BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 8337776 · Received February 13, 2019

    Report

    Report Number
    2025587-2019-00590
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    September 23, 2018
    Report Date
    February 20, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED ADVERSE EVENTS. A REVIEW OF THE MEDTRONIC GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED DEVICE IDENTIFIER SERIAL NUMBER CONFIRMED THESE OBSERVATIONS HAVE NOT BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CITATION: PIAYDA K ET AL. VALVULOPLASTY BALLOON ENTRAPMENT IN A SELF-EXPANDING AORTIC VALVE STENT FRAME AFTER INADVERTENT WIRE PASSAGE THROUGH THE OUTFLOW STRUTS. CATHETER CARDIOVASC INTERV. 2019 JAN 1;93(1):174-177. DOI: 10.1002/CCD.27858. EPUB 2018 SEP 23. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6) YEAR-OLD MALE PATIENT WITH CORONARY ARTERY DISEASE, POOR LEFT VENTRICULAR FUNCTION AND SEVERE AORTIC STENOSIS PRESENTED WITH CARDIOGENIC SHOCK AND CONSEQUENTLY UNDERWENT IMPLANT OF A 26 MM MEDTRONIC EVOLUT PRO BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED). FOLLOWING SUCCESSFUL VALVE DEPLOYMENT, A PIGTAIL CATHETER WAS POSITIONED IN THE ASCENDING AORTA AND AORTOGRAPHY AND TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED PARAVALVULAR LEAKAGE WITH MODERATE AORTIC REGURGITATION. SUBSEQUENTLY, DURING BALLOON AORTIC VALVULOPLASTY, UNINTENDED WIRE PASSAGE THROUGH THE VALVE¿S OUTFLOW STRUTS CAUSED THE 22 MM NON-MEDTRONIC BALLOON TO BECOME ENTRAPPED IN AN UPPER CELL OF THE STENT FRAME (ALONG THE OUTFLOW STRUTS). SEVERAL ATTEMPTS TO PUSH, PULL, AND STRAIGHTEN THE BALLOON WERE UNSUCCESSFUL. THE BALLOON WAS INFLATED WITH 3 STANDARD ATMOSPHERE AND RUPTURED. THEN A 20 MM NON-MEDTRONIC BALLOON WAS FIXED TO THE VALVE AND THE RUPTURED BALLOON WAS REMOVED UNDER RAPID PACING AND HIGH TRACTION FORCE. A SECOND 22 MM NON-MEDTRONIC BALLOON WAS USED FOR POST-DILATATION AND THE MODERATE AORTIC REGURGITATION WAS REDUCED TO MILD (GRADE ONE). IT WAS NOTED THAT ONLY PROXIMAL PARTS OF THE RUPTURED BALLOON WERE REMOVED FROM THE PATIENT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED THE VALVE WITHOUT ANY BALLOON FRAGMENTS IN THE UPPER STENT FRAME. FLUOROSCOPY REVEALED BALLOON FRAGMENTS IN THE RIGHT COMMON FEMORAL ARTERY, AND AFTER ACCESS SITE CLOSURE, A SUBTOTAL STENOSIS WAS OBSERVED. ONLY A CORONARY GUIDE WIRE COULD PASS THE OBSTRUCTION, AS A RESULT, A CORONARY DRUG ELUTING STENT WAS IMPLANTED AND SUCCESSFULLY RESTORED UNLIMITED FLOW AND COVERED THE REMAINING BALLOON FRAGMENTS. AT 3 AND 9 MONTHS FOLLOWING THE PROCEDURE, TRANSTHORACIC ECHOCARDIOGRAPHY EXHIBITED NORMAL VALVE GRADIENTS, MILD AORTIC REGURGITATION, AND NO SIGNS OF VALVE DYSFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130748 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention