BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1030234 · Received April 16, 2008

    Report

    Report Number
    9616099-2008-01009
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    January 3, 2008
    Report Date
    March 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. A MALE FROM THE CLINICAL STUDY EXPERIENCED A DISSECTION DURING A PCI. PAST MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. PCI WAS PERFORMED IN THE MID LEFT ANTERIOR DESCENDING. THE REFERENCED VESSEL DIAMETER WAS 4.06MM AND THE LESION LENGTH MEASURED 17MM. THE VESSEL WAS CLASSIFIED AS TYPE B2 WITH 70% STENOSIS AND BIFURCATED REQUIRING DOUBLE GUIDEWIRE. PRE-DILATION WAS CONDUCTED BEFORE THE IMPLANTATION OF A 3.0 X 18MM CYPHER SELECT PLUS DEPLOYED AT 20 ATMS. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. KISSING BALLOON TECHNIQUE WAS CONDUCTED. A DISTAL SMALL EDGE DISSECTION WAS NOTED AND A 3.0 X 18 MM CYPHER SELECT PLUS WAS DEPLOYED AT 18ATM. POST-DILATION WAS CONDUCTED BECAUSE THE STENT WAS NOT FULLY EXPANDED AND THE EVENT RESOLVED WITHOUT SEQUELS. DISCHARGED MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. AT ONE-MONTH FOLLOW UP, THE PT REPORTED ANGINA PECTORIS. NO PT INJURY WAS REPORTED. THE PRODUCT REMAINS IMPLANTED THE PT, AND IS THUS NOT AVAILABLE FOR EVAL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU, IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADD'L INTERVENTION, I.E. PLACEMENT OF ADD'L STENTS. IT ALSO WARNS THE BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. BASED ON THE INFO PROVIDED, THERE ARE POSSIBLE VESSEL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE MALE PT WAS ENROLLED IN THE STUDY IN 2008. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING. THE LESION WAS BIFURCATED REQUIRING DOUBLE GUIDEWIRE. A 3.0 X 18MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 20 ATM. A SMALL TYPE A DISSECTION WAS NOTED AFTER THE STENT WAS IMPLANTED. 3.0 X 08MM CYPHER SELECT WAS IMPLANTED AT 18 ATM IN ORDER TO TREAT THE DISSECTION. THE TWO STENTS WERE OVERLAPPING. AT THE ONE MONTH FOLLOW-UP ON THE FOLLOWING MONTH, THE PT HAD ANGINA PECTORIS.

    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 13320063

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention HEPARIN| GUIDING CATHETER SIZE (FR) 6