BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1080187 · Received July 21, 2008

    Report

    Report Number
    9616099-2008-01810
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    October 17, 2006
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE MONTHS POST RESTENOSIS TREATMENT, AGAIN, THE PATIENT COMPLAINED OF CHEST DISCOMFORT. STRESS MYOCARDIAL SCINTIGRAPHY WAS CONDUCTED AND ISCHEMIA AND REDISTRIBUTION PHENOMENON WERE OBSERVED AT THE INFERIOR WALL. A CAG WAS CONDUCTED AND RESTENOSIS WAS OBSERVED AT THE FRACTURED AREAS; TO TREAT THE RESTENOSIS, CUTTING BALLOON WAS CONDUCTED AND THE PROCEDURE WAS SAFELY FINISHED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN INDICATED THAT ONE OF THE PROBABLE CAUSES OF THE RESTENOSIS IN THE FRACTURE MIGHT BE DUE TO THE MECHANICAL STIMULUS OF THE STENT OR THAT THE FRACTURE LEADS TO A LACK OF THE SIROLIMUS AT THE FRACTURED AREA. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. PLEASE NOTE THAT THIS EVENT INVOLVES THREE PRODUCTS TWO OF WHICH ARE ASSOCIATED WITH THE SAME CATALOG AND LOT NUMBER AND REPORTED UNDER MANUFACTURING NUMBER 9616099-2008-01808. THE THIRD PRODUCT IS BEING REPORTED UNDER THIS REPORT WITH MANUFACTURING NUMBER 9616099-2008-01810. PLEASE FIND BELOW THE ARTICLE'S CITATION ALONG WITH A COPY OF THE ARTICLE. "A CASE OF MULTIPLE STENT FRACTURES FOLLOWING CYPHER STENT IMPLANTATION", INTERNATIONAL JOURNAL OF CARDIOLOGY 2008, 23 193-198. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE, FIVE MONTHS POST STENT IMPLANT, THE PATIENT PRESENTED WITH RESTENOSIS ASSOCIATED WITH MULTIPLE STENT FRACTURES. AS INDICATED, DUE TO THE PROGRESS OF CLAUDICATION INTERMITTENS, THE PATIENT COMPLAINED OF CHEST PAIN DURING EXERTION AS THE PATIENT'S WALKING TIME BECAME LONGER. THREE MONTHS LATER, A CORONARY ANGIOGRAM (CAG) WAS CONDUCTED REVEALING A DIFFUSED HIGHLY STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (RCA); THE FLOW AT THE DISTAL END OF RCA WAS SLOW. THERE WAS NO ABNORMALITY OBSERVED IN THE LEFT CORONARY ARTERY. AT THE SAME TIME, ANGIOGRAPHY OF THE LOWER EXTREMITY WAS CONDUCTED AND A CHRONIC TOTAL OCCLUSION, 10CM LONG, WAS OBSERVED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A FEW DAYS LATER, THE PATIENT UNDERWENT TREATMENT OF THE LESION IN THE RCA AND THREE 2.5X28MM CYPHERS WERE SUCCESSFULLY IMPLANTED FROM THE DISTAL END TO THE MID RCA. THE PATIENT ALSO UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE LESION IN THE SFA. FIVE MONTHS POST STENT IMPLANT THE PATIENT COMPLAINED OF CHEST DISCOMFORT DURING EXERTION. A CAG WAS PERFORMED; HINGED POINTS IN FOUR PLACES WERE OBSERVED. FRACTURES AND RESTENOSIS WERE OBSERVED AT THE HINGED POINTS. THERE WERE TWO FRACTURES AT THE OVERLAPPING AREA AND TWO FRACTURES AT THE CENTER OF THE STENTS. THE RESTENOSIS AND THE FRACTURES WERE TREATED WITH BALLOON ANGIOPLASTY. THE PROCEDURE WAS SAFELY FINISHED.

    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 I0106199

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R