BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1962044 · Received January 17, 2011

    Report

    Report Number
    3003742446-2011-00034
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    November 11, 2010
    Report Date
    December 23, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. CONCOMITANT DEVICES INCLUDE NON-CORDIS 2.0X12MM BALLOON CATHETER AND UNKNOWN 4.0X12MM BALLOON CATHETER.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY (B)(4) STUDY, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION ONE DAY AFTER THE INDEX PROCEDURE AS EVIDENCED BY ELEVATED CARDIAC ENZYMES. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDES PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, ANGINA, HYPERLIPIDEMIA, AND HYPERTENSION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS DESCRIBED AS DE NOVO, NON-THROMBOSED, 90% STENOSED, TYPE B1, 20MM IN LENGTH, WITH NO CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 2.0X12MM NON-CORDIS BALLOON CATHETER AT 12ATMS AND A 3.0X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 14ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 4.0X12MM BALLOON CATHETER AT 16ATMS. ADDITIONALLY, ATTEMPTS TO CROSS AN UNKNOWN GUIDE WIRE THROUGH A CHRONIC TOTAL OCCLUSION IN THE FIRST DIAGONAL WERE UNSUCCESSFUL AT THIS TIME AND THE PHYSICIAN DID NOT PROCEED WITH FURTHER INTERVENTION. ONE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED CK-MB OF 12.5 (ULN 4.9) AND ELEVATED TROPONIN I OF 2.84 (ULN 0.039). IT WAS REPORTED THAT THE ENZYME ELEVATION WAS "SECONDARY TO THE CHRONIC TOTAL OCCLUSION IN THE FIRST DIAGONAL AND FAILED ATTEMPTS TO TREAT IT". NO TREATMENT WAS GIVEN AND THE EVENT RESOLVED WITH SEQUELAE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. PERCUTANEOUS CARDIOVASCULAR INTERVENTION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS SUCH AS THE FAILED ATTEMPTS TO TREAT THE CHRONIC TOTAL OCCLUSION IN THE FIRST DIAGONAL, MAY HAVE CONTRIBUTED TO THE ELEVATED ENZYMES LEADING TO A DIAGNOSIS OF MYOCARDIAL INFARCTION. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES ONE DAY AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS DESCRIBED AS DE NOVO, NON-THROMBOSED, 90% STENOSED, TYPE B1, 20MM IN LENGTH, WITH NO CALCIFICATION. THE LESION WAS PRE-DILATED WITH A 2.0X12MM NON-CORDIS BALLOON CATHETER AT 12ATMS. A 3.0X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 14ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 4.0X12MM BALLOON CATHETER AT 16ATMS. ONE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED CK-MB OF 12.5 (ULN 4.9) AND ELEVATED TROPONIN I OF 2.84 (ULN 0.039). IT WAS REPORTED THAT THE ENZYME ELEVATION WAS "SECONDARY TO CHRONIC TOTAL OCCLUSION DIAGONAL WITH ATTEMPTED CATH BASED INTERVENTION." NO TREATMENT WAS GIVEN AND THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. THE INVESTIGATOR FELT THE EVENT WAS RELATED TO THE INDEX PROCEDURE. THE STUDY COORDINATOR STATED THE INVESTIGATOR FELT THE ELEVATED CARDIAC ENZYMES WERE INDICATIVE OF A MYOCARDIAL INFARCTION. SHE CONFIRMED THAT NO TREATMENT WAS PERFORMED AND THE PATIENT WAS DOING GOOD. SHE STATED THAT NO ATTEMPT WAS MADE TO IMPLANT A CYPHER STENT IN THE DIAGONAL ARTERY. SHE STATED THAT THE INVESTIGATOR COULD NOT GET A GUIDE WIRE THROUGH THE VESSEL AND DID NOT PROCEED WITH FURTHER INTERVENTION. SHE STATED THE GUIDE WIRE USED WAS UNKNOWN.

    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 15226576

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other