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

Model Number	TF-27A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Dyspnea (1816); No Information (3190)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2013, a 27 mm trifecta valve was implanted.On (b)(6) 2019, the device was explanted.Additional information has been requested.
Event or Problem Description
On (b)(6) 2013, a 27mm trifecta valve was implanted.On (b)(6) 2019, the device was explanted due to a loose or torn leaflet and the patient was experiencing shortness of breath.The device was replaced with a 25mm inspiris valve and the patient is reported to be recovering.
Additional Manufacturer Narrative
Explant was reported due to a torn leaflet.The torn leaflet was confirmed; leaflet 1 was torn.Leaflet 3 contained calcifications.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the tear could not be conclusively determined, however the calcification noted 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.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9344649
• Report Number: 3008452825-2019-00577
• Device Sequence Number: 2157098
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 11/29/2013
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 3576036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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: 69 YR