BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1881363 · Received October 25, 2010

    Report

    Report Number
    3003742446-2010-00371
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    April 16, 2010
    Report Date
    September 28, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATED THAT THE PHYSICIAN HEARD A "CRACK" WHEN HE INSERTED THE STENT INTO THE SHEATH. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DE NOVO AND A B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 3 X 8MM DURASTAR BALLOON AT 15ATM. POST-PROCEDURE STENOSIS WAS 0%. AN ATTEMPT WAS MADE TO DELIVER CXS13350, AS THE CYPHER WAS BEING INSERTED INTO THE SHEATH; THE PHYSICIAN HEARD A "CRACK". HE FELT THAT THE TUBE FOR THE STENT HAD BEEN FRACTURED, AND DECIDED TO ABANDON THE IMPLANT ATTEMPT BEFORE THE STENT HAD ENTERED THE PATIENT'S BODY. THE STENT WAS REMOVED FROM THE SHEATH AND GIVEN TO THE SALES REPRESENTATIVE, ALTHOUGH THE REPRESENTATIVE FOR THAT ACCOUNT NEVER RECEIVED THE DEVICE. ANOTHER CXS13350 WAS DEPLOYED AT 15ATM. THE STENT WAS POST-DILATED WITH A 3.75 X 10MM BALLOON AT 16ATM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE PRODUCT THE REPORTED CUSTOMER COMPLAINT OF BODY SHAFT CRACKED COULD NOT BE CONFIRMED. THERE ARE PROCEDURAL FACTORS THAT CAN CONTRIBUTE TO THIS TYPE OF EVENT SUCH AS TIGHTENING OF THE TOOHEY BORST VALVE AFTER INSERTION OF THE STENT, IF TIGHTENED TOO MUCH THEN THE STENT DELIVERY SYSTEM WON'T ADVANCE AND COULD POSSIBLY CRACK. WITH THE VERY LIMITED INFORMATION IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT. THERE IS NOTHING IN THE DHR OR THE REPORTED EVENT THAT WOULD INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT IS A (B)(6) MALE WITH A HISTORY OF OBESITY, ANGINA, (B)(4) STUDY FOR ISCHEMIA, TIA, PVD/CLAUDICATION, COPD, AND SMOKING. THE TARGET LESION WAS THE PROXIMAL LAD. VESSEL DIAMETER WAS 3.6MM AND THE LESION LENGTH WAS 1MM. THE LESION WAS DE NOVO AND A B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 3 X 8MM DURASTAR BALLOON AT 15ATM. POST-PROCEDURE STENOSIS WAS 0%. A CXS13350 WAS ATTEMPTED. AS THE CYPHER WAS BEING INSERTED INTO THE SHEATH, THE PHYSICIAN HEARD A "CRACK." HE FELT THAT THE TUBE FOR THE STENT HAD BEEN FRACTURED, AND DECIDED TO ABANDON THE IMPLANT ATTEMPT BEFORE THE STENT HAD ENTERED THE PATIENT'S BODY. THE STENT WAS REMOVED FROM THE SHEATH AND GIVEN TO THE SALES REP. ANOTHER CXS13350 WAS DEPLOYED AT 15ATM. THE STENT WAS POST-DILATED WITH A 3.75 X 10MM BALLOON AT 16ATM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    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 15094586

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR