BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2093340 · Received April 19, 2011

    Report

    Report Number
    9612164-2011-00261
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS/CONCLUSIONS: (TIGHT INSTENT RESTENOSIS, LESION NOT ADEQUATELY OPENED DESPITE NUMEROUS PRE-DILATION ATTEMPTS). CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED (THE RETURNED DEVICE INFLATED AND THE STENT EXPANDED WITH NO ABNORMALITIES NOTED DURING EVAL PROCESS). EVAL SUMMARY: THE BALLOON FOLDS ON THE PROXIMAL PILLOW WERE PARTIALLY OPENED AND DISTURBED. THE DISTAL BALLOON FOLDS WERE OPENED AND DISTURBED. THE FIRST DISTAL STENT SEGMENT WAS PARTIALLY EXPANDED. THE REMAINING SEGMENTS WERE INTACT WITH NO EVIDENCE OF DEFORMATION. THE DEVICE UNDERWENT INFLATION AND DEFLATION TIME TESTING AND PERFORMED TO SPECS. (REF MFR# 9612164201100262). 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

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 3.5 MM DIAMETER X 9 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA OF A NSTEMI PT WITH DOUBLE VESSEL CORONARY DISEASE. THE MID RCA SHOWED TIGHT INSTENT RESTENOSIS. DURING THE PROCEDURE, THE OSTIUM OF THE RCA WAS PRE-DILATED TWICE; HOWEVER, FAILED TO DILATE ADEQUATELY. THE MID RCA WAS ALSO PRE-DILATED, BUT AGAIN FAILED TO DILATE ADEQUATELY. THE MID RCA STENOSIS WAS SUCCESSFULLY TREATED WITH A 3.5 MM X 16 MM RESOLUTE INTEGRITY STENT WITH A GOOD RESULT. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE 3.5 MM X 9 MM RESOLUTE INTEGRITY STENT TO THE OSTIUM OF THE RCA. THE DEVICE WAS INFLATED TO 28 ATMS BUT THE STENT FAILED TO DEPLOY. THE DEVICE WAS REMOVED WITH NO REPORTED ISSUES. THE PHYSICIAN THEN ATTEMPTED TO USE ANOTHER 3.5 MM X 9 MM RESOLUTE INTEGRITY STENT, HOWEVER, THIS ALSO FAILED TO DEPLOY AND WAS REMOVED. SEVERAL ADD'L ATTEMPTS WERE THEN MADE TO PRE-DILATE THE OSTIUM, HOWEVER, THE OSTIUM WOULD NOT EXPAND AND THE PROCEDURE WAS STOPPED AT THIS POINT. POST PROCEDURE, PT STATUS WAS REPORTED AS OK AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005199771

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK