BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2110912 · Received June 2, 2011

    Report

    Report Number
    3003742446-2011-00280
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 16, 2013
    Report Date
    January 25, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATED THAT A PATIENT EXPERIENCED A DISSECTION AND SLIGHT ELEVATION IN TROPONIN I AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR ANGINA, PERCUTANEOUS CORONARY INTERVENTION ((B)(4) 2005), HYPERLIPIDEMIA AND HYPERTENSION. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS DE NOVO, 99% STENOSED FOR GREATER THAN 3 MONTHS WITH A TIMI FLOW OF 0 PRE-PROCEDURE. THE LESION WAS ALSO LOCATED AT A BIFURCATION. THE LESION WAS PRE-DILATED WITH A 3.0MM X 10 DURASTAR BALLOON AT 21 ATMS FOLLOWED BY THE IMPLANT OF A 2.5MM X 18MM CYPHER STENT AT 21 ATMS. THE STENT WAS THEN POST-DILATED USING THE 3.0MM X 10MM DURASTAR WITH EXCELLENT RESULTS. IT WAS NOTED THAT THE 50% LESION DISTAL IN THE FIRST DIAGONAL APPEARED TO BE MORE HAZY AND SLIGHTLY MORE SIGNIFICANT. WE USED THE SAME BALLOON TO DILATE THAT LESION AT LOW PRESSURE OF 2 AND 4 ATMOSPHERES. UNFORTUNATELY THAT RESULTED IN A SMALL LINEAR DISSECTION. CONSEQUENTLY A 2.5 X 8-MM CYPHER DRUG-ELUTING STENT WAS DEPLOYED IN THE FIRST DIAGONAL AT 14 ATMOSPHERES WITH EXCELLENT FINAL RESULT. THE PRE-PROCEDURE TROPONIN I WAS 0.09 (UL: 0.3 NG/M), AT 6-12 HOURS AFTER THE PROCEDURE THE TROPONIN I WAS 0.31, SLIGHTLY ABOVE NORMAL. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. 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. DISSECTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE IFU CAUTIONS THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION. THE ACT OF CORONARY STENTING IN A BIFURCATION IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ASIDE FROM THE INHERENT RISK OF THE PROCEDURE THAT, VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. ELEVATED CARDIAC ENZYMES ARE A COMMON RESULT OF IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE, NO ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00280 AND 9616099-2011-00429.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: METOPROLOL 50MG (START (B)(6) 2010), TRICOR 48MG ((B)(6) 2010), ASPIRIN 81MG ((B)(6) 2011) AND PLAVIX 75MG ((B)(6) 2011). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS BEING TREATED FOR A 99% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED WITH A 3.0 X 10MM DURASTAR BALLOON AT 21 ATM. A 2.5 X 18MM CYPHER STENT WAS DEPLOYED IN THE TARGET LESION AT 21 ATM WITH SUB-OPTIMAL DEPLOYMENT. IT WAS REPORTED THAT THE BALLOON USED TO DILATE THE 1ST DIAGONAL ARTERY CAUSED A TYPE A SMALL LINEAR DISSECTION AFTER THE BALLOON WAS USED ON 50% LESION IN THE DISTAL TO THE 1ST STENT. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CYPHER STENT AND PROBABLY RELATED TO THE INDEX PROCEDURE. A 2.5 X 8MM CYPHER WAS DEPLOYED SUCCESSFULLY AS TREATMENT AND WAS OVERLAPPING THE 1ST CYPHER STENT. THE STENTS WERE POST-DILATED WITH A 3.0 X 10MM BALLOON AT 21 ATM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE LESION WAS FIRST DILATED USING A 3.0 X 10-MM DURA STAR BALLOON. AFTER THAT A 2.5 X 18-MM CYPHER DRUG-ELUTING STENT WAS DEPLOYED. THE STENT WAS POST DILATED USING THE 3.0 X 10-MM DURA STAR BALLOON. THE RESULT WAS EXCELLENT. IT WAS NOTED THAT THE 50% LESION DISTAL TO THE STENT AT THAT POINT APPEARED TO BE MORE HAZY AND SLIGHTLY MORE SIGNIFICANT. THE SAME BALLOON WAS USED TO DILATE THAT LESION AT LOW PRESSURE (2 AND 4 ATMOSPHERES). UNFORTUNATELY THAT RESULTED IN A SMALL LINEAR DISSECTION. CONSEQUENTLY A 2.5 X 8 MM CYPHER DRUG-ELUTING STENT WAS DEPLOYED THERE AT 14 ATMOSPHERES WITH EXCELLENT FINAL RESULT.

    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 15272482

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention COZAAR 100MG