BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1171528 · Received September 17, 2008

    Report

    Report Number
    9616099-2008-02273
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, AS OF TO DATE, THE EVALUATION HAS NOT BEEN COMPLETED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    BALLOON BURST. THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE LESION WAS PREDILATED, AT AN UNKNOWN PRESSURE. THEN A 2.5X23 MM CYPHER STENT WAS DELIVERED TO THE LESION AND THE BALLOON WAS INFLATED AT 12 ATMOSPHERES (ATM). HOWEVER, THE PHYSICIAN FELT THE INFLATION TOOK A LONG TIME, HE DEFLATED THE BALLOON 10 SECONDS LATER. THE BALLOON WAS INFLATED AGAIN AT 14 ATM FOR 30 SECONDS WITHOUT PROBLEM. THEN DURING A THIRD INFLATION, THE PHYSICIAN CONFIRMED THE BALLOON WAS RUPTURED. THE PHYSICIAN CONFIRMED, IN A CORONARY ANGIOGRAM (CAG), CONTRAST MEDIUM WAS LEAKING. THEREFORE, AFTER 10 SECONDS, THE PHYSICIAN DEFLATED THE BALLOON. A CAG WAS CONDUCTED AGAIN 5 MINUTES LATER AND THERE WAS NO PROBLEM OBSERVED ON THE PATIENT. THE PROCEDURE WAS SAFELY FINISHED. ONCE THE DEVICE WAS REMOVED FROM THE PATIENT, THE BALLOON WAS INFLATED AND LIQUID SPOUTED OUT FROM THE DISTAL END OF THE BALLOON AND SO, A PINHOLE RUPTURE WAS OBSERVED. THERE WAS NO PATIENT INJURY REPORTED. FURTHER INFO INDICATED THE TARGET LESION WAS IN THE DISTAL END OF THE MID RIGHT CORONARY ARTERY. THE LESION WAS DE NOVO; HOWEVER, THE PROXIMAL AND MID SECTIONS OF THE VESSEL HAD BEEN PREVIOUSLY TREATED WITH A MICRO DRIVER STENT. THE LESION WAS FURTHER DESCRIBED AS CALCIFIED PRESENTING 99% STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13410502

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR BALANCE GUIDEWIRE| VOYAGER 2.0/15MM BALLOON CATHETER| EVERESTC- 3200 INFLATION DEVICE| VIKINGJR-4.0SH GUIDE CATHETER