BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1033584 · Received April 23, 2008

    Report

    Report Number
    3003742446-2008-00066
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    September 19, 2006
    Report Date
    March 27, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DEVICE WITH UNK CATALOG AND LOT NUMBERS IS NOT AVAILABLE FOR TESTING AND EVAL. ADDITIONAL INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS PT WAS REPORTEDLY DIAGNOSED WITH TOTAL ATHEROSCLEROTIC OCCLUSION OF THE MID-TO-DISTAL SECTION OF THE RIGHT CORONARY ARTERY. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE FOLLOWING DAY, AND THE PT RECEIVED A 33MM CYPHER 33 MM STENT TO CORRECT THE OCCLUSION THE RIGHT CORONARY ARTERY, WHICH WAS THE SITE OF TWO PRIOR BARE METAL STENTS. APPROX 14 MONTHS LATER, THE PT WAS DIAGNOSED WITH UNSTABLE ANGINA DUE TO IN-STENT RESTENOSIS OF THE CYPHER STENT AT THE RIGHT CORONARY ARTERY. THE PT UNDERWENT QUADRUPLE CORONARY ARTERY BYPASS SURGERY INCLUDING THE RIGHT CORONARY ARTERY ON THE FOLLOWING DAY. THIS PT OF UNK PAST MEDICAL HISTORY EXPERIENCED IN-STENT RESTENOSIS APPROX 1 YEAR AFTER IMPLANTATION OF A CYPHER STENT. THE INDICATION OF THE INDEX PROCEDURE WAS DIAGNOSIS OF TOTALLY OCCLUDED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THIS VESSEL WAS PREVIOUSLY REVASCULARIZED AT AN UNK TIME WITH TWO UNK BARE METAL STENTS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE RIGHT CORONARY ARTERY. DESCRIPTION OF THE VESSEL SUCH AS TORTUOSITY, PRESENCE OF CALCIFICATION, ETC, WAS NOT REPORTED. VESSEL CLASSIFICATION WAS NOT REPORTED. THERE WAS NO INFO REGARDING PROCEDURAL DETAILS SUCH AS: DEBULKING OR PRE-DILATION OF LESION BEFORE STENT DEPLOYMENT, PRE AND POST PROCEDURE CARDIAC ENZYME VALUES OR PRE AND INTRA PROCEDURE MEDICATIONS USED. ONE CYPHER STENT OF 33 MM IN LENGTH AND UNK DIAMETER, UNK LOT NUMBER AND UNK EXPIRATION DATE, WAS DEPLOYED AT UNK PRESSURE IN THE RCA. POST DILATION OF STENT WAS NOT REPORTED. THE RESIDUAL DIAMETER STENOSIS WAS NOT REPORTED. TIMI FLOW WAS NOT REPORTED. THE REPORT DID NOT INDICATE WHEN THE PT WAS DISCHARGED FROM THE HOSP NOR INDICATED WHAT MEDICATIONS WERE PRESCRIBED AT DISCHARGE. APPROX A YEAR AND TWO MONTHS POST INDEX PROCEDURE, THE PT EXPERIENCED CHEST PAIN AND CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS OF THE CYPHER STENT IMPLANTED IN THE RCA. RATE OF RESTENOSIS WAS NOT REPORTED. THE PT UNDERWENT A QUADRUPLE CORONARY ARTERY BYPASS GRAFT SURGERY INCLUDING BYPASS OF THE RCA. NO OTHER PT INJURY WAS REPORTED. THE PRODUCT REMAINED IMPLANTED IN THE PT AND IS THUS NOT AVAILABLE FOR EVAL. A DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER OF THE PRODUCT WAS NOT REPORTED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED OR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM TO 4.00 MM. THE IFU ALSO INDICATES THAT THE SAFETY AND EFFECTIVENESS OF THE CYPHER STENT HAS NOT YET BEEN ESTABLISHED IN PTS WITH CHRONIC TOTAL OCCLUSIONS. THE ACC DEFINES THIS TYPE OF LESION (TYPE C = EXAMPLE: TOTAL OCCLUSION GREATER THAN 3 MONTHS OLD AND/OR BRIDGING COLLATERALS) AS A HIGH-RISK LESION WITH LESS THAN 60% SUCCESS RATE OF TREATMENT. WITH SUCH LIMITED PT AND PROCEDURAL INFO AVAILABLE FOR REVIEW, THE LACK OF AVAILABILITY OF PRODUCT LOT NUMBER TO PERFORM A DHR REVIEW AND THE UNAVAILABILITY OF THE PRODUCT TO ANALYZE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS. HOWEVER, THE EXISTENCE OF TWO BARE METAL STENTS, THE LESION CHARACTERISTICS (TOTALLY OCCLUDED AND LONG LESION) AND THE PROGRESSION OF THE PT'S CORONARY ARTERY DISEASE (2 OTHER VESSELS BYPASSED), MAY HAVE CONTRIBUTED TO THIS EVENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R