BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2062090 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00083
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, METHOD: X-RAY, FLUOROSCOPY, IVUS, CT, MRI, ETC. EVAL, RESULTS: PT VESSEL/LESION MORPHOLOGY. USE OF FORCE TO ADVANCE THE DEVICE. STENT DEFORMATION AND FAILURE TO DELIVER DEVICE. EVAL, CONCLUSION: PT VESSEL/LESION MORPHOLOGY. USE OF FORCE TO ADVANCE THE DEVICE. EVAL SUMMARY: CRIMP IMPRESSIONS AND THE PROXIMAL PILLOW WERE EVIDENT ON THE BALLOON. THE DISTAL TUBING WAS PINCHED IMMEDIATELY PROXIMAL TO THE BALLOON BOND AND KINKED APPROXIMATELY 21CM PROXIMAL TO THE BALLOON BOND. THE RETURNED STENT WAS STRETCHED AND DEFORMED APART FROM TWO SEGMENTS AT EITHER END OF THE STENT. CINE REVIEW: STILL IMAGES SHOWED 3 STENTS SUCCESSFULLY DEPLOYED IN THE LAD AND D1 VESSELS WITH GOOD BLOOD FLOW RESTORED POST DEPLOYMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 2.75 MM DIAMETER X 24MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN THE DISTAL LAD WHICH WAS REPORTED TO BE MODERATELY TORTUOUS AND EXHIBITING 80 - 90% STENOSIS FOLLOWING PRE-DILATION. IT WAS ALSO CONFIRMED THAT RESISTANCE WAS ENCOUNTERED AND FORCE WAS USED ATTEMPTING TO DELIVER THE RESOLUTE STENT ACROSS THE LESION. THE GUIDE CATHETER AND GUIDE WIRE PLACEMENT WAS LOST AS THE PHYSICIAN ATTEMPTED TO DELIVER THE STENT. THE PHYSICIAN REPORTED SOME RESISTANCE WITHDRAWING THE RESOLUTE DEVICE THROUGH THE GUIDE CATHETER AND THE STENT SLIPPED OFF THE DELIVERY SYSTEM DURING INSPECTION POST REMOVAL. FURTHER PRE-DILATIONS WERE COMPLETED ON THE LESION PRIOR TO THE SUCCESSFUL DEPLOYMENT OF ANOTHER RESOLUTE STENT. THERE WERE NO ABNORMALITIES NOTED WHEN WITHDRAWING THE DEVICE FROM THE PACKAGING HOOP OR WHEN REMOVING THE PROTECTIVE SHEATH FROM THE DEVICE. A MEDTRONIC INTEGRITY STENT WAS SUBSEQUENTLY DEPLOYED SUCCESSFULLY (B)(4). IT WAS LATER REPORTED THAT THE PT DEVELOPED SHOCK CHARACTERISTICS AND PT DEATH OCCURRED. DATE OF DEATH IS UNK. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE U.S DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001233160

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR