BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1033585 · Received April 23, 2008

    Report

    Report Number
    9616099-2008-01076
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MFG ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUAL REQUIREMENTS FOR PROD ACCEPTANCE. VESSEL OCCLUSION DURING STENT IMPLANTATION IS A KNOWN POTENTIAL COMPLICATION OF CORONARY STENTING. THE IFU WARNS THAT IMPLANTING A STENT MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADD'L INTERVENTION. IN THIS CASE, THE LESION WAS A LONG (28MM), TOTAL OCCLUDED TYPE C STENOSIS. PER THE IFU, THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IS NOT ESTABLISHED IN TOTAL OCCLUSIONS AND SHOULD NOT BE USED IN AREAS THAT ARE NOT AMENABLE TO BALLOON ANGIOPLASTY. THE SUBSEQUENT RISE IN CARDIAC ENZYMES IS RELATED TO THE HYPOPERFUSION AND ALSO TO THE RESTORATION OF FLOW TO A CHRONICALLY OCCLUDED AREA OF THE MYOCARDIUM. THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENTS ARE ELATED TO A MFG ISSUE OR ANY DEFECT OF THE DEVICE. THERE ARE VESSEL AND LESION FACTORS THAT CONTRIBUTED TO THESE EVENTS. CYPHER SELECT PROD IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    THIS FEMALE PT WITH A HISTORY OF HYPERTENSION AND HYPERLIPIDEMIA WAS ADMITTED FOR CORONARY EVAL DUE TO UNSTABLE ANGINA WITH RESTING ECG CHANGES. SHE WAS CURRENTLY TAKING ACE INHIBITORS AND BETA-BLOCKERS. ALL MEASURED BASELINE LABS AND VITAL SIGNS WERE WITHIN NORMAL LIMITS. AT THE TIME OF THE PROCEDURE, THE PT WAS GIVEN ASPIRIN, PLAVIX AND HEPARIN. ACTS WERE NOT MONITORED. ANGIOGRAPHY REVEALED A TOTALLY OCCLUDED, 28MM, DE NOVO, CONCENTRIC, C-TYPE LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSEL WAS 2.75MM IN DIAMETER. THE SITE WAS PREDILATED WITH A 2.0 X 15MM BALLOON INFLATED TO 14 ATMS. A 2.75 X 33MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 14 ATMS. FOLLOWING STENT DEPLOYMENT, THERE WAS INSUFFICIENT FLOW THROUGH THE VESSEL. THE STENT WAS POST DILATED WITH A 3.0 X 15MM BALLOON INFLATED TO 18 ATMS. FLOW WAS RESTORED AND THE PROCEDURE WAS COMPLETED. AT SIX HRS POST PROCEDURE, THE CK WAS ELEVATED 4 TIMES ULN AND THE CK-MB WAS ELEVATED <2 TIMES ULN. NO ADD'L TREATMENT WAS REQUIRED AND THE EVENT RESOLVED WITHOUT SEQUELAE. THE PT WAS DISCHARGED AFTER 5 DAYS HOSPITALIZATION WITH ORDERS FOR DAILY ADMINISTRATION OF ASPIRIN, PLAVIX, STATINS, ACE INHIBITORS, AND BETA BLOCKERS.

    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 13311411

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R ASPIRIN| HEPARIN| PLAVIX