BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 2873434 · Received December 14, 2012

    Report

    Report Number
    9612164-2012-01778
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TARGET LESION EXHIBITED MODERATE CALCIFICATION AND 90% STENOSIS). RELATED TO ANOTHER DRUG/DEVICE (DAMAGE OBSERVED ON RETURNED DEVICE IS CONSISTENT WITH THE STENT CATCHING ON THE GUIDELINER). EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TARGET LESION EXHIBITED MODERATE CALCIFICATION AND 90% STENOSIS). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (DAMAGE OBSERVED ON RETURNED DEVICE IS CONSISTENT WITH THE STENT CATCHING ON THE GUIDELINER).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.75 X 18 MM INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT TO TREAT A LESION IN THE MID RCA WITH MODERATE CALCIFICATION AND 90% STENOSIS. LESION PRE-DILATION WAS PERFORMED. TWO ATTEMPTS WERE MADE TO DELIVER THE STENT, HOWEVER RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE TO THE TARGET LESION AND THE DELIVERY SYSTEM WAS REMOVED. IT WAS REPORTED THAT THE STENT SEPARATED FROM THE DELIVERY SYSTEM ON REMOVAL AND LOOKED "MISSHAPEN." THE PHYSICIAN THEN ATTEMPTED TO DELIVER ANOTHER 2.75 X 18 INTEGRITY RX CORONARY STENT. IT WAS REPORTED THAT THE DEVICE SEEMED TO BE GETTING STUCK IN THE GUIDELINER AND RESISTANCE WAS AGAIN ENCOUNTERED ADVANCING THE DEVICE. THIS DEVICE ALSO FAILED TO REACH THE LESION AND THE STENT OF THIS DEVICE WAS ALSO REPORTED TO HAVE SEPARATED FROM THE DELIVERY SYSTEM, ON REMOVAL. A NON-MEDTRONIC STENT WAS SUCCESSFULLY USED TO TREAT THE PATIENT. POST-PROCEDURE PATIENT STATUS WAS REPORTED AS STABLE AND NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE DISTAL TIP WAS SLIGHTLY FLARED AND DAMAGED. THE PROXIMAL PILLOW WAS SLIGHTLY BUNCHED. THE STENT WAS RETURNED, HOWEVER WAS NOT PRESENT ON THE BALLOON. CRIMP IMPRESSIONS WERE VISIBLE ON THE BALLOON. STENT SEGMENTS ONE TO FIVE ON ONE END WERE INTACT; STRUTS ON THE FIRST SEGMENT OF THE OTHER END WERE RAISED AND SLIGHTLY STRETCHED. THE REMAINING SEGMENTS WERE MISALIGNED, DEFORMED AND OVERLAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0005539379

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR