BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3802399 · Received May 9, 2014

    Report

    Report Number
    2025587-2014-00272
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 31, 2014
    Report Date
    August 2, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, A GORE INTRODUCER REMAINED ON THE DISTAL END OF THE DELIVERY CATHETER SYSTEM (DCS). THE HANDLE APPEARED INTACT. THE FOLLOWING OBSERVATIONS WERE MADE ONCE THE VALVE WAS RELEASED AFTER THE RECEIPT PHOTOS WERE TAKEN WITH THE VALVE LOADED. THE MICRO KNOB (THUMB WHEEL) APPEARED TO RETRACT AND ADVANCE THE CAPSULE. THE MACRO (CURSOR) MOVED TO FULLY ADVANCE AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. THE DISTAL TIP OF THE CAPSULE SEATED FLUSH AGAINST THE PLUNGER TIP WHEN FULLY ADVANCED. WHEN THE DCS WAS RECEIVED A 1.31 MM GAP WAS SHOWN BETWEEN THE DISTAL TIP OF THE CAPSULE AND PLUNGER. SEVERAL KINKS OR TELESCOPING WERE OBSERVED ALONG THE CAPSULE BETWEEN THE PROXIMAL AND DISTAL ENDS. A KINK WAS OBSERVED ON THE PROXIMAL END OF THE CAPSULE. TINY STRESS MARKS WERE OBSERVED ALONG THE RADIOPAQUE MARKER BAND AND DISTAL TIP OF THE CAPSULE. INVESTIGATION REMAINS IN PROGRESS, ONCE THE INVESTIGATION AND DEVICE HISTORY REVIEW IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE PLACEMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK, REQUIRING TEMPORARY PACING FOR THE REMAINDER OF THE IMPLANT PROCEDURE AND FOR 24 HOURS POST-PROCEDURE. FOLLOWING AN ELEC TROPHYSIOLOGY CONSULTATION A PERMANENT PACEMAKER WAS IMPLANTED. THE VALVE REMAINS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281756 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention