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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
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.
 
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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 Key11735318
MDR Text Key247675411
Report Number2648612-2021-00043
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P810002
Number of Events Reported1
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
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
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/27/2021
Supplement Dates Manufacturer Received05/12/2021
Supplement Dates FDA Received05/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
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