BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1243776 · Received November 24, 2008

    Report

    Report Number
    2024168-2008-01219
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 30, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION AND ISCHEMIA ARE KNOWN PATIENT EFFECTS ASSOCIATED WITH CORONARY ARTERY STENTING PROCEDURES, AND BOTH ARE LISTED AS POTENTIAL ADVERSE EVENTS IN THE DEVICE INSTRUCTIONS FOR USE. IN THIS CASE, THERE WERE NO DIFFICULTIES REPORTED DEPLOYING THE STENT IMPLANT DURING THE PROCEDURE, AND NO DAMAGE WAS NOTED TO THE STENT DELIVERY SYSTEM PRIOR TO OR AFTER USE. THUS, ALTHOUGH THERE ARE NO INDICATIONS OF A PRODUCT QUALITY ISSUE AFFECTING THE OUTCOME OF THE PROCEDURE, A DEFINITE ROOT CAUSE FOR THE DISSECTION AND ISCHEMIA CAN BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRAIL THAT PREDILATATION WAS PERFORMED PRIOR TO STENTING. A XIENCE V STENT WAS IMPLANTED IN THE MID RCA (3.0 X 28 MM) AND THE PROCEDURE WAS ENDED. POST PROCEDURE, THE PATIENT SHOWED SYMPTOMS OF ISCHEMIA AND A REPEAT ANGIOGRAPHY SHOWED THAT A DISSECTION HAD OCCURRED DISTAL TO THE IMPLANTED STENT. TWO ADDITIONAL XIENCE V STENTS WERE USED TO TREAT THE DISSECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention