BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2871313 · Received December 13, 2012

    Report

    Report Number
    9612164-2012-01769
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. EVALUATION CONCLUSION: THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES HAVE NOT BEEN PROVIDED FOR REVIEW). INHERENT RISK OF PROCEDURE (BALLOON RUPTURE). EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES HAVE NOT BEEN PROVIDED FOR REVIEW). KNOWN INHERENT RISK OF PROCEDURE (BALLOON RUPTURE). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 2.25MM DIAMETER X 14MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN THE DIAGONAL OF A PATIENT. IT WAS REPORTED THAT THE LESION WAS PRE-DILATED AND THE RESOLUTE INTEGRITY DEVICE WAS INFLATED TO 9ATMS AND THE BALLOON RUPTURED. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: NO RESISTANCE NOTED PASSING A 0.015'' PATENCY MANDREL THROUGH THE INNER LUMEN. NEGATIVE PURGE CONFIRMED THE PRESENCE OF A LEAK. ON INFLATION THE DEVICE FAILED TO MAINTAIN PRESSURE AND WATER WAS OBSERVED LEAK FROM THE BALLOON. A SHORT PARTIALLY RADIAL TEAR WAS EVIDENT ON THE BALLOON DISTAL TO THE PROXIMAL INNER SHAFT MARKER. IMAGE REVIEW AND PROCEDURAL REPORT: PROCEDURAL IMAGES CONFIRM THE PRESENCE OF A LESION IN THE MID DIAGONAL TO THE LAD. THERE IS NO EVIDENCE OF MAJOR CALCIFICATION IN THE VESSEL, ALTHOUGH SPIDER VIEW IMAGES SUGGEST THAT THERE MAY BE A SLIGHT DEGREE OF CALCIFICATION PRESENT. THE VESSEL WAS WIRED FOLLOWED BY PRE-DILATATION ACTIVITIES. THE PRE-DILATATION OF THE LESION DID NOT FULLY RESOLVE THE STENOSIS AS RESIDUAL STENOSIS REMAINED. THE LESION APPEARED TO BE PARTIALLY RESISTANT TO FULL OPENING WITH THE BALLOON. PRE-DILATATION WAS FOLLOWED BY SUCCESSFUL DELIVERY AND POSITIONING OF THE RESOLUTE INTEGRITY STENT ACROSS THE TARGET LESION. THE IMAGES DID NOT SHOW ANY POSITIONING DIFFICULTIES. STENT DEPLOYMENT CONFIRMS LEAKAGE OF CONTRAST SOLUTION OUT OF THE BALLOON, CONFIRMING THE BALLOON LEAK. IMAGES CONFIRM THE POST DILATATION OF THE NEWLY DEPLOYED STENT WITH A SHORT BALLOON, IDENTIFIED FROM THE PROCEDURAL NOTES AS AN NC QUANTUM APEX 2.25 X 8MM BALLOON. THIS BALLOON WAS INFLATED FOR MULTIPLE POST DILATATIONS. CORONARY ANGIOGRAPHY (CAG) IMAGES SHOW WHAT APPEARS TO BE A VESSEL DISSECTION AFTER THE POST DILATATION ACTIVITIES. THERE WAS NO EVIDENCE OF THE A 2.0 X 8MM MINI-VISION STENT WAS DELIVERED AND DEPLOYED INSIDE THE RESOLUTE INTEGRITY STENT. THE MINI-VISION AND RESOLUTE INTEGRITY STENTS WERE POST DILATED. CAG IMAGES OF THE VESSEL AFTER THE POST DILATATION ACTIVITIES CONFIRMED THAT THERE WAS NO EVIDENCE OF VESSEL DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006045053

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR