SJM? MECHANICAL HEART VALVE CVD0040

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-25 for SJM? MECHANICAL HEART VALVE CVD0040 manufactured by St. Jude Medical Puerto Rico, Inc..

Event Text Entries

[187082399] In an article, multiple patient deaths with arrhythmia and no fault effects sepsis, intracranial hemorrhage and vascular bleeding were reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[187082400] It was reported that a study was conducted where medical records from january 2008 to december 2018 for 25 mitral valve patients, including 4 abbott mechanical heart valves, requiring reoperation were collected. The majority of mitral valve dysfunction were paravalvular leaks, open - closure dysfunction, and perforation. Two patients died of cardiac causes before reoperation (one died in the hospital due to malignant arrhythmia, the other self-discharged due to financial issues and died of heart failure after 22 days) and an unknown number of patients required blood transfusions. Post-operative complications included cardiac dysfunction, arrhythmia, sepsis, pulmonary infection, gastrointestinal bleeding, cerebral hemorrhage, chronic renal dysfunction, and surgical hemorrhage. Five (5) patients died after reoperation from cardiac dysfunction, septic shock, and self-discharge. No abbott device caused any deaths. Manufacturer report number: 2648612-2020-00029.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2648612-2020-00030
MDR Report Key9878398
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-03-25
Date of Report2020-03-25
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAMELA YIP
Manufacturer Street5050 NATHAN LANE N
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL PUERTO RICO, INC.
Manufacturer StreetP.O. BOX 998 LOT 20 B ST.
Manufacturer CityCAGUAS, PUERTO RICO 00725
Manufacturer CountryRQ
Manufacturer Postal Code00725
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSJM? MECHANICAL HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
Product CodeLWQ
Date Received2020-03-25
Model NumberCVD0040
Catalog NumberCVD0040
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL PUERTO RICO, INC.
Manufacturer AddressP.O. BOX 998 LOT 20 B ST. CAGUAS, PUERTO RICO 00725 RQ 00725


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention 2020-03-25

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