BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040295 · Received May 7, 2008

    Report

    Report Number
    9616099-2008-01247
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    November 6, 2007
    Report Date
    April 9, 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

    PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. THIS PROD IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODS USED FOR THE SAME PT. PLEASE REFERENCE MFR REPORT #: 9616099-2008-01245, -01246 AND -01247.

    Description of Event or Problem · 1

    THE REPORT REC'D FROM THE AFFILIATE INDICATED THAT APPROX SEVEN MOS AFTER THE INDEX PROCEDURE, THE PT HAD AN EMERGENT PERCUTANEOUS CORONARY INTERVENTION (PCI) DUE TO A RESTENOSIS OF A PREVIOUSLY IMPLANTED CYPHER 3.0 X 28 MM STENT (ADVERSE EVENT #1/AE#1) THE STENT WAS IMPLANTED IN THE PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) TARGET LESION. CORONARY ANGIOGRAPHY WAS REPORTEDLY DONE PREVIOUSLY, BUT NO DATE OR DETAILS WERE AVAILABLE. THE RESTENOSIS WAS TREATED BY BALLOON ANGIOPLASTY ONLY (POBA) USING A LACROSSE BALLOON/UNK LENGTH AT 12 ATM FOR FOUR TIMES. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA PECTORIS. THE THREE TARGET LESIONS FOR THE INDEX PROCEDURE WERE THE PROXIMAL RIGHT CORONARY ARTERY (RCA), DISTAL RCA, AND THE PROXIMAL/MID LAD. LESION #1 WAS THE PROXIMAL/MID LAD. THE LESION WAS REPORTED TO BE : SLIGHTLY CALCIFIED AND SLIGHTLY TORTUOUS. DIRECTIONAL CORONARY ATHERECTOMY (DCA) WAS DONE. A CYPHER 3.0 X 28 (STENT #1) WAS IMPLANTED AT 6 ATM. THE STENT WAS IMPLANTED AT 6 ATM. THE STENT WAS POST-DILATED WITH A QUANTUM MAVERICK BALLOON. NO ADD'L DETAILS WERE KNOWN REGARDING THIS PROCEDURE. FIVE WEEKS LATER, ANOTHER PCI WAS DONE TO TREAT THE PROXIMAL AND DISTAL RCA LESIONS. THE LESIONS WERE PRE-DILATED. A CYPHER 3.0 X 23 MM STENT (STENT #2) WAS IMPLANTED IN THE DISTAL RCA LESION (LESION #2) AND A CYPHER 3.0 X 13 MM STENT (STENT #3) WAS IMPLANTED IN THE PROXIMAL RCA (LESION #3). THE STENTS WERE POST-DILATED WITH A QUANTUM MAVERICK BALLOON. NO ADD'L INFO REGARDING THIS PROCEDURE WAS AVAILABLE. AE# 2: APPROX EIGHT MOS AFTER THE INDEX PROCEDURE, ANOTHER PCI WAS DONE DUE TO A RESTENOSIS OF THE CYPHER STENT IMPLANTED IN THE LAD. AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED. CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY WAS DONE THE NEXT DAY TO THE LAD. THE RIGHT CORONARY ARTERY HAD A 75% STENOSIS. NO DETAILS WERE AVAILABLE. AE#3: APPROX ONE YR AFTER THE INDEX PROCEDURE THE PT COMPLAINED OF CHEST PAIN. RESTENOSIS WAS OBSERVED IN BOTH CYPHER STENTS IMPLANTED IN THE RCA. THERE WAS FULL OCCLUSION. ANGIOPLASTY USING A CUTTING BALLOON WAS DONE. RESTENOSIS (ISR) WAS NOTED IN THE CYPHER STENT IN THE LAD AND ALSO AT THE EDGE OF THE STENT. THE PHYSICIAN'S COMMENT WAS THAT HE SUSPECTED THE PT MIGHT HAVE A POSSIBLE ALLERGY TO THE POLYMER OF THE DEVICE(S).

    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 13184450

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R QUANTUM MAVERICK BALLOON