BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153446 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02171
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 20, 2008
    Report Date
    August 12, 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

    HEPARIN 5,000 UNITS WERE GIVEN. ACT WAS NOT MEASURED. APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND WAS HOSPITALIZED. A CORONARY ANGIOGRAPHY WAS PERFORMED AND THROMBUS WAS OBSERVED IN THE CYPHER STENT THAT HAD BEEN IMPLANTED IN THE PDA. THE THROMBUS WAS TREATED WITH ASPIRATION AND BALLOON ANGIOPLASTY. IT WAS REPORTED THAT THE PT RECOVERED AND WAS DISCHARGED 12 DAYS LATER. IT WAS REPORTED THAT THE CAUSE OF THE ADVERSE EVENT WAS UNKNOWN. THE PT HAD BEEN MAINTAINED ON ASA 100 MG/DAY SINCE ONE WEEK PRIOR TO THE INDEX PROCEDURE, AND ON TICLOPIDINE HYDROCHLORIDE 200 MG FROM ONE WEEK PRIOR TO THE INDEX PROCEDURE, AND WAS DISCONTINUED IN THE MONTH PRIOR TO THE REPORTED THROMBUS. THE TICLOPIDINE HYDROCHLORIDE WAS RESTARTED WHEN THE PT WAS ADMITTED WITH CHEST PAIN AND IN-STENT THROMBOSIS. THE PATIENT'S MEDICAL HISTORY INCLUDED ANGINA PECTORIS WITH EFFORT, DIABETES AND A PAST HISTORY OF PERCUTANEOUS CORONARY INTERVENTION (PCI). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A REVIEW OF DEVICE REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSED THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO NON-CONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. THE PT'S TICLOPIDINE WAS DISCONTINUED PRIOR TO THE EVENT. ALTHOUGH ACCORDING TO THE INSTRUCTION FOR USE (IFU) TICLOPIDINE SHOULD BE ADMINISTERED FOR THREE MONTHS POST PROCEDURE, IT FURTHER CAUTIONS THAT THE PERIOD OF ANTIPLATELET ADMINISTRATION MUST BE PROLONGED OR SHORTENED APPROPRIATELY DEPENDING ON EACH PT'S CONDITION. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS, AND VESSEL DISSECTION. AS OUTLINED IN THE IFU, THE USE OF THE CYPHER IS CONTRAINDICATED IN LESIONS IN THE BIFURCATION AREA. THE PT'S HISTORY OF DIABETES AND PST HISTORY OF PCI, ALONG WITH THE REPORTED VESSEL DISSECTION AND BIFURCATION LESION ARE IDENTIFIED FACTORS POSSIBILITY CONTRIBUTING TO THE REPORTED CHEST PAIN AND DEMONSTRATED VERY LATE IN-STENT THROMBOSIS.

    Description of Event or Problem · 1

    APPROXIMATELY 28 MONTHS AFTER THE INDEX PROCEDURE IN WHICH A CYPHER STENT WAS IMPLANTED AFTER VESSEL DISSECTION WITH A GUIDEWIRE OCCURRED, THE PT WAS ADMITTED WITH CHEST PAIN AND IN-STENT THROMBUS WAS OBSERVED. THE INDEX TARGET LESION WAS A DE-NOVO, BIFURCATION, SUBTOTAL OCCLUSION, AND TYPE B2 OF THE POSTERIOR DESCENDING ARTERY (PDA). THE LESION LENGTH WAS APPROX 20 MM AND VESSEL DIAMETER WAS APPROX 2.5 MM. THE PROCEDURE WAS AN ELECTIVE CASE. WHEN THE UNKNOWN GUIDEWIRE (GW) WAS INSERTED, A DISSECTION OCCURRED. PRE-DILATION OF THE POSTERIOR DESCENDING BRANCH (PDA) WAS CONDUCTED WITH AN UNKNOWN BALLOON (1.25/12 MM) AT UNKNOWN ATM FOR 15 SECONDS. THE CYPHER (2.5/23 MM) WAS IMPLANTED AT 12 ATM FOR 15~20 SECONDS. THE DISSECTION WAS FULLY RESOLVED BY THE IMPLANTATION OF THE CYPHER. POST-DILATATION WAS NOT CONDUCTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS 0%. IT IS NOT KNOWN IF THE STENT EXTENDED A MINIMUM OF 5 MM BEYOND EITHER SIDE OF THE LESION, AND IT WAS REPORTED THAT THERE MIGHT HAVE BEEN UNTREATED LESION PROXIMAL AND DISTAL TO THE CYPHER. THERE WAS GOOD WALL APPOSITION BETWEEN ALL AREAS OF THE STENT AND THE VESSEL. TIMI FLOW BEFORE THE PROCEDURE WAS 2 AND 3 AFTER THE PROCEDURE.

    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 I0106062

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R UNKNOWN GUIDEWIRE (GW)| UNKNOWN BALLOON (1.25/12 MM)