BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001517 · Received February 20, 2008

    Report

    Report Number
    9616099-2008-00407
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIX MONTHS POST-PROCEDURE, THE PATIENT UNDERWENT A RE-PCI FOR RESTENOSIS. THE CRFS INDICATE THAT THE INVOLVED THREE DEVICES. HOWEVER, THE CRF ALSO INDICATES THE FIRST TARGET VESSEL (MID LAD) HAD 80% FOCAL IN-STENT RESTENOSIS AND DISTAL PERI-STENT RESTENOSIS. THE 2ND TARGET VESSEL (MID RCA) HAD 3% DIFFUSE IN-STENT RESTENOSIS. THE 3RD TARGET VESSEL (DISTAL RCA) HAD 90% FOCAL IN-STENT RESTENOSIS. THE MID LAD WAS TREATED WITH A 2.5 X 23MM EVEROLIMUS STENT. THE MID RCA WAS TREATED WITH A 3 X 23MM EVEROLIMUS STENT. THE DISTAL RCA WAS TREATED WITH BALLOON DILATION ONLY. GIVEN THE INFORMATION AVAILABLE, ALL THE STENTS WILL BE CODED FOR RESTENOSIS. SHOULD ADDITIONAL INFORMATION BE SUBMITTED, THE CODES WILL BE REASSESSED. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2008-00408, 9616099-2008-00409, 9616099-2008-00410. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE STUDY. THE PATIENT WAS A FEMALE WITH 2-VESSEL DISEASE AND A HISTORY OF PREVIOUS PCI, HYPERTENSION, AND HYPERLIPIDEMIA. MEDICATIONS AT BASELINE WERE ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS, AND BETA BLOCKERS. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. HEART RATE AT BASELINE WAS 70/MIN. BLOOD PRESSURE WAS 120/80 AND LVEF WAS >50%. PRE-PROCEDURE TROPONIN WAS 3 TIMES ABOVE THE UPPER NORMAL LEVEL (UNL). MEDICATIONS DURING THE PROCEDURE WERE ASPIRIN AND HEPARIN. THE FIRST TARGET VESSEL WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 13MM. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS A FOCAL RESTENOSIS OF A LIBERTE STENT. THE LESION WAS SMOOTH, NOT OSTIAL, AND ECCENTRIC. THE LESION WAS NOT PRE-DILATED. A CYPHER WAS DEPLOYED AT 12 ATM. POST-PROCEDURE STENOSIS WAS 0%. THE SECOND TARGET VESSEL WAS THE MID RIGHT CORONARY ARTERY (RCA). VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 12MM. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS A DIFFUSE RESTENOSIS OF A LIBERTE STENT. THE LESION WAS NOT OSTIAL, MILDLY ANGLED, AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2 X 15MM BALLOON AT 14ATM. ANOTHER CYPHER WAS DEPLOYED AT 12ATM. THE STENT WAS POST-DILATED BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-DILATION WAS CONDUCTED WITH A 3 X 8MM BALLOON AT 18ATM. POST-PROCEDURE STENOSIS WAS 0%. THE THIRD TARGET VESSEL WAS THE DISTAL RCA. VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 28MM. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS A DIFFUSE RESTENOSIS OF A LIBERTE STENT. THE LESION WAS SMOOTH AND ECCENTRIC. THE LESION WAS PRE-DILATED WITH A 2 X 15MM BALLOON AT 12ATM. THIRD CYPHER WAS DEPLOYED AT 12ATM. POST-PROCEDURE STENOSIS WAS 0%. THE FOURTH TARGET VESSEL WAS THE POSTERIOR DESCENDING ARTERY (PDA). VESSEL DIAMETER WAS 2.2MM AND THE LESION LENGTH WAS 15MM. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS A DIFFUSE RESTENOSIS OF A LIBERTE STENT. THE LESION WAS SMOOTH AND ECCENTRIC. THE LESION WAS PRE-DILATED WITH A 2 X 15MM BALLOON AT 12ATM. A CYPHER(FOURTH) WAS DEPLOYED AT 12ATM. POST-PROCEDURE STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 2 DAYS LATER. MEDICATIONS AT DISCHARGE WERE ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS, AND BETA BLOCKERS. THE PATIENT WAS FOLLOWED UP A MONTH LATER AND WAS ASYMPTOMATIC. MEDICATIONS WERE ONGOING AND UNINTERRUPTED.

    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 13176723

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention STATINS| HEPARIN| DEVICES: GUIDING CATHETER SIZE (FR) 6| MEDICATIONS: ASPIRIN| CLOPIDOGREL| BETA BLOCKERS| ACE INHIBITORS