BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2080183 · Received May 6, 2011

    Report

    Report Number
    3003742446-2011-00226
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    December 27, 2010
    Report Date
    April 11, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND WERE UPDATED. ADDITIONAL INFORMATION CONFIRMED THE CYPHER RX STENT WAS POST-DILATED PER ROUTINE PROTOCOL FOR OPTIMAL EXPANSION OF THE STENT STRUTS. THEREFORE, THIS COMPLAINT WILL BE UNREPORTED AS IT WILL NO LONGER BE DEEMED MDR REPORTABLE. A 2.5X10 MM DURASTAR BALLOON CATHETER WAS ADVANCED OVER THE WIRE IN THE MID AND PROXIMAL SEGMENT OF THE STENT AND INFLATED UP TO 16 ATMS FOR 30 SECS. THE BALLOON WAS DEFLATED AND PULLED BACK INTO THE GUIDING CATHETER AND ANGIOGRAPHIC IMAGES SHOWED ADEQUATE APPOSITION OF THE STENT STRUTS TO THE VESSEL WALL. FINAL ANGIOGRAPHIC IMAGES CONFIRMED ADEQUATE APPOSITION OF THE STENT STRUTS TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS TO THE PATIENT. THE INVESTIGATOR CONFIRMED THAT "SOME WASTE" REPORTED ON THE REPEAT ANGIOGRAPHY WAS PLAQUE. THE CYPHER RX STENT WAS POST-DILATED PER ROUTINE PROTOCOL FOR OPTIMAL EXPANSION OF THE STENT STRUTS AGAINST PLAQUE IN THE ARTERY.

    Description of Event or Problem · 1

    THE PROCEDURE NOTE INDICATED THAT THERE WAS MILD MID LEFT ANTERIOR ARTERY (LAD) STENOSIS UP TO 40%. THERE WAS SIGNIFICANT MID SEGMENT FIRST DIAGONAL BRANCH STENOSIS UP TO 90%. THE REFERENCE DIAMETER WAS 2.5 MM IN DIAMETER AND THE LESION LENGTH WAS 18 MM. THERE WAS SOME OSTIAL DIAGONAL DISEASE UP TO 30%. A KINETIX WIRE WAS ADVANCED OVER THE 3DRC GUIDING CATHETER AND PASSED INTO THE LAD AND PARKED IN THE FIRST DIAGONAL BRANCH. A 2.0X14 MM SPRINTER BALLOON CATHETER WAS ADVANCED OVER THE STENTED SEGMENT. THE BALLOON WAS INFLATED TO 40 ATMS FOR 30 SECS. THE BALLOON WAS DEFLATED AND PULLED BACK INTO THE GUIDING CATHETER AND A 2.5X18 MM CYPHER RX STENT WAS ADVANCED OVER THE GUIDE WIRE. THE STENT WAS POSITIONED IN THE MID SEGMENT OF THE DIAGONAL BRANCH WHERE THERE WAS STENOSIS AND DEPLOYED AT 14 ATMS FOR 30SECS. THE BALLOON WAS DEFLATED AND PULLED BACK INTO THE GUIDING CATHETER AND ANGIOGRAPHIC IMAGES THAT WERE OBTAINED REVEALED SOME WASTE IN THE MID SEGMENT OF THE STENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE CYPHER RX STENT WAS POST-DILATED DUE TO MALPOSITION. THE TARGET LESION WAS LOCATED IN THE FIRST DIAGONAL. THE LESION WAS DESCRIBED AS DE NOVO, NON-THROMBOSED, 90% STENOSED, TYPE C, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 2.0X15MM DURASTAR RX PTCA BALLOON CATHETER AT 40ATMS. A 2.5X18MM CYPHER RX STENT WAS IMPLANTED AT 14ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 2.5X10MM BALLOON CATHETER AT 16ATMS DUE TO MALPOSITION. THREE WEEKS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED LOWER BACK PAIN. THE EVENT WAS MEDICALLY MANAGED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15246276

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR 2.0X15MM DURASTAR RX PTCA BALLOON CATHETER