BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1083348 · Received July 28, 2008

    Report

    Report Number
    2953200-2008-00609
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS AND CONCLUSION: DEVICE NOT INSPECTED WHEN REMOVED FROM PACKAGING.

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 15MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS IMPLANTED INTO A PT FOR THE TREATMENT OF AN UNKNOWN LESION. LESION MORPHOLOGY IS UNK. UNKNOWN IF VESSEL WAS PRE-DILATED. IT WAS REPORTED THAT THE DEVICE WAS ADVANCED TO THE LESION SITE AND WHEN THE PHYSICIAN INFLATED THE BALLOON, IT WAS NOTICED THAT THE STENT WAS NOT PRESENT ON THE BALLOON. THE STENT WAS REPORTED FOUND ON THE PROCEDURAL TABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. THE DELIVERY SYSTEM WAS RETURNED AND ITS INVESTIGATION WAS COMPLETE. THE UN-DEPLOYED STENT WAS NOT RETURNED. THE DELIVERY SYSTEM WAS RETURNED COILED IN A SMALL ZIP LOCK BAG. THE SHAFT WAS KINKED AT 43 CM. 74.5CM AND 98.5CM DISTAL TO THE STRAIN RELIEF. THE Z-COMPONENT WAS LOCATED AT THE DOCK JOINT. THERE WAS BLOOD RESIDUE ON THE SHAFT AND TUBING. THE BALLOON HAD BEEN INFLATED. A NON-MEDTRONIC STENT STYLETTE AND LONG ORANGE SHEATH WERE RETURNED ALONG WITH THE DELIVERY SYSTEM. THERE WAS EVIDENCE OF A CRYSTALLINE RESIDUE IN THE BALLOON AND HARDENED BLOOD ON THE BALLOON. IT WAS NOT CONFIRMED IF THE STENT WAS PRESENT ON THE STYLETTE AND WITHIN THE PROTECTOR WHEN LOCATED. THE INVESTIGATION WAS INCONCLUSIVE IN DETERMINING THE CAUSE OF THE STENT SLIPPAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000606968

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK