MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	TF-27A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2013, a 27mm trifecta valve was successfully implanted.Five years later on (b)(6) 2018, the device was explanted as a result of an unspecified structural valve deterioration (svd).The patient is reported to be recovering.
Event or Problem Description
On (b)(6) 2013, a 27mm trifecta valve was successfully implanted.Five years later a severe leak was confirmed on a tee.On (b)(6) 2018, the device was explanted as a result of structural valve deterioration (svd).Upon explantation, the leaflet was observed to be torn, originating at the nadir of the device up along the stent post.The device was replaced with a 27mm trifecta valve and the patient is reported to be recovering.
Additional Manufacturer Narrative
The reported torn leaflet was confirmed.Leakage was also reported.Morphological and histopathological examination revealed leaflets 1 and 2 were torn away from their shared stent post.Focal fibrous pannus ingrowth was present on the outflow surface of leaflet 3, straddling the commissure between leaflets 1 and 3, and on the inflow surface of leaflet 2.Additional unidentified white tissue was received with the valve.There was no evidence of inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the torn leaflets and resultant leakage could not be conclusively determined; however, the pannus noted on the leaflets, especially that which was straddling the commissure at stent post 1, had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.Information from the field indicated that the valve had been implanted for over 5 years.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 8222704
• Report Number: 3007113487-2019-00002
• Device Sequence Number: 18901148
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 06/10/2015
• Device Model Number: TF-27A
• Device Lot Number: 4136397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/24/2019
• 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: 68 YR