BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083520 · Received July 25, 2008

    Report

    Report Number
    9616099-2008-01828
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    June 26, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: "CONTRIBUTION OF ORGANIZED THROMBUS TO IN-STENT RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION: OPTICAL COHERENCE TOMOGRAPHY FINDINGS". PUBLISHED IN THE EUROPEAN HEART JOURNAL VOL. 29, NUMBER 11 PP. 1385. EUROPEAN HEART JOURNAL ADVANCE ACCESS ORIGINALLY PUBLISHED ONLINE ON DECEMBER 12, 2007 EUROPEAN HEART JOURNAL 2008 29(11): 1385; DOI: 10.1093/EURHEARTJ/EHM570. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS REPORT IS FOR TWO DEVICES WITH THE SAME CATALOG NUMBER AND UNKNOWN LOT NUMBER. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A LITERATURE SEARCH REVEALED AN ARTICLE ENTITLED "CONTRIBUTION OF ORGANIZED THROMBUS TO IN-STENT RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION: OPTICAL COHERENT TOMOGRAPHY FINDINGS". THE ARTICLE WAS PUBLISHED IN THE EUROPEAN HEART JOURNAL. A MALE EXPERIENCED IN-STENT RESTENOSIS ONE YEAR POST IMPLANTATION OF TWO CYPHER STENTS. PAST MEDICAL HISTORY INCLUDED HYPERCHOLESTEROLEMIA AND DIABETES MELLITUS. PCI WAS PERFORMED IN A 90% STENOTIC LESION IN THE MID RCA. TWO 3.0 X 33MM CYPHER STENTS WERE DEPLOYED IN THE CULPRIT LESION WITH SATISFACTORY RESULTS. IVUS CONFIRMED WELL-EXPANDED AND APPOSED STENTS WITH NO PLAQUE PROTRUSION. MEDICATIONS AT DISCHARGE INCLUDED ASPIRIN AND TICOLPIDIN FOR ONE YEAR. TWELVE MONTHS FOLLOW-UP CORONARY ANGIOGRAPHY SHOWED A 99% STENOSIS WITH ORGANIZED THROMBUS WITHIN BOTH STENTS. TREATMENT WAS NOT DESCRIBED IN THE ARTICLE. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, REVIEW OF THE MANUFACTURING RECORDS (DHR) COULD NOT BE PERFORMED. RESTENOSIS AND THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. THE AUTHORS OF THE ARTICLE SUGGEST THAT INTRA-STENT THROMBUS ACCUMULATION MAY REPRESENT A NEW POTENTIAL MECHANISM OF RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES) AND VESSEL/LESION FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    AN ARTICLE WAS OBTAINED DURING A LITERATURE SEARCH ENTITLED "CONTRIBUTION OF ORGANIZED THROMBUS TO IN-STENT RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION: OPTICAL COHERENCE TOMOGRAPHY FINDINGS". THE ARTICLE INDICATED THAT: TWELVE MONTHS AFTER IMPLANTATION OF TWO CYPHER 3.0 X 33 MM STENTS IN THE MID RIGHT CORONARY ARTERY (INDEX PROCEDURE), CORONARY ANGIOGRAPHY WAS DONE IN FOLLOW-UP. A 99% RESTENOSIS WITH A CONTRAST-FILLING DEFECT WAS FOUND. THE ARTICLE STATED THAT ORGANIZED THROMBUS CONTRIBUTED TO THE RESTENOTIC PROCESS THAT AN OPTICAL COHERENCE TOMOGRAPHY (OCT) MAY BE USEFUL.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization