BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1398518 · Received June 3, 2009

    Report

    Report Number
    2024168-2009-00968
    Event Type
    Injury
    Date Received
    June 3, 2009
    Date of Event
    May 5, 2009
    Report Date
    May 9, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION -PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. VASOSPASM (CORONARY ARTERY SPASM) AS LISTED IN THE VOYAGER NC INSTRUCTION FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY DILATATION. ADD'L VASOSPASM IS LISTED IN THE NO FAULT RISK ASSESSMENT AS A PROCEDURAL COMPLICATION. AS THERE WAS NO REPORTED PRODUCT MALFUNCTION DURING THE TIME OF THE POST DILATATION, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE VASOSPASM WAS TREATED WITH MEDICATION. HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/REQUIRED INTERVENTION. REPORTING RATIONALE: VASOSPASM/NO REFLOW REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION WAS REPORTED. IT WAS REPORTED VIA A TRIAL THAT DURING POST DILATATION OF A XIENCE V STENT WITH A VOYAGER BALLOON, THERE WAS NO REFLOW IN THE TARGET ARTERY. THE PHYSICIAN REPORTED THAT THE NO REFLOW WAS MOST LIKELY VASOSPASM. THIS WAS TREATED WITH ADENOSINE 120MCG INTRA-CORONARY (IC) X 1 WITH IC NITROGLYCERIN. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention STENT: XIENCE V RX