BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 1943789 · Received December 21, 2010

    Report

    Report Number
    2953200-2010-02605
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: TORTUOUS, CALCIFIED RCA. FORCE APPLIED DURING ATTEMPTED ADVANCEMENT OF STENT. STENT EMBOLISM. CONCLUSION: TORTUOUS, CALCIFIED RCA. FORCE APPLIED DURING ATTEMPTED ADVANCEMENT OF STENT. EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM WAS RECEIVED FOR EVALUATION; THE STENT HAD BEEN IMPLANTED IN THE PATIENT. CRIMP IMPRESSIONS AND THE PROXIMAL PILLOW WERE EVIDENT ON THE BALLOON. THE FOLDS ON THE PROXIMAL PILLOW WERE PARTIALLY OPENED AND DISTURBED.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO ADVANCE A 3.0 MM DIAMETER X 12MM LENGTH INTEGRITY RAPID EXCHANGE (RX) TO A HEAVILY CALCIFIED DISTAL LESION IN A VERY TORTUOUS RCA. UPON REALIZING THAT THE LESION WOULD BE TOO DIFFICULT TO CROSS, THE CUSTOMER PULLED BACK THE STENT, BUT REALIZED THE STENT HAD COME OFF THE BALLOON IN AN AREA OF THE RCA THAT WAS NOT INTENDED TO BE STENTED. HE HAD TO USE ANOTHER BMS TO DEPLOY THE INTEGRITY STENT WHERE IT HAD LANDED. PRIOR TO THIS, AN ATTEMPT WAS MADE TO ADVANCE A 3.0MM DIAMETER X 18MM LENGTH INTEGRITY RAPID EXCHANGE (RX) STENT TO THE LESION (REF MFR # 2953200-2010-02606). THE LESION HAD PREVIOUSLY BEEN PREDILATED; HOWEVER, THE STENT COULD NOT BE DELIVERED AND WAS NOTED TO BE DAMAGED WHEN WITHDRAWN. NO OTHER CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0004541073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention