BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2971930 · Received February 21, 2013

    Report

    Report Number
    9612164-2013-00194
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: RELATED TO OPERATIONAL CONTEXT (NO MANUFACTURING ROOT CAUSE FOUND FOR THIS EVENT. ROOT CAUSE OF THE REPORTED BALLOON BURST WAS MOST LIKELY PROCEDURAL RELATED). CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (NO MANUFACTURING ROOT CAUSE FOUND FOR THIS EVENT. ROOT CAUSE OF THE REPORTED BALLOON BURST WAS MOST LIKELY PROCEDURAL RELATED).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (BALLOON RUPTURE, STENT DEFORMATION). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (BALLOON RUPTURE, STENT DEFORMATION).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG-ELUTING STENT TO TREAT A CALCIFIED LESION. LESION PRE-DILATATION WAS PERFORMED PRIOR TO STENT IMPLANT. IT WAS REPORTED THAT THE BALLOON OF THE DEVICE BURST PRIOR TO NOMINAL PRESSURE. THE RESOLUTE INTEGRITY STENT WAS NOT WELL DEPLOYED AND THE BALLOON BECAME CAUGHT ON THE STENT. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BALLOON, HOWEVER THE STENT WAS DAMAGED DURING THE RETRIEVAL ATTEMPTS. TWO BALLOONS WERE USED IN AN EFFORT TO OPEN THE STENT, HOWEVER IT WAS REPORTED THAT THE STENT WAS CRUSHED. ANOTHER STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE TARGET LESION. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THERE IS NO EVIDENCE OF DELIVERY DIFFICULTIES WITH THE RESOLUTE INTEGRITY STENT. DEPLOYMENT IMAGES CONFIRM THAT THE STENT BALLOON WAS ONLY PARTIALLY INFLATED RESULTING IN PARTIAL DEPLOYMENT OF THE STENT. THE DELIVERY CATHETER BALLOON REMOVAL DIFFICULTIES WERE NOT CAPTURED ON THE IMAGES BUT THE DEPLOYED STENT LENGTH APPEARS SHORTER THAN ANTICIPATED. THE PROXIMAL BALLOON APPEARED TO FILL WITH CONTRAST HOWEVER THERE WAS NO CONTRAST EVIDENT IN THE MID TO DISTAL WORKING LENGTH AND CONE OF THE BALLOON. THESE CHARACTERISTICS SUGGEST THAT THERE MAY HAVE BEEN A LEAK IN THE BALLOON MATERIAL. POST DILATATION AND DEPLOYMENT OF A SHORTER STENT, OVERLAPPING WITH THE DISTAL END OF THE STENT, RESULTED IN A GOOD RESULT. ATTEMPTED DELIVERY OF A LONG STENT THROUGH A PREVIOUSLY DEPLOYED STENT IN THE PROXIMAL VESSEL WAS INITIALLY UNSUCCESSFUL. THE TARGET DISTAL END OF THE PROXIMAL STENT AND THE MID VESSEL WERE BALLOONED, FOLLOWED BY SUCCESSFUL DELIVERY AND DEPLOYMENT OF ANOTHER PROXIMAL STENT, INSIDE AND PARTIALLY EXITING, THE MID VESSEL. GOOD VESSEL FLOW WAS APPARENT AFTER THE STENTING AND BALLOONING ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75955 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006154994

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention