BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1216815 · Received October 30, 2008

    Report

    Report Number
    9616099-2008-02578
    Event Type
    Injury
    Date Received
    October 30, 2008
    Date of Event
    September 7, 2008
    Report Date
    October 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. THE SEVERITY OF THE RESTENOSIS IS DIRECTLY RELATED TO THE COMPROMISED VESSEL FLOW LEADING TO MI. REVIEW OF THE INFO PROVIDED SUGGESTS THAT THERE ARE PT FACTORS (SPECIFICALLY DIABETES AND PROGRESSION OF SEVERE CAD), VESSEL/LESION FACTORS (SMALL VESSEL DIAMETERS) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PT'S EVENTS. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES: HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PT AND REPORTED UNDER MFG NUMBER: 961609-2008-02577.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE REGISTRY INDICATED THAT APPROX FIVE MOS POST STENTING PROCEDURE; THE PT PRESENTED WITH AN ANTERIOR MYOCARDIAL INFARCTION (MI). THE INDICATION FOR THE PROCEDURE WAS A PREVIOUS NON Q-WAVE MYOCARDIAL INFARCTION (MI). THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE PROXIMAL CIRCUMFLEX CORONARY (PCIRC) AND A LESION IN THE LEFT MAIN CORONARY ARTERY (LM). THE DE NOVO LESION IN THE PROXIMAL CIRC WAS 10MM LONG WITH A 2.5MM REFERENCE VESSEL DIAMETER AND PRESENTED 90% DIAMETER STENOSIS. THE OSTIAL LESION WAS CONCENTRIC AND PRESENTED WITH AN IRREGULAR CONTOUR, MODERATE TORTUOSITY OF THE PROXIMAL SEGMENT, WITHOUT CALCIFICATION, ANGULATION >OR= 45 DEGREES & <90 DEGREES, THERE WAS NO THROMBUS AT THE SITE; THE LESION WAS CLASSIFIED AS TYPE B2. THE LESION WAS PRE-DILATED TO 14 ATMOSPHERES (ATMS). THEN A 2.5X13 MM CYPHER STENT WAS DEPLOYED TO 18 ATM. POST DILATION WAS NOT CONDUCTED. THE LESION IN THE LEFT MAIN ARTERY WAS 15MM LONG WITH A 2.7MM REFERENCE VESSEL DIAMETER AND PRESENTED 80% STENOSIS. THE DE NOVO LESION IS CONCENTRIC PRESENTED AN IRREGULAR CONTOUR, MODERATE TORTUOSITY OF THE PROXIMAL SEGMENT; THE LESION WAS CLASSIFIED AS TYPE B2. THE LESION PRE-DILATED TO 14 ATMS THEN A 2.75X18 MM CYPHER STENT WAS SUCCESSFULLY DEPLOYED TO 18 ATMS. RESIDUAL STENOSIS WAS 0%. THERE WERE NO PROBLEMS DURING IMPLANT OR DURING THE INDEX PROCEDURE, THE PT WAS DISCHARGED THE FOLLOWING DAY. DURING THE 30 DAY FOLLOW UP, THE PT WAS ASYMPTOMATIC. HOWEVER, APPROX FIVE MOS POST IMPLANT, THE PT PRESENTED WITH AN ANTERIOR MYOCARDIAL INFARCTION, RELATED TO THE TARGET VESSEL. A CORONARY ANGIOGRAM WAS PERFORMED AND WAS FOLLOWED BY A RE-INTERVENTION. ACCORDING TO THE PT, THE RE-INTERVENTION WAS CONDUCTED TO TREAT "STENOSIS AT THE SAME VESSEL AND BEFORE THE CYPHER STENTS". THE EVENT WAS RESOLVED WITH SEQUELS. HOWEVER DURING THE SIX MONTH FOLLOW UP THE PT WAS REPORTED TO BY ASYMPTOMATIC. A MALE FROM THE REGISTRY EXPERIENCED RESTENOSIS APPROX SIX MOS POST IMPLANTATION OF TWO CYPHER STENTS. PAST MEDICAL HISTORY INCLUDED PREVIOUS CABG FAMILY HISTORY OF CAD, HYPERTENSION, HYPERLIPIDEMIA, DIABETES MELLITUS, PAST SMOKER, MYOCARDIAL INFARCTION AND CHRONIC PULMONARY DISEASE. THIS PT'S HISTORY PUTS HIM AT INCREASED RISK FOR MACE. THE PT WAS DIAGNOSED WITH 3-VESSEL DISEASE. THE INDICATION FOR THE PROCEDURE WAS A PREVIOUS MI. TWO LESIONS WERE TREATED DURING THE INDEX PROCEDURE. A 2.5X13MM CYPHER SELECT PLUS WAS IMPLANTED AT 18 ATM IN A TYPE B2 OSTIAL LESION WITH MODERATE TORTUOSITY, 2.5 MM IN DIAMETER AND 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX ARTERY. THE RATED BURST PRESSURE INDICATE IN THE IFU IS 16 ATMOSPHERES. A 2.75 X 18 CYPHER SELECT PLUS WAS IMPLANTED IN A TYPE B2 LESION WITH MODERATE TORTUOSITY, 2.7 MM IN DIAMETER AND 80% STENOSIS IN THE PROTECTED LEFT MAIN TRUNK. THE PT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. MEDICATIONS AT DISCHARGE INCLUDED ASPIRIN, CLOPIDOGREL, INSULIN, ACE INHIBITORS, AND BETA-BLOCKERS. APPROX SIX MOS LATER, THE PT WAS ADMITTED AT ANOTHER HOSPITAL WITH AN ACUTE ANTERIOR MI. THE PT REPORTED VIA PHONE DURING THE SIX-MONTH FOLLOW UP THAT RE-PCI WAS CONDUCTED TO TREAT "STENOSIS AT THE SAME VESSEL AND BEFORE CYPHER STENT". SINCE DETAILED INFO COULD NOT BE OBTAINED PERTAINING WHICH CYPHER STENT WAS RESTENOSED, BOTH PRODUCTS ARE REPORTED WITH RESTENOSIS AND MI. THE PRODUCTS REMAIN IMPLANTED IN THE PT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN.

    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 13340306

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R ACE INHIBITORS| CONCOMITANT PRODUCTS 6F GUIDE CATHETER| STATINS| BETABLOCKERS| MEDICATIONS INCLUDED ASPIRIN| CLOPIDOGREL| UNFRACTIONATED HEPARIN| DIABETES TREATMENT| 2.5X15MM PRE-DILATION BALLOON| ASAHI SOFT GUIDEWIRE