BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1920420 · Received December 10, 2010

    Report

    Report Number
    9616099-2010-00938
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00938, 9616099-2010-00939 AND 9616099-2010-00940. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 2/2/2011. IT WAS INITIALLY REPORTED THAT THREE STENTS WERE IMPLANTED AND IT WAS NOT REPORTED HOW MANY OF THE STENTS FRACTURED. ADDITIONAL INFORMATION INDICATED THAT ONLY ONE OF THE THREE STENTS WAS FRACTURED, THEREFORE, ONLY ONE OF THE STENTS ASSOCIATED WITH THIS COMPLAINT WERE MDR REPORTABLE. THE DEVICE ASSOCIATED WITH THIS REPORT NO LONGER MEETS MDR REPORTABILITY CRITERIA. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00938, 9616099-2010-00939 AND 9616099-2010-00940.

    Description of Event or Problem · 1

    AS REPORTED VIA THE AMERICAN HEART JOURNAL (2010;160:775.E1-775.E9) ARTICLE ENTITLED "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION" A PATIENT EXPERIENCED A DISLOCATED STENT FRACTURE WITH RESTENOSIS 6-9 MONTHS AFTER STENT IMPLANTATION, AND LATER HAD ANOTHER RESTENOSIS AT THE AREA OF THE STENT FRACTURE. THIS CASE IS 8TH OF 29 EVENTS. THE PATIENT WAS A (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LEFT ANTERIOR DESCENDING (LAD), BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS NOR A CHRONIC TOTAL OCCLUSION. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, THREE CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE TOTAL STENT LENGTH WAS 56MM AND THE DIAMETER OF THE STENT WAS 3.0MM; HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAPHY SIX TO NINE MONTHS AFTER STENT IMPLANTATION, THE STENT WAS NOTED TO BE FRACTURED AND DISPLACED WITH 56% RESTENOSIS. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY INITIALLY, BUT LATER HAD THE IMPLANTATION OF A PACLITAXEL-ELUTING STENT DUE TO FURTHER RESTENOSIS.

    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 54 YR Hospitalization| R