BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1041276 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01257
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 12, 2008
    Report Date
    April 13, 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 EVAL AND TESTING; HOWEVER, AS OF TO DATE, THE EVAL 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

    THE DEVICE FAILED TO CROSS THE LESION, UPON REMOVAL, THE DISTAL PART OF THE STENT WAS FLARED. THE REPORT RECEIVED INDICATED THAT DURING A CORONARY PROCEDURE, THE 3.5X18MM CYPHER WAS BEING DELIVERED TO THE TARGET LESION BY DIRECT STENTING; HOWEVER, THE DEVICE BECAME STUCK WITH A STENT WHICH WAS IMPLANTED PREVIOUSLY. THEREFORE, BALLOON ANGIOPLASTY WAS CONDUCTED AT THE PROXIMAL LEFT ANTERIOR DESCENDING AND THEN THE CYPHER WAS RE-DELIVERED. AGAIN, THE DEVICE GOT STUCK AND DID NOT CROSS THE TARGET LESION. THE CYPHER WAS REMOVED FROM THE PT AND THE PHYSICIAN OBSERVED THE DISTAL PART OF THE STENT WAS FLARED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY IMPLANTING ANOTHER CYPHER STENT AND CONDUCTING POST-DILATION AT THE TARGET LESION. THERE WAS NO PT INJURY REPORTED. ADDITIONAL INFO INDICATED THERE WERE NO ANOMALIES ON THE DEVICE BEFORE USE AND DURING THE PROCEDURE THERE WAS NO EXCESSIVE FORCE APPLIED WHILE ADVANCING OR TRYING TO CROSS THE LESION; HOWEVER, THERE WAS SOME DIFFICULTY ENCOUNTERED. THE PHYSICIAN THINKS, THE STENT GOT STUCK WITH THE STENT STRUT OF THE ALREADY IMPLANTED STENT AND AS A RESULT THE STENT UPLIFTED.

    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 13332022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK RUNTHROUGH NS GUIDE WIRE| QUANTUM MAVERICK 3.5/15MM BALLOON CATHETER| LAUNCHER 6F EBU3.5 GUIDE CATHETER AND