BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1961154 · Received January 14, 2011

    Report

    Report Number
    3003742446-2011-00032
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THE STUDY COORDINATOR CONFIRMED THE PATIENT DID NOT HAVE A HISTORY OF PREVIOUS REVASCULARIZATION AND THAT THE PATIENT DID NOT HAVE ANY PRIOR STENTS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) STUDY, A DISSECTION OCCURRED AFTER IMPLANTATION OF THE CYPHER RX STENT. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND RAMUS. THE LESION IN THE PROXIMAL RCA WAS DESCRIBED AS DE NOVO, TYPE A, NON-THROMBOSED, 99% STENOSED, 4MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. THE RATED BURST PRESSURE (RBP) INDICATED IN THE INSTRUCTIONS FOR USE (IFU) IS 16 ATMOSPHERES. EXCEEDING THE RBP CAN RESULT IN DAMAGE TO VESSEL INTIMA. THE PRECAUTIONS FOR USE IN THE IFU STATE THAT BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION AND THAT EXCEEDING THE RECOMMENDED RATED BURST PRESSURE (RBP) AS INDICATED ON THE PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. PRE AND POST-DILATION WERE NOT PERFORMED. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. A TYPE A DISSECTION OCCURRED AFTER CYPHER RX STENT IMPLANTATION. THE DISSECTION WAS NOT FLOW-LIMITING. TO TREAT THE DISSECTION, A 3.5X13MM CYPHER RX STENT WAS INSERTED BUT COULD NOT BE DELIVERED DUE TO RESISTANCE WITH THE NON-CORDIS GUIDE WIRE (BMW, GUIDANT). THEREFORE, A DIFFERENT 3.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED TO TREAT THE DISSECTION. THE PATIENT DID NOT EXPERIENCE ANY CHEST PAIN. POST-DILATION WAS NOT PERFORMED. THE TARGET LESION IN THE RAMUS WAS DESCRIBED AS DE NOVO, TYPE A, 4MM IN LENGTH, 80% STENOSED, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. POST-DILATION WAS NOT PERFORMED. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PERCUTANEOUS CORONARY INTERVENTIONS (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 ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. THE IFU ALSO WARNS THAT THE BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. USE OF PRESSURES HIGHER THAN SPECIFIED ON PRODUCT LABEL MAY RESULT IN RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (99% STENOSED) AND PROCEDURAL FACTORS (NO PRE-DILATION PERFORMED, STENT DEPLOYMENT OVER RATED BURST PRESSURE) THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, A DISSECTION OCCURRED AFTER IMPLANTATION OF THE CYPHER RX STENT. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND RAMUS. THE LESION IN THE PROXIMAL RCA WAS DESCRIBED AS DE NOVO, TYPE A, NON-THROMBOSED, 99% STENOSED, 4MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. PRE AND POST-DILATION WERE NOT PERFORMED. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. A DISSECTION OCCURRED AFTER CYPHER RX STENT IMPLANTATION. A 3.5X13MM CYPHER RX STENT COULD NOT BE DEPLOYED TO TREAT THE DISSECTION DUE TO RESISTANCE WITH THE BMW GUIDING CATHETER. THEREFORE, A DIFFERENT 3.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED TO TREAT THE DISSECTION. POST-DILATION WAS NOT PERFORMED. THE TARGET LESION IN THE RAMUS WAS DESCRIBED AS DE NOVO, TYPE A, 4MM IN LENGTH, 80% STENOSED, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. POST-DILATION WAS NOT PERFORMED. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING STENT IMPLANTATION. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THE STUDY COORDINATOR CONFIRMED THE DISSECTION WAS NOT FLOW LIMITING. THE DISSECTION WAS GRADE A. THE PATIENT DID NOT EXPERIENCE ANY CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15267027

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BMW GUIDEWIRE