BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1023338 · Received April 1, 2008

    Report

    Report Number
    9616099-2008-00823
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    November 13, 2007
    Report Date
    March 6, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2008-00824. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY 4 MONTHS POST-PROCEDURE, THE PATIENT HAD A CLINICALLY DRIVEN RE-PCI. THERE WAS A 75% FOCAL STENOSIS OF THE STENTS IN THE DISTAL RCA AND PDA. THERE WAS 0% STENOSIS IN THE MID RCA. BOTH STENTS WERE TREATED WITH BALLOON DILATION. THE REPORT IS FROM THE STUDY. THE PATIENT WAS A MALE WITH A HISTORY OF PREVIOUS PCI, PREVIOUS CABG, SMOKING, DIABETES (TREATED WITH ORAL MEDICATION AND WITH RETINOPATHY, NEUROPATHY OR NEPHROPATHY), AND MODERATE TO SEVERE RENAL DISEASE. MEDICATIONS AT BASELINE WERE ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS, AND BETA BLOCKERS. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA PECTORIS. MEDICATIONS DURING THE PROCEDURE WERE ASPIRIN, CLOPIDOGREL, INTEGRILIN, AND HEPARIN. HEART RATE AT BASELINE WAS 73/MIN AND BLOOD PRESSURE WAS 112/60. THE FIRST TARGET LESION WAS THE DISTAL RIGHT CORONARY ARTERY (RCA). VESSEL DIAMETER WAS 2.7MM AND THE LESION LENGTH WAS 26MM. PRE-PROCEDURE STENOSIS WAS 80% AND TIMI FLOW WAS 3. THE LESION WAS DE NOVO, SMOOTH CONTOUR, CONCENTRIC, AND A TYPE C CLASSIFICATION. THE LESION WAS PRE-DILATED WITH 2.5 X 20MM BALLOON AT 12 ATM. A CYPHER WAS DEPLOYED AT 12MM AND WAS POST-DILATED WITH A 3 X 15 MM BALLOON AT 12 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE 2ND TARGET LESION WAS THE MID RCA. VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 25MM. PRE-PROCEDURE STENOSIS WAS 80% AND TIMI FLOW WAS 3. THE LESION WAS DE NOVO, SMOOTH CONTOUR, CONCENTRIC, AND A TYPE C CLASSIFICATION. THE LESION WAS PRE-DILATED WITH A 2.5 X 20 MM BALLOON AT 12 ATM. ANOTHER CYPHER WAS DEPLOYED AT 12 ATM AND POST-DILATED WITH A 3 X 15 MM BALLOON AT 12 ATM BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE 3RD TARGET WAS THE POSTERIOR DESCENDING ARTERY (PDA). VESSEL DIAMETER WAS 2.25MM AND LESION LENGTH WAS 8MM. PRE-PROCEDURE STENOSIS WAS 80% AND TIMI FLOW WAS 3. THE LESION WAS DE NOVO, SMOOTH CONTOUR, CONCENTRIC, AND A TYPE C CLASSIFICATION. THE LESION WAS NOT PRE-DILATED. A THIRD CYPHER WAS DEPLOYED AT 14 ATM. POST-PROCEDURE STENOSIS WAS 0% AND TIMI FLOW WAS 3. IVUS WAS NOT USED AND THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS DISCHARGED 2 DAYS POST-PROCEDURE. MEDICATIONS AT DISCHARGE WERE ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS, AND BETA BLOCKERS. THE PATIENT WAS FOLLOWED UP 6 MONTHS POST PROCEDURE AND HE WAS ASYMPTOMATIC.

    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 13196588

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention BETA-BLOCKERS| ACE INHIBITORS| CLOPIDOGREL| STATINS| ASPIRIN| HEPARIN| INTEGRILIN