BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1140111 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02114
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    February 3, 2008
    Report Date
    August 1, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT THE INDEX PROCEDURE WAS ELECTIVE, BUT THE PATIENT WAS ADMITTED WITH STABLE ANGINA PECTORIS. THE PROCEDURE WAS PERFORMED THE SAME DAY, AND NO STAGE PROCEDURE WAS PLANNED. THE PATIENT'S MEDICAL HISTORY CONSISTED OF HYPERTENSION, HYPERLIPIDEMIA, CURRENT SMOKER, PERIPHERAL VASCULAR DISEASE, AND A CHARLSON COMORBIDITY OF ONE. THE DISEASE EXTENT WAS THREE VESSELS, AND THE NUMBER OF LESIONS TREATED DURING THIS PROCEDURE WAS ONE. THE PATIENT WAS STARTED ON ASPIRIN 75MG 30 DAYS PRIOR TO THE INDEX PROCEDURE, STATINS AND BETABLOCKERS. AT THE TIME OF THE PROCEDURE, THE PATIENT RECEIVED ASPIRIN, UNFRACTIONATED HEPARIN, AND A LOADING DOSE OF CLOPIDOGREL 75MG. A BASELINE (ECG) ELECTROCARDIOGRAM WAS NOT PERFORMED. THE BLOOD PRESSURE WAS 141/70, A HEART SINUS RATE OF 70, AND THE (LVEF) LEFT VENTRICULAR EJECTION WAS NOT AVAILABLE. DURING THE INDEX PROCEDURE, A 6FRENCH-GUIDING CATHETER WAS UTILIZED. THE TARGET SITE WAS THE NATIVE (PCIRC) PROXIMAL CIRCUMFLEX CORONARY ARTERY WITH A VESSEL DIAMETER OF 2.99MM AND A LESION LENGTH OF 30MM. THE LESION WAS DE-NOVO, NON-OSTIAL, BIFURCATION, CONCENTRIC, ANGULATED >/=45 & </= 90 DEGREES, ABSENT THROMBUS, TYPE B II, WITH MODERATE CALCIFICATION AND TORTUOSITY. THE LESION WAS PRE-DILATED WITH A 2.5X12MM UNKNOWN BRAND BALLOON AT 14 ATMOSPHERES. A CYPHER SELECT PLUS STENT WAS ELECTIVELY DEPLOYED AT 14 ATMOSPHERES WITH SATISFACTORY RESULTS. POST DILATION WAS PERFORMED BECAUSE OF INSUFFICIENT FLOW. THE POST DILATION WAS PERFORMED WITH 15X3MM UNKNOWN BRAND BALLOON AT 16 ATMOSPHERES. DURING THE PROCEDURE, THERE WAS BIFURCATION AT THE CIRCUMFLEX AND FIRST (OM) OBTUSE MARGINAL BRANCH THAT POST PRE-DILATION OF THE OM, IT WAS IMPOSSIBLE TO STENT BECAUSE THE CALCIFICATION AND TORTUOSITY. FOLLOWING PLACEMENT OF THE CIRCUMFLEX STENT, THE OM BECAME COMPLETELY OCCLUDED. HOWEVER, GOOD RETROGRADE COLLATERAL SUPPORT WAS SEEN WITH NO ECG CHANGES. NO FURTHER ACTION WAS REQUIRED. THE MEDICATION AFTER THE (PCI) PERCUTANEOUS CORONARY INTERVENTION AND PRIOR TO DISCHARGE, CONSISTED OF ASPIRIN 75MG PERMANENTLY AND CLOPIDOGREL 75MG FOR 12 MONTHS. THE MEDICATION AT DISCHARGED CONSISTED OF ASPIRIN 75MG PERMANENTLY, CLOPIDOGREL 75MG FOR 12 MONTHS, STATINS, AND BETA-BLOCKERS. THE THIRTY-DAY FOLLOW UP REPORT CONDUCTED VIA TELEPHONE, INDICATED THAT THE PATIENT HAD ANGINA PECTORIS, CONTINUES THE TREATMENT WITH ASPIRIN AND CLOPIDOGREL THAT HAVE NEVER BEEN STOPPED, STATINS, ACE INHIBITORS, AND BETA BLOCKERS. THE SIX MONTHS FOLLOW UP REPORT CONDUCTED VIA TELEPHONE, INDICATED THAT THE PATIENT HAD ANGINA PECTORIS. ADDITIONALLY, THE PATIENT REPORTED DISCONTINUATION OF ANTIPLATELET THERAPY BECAUSE OF PLANNED DENTAL SURGERY PERFORMED IN EARLY 2008, HOWEVER STATINS AND BETA-BLOCKERS CONTINUE TO BE TAKEN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS PRODUCT IS SIMILAR TO US CYPHER STENT.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, AN INCIDENTAL FINDING OF INSUFFICIENT FLOW WAS NOTED THAT REQUIRED POST DILATION, AND INADVERTENTLY SIDE BRANCH OCCLUSION OF THE (OBTUSE MARGINAL). HOWEVER, THERE WAS GOOD RETROGRADE FLOW AND NO INTERVENTION WAS CONDUCTED. ADDITIONALLY, THE ONE-YEAR FOLLOW-UP, REPORT CONDUCTED VIA TELEPHONE, INDICATED THAT THE PATIENT WAS ASYMPTOMATIC, AND THE SUBJECT WAS NOTIFIED OF THE PROTOCOL CHANGES. THE PATIENT INDICATED THAT SHE UNDERWENT AN ELECTIVE CARDIAC SURGICAL PROCEDURE THAT CONSISTED OF CORONARY ARTERY BYPASS GRAFTING. THE EVENT DESCRIPTION INDICATED THAT THE PATIENT CONTINUES WITH ANGINAL SYMPTOMS DURING FOLLOW-UP APPOINTMENTS. BASED ON THE ANGIOGRAPHY FINDINGS MADE AT THE INDEX PROCEDURE, IT WAS DECIDED THAT THIS PATIENT REQUIRED (CABG) CORONARY ARTERY BYPASS GRAFTING SURGERY DUE TO LACK OF IMPROVEMENT SINCE STENT INSERTION. THE EVENT WAS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. ADDITIONALLY, THE CABG WAS PERFORMED IN FOUR NON-TARGET SITE VESSELS WITHOUT ANY COMPLICATIONS. HOWEVER, THE EVENT WAS CONSIDERED A SERIOUS ADVERSE EVENT WITH HOSPITALIZATION REQUIRED. THE MEDICATION AFTER THE SURGERY CONSISTED OF ASPIRIN THAT HAS NEVER BEEN STOPPED, ACE INHIBITORS, STATINS, BETA-BLOCKERS, BUT HAS STOPPED TAKEN CLOPIDOGREL. AN ECG WAS NOT PERFORMED. THE EVENT RESOLVED WITHOUT SEQUEL.

    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 13208459

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 6FRENCH UNKNWON BRAND GUIDING CATHETER