BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153452 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02159
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    June 16, 2007
    Report Date
    August 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBERS ARE 9616099-2008-02158 AND 9616099-2008-02159.. THIS PT EXPERIENCED DISSECTION DURING THE IMPLANTATION OF TWO CYPHER SELECT+ STENTS. MEDICAL HISTORY LISTED ONLY A RISK FACTOR OF SMOKING. THE INDEX PROCEDURE WAS PERFORMED IN THE SETTING OF ACUTE INFERIOR STEMI (PAIN ONSET TO PCI < 6H) WITH CARDIAC ARREST. DURING THE INDEX PROCEDURE, ONE 2.5/33 MM CYPHER WAS IMPLANTED IN THE PT'S PROXIMAL RCA. THE TARGET SITE WAS DESCRIBED AS A TYPE C LESION: CTO, 25 MM IN LENGTH, MODERATE TORTUOSITY OF PROXIMAL SEGMENT, ANGULATION GREATER THAN OR EQUAL TO 40 DEGREES AND < 90 DEGREES, MODERATE CALCIFICATION WITH THROMBUS PRESENT. THE LESION WAS PRE-DILATED AND THE STENT WAS IMPLANTED AT 12 ATM WITH A SATISFACTORY RESULT; TIMI III FLOW WAS RESTORED. A 3.0/18 MM CYPHER WAS IMPLANTED IN THE PROXIMAL LAD. THIS TARGET SITE WAS ALSO DESCRIBED AS A TYPE C LESION: 99% STENOSED (TIMI II FLOW) WITH 14 MM LESION LENGTH, BIFURCATED WITH AN INABILITY TO PROTECT A MAJOR SIDE BRANCH AND MODERATELY CALCIFIED. THE STENT WAS IMPLANTED DIRECTLY AT 12 ATM WITH A SATISFACTORY RESULT; TIMI III FLOW WAS RESTORED. A 2.5/23 MM CYPHER WAS IMPLANTED IN THE MID-RCA. THIS TARGET SITE WAS DESCRIBED AS A TYPE B2 LESION: 60% STENOSIS WITH 26 MM LESION LENGTH, MODERATE TORTUOSITY OF PROXIMAL SEGMENT AND ANGULATION GREATER THAN OR EQUAL TO 45 DEGREES AND < 90 DEGREES. THE STENT WAS IMPLANTED DIRECTLY AT 12 ATM, OVERLAPPING THE 1ST STENT TO COVER A DISSECTION. THE END RESULT WAS SATISFACTORY AND TIMI III FLOW WAS MAINTAINED. THE PATIENT WAS DISCHARGED ON ASA AND PLAVIX AND REMAINED ASYMPTOMATIC AT THE 1-MONTH FOLLOW-UP. NEARLY 3 MONTHS POST-PROCEDURE, THE PT WAS READMITTED. THE DATABASE NOTED, "DISSECTION BEHIND STENT IN LAD. NO CLINICAL SYMPTOMS." A 2.5/18 MM CYPHER WAS IMPLANTED. FURTHER NOTED IN THE DATABASE, "FIRST PROCEDURE DURING AMI AND RESUSCITATION. ROUTINE FOLLOW UP WITH CLINICALLY SILENT DISSECTION AFTER STENT IN LAD." ANGIOGRAPHY DEMONSTRATED NO INTENT OR PERI-STENT RESTENOSIS IN THE RCA STENTS BUT THE LAD STENT DID HAVE SOME DISTAL PERI-STENT RESTENOSIS. THE PT WAS ASYMPTOMATIC AT THE 6-MONTH AND 1-YEAR FOLLOW-UP. NO PRODUCTS COULD BE RETURNED FOR EVAL; THEY REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THIS LOT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. VESSEL DISSECTION AND RESTENOSIS ARE BOTH POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENTS.

    Description of Event or Problem · 1

    EIGHTY-ONE DAYS POST INDEX PROCEDURE, THE PT RETURNED FOR A STAGED PROCEDURE/RE-PCI. THE PT HAD A ROUTINE FOLLOW-UP WITH CLINICALLY SILENT DISSECTION AFTER STENTING THE LEFT ANTERIOR DESCENDING BRANCH. IT WAS NOTED THAT THE STENT PREVIOUSLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING BRANCH HAD DISTAL PERI-STENT RESTENOSIS. IN ADDITION A 50% LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING BRANCH WAS STENTED WITH A 2.5 X 18 MM CYPHER SELECT PLUS STENT. A PATIENT WAS INITIALLY ENROLLED IN THE STUDY IN 2007 WITH 2-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS AN INFERIOR, ACUTE MYOCARDIAL INFARCTION. THE FIRST LESION TREATED WAS IN THE PROXIMAL RIGHT CORONARY ARTERY. IT WAS DE NOVO, TOTALLY OCCLUDED, IRREGULAR, MODERATELY TORTUOUS, CONCENTRIC AND MODERATELY CALCIFIED WITH ANGULATIONS BETWEEN 45 AND 90 DEGREES. IT WAS NOTED THAT THE VESSEL HAD THROMBUS PRESENT. THE LESION WAS PRE-DILATED AND A 2.5 X 33 MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 12 ATM. THE SECOND LESION TREATED WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING BRANCH. IT WAS DE NOVO, BIFURCATED, IRREGULAR, CONCENTRIC AND MODERATELY CALCIFIED. A 3.0 X 18 MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 12 ATM. THE THIRD LESION TREATED WAS IN THE MID RIGHT CORONARY ARTERY. IT WAS DE NOVO, MODERATELY TORTUOUS, AND ECCENTRIC WITH ANGULATIONS BETWEEN 45 TO 90 DEGREES. A 2.5 X 23 MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 12 ATM TO TREAT A DISSECTION. THE PATIENT'S INTRA PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, INTEGRILIN AND HEPARIN. THE PT'S POST PROCEDURE MEDICATION INCLUDED ASPIRIN, CLOPIDOGREL, HEPARIN. STATINS 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 13224383

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention A 6F GUIDING CATHETER| A 2.5 X 20 MM BALLOON CATHETER.