BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2243901 · Received August 24, 2011

    Report

    Report Number
    9612164-2011-01002
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (MATERIAL DISTORTION MOST LIKELY CAUSED BY THE BALLOONING OF THE SIDE BRANCH THROUGH THE CELL OF THE PREVIOUSLY DEPLOYED ENDEAVOR RESOLUTE STENT), (PHYSICIAN ATTEMPTED TO TREAT THE DIAGONAL OSTIUM BY BALLOONING THE SIDE BRANCH THROUGH THE CELL OF THE PREVIOUSLY DEPLOYED ENDEAVOR RESOLUTE STENT), (STENT DEFORMATION, COMPROMISING OF SIDE BRANCH PATENCY). CONCLUSION: (MATERIAL DISTORTION MOST LIKELY CAUSED BY THE BALLOONING OF THE SIDE BRANCH THROUGH THE CELL OF THE PREVIOUSLY DEPLOYED ENDEAVOR RESOLUTE STENT), (PHYSICIAN ATTEMPTED TO TREAT THE DIAGONAL OSTIUM BY BALLOONING THE SIDE BRANCH THROUGH THE CELL OF THE PREVIOUSLY DEPLOYED ENDEAVOR RESOLUTE STENT). EVAL SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVAL. PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE IMAGES CONFIRM THE LOCATION AND MORPHOLOGY OF THE TARGET LESION. THE IMAGES CONFIRM THAT THERE WAS NO DISTORTION IN THE ENDEAVOR RESOLUTE STENT PROFILE AFTER DEPLOYMENT AND PRIOR TO BALLOONING OF THE DIAGONAL BRANCH. FOLLOWING STENT DEPLOYMENT, THE OSTIUM AT THE BIFURCATION APPEARS TO HAVE BEEN PARTIALLY JAILED BY THE STENT. TREATMENT OF THE DIAGONAL OSTIUM WAS ATTEMPTED BY BALLOONING THE SIDE BRANCH THROUGH THE CELL OF THE PREVIOUSLY DEPLOYED STENT. THE IMAGES CLEARLY SHOW A RESISTANCE TO BALLOON EXPANSION AT THE LEVEL WHERE THE BALLOON WAS POSITIONED THROUGH THE CELL OF THE STENT. POST-BALLOONING, THE STENT PROFILE APPEARS TO BE DISTORTED. THERE IS NO EVIDENCE OF STENT WELD OR STENT STRUT MATERIAL FRACTURE FROM THE IMAGES. SUBSEQUENT IMAGES SHOW POST DILATATION OF THE NEWLY DEPLOYED STENT. AT THE END OF THE PROCEDURE, A DISTORTION IN THE STENT PROFILE IS STILL EVIDENT ON THE FLUOROSCOPY IMAGES. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT - (B)(4).

    Description of Event or Problem · 1

    AN ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED, BY DIRECT STENTING, IN A BIFURCATED LESION IN THE LAD/1ST DIAGONAL. THE TARGET LESION EXHIBITED 70-99% STENOSIS AND MODERATE CALCIFICATION. THE DELIVERY SYSTEM BALLOON WAS THEN USED AT THE BIFURCATION SITE TO FURTHER OPEN A STENT CELL. SUBSEQUENT PROCEDURAL IMAGES APPEARED TO SHOW A MID STENT STRUT FRACTURE. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001135849

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK