primary care physician approximately two months post implant concerned about indications of an infection.The primary care physician suggested that the patient go to the er where they were admitted.The patient was hospitalized for approximately five days during which time the device was explanted and replaced.The events reported to occur are as follows: ruptured implant, outward signs of infection, fever, chills, presented with fever, chills -- sepsis was suspected, chest pain, swelling to left breast, infected wound, left breast red, edematous appearance, erythema/redness, medial edema, via ultrasound -- edema within the inferior aspect of the left breast suggests underlying mastitis, left breast infected, pain, cellulitis and skin infection, pain and redness, fever, chills, cellulitis of breast, left breast edema/cellulitis with a small wound positive for (b)(6), via ultrasound -- peri-implant fluid collection measuring at least 4 cm in size and possibly larger.Left breast large seroma; left breast infected seroma, 150 ml of cloudy serous fluid in the left breast (aspirated), left breast with small open wound, little exudate, wound dehiscence, and left side breast induration.The following events have been deemed not related to the device: ecchymosis, bruising, breast rash from tegaderm, shortness of breath, and nausea.The device was explanted.Affected side is left.

• 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: 9949910
• Report Number: 9617229-2020-07234
• Device Sequence Number: 14235933
• Product Code: FTR
• UDI-Device Identifier: 10888628008427
• UDI-Public: 10888628008427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

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: 01/23/2021
• Device Model Number: TRF-770
• Device Catalogue Number: TRF-770
• Device Lot Number: 2872173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/10/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 95