BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1111919 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01946
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 15, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT A PT EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PT'S HISTORY IS SIGNIFICANT FOR NON-TARGET VESSEL RELATED PCI, HYPERTENSION, HYPERLIPIDAEMIA, PRIOR MI AND CURRENT TOBACCO ABUSE. THE INDICATION FOR THE PROCEDURE WAS SILENT ISCHEMIA. THE TARGET VESSEL WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), WITH 95% STENOSIS, AT AN OSTIUM AND IN THE AREA OF A BIFURCATION. THE LESION WAS PRE-DILATED WITH A 2.0MM X 12MM BALLOON AT 12 ATMS FOLLOWED BY A 3.0MM X 23MM CYPHER SELECT STENT AT 16 ATMS. THE STENT WAS SATISFACTORILY IMPLANTED AND DID NOT REQUIRE POST-DILATION. THE PT WAS DISCHARGED TWO DAYS LATER. APPROX ELEVEN MONTHS LATER, THE PT WAS EXPERIENCING DYSPNEA AND ANGINA. REPEAT ANGIOGRAPHY WAS PERFORMED AND REVEALED 80% PROLIFERATIVE IN STENT AND DISTAL RESTENOSIS OF THE CYPHER STENT. THIS EVENT WAS TREATED BY IMPLANTING A DRUG ELUTING STENT MADE BY DIFFERENT MANUFACTURER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. PTS THAT SMOKE HAVE AN INCREASED RISK OF A POTENTIAL ADVERSE EVENT. THE ACT OF CORONARY STENTING IN A BIFURCATION IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT PT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT.

    Description of Event or Problem · 1

    THIS PT WAS ENROLLED IN THE STUDY IN 2007 WITH 1-VESSEL DISEASE. THE MAIN INDICATION FOR THE PROCEDURE WAS SILENT ISCHEMIA. ON THE FOLLOWING MONTH, THE PT HAD DYSPNEA. PROLIFERATIVE (IN STENT AND BEYOND (DISTA) 80% RESTENOSIS WAS CONFIRMED VIA CORONARY ANGIOGRAM AT THE TARGET LESION. THE RESTENOSIS WAS TREATED WITH A TAXUS STENT. THE TARGET LESION WAS A NATIVE, DE NOVO, BIFURCATED, OSTIAL, IRREGULAR, READILY ACCESSIBLE, ECCENTRIC, TYPE B2 PROXIMAL LEFT ANTERIOR DESCENDING. THE REFERENCE VESSEL DIAMETER WAS 3MM AND THE LESION LENGTH WAS 21MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 95%. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM BALLOON AT 12 ATM AND A 3.0 X 23MM CYPHER SELECT STENT WAS IMPLANTED AT 16 ATM WITH SATISFACTORY RESULTS. THE STENT WAS NOT POST-DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS 0%. THE PT'S PRE-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, STATINS, AND CLOPIDOGREL. THE PT'S INTRA-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, CLOPIDOGREL AND HEPARIN. THE PT'S POST-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, STATINS, ACE INHIBITORS, BETA-BLOCKERS AND CLOPIDOGREL.

    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 13187777

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R WERE USED DURING THE PROCEDURE.| A 6FR GUIDING CATHETER AND A 2X12MM BALLOON