BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3151370 · Received June 7, 2013

    Report

    Report Number
    9612164-2013-00612
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE -DISLODGEMENT; PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE -POSITIONING DIFFICULTIES; NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED-DEVICE NOT AVAILABLE FOR RETURN; RELATED TO OPERATIONAL CONTEXT -LONG STENT MAY NOT HAVE BEEN SUITABLE FOR THE VESSEL MORPHOLOGY. CONCLUSION: INHERENT RISK OF PROCEDURE -DISLODGEMENT; PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE -POSITIONING DIFFICULTIES; RELATED TO OPERATIONAL CONTEXT -LONG STENT MAY NOT HAVE BEEN SUITABLE FOR THE VESSEL MORPHOLOGY. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN A CALCIFIED MID RCA LESION AFTER PRE-DILATATION WITH A SPRINTER BALLOON. NO ABNORMALITY WAS NOTED DURING DEVICE PREPARATION. STENT WAS UNABLE TO CROSS SO PHYSICIAN PULLED STENT CATHETER BACK INTO THE GUIDE WHICH WAS NOT CO-AXIAL ALIGNED WITH THE VESSEL LUMEN. THE STENT CAME OFF THE BALLOON PARTIALLY INSIDE THE GUIDE. THE STENT WAS REMOVED THRU THE 6F SHEATH AND MOVED TO THE PATIENTS LEFT PROFUNDA ARTERY IN THE LEG. INTERVENTIONAL RADIOLOGIST CALLED TO ASSIST AND THEY WERE ABLE TO REMOVE THE STENT FROM THE LEFT PROFUNDA WITH A SNARE SUCCESSFULLY AND CASE WAS ABORTED. PATIENT WAS STABLE. IT WAS CONFIRMED THAT FORCE WAS USED DURING THE ATTEMPTED DELIVERY. IMAGE REVIEW: THE IMAGES SHOW CORONARY ANGIOGRAPHIC (CAG) IMAGES OF THE LEFT AND RIGHT CORONARY ARTERIES. THE RCA SHOWS LESIONS IN THE MID AND DISTAL VESSEL. THE DISTAL AND MID RCA WERE PRE-DILATED WITH THE SAME 2.0 X 12MM SPRINTER BALLOON. CAG OF THE RCA AFTER BALLOONING SHOWS RESIDUAL STENOSIS IN THE PRE-DILATED LESIONS. THE 2.25 X 30MM RESOLUTE INTEGRITY STENT WAS THEN INTRODUCED INTO THE VESSEL AND DELIVERY WAS ATTEMPTED TO THE DISTAL LESION. THIS STENT WAS WITHDRAWN WITHOUT DEPLOYMENT. IT APPEARS MOST LIKELY THAT HE TORTUOSITY OF THE MID TO DISTAL RCA IMPACTED ON THE SUCCESSFUL DELIVERY OF THE STENT. FINAL IMAGES SHOW THE DISLODGED STENT AT THE TIP OF THE SHEATH AND ALSO SHOW THE MIGRATED STENT IN THE PROFUNDA ARTERY. IMAGES SHOWING THE SUCCESSFUL SNARING AND REMOVAL OF THE STENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253353 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention