BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10553243 · Received September 18, 2020

    Report

    Report Number
    2134265-2020-12654
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 21, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM: UPDATED. B7: OTHER RELEVANT HISTORY: UPDATED.

    Additional Manufacturer Narrative · 0

    B6: RELEVANT TESTS/LABORATORY DATA: UPDATED.

    Description of Event or Problem · 0

    PROTECTED TAVR STUDY. IT WAS REPORTED THAT THE DISTAL FILTER FAILED TO MAINTAIN POSITION. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF INDEX PROCEDURE. AFTER HEPARIN HAD BEEN GIVEN AND PRIOR TO SENTINEL DEVICE INSERTION, THE ACTIVATED CLOTTING TIME (ACT) WAS 288 SEC. AN INTRODUCER SHEATH WAS PLACED INTO THE RADIAL ARTERY AND A SENTINEL CEREBRAL PROTECTION SYSTEM WAS INSERTED WITH THE PROXIMAL FILTER INTO BRACHIOCEPHALIC ARTERY, AND DISTAL FILTER IN THE LEFT COMMON CAROTID ARTERY. THE NATIVE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A NON-BSC PROSTHETIC VALVE INTO THE CORRECT ANATOMICAL LOCATION. HOWEVER, THE DISTAL FILTER OF THE SENTINEL CEREBRAL PROTECTION SYSTEM DISLODGED PRIOR TO COMPLETION OF THE PROCEDURE. WHEN THE VALVE WAS BEING MOVED THROUGH THE ANATOMY, IT TOUCHED THE SENTINEL CEREBRAL PROTECTION SYSTEM WIRE AND MOVED THE DISTAL FILTER. THE DISTAL FILTER WAS ABLE TO BE REDEPLOYED INTO THE LEFT COMMON CAROTID ARTERY. RECAPTURE OF THE DISTAL FILTER WAS NOT REQUIRED AND THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS RETRIEVED SUCCESSFULLY, WITHOUT COMPLICATIONS. ONE DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED HOME ON 81 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL. IT WAS FURTHER REPORTED THAT UPON DISLODGEMENT, THE DISTAL FILTER OF THE SENTINEL DEVICE WAS AT THE OSTIUM OF THE LEFT COMMON CAROTID(LCC) AND NOT HANGING IN THE AORTIC ARCH. THE DISTAL FILTER WAS THEN ABLE TO BE REDEPLOYED.

    Description of Event or Problem · 0

    PROTECTED TAVR STUDY. IT WAS REPORTED THAT THE DISTAL FILTER FAILED TO MAINTAIN POSITION. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF INDEX PROCEDURE. AFTER HEPARIN HAD BEEN GIVEN AND PRIOR TO SENTINEL DEVICE INSERTION, THE ACTIVATED CLOTTING TIME (ACT) WAS 288 SEC. AN INTRODUCER SHEATH WAS PLACED INTO THE RADIAL ARTERY AND A SENTINEL CEREBRAL PROTECTION SYSTEM WAS INSERTED WITH THE PROXIMAL FILTER INTO BRACHIOCEPHALIC ARTERY, AND DISTAL FILTER IN THE LEFT COMMON CAROTID ARTERY. THE NATIVE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A NON-BSC PROSTHETIC VALVE INTO THE CORRECT ANATOMICAL LOCATION. HOWEVER, THE DISTAL FILTER OF THE SENTINEL CEREBRAL PROTECTION SYSTEM DISLODGED PRIOR TO COMPLETION OF THE PROCEDURE. WHEN THE VALVE WAS BEING MOVED THROUGH THE ANATOMY, IT TOUCHED THE SENTINEL CEREBRAL PROTECTION SYSTEM WIRE AND MOVED THE DISTAL FILTER. THE DISTAL FILTER WAS ABLE TO BE REDEPLOYED INTO THE LEFT COMMON CAROTID ARTERY. RECAPTURE OF THE DISTAL FILTER WAS NOT REQUIRED AND THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS RETRIEVED SUCCESSFULLY, WITHOUT COMPLICATIONS. ONE DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED HOME ON 81 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT THE DISTAL FILTER FAILED TO MAINTAIN POSITION. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR ANOTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN AT THE TIME OF INDEX PROCEDURE. AFTER HEPARIN HAD BEEN GIVEN AND PRIOR TO SENTINEL DEVICE INSERTION, THE ACTIVATED CLOTTING TIME (ACT) WAS 288 SEC. AN INTRODUCER SHEATH WAS PLACED INTO THE RADIAL ARTERY AND A SENTINEL CEREBRAL PROTECTION SYSTEM WAS INSERTED WITH THE PROXIMAL FILTER INTO BRACHIOCEPHALIC ARTERY, AND DISTAL FILTER IN THE LEFT COMMON CAROTID ARTERY. THE NATIVE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A NON-BSC PROSTHETIC VALVE INTO THE CORRECT ANATOMICAL LOCATION. HOWEVER, THE DISTAL FILTER OF THE SENTINEL CEREBRAL PROTECTION SYSTEM DISLODGED PRIOR TO COMPLETION OF THE PROCEDURE. WHEN THE VALVE WAS BEING MOVED THROUGH THE ANATOMY, IT TOUCHED THE SENTINEL CEREBRAL PROTECTION SYSTEM WIRE AND MOVED THE DISTAL FILTER. THE DISTAL FILTER WAS ABLE TO BE REDEPLOYED INTO THE LEFT COMMON CAROTID ARTERY. RECAPTURE OF THE DISTAL FILTER WAS NOT REQUIRED AND THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS RETRIEVED SUCCESSFULLY, WITHOUT COMPLICATIONS. ONE DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED HOME ON 81 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019407 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025119281 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR