BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 700068 · Received April 12, 2006

    Report

    Report Number
    9616099-2006-00393
    Event Type
    Injury
    Date Received
    April 12, 2006
    Date of Event
    September 22, 2005
    Report Date
    April 12, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIVE MONTHS AFTER THE INDEX PROCEDURE, THERE WAS RESTENOSIS WITHIN THE STENT. A SECOND STENT WAS DEPLOYED TO TREAT THE RESTENOSIS. SEVEN MONTHS LATER, THERE WAS RESTENOSIS IN THE SAME LESION THAT WAS TREATED. THIS PT'S INITIAL ADVERSE EVENT WAS PREVIOUSLY REPORTED UNDER MFG NUMBER 9616099-2005-00842 AND 9610978-2005-01302. PCI WAS PERFORMED ON THIS PT PRESENTED FOR ELECTIVE TREATMENT OF A 50% DE NOVO LESION THE MID LAD. THE (B2) CONCENTRIC LESION WAS BIFURCATED AND HAD MODERATE CALCIFICATION. PRE-PROCEDURE MEDICATIONS INCLUDED ASA 100 MG/DAY. TICLOPIDINE HYD 200 MG/DAY AND WARFARIN 2.5MG/DAY. INTRA-PROCEDURE MEDICATIONS INCLUDED 10,000 UNITS OF HEPARIN, ASA 100 MG/DAY, TICLOPIDINE HYD 200 MG/DAY AND WARFARIN 2.5MG/DAY. THE LESION WAS ROTABLADED. DIRECT STENTING WAS THEN PERFORMED WITH A CYPHER (2.5X18MM) AT 16ATM. TIMI III FLOW WAS RECORDED PRE AND POST-PROCEDURE. RESIDUAL STENOSIS MEASURED 15% IVUS WAS CONDUCTED. POST-PROCEDURE MEDICATIONS INCLUDED 10,000 UNITS OF HEPARIN, ASA 100 MG/DAY, TICLOPIDINE HYD 200 MG/DAY AND WARFARIN 2.5MG/DAY. THE PT REPORTED THAT EXERTIONAL CHEST PAIN REAPPEARED APPROC FIVE MONTHS LATER AND RE-HOSPITALIZED APPROC SIX WKS LATER. ON THE FOLLOWING DAY AFTER HOSPITALIZATION, 99% RESTENOSIS IN THE IMPLANTED BX VELOCITY (SIZE UNK) IN THE RCA. A CYPHER (3.0/23MM) WAS IMPLANTED AT THE LESION TO TREAT THE RESTENOSIS. AT THE SAME TIME, THERE WAS 90% RESTENOSIS AT THE DISTAL END OF THE MID LEFT ANTERIOR. TO TREAT THE TARGET LESION, 2ND CYPHER (2.5/18MM:) WAS IMPLANTED. THE PT WAS IN STABLE CONDITION AND WAS DISCHARGED FROM THE HOSP THE FOLLOWING DAY. APPROX ONE YEAR AFTER THE INDEX PROCEDURE, THE PT HAD A NON-Q-WAVE MYOCARDIAL INFARCTION AND WAS HOSPITALIZED. CONTROL ANGIOGRAPHY WAS CONDUCTED AND 99% RESTENOSIS WAS OBSERVED WITHIN THE CYPHER STENT PREVIOUSLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. POBA WAS CONDUCTED WITH A BALLOON (3.0/10MM: APOLLO HP) AT 18 ATM. THE PT WAS DISCHARGED FROM THE HOSP FOUR DAYS LATER. THREE MONTHS LATER, A CORONARY ARTERY BYPASS GRAFT (CABG) WAS CONDUCTED. THE SAPHENOURS VEIN WAS GRAFTED FROM THE LAD AND LITA WAS GRAFTED TO SV AND D1. THE PT REMAINED HOSPITALIZED FOR SEVERAL WKS AND WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R