BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 971337 · Received December 27, 2007

    Report

    Report Number
    9616099-2007-02610
    Event Type
    Injury
    Date Received
    December 27, 2007
    Date of Event
    September 7, 2007
    Report Date
    November 30, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA WITH RESTING ECG CHANGES AND A BICYCLE/EXERCISE STRESS TEST. THE PATIENT WAS REPORTED TO HAVE THREE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE INDEX PROCEDURE. THE TARGET LESION WAS THE LEFT MAIN CORONARY ARTERY. THE LESION WAS REPORTED TO BE: PROTECTED BY AT LEAST ONE PATIENT GRAFT DISTALLY, 2.7 MM VESSEL DIAMETER, 30 MM LENGTH, A 100% OCCLUSION, RESTENOTIC AFTER AN OTHER INTERVENTION (CABG), A BIFURCATION LESION, A CHRONIC TOTAL OCCLUSION GREATER THAN THREE (3) MONTHS (CTO>3 MONTHS), SMOOTH, READILY ACCESSIBLE PROXIMAL SEGMENT, AN ANGULATION OF GREATER THAN 45 DEGREES AND <90 DEGREES (>45 DEGREES AND <90 DEGREES), CONCENTRIC, LITTLE OR NO CALCIUM, ABSENT OF THROMBUS, AND TYPE C. A 6 FR. GUIDING CATHETER WAS USED. THE LESION WAS PRE-DILATED AS PLANNED WITH A 3.0 X 30 MM BALLOON AT 8 ATM. THERE WAS NO INFO AVAILABLE REGARDING THE DEPLOYMENT PRESSURE USED TO IMPLANT THE STUDY DEVICE. THE RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE DAY AFTER THE INDEX PROCEDURE. THERE WAS NO REPORTED PROCEDURAL COMPLICATION OR DEVICE DEVIATION REPORTED. FOLLOW-UP PHONE CONTACTS WITH THE PATIENT AT THE ONE, SIX, AND ONE-YEAR PERIODS INDICATED THE PATIENT WAS ASYMPTOMATIC AND CONTINUING HIS MEDICAL REGIMEN. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. A REPORT WAS RECEIVED INDICATING THAT AN STUDY PATIENT HAD LATE THROMBOSIS OF A PREVIOUSLY IMPLANTED CYPHER SELECT PLUS 3.0 X 33MM STENT APPROX NINE MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT IS A MALE PATIENT WITH A MEDICAL HISTORY OF PREVIOUS PERCUTANEOUS CORONARY-INTERVENTION (PCI) 2006, PREVIOUS CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY - 2004, HYPERTENSION, HYPERLIPIDAEMIA AND PREVIOUS SMOKING. THE PATIENT'S MEDICAL HISTORY OF RE-PCI, PREVIOUS CABG SURGERY, AND SMOKING PUT HIM AT AN INCREASED RISK FOR ANOTHER MACE EVENT. THE PT'S MEDICAL REGIMEN PRIOR TO THE PROCEDURE WAS CLOPIDOGREL 75 MG (=<30 DAYS PRIOR TO THE PROCEDURE), AND STATINS. THE PATIENT HAD AN UNEVENTFUL STAY POST-PROCEDURE AND WAS DISCHARGED AN ASPIRIN 100 MG PERMANENTLY, CLOPIDOGREL 75 MG PERMANENTLY, STATINS, AND BETA BLOCKER THERAPY. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. MFG RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE TARGET LESION FOR THE PROCEDURE WAS REPORTED TO BE A BIFURCATION LESION REQUIRING DOUBLE-GUIDEWIRE TECHNIQUE, A CTO LESION AND TYPE C (COMPLEX). STENT IMPLANTATION IS CONTRAINDICATED IN PATIENT'S WITH LESIONS JUDGED TO PREVENT COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. ALSO, THE SAFETY AND EFFECTIVENESS OF THE CYPHER SELECT PLUS STENTS HAS NOT BEEN PROVEN IN CTO LESIONS. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADD'L RISKS NOT DESCRIBED IN THE LABELING. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE EVENT. THERE IS NO INDICATION THE EVENT IS DESIGN OR MFG RELATED. LATE THROMBOSIS IS A KNOWN COMPLICATION OF CORONARY STENTING. BASED ON THE AVAILABLE INFO, THERE ARE PATIENT AND VESSEL/LESION FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE E-SELECT REGISTRY INDICATED THAT APPROX NINE (9) MONTHS AFTER THE INDEX PROCEDURE THE PATIENT HAD A CLINICALLY DRIVEN RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) DUE TO LATE THROMBOSIS (LT) OF A PREVIOUSLY IMPLANTED CYPHER SELECT PLUS 3.0 X 33MM STENT. THE PATIENT HAD BEEN ADMITTED WITH SYMPTOMS OF CHEST PAIN AND A POSITIVE STRESS TEST. THE TARGET LESION FOR THE CYPHER SELECT PLUS 3.0 X 33MM STENT WAS THE LEFT MAIN WITH THE STENT EXTENDING DOWN DISTALLY TO THE PROXIMAL CIRCUMFLEX. THE DIAGNOSIS OF LT WAS MADE BY ANGIOGRAPHY. THE LT LESION WAS REPORTED TO BE AN 80% OCCLUSION OF THE TARGET VESSEL/NON TARGET LESION WITH TIMI 3 FLOW-PROXIMAL CIRCUMFLEX. THERE WAS NO REPORTED EVIDENCE OF MI. THE PATIENT WAS CONTINUING WITH HIS ANTIPLATELET THERAPY AS PLANNED AT DISCHARGE. THE EVENT WAS REPORTED TO BE MODERATE IN SEVERITY, A SERIOUS ADVERSE EVENT (SAE) REQUIRING IN-PATIENT HOSPITALIZATION, POSSIBLY RELATED TO THE STUDY DEVICE, AND UNRELATED TO THE STUDY PROCEDURE/OR OTHER CORDIS PRODUCT. THE LT WAS TREATED BY IMPLANTATION OF TWO (2) XIENCE DRUG-ELUTING STENTS: A 2.5 X 18MM, AND A 3.0 X 12 MM STENT. THE EVENT OUTCOME WAS REPORTED TO BE COMPLETE AND THE EVENT WAS RESOLVED WITHOUT SEQUEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0806199

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R 2.0 X 30 MM BALLOON| 6 FR GUIDING CATHETER