MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturing reference number: 3001883144-2021-00052.The article, "propensity matched long-term analysis of mechanical versus stentless aortic valve replacement in the younger patient", was reviewed.This research article is a retrospective multi center experience to compare the long-term outcomes to mechanical prostheses in younger patients (age <_60 years).Edwards prima plus prostheses (edwards lifescience), (b)(4) prostheses (abbott) , freestyle prostheses (medtronic), elan prostheses (vascutek), carbomedics standard prostheses (carbomedics inc), sjm mechanical prosthesis (abbott), medtronic open pivot prostheses (medtronic), on-x prostheses (medical carbon research institute), ultracor prostheses (aortech (b)(4)) and sorin prostheses (sorin group) were associated with the study.There is no allegation of malfunction of the abbott devices.The primary and correspondence author of the article is torsten christ, department of cardiovascular surgery, charite-universitat tsmedizin berlin, corporate member of freie universitat berlin, humboldt-universitat zu berlin, and berlin institute of health, berlin, germany with the corresponding email: torsten.Christ@charite.De.

Manufacturer Narrative

As reported in a research article, periprocedural stroke, major bleeding, implantation of permanent pacemaker, endocarditis, structural failure, aortic stenosis, aortic regurgitation and re-operation was found in recipients of prosthetic heart valves.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.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 11735318
• MDR Text Key: 247675411
• Report Number: 2648612-2021-00043
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR