MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a total of 15 patients at high or prohibitive risk of coronary obstruction were identified as candidates for the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (basilica) procedure between october 2019 and january 2021; trifecta (abbott), hancock ii (medtronic), freedom solo (sorin), and mitroflow (sorin) devices were associated with the study.An event of three patients that were implanted with a trifecta valve requiring a valve in valve procedure due to aortic stenosis, aortic regurgitation, or a combination of aortic stenosis and aortic regurgitation was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "prevention of coronary obstruction in patients at risk undergoing transcatheter aortic valve implantation: the hamburg bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (basilica) experience", was reviewed.This article is a prospective single center experience to assess the clinical outcome of the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary obstruction (basilica) technique in a single-center patient cohort considered at high or prohibitive risk of transcatheter aortic valve implantation (tavi)-induced coronary obstruction.Trifecta (abbott), hancock ii (medtronic), freedom solo (sorin), and mitroflow (sorin) were the devices associated with the study.The article concluded that the basilicia technique as a safe and effective preventive option in patients at high or prohibitive risk of iatrogenic coronary obstruction during native valve tavi and (valve in valve (viv) tavi.The primary and corresponding author of the article is sebastian ludwig, md, department of cardiology, university heart and vascular center hamburg, university medical center hamburg eppendorf, martinistrasse 52, 20246 hamburg, germany, with the email se.Ludwig@uke.De.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12254747
• MDR Text Key: 266850328
• Report Number: 3014918977-2021-00040
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR