BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 782016 · Received November 13, 2006

    Report

    Report Number
    3003742446-2006-00691
    Event Type
    Injury
    Date Received
    November 13, 2006
    Date of Event
    October 16, 2006
    Report Date
    November 13, 2006
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEWS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THIS PATIENT PRESENTED TO CATH FOR EMERGENT TREATMENT WITH AN ACUTE MYOCARDIAL INFARCTION, RESTING ANGINA AND 1-VESSEL DISEASE WAS FOUND. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA OF 10-20MM IN LENGTH IN AN UNK VESSEL DIAMETER. THE (B2) LESION WAS CONCENTRIC. A 3.0X28MM CYPHER STENT (CATALOG AND LOT NUMBERS UNK) WAS DEPLOYED AT 20 ATM. THERE WAS 1:1 STENT TO VESSEL SIZING AND THE STENT APPEARED TO HAVE BEEN PERFECTLY DEPLOYED ANGIOGRAPHICALLY. HEALTHY TISSUE WAS COVERED BY THE STENT. RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI 0 AND III FLOWS WERE RECORDED PRE AND POST- PROCDURE, RESPECTIVELY. ACTS PRE-PROCEDURE MEASURED 170 AND 212, POST- PROCEDURE. A TOTALLY OCCLUDED, TYPE C LESION IN THE DISTAL RCA WAS ALSO TREATED WITH 2 3.0X23MM CYPHER STENT, AT 16 ATM. APPROXIMATELY 16 DAYS AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH RESTING ANGINA, RESTENOSIS AT PREVIOUS SITE OF PREVIOUS PTCA, AND NON-Q MI. STENT THROMBOSIS, TWO WEEKS POST CYPHER STENTS IMPLANTATION. PATIENT HAD RECENTLY STOPPED PLAVIX FOR A NUMBER OF DAYS. A MALE PT WITH A HISTORY HYPERTENSION, DIABETES, SMOKING, MULTIPLE PREVIOUS PCI, HYPERLIPIDEMIA AND A FAMILY HISTORY OF CAD EXPERIENCED A THROMBOTIC EVENT SIXTEEN DAYS POST CYPHER STENT IMPLANTATION. INITIALLY, THIS PT WAS ADMITTED WITH RESTING ANGINA AND UNDERWENT AN URGENT ANGIOGRAM THAT REVEALED LESIONS IN HIS DISTAL RCA AND PROXIMAL RCA. THIS PT'S HISTORY, AGGRESSIVE CAD AND URGENT PRESENTATION WITH ANGINA PUT HIM AT INCREASED RISK FOR MACE. IN ADDITION, HIS WORSENING ANGINA PUTS HIM IN A HYPERCOAGUABLE STATE AND AT INCREASED RISK FOR THROMBOTIC EVENTS SPECIFICALLY. THE PRE OR INTRA PROCEDURAL ADMINISTRATION OF ASA, PLAVIX, HEPARIN OR GPIIBIIA WAS NOT REPORTED. THE HIGHEST INTRA PROCEDURAL ACT REPORTED WAS 212. THE DISTAL RCA WAS DESCRIBED AS A CTO, TYPE-C, 10-20MM IN LENGTH, AND 100% OCCLUDED. THE SAFETY AND EFFECTIVENESSS OF THE CYPHER STENT HAS NOT BEEN ESTABLISHED IN THESE TYPES OF VESSELS AND/OR LESIONS. THE LESION WAS PRE-DILATED PRIOR TO THE PLACEMENT OF 3.00 X 28MM CYPHER STENT AT A MAXIMUM INFLATION PRESSURE OF 20ATM. ACCORDING TO THE IFU, THE RATED BURST PRESSURE OF THE CYPHER STENT SHOULD NOT BE EXCEEDED IN ORDER TO PREVENT INTIMAL DAMAGE OR VESSEL DISSECTION. THE PROXIMAL RCA LESION WAS DESCRIBED AS DE NOVO, TYPE B2, 10-20MM IN LENGTH, AND 50% OCCLUDED. THE LESION WAS NOT PRE-DILATED PRIOR TO THE PLACEMENT OF TWO 3.00 X 23MM CYPHER STENTS AT MAXIMUM INFLATION PRESSURES OF 16ATM. ACCORDING TO THE IFU, THE USE OF MORE THAN TWO CYPHER STENTS HAS NOT BEEN CLINICALLY STUDIED. THE PROCEDURE WAS COMPLETED WITH A RESULTANT TIMI FLOW OF 3 AND A RESIDUAL STENOSIS OF 0%. THE PT WAS DISCHARGED FROM THE CATH LAB ON MEDICATIONS THAT INCLUDED PLAVIX. THE POST PROCEDURAL ADMINISTRATION OF ASA WAS NOT REPORTED. SIXTEEN DAYS AFTER THE INDEX PROCEDURE, THE PT UNDERWENT A REPEAT ANGIOGRAM THAT REVEALED A THROMBUS WITHIN THE PREVIOUSLY IMPLANTED CYPHER STENTS IN THE PROXIMAL RCA. OF NOTE, THE PHYSICIAN REPORTED THAT THE PT WAS STOPPED TAKING HIS PLAVIX FOR THE LAST FEW DAYS. THIS WAS TREATED WITH ATHERECTOMY, ASPIRATION AND PTCA. THE PHYSICIAN ALSO INDICATED THAT THE PT TOLD HIM THAT HE MISSED A PLAVIX PILL. HE WAS UNCLEAR HOW MANY WERE INVOLVED. THE PRODUCTS REMAIN IMPLANTED IN THE PT AND ARE THUS NOT AVAILABLE FOR EVAL. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. THERE ARE PT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R MAVERICK (2) MONORAIL BALLOON RE CATHETER 2.50X15| SPRINTER BALLOON 2.0X20| MAVERICK OTW BALLOON CATHETER 3.0X20MM| PLAVIX