BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT COR 15MM 3.5MM SMALL SDS

    MDR report key: 982870 · Received January 22, 2008

    Report

    Report Number
    1016427-2008-00019
    Event Type
    Injury
    Date Received
    January 22, 2008
    Date of Event
    March 8, 2005
    Report Date
    December 25, 2007
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY THREE (3) MONTHS AFTER THE PATIENT'S INDEX PROCEDURE FOR CYPHER STENT IMPLANTATION, THE PATIENT HAD CHEST PAIN THAT LASTED FOR ONE DAY. THE PATIENT WAS TAKEN EMERGENTLY TO THE HOSPITAL. CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS NOTED IN THE TWO (2) PREVIOUSLY IMPLANTED CYPHER STENTS. AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED. THE LATE THROMBOSIS (LT) WAS TREATED BY ASPIRATION OF THE THROMBUS AND ANGIOPLASTY USING A MAVERICK 3.0 X 20 MM BALLOON. THE PATIENT WAS REPORTED TO HAVE RECOVERED AND WAS DISCHARGED SEVENTEEN DAYS AFTER ADMISSION. THE PHYSICIAN'S COMMENT REGARDING THE POSSIBLE CAUSE OF THE LT WAS THAT THE PATIENT WAS ON DIALYSIS AND THE LESION WAS AN IN STENT RESTENOSIS (ISR). THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS REPORTED TO BE THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS REPORTED TO BE: CONCENTRIC, BIFURCATED, CALCIFIED, A FLEXION LESION, 40 MM IN LENGTH, 3.2 VESSEL DIAMETER, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 3.0 X 20 MM BALLOON AT 12 ATM FOR 30 SEC. A CYPHER 3.0 X 23 MM STENT (STENT #1) WAS THEN IMPLANTED AT 14 ATM FOR 30 SEC. A CYPHER 3.5 X 23 MM STENT WAS THEN IMPLANTED PROXIMALLY AT 14 ATM FOR 30 SEC IN OVERLAPPING FASHION. THE STENTS WERE NOT POST-DILATED. IVUS WAS DONE. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 1 AND TIMI 3 POST-PROCEDURE. AN ACT WAS NOT MEASURED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR. REPORT #9616099-2008-00184, #9616099-2008-00185, AND #1016427-2008-00019.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT APPROXIMATELY SEVEN YEARS AND THREE MONTHS AFTER IMPLANTATION, THE PATIENT EXPERIENCED RESTENOSIS OF THE PREVIOUSLY IMPLANTED PALMAZ SCHATZ 3.5 MM CORONARY STENT. THE STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) TARGET LESION. NO ADDITIONAL PROCEDURAL INFORMATION WAS AVAILABLE. THE RESTENOSIS WAS TREATED BY ELECTIVE IMPLANTATION OF TWO CYPHER STENTS: A 3.0 X 23 MM AND A 3.5 X 23 MM STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENT COR 15MM 3.5MM SMALL SDS CORONARY SDS/STENTS (MAF) MAF CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R