BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2960255 · Received February 14, 2013

    Report

    Report Number
    9612164-2013-00168
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (BALLOON RUPTURE). RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF BALLOON BURST IS MOST LIKELY PROCEDURAL RELATED). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (BALLOON RUPTURE). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (ROOT CAUSE OF BALLOON BURST IS MOST LIKELY PROCEDURAL RELATED).

    Description of Event or Problem · 1

    A 3.0 X 22 MM RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD. KISSING BALLOON TECHNIQUE WAS THEN PERFORMED IN THE LAD AND DIAGONAL BRANCH USING A 2.5 X 15 MM SPRINTER LEGEND BALLOON AND THE BALLOON OF THE 3.0 X 22 MM RESOLUTE INTEGRITY DELIVERY SYSTEM. A DIAGONAL PROXIMAL DISSECTION WAS OBSERVED, COMPROMISING FLOW. THE PHYSICIAN ASSESSED THAT THE DISSECTION WAS DUE TO THE KISSING BALLOON TECHNIQUE AND WAS NOT RELATED TO THE DEVICES. A 2.5 X 22 MM RESOLUTE INTEGRITY STENT WAS ADVANCED TO THE PROXIMAL SEGMENT OF THE DIAGONAL TO TREAT THE DISSECTION. THE BALLOON OF THE 2.5 X 22 MM DEVICE WAS INFLATED TO 10 ATM. CONTRAST WAS OBSERVED IN THE DIAGONAL AND DA (OUTSIDE THE BALLOON), WHICH INDICATED A BALLOON RUPTURE HAD OCCURRED. THE DISSECTION WAS SUCCESSFULLY TREATED USING A 2.25 X 18 MM RESOLUTE INTEGRITY STENT. PATIENT STATUS POST PROCEDURE WAS REPORTED AS OK AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 1ST DISTAL SEGMENT WAS FLARED. A SMALL AMOUNT OF BLOOD WAS EVIDENT IN THE PROXIMAL PILLOW. A SMALL LONGITUDINAL TEAR WAS PRESENT ON THE PROXIMAL PILLOW. PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE IMAGES SHOW A LESION IN THE LAD AND DIAGONAL BRANCH. A STENT (RSINT30022X) IS POSITIONED AND DEPLOYED IN THE LAD. KISSING BALLOON TECHNIQUE IS PERFORMED AND FOLLOWING THIS A DISSECTION CAN BE SEEN IN THE DIAGONAL BRANCH. THE FOLLOWING IMAGE SHOWS A STENT, MOST LIKELY THE RSINT25022X, POSITIONED IN THE DIAGONAL BRANCH TO TREAT THE DISSECTION. THERE ARE NO IMAGES OF BALLOON INFLATION BUT CONTRAST CAN BE SEEN AROUND THE STENT AND DISTAL TO THE BALLOON/STENT. ANOTHER STENT (RSINT25018X) IS SUCCESSFULLY POSITIONED AND DEPLOYED IN THE DIAGONAL BRANCH. THE DEGREE OF STENOSIS IS SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65034 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006193552

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR