BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 818248 · Received February 12, 2007

    Report

    Report Number
    9616099-2007-00296
    Event Type
    Death
    Date Received
    February 12, 2007
    Date of Event
    July 7, 2006
    Report Date
    January 17, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT PRESENTED FOR ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A DE NOVO LESION IN THE LEFT MAIN TRUCK (LMT) TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) OF 44MM IN LENGTH IN A 3.04MM VESSEL DIAMETER AT A BIFURCATION. THE (TYPE C) ECCENTRIC LESION WAS ALSO CALCIFIED. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 1001 MG/DAY AND TICLOPIDINE HYDROCHLORIDE 200 MG/DAY. INTRA-PROCEDURE MEDICATIONS INCLUDED HEPARIN 8000 UNITS. THE LESION WAS PRE-DILATED WITH A 3.0 X 20MM BALLOON AT 20 ATMOSPHERES (ATM) BEFORE DEPLOYING A 3.0 X 33MM CYPHER STENT AT 18 ATM. THEN A 3.0 X 28MM CYPHER STENT WAS DEPLOYED AT 22 ATM, OVERLAPPING THE PREVIOUS STENT. POST-DILATION WAS CONDUCTED WITH A 3.0 X 20MM BALLOON AT 15 ATM. IVUS WAS NOT CONDUCTED. RESIDUAL DIAMETER STENOSIS MEASURED 24%. TIMI III FLOWS WERE RECORDED PRE AND POST-PROCEDURE. ACT WAS NOT MONITORED. PCI WAS PERFORMED NEXT ON A DE NOVO LESION IN THE HIGH LATERAL BRANCH THAT WAS 12MM IN LENGTH IN A 2.23MM VESSEL DIAMETER AT A BIFURCATION. THE (B2) LESION WAS ALSO CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.25 X 14MM BALLOON ATM 8 ATM BEFORE DEPLOYING A 2.5 X 18MM CYPHER STENT AT 18 ATM. THE BIFURCATED PORTION OF THE LMT TO THE PROXIMAL LAD WAS TREATED BY T-STENTING. POST-DILATION WAS CONDUCTED WITH A 2.25 X 14MM BALLOON BY KISSING BALLOON TECHNIQUE WITH THE POST-DILATION BALLOON USED FOR THE LMT AND THE PROXIMAL LAD. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST-PROCEDURE. ACT WAS NOT MEASURED. POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 1001 MG/DAY AND TICLOPIDINE HYDROCHLORIDE 200 MG/DAY. SIX MONTHS LATER, RESTENOSIS WAS CONFIRMED IN ALL OF THE STENTS. POBA WAS CONDUCTED WITH A 2.5 X 15MM BALLOON AT 15 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 25%. APPROX SIX TO SEVEN WEEKS LATER, THE PT HAD BEEN HOSPITALIZED FOR A LONG TIME DUE TO A BURN. HE DEVELOPED AN ACUTE MYOCARDIAL INFARCTION AND VENTRICULAR TACHYCARDIA. HE WENT INTO CARDIOPULMONARY ARREST. ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS FOUND IN ALL OF THE PREVIOUSLY IMPLANTED CYPHER STENTS. POBA WAS DONE TO TREAT THE THROMBUS. HOWEVER, THE PT EXPIRED THE FOLLOWING DAY DUE TO HEART FAILURE. A POSTMORTEM WAS NOT PERFORMED. THE PHYSICIAN COMMENTED THAT THE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE PT WAS A DIALYSIS PT. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED SIROLIMUS DRUG ELUTING STENT. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVALUATION. ADD'L INFO RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED IN THE SAME PT THAT WERE SUBMITTED UNDER THE FOLLOWING MFG NUMBER 9616099-2007-00294, AND 00295.

    Description of Event or Problem · 1

    SIX MONTHS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), RESTENOSIS WAS CONFIRMED IN ALL OF THE PREVIOUSLY TREATED LESIONS. THE PT WAS TREATED BUT SIX MONTHS LATER, DEVELOPED ADD'L ADVERSE EVENTS AND SUBSEQUENTLY DIED.

    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 I0905002

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L| R