BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2010372 · Received March 8, 2011

    Report

    Report Number
    3003742446-2011-00124
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    December 24, 2009
    Report Date
    February 8, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CYPRESS STUDY DATABASE STATES THAT DURING THE STAGED PROCEDURE ON (B)(6) 2010 FOR TREATMENT OF THE DISTAL RCA, THE PATIENT SUFFERED A PERI-PROCEDURAL MYOCARDIAL INFARCTION (MI). THE EVENT WAS CAUSED BY A TRANSIENT OCCLUSION OF THE RIGHT AV GROOVE AT THE BIFURCATION SITE INTO THE POSTERIOR DESCENDING ARTERY (PDA) WHICH WAS COVERED BY THE DISTAL CYPHER (CXS23350/ LOT 15031284) STENT. THE SIDE BRANCH WAS RESCUED WITH BALLOON ANGIOPLASTY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. (B)(4). PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT OF AN MI, WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2011-00122, 3003742446-2011-00123, 3003742446-2011-00124, 3003742446-2011-00125, AND 3003742446-2011-00126.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS MDR REPORT IS BEING SENT AS A CORRECTION IS BEING MADE TO THE FILE. THE EVENT OF MYOCARDIAL INFARCTION AND SIDE BRANCH OCCLUSION OCCURRED ON (B)(6) 2009 NOT (B)(6) 2010 AS ORIGINALLY REPORTED. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00122, 3003742446-2011-00123, 3003742446-2011-00124, 3003742446-2011-00125, AND 3003742446-2011-00126.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE (B)(4) STUDY DATABASE STATES THAT A SIDE BRANCH OCCLUSION OCCURRED POST IMPLANTATION OF A CYPHER STENT AND A PERI-PROCEDURAL MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED AS EVIDENCED BY ELEVATED CARDIAC ENZYMES. THE PATIENT IS A (B)(6) WOMAN WITH A HISTORY OF MI, PREVIOUS PCI IN THE TARGET VESSEL WITH PLACEMENT OF A STENT, DYSLIPIDEMIA, HYPERTENSION, CHF WITH LVEF LESS THAN 30%, AND SMOKING, WHO PRESENTED WITH A 80% STENOSIS IN THE DISTAL LAD, A 95% STENOSIS IN THE 1ST OBTUSE MARGINAL (OM1), A 70% LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) (LESION LENGTH 20 MM), A 70% LESION IN THE MID RCA (LESION LENGTH GREATER THAN 30 MM), AND A 80% STENOSIS IN THE DISTAL RCA (BIFURCATING LESION, LENGTH 25 MM BY VISUAL ESTIMATE). THE PATIENT UNDERWENT THE INDEX PROCEDURE AND TREATMENT OF TWO TARGET LESIONS. A STAGED PROCEDURE WAS PLANNED. THE FIRST TARGET LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) WAS TREATED WITH PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS23350/ LOT 15045472) STENT. THE SITE REPORTED A 0% FINAL RESIDUAL TARGET LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE SECOND TARGET LESION IN THE 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS13225/ LOT 15053568) STENT. THE SITE REPORTED A 0% FINAL RESIDUAL TARGET LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. DUE TO EXCESSIVE DYE, THE STAGED PROCEDURE WITH TREATMENT OF THREE TARGET LESIONS IN THE RCA WAS PLANNED. TWO DAYS POST INDEX PROCEDURE, A STAGED PROCEDURE WAS PERFORMED WITH THE PLACEMENT IF THREE CYPHER STENTS. PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS23350/ LOT 15031284) STENT WAS PERFORMED IN THE DISTAL RCA. TRANSIENT OCCLUSION OF THE RIGHT AV GROOVE AT THE BIFURCATION SITE INTO THE PDA OCCURRED. THE SIDE BRANCH WAS RESCUED WITH BALLOON ANGIOPLASTY AND THE EVENT RESOLVED. BALLOON ANGIOPLASTY WAS PERFORMED IN THE MID RCA WITH SUBSEQUENT PLACEMENT OF ONE CYPHER (CXS33350/ LOT 15049639) STENT, OVERLAPPING THE INITIAL STENT TO FULLY COVER THE LESION. THIS WAS FOLLOWED BY POST-STENT BALLOON ANGIOPLASTY. THE THIRD LESION IN THE PROXIMAL RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS28300/ LOT 15031274) STENT OVERLAPPING THE NEXT INITIAL STENT TO FULLY COVER THE LESION. THE SITE REPORTED A 0% FINAL RESIDUAL TARGET LESION STENOSIS WITH NO DISSECTION IN ALL THREE LESIONS WITH FINAL TIMI 3 FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTIPLATELET THERAPY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE IFU STATES THAT PLACEMENT OF A STENT HAS THE POTENTIAL TO COMPROMISE SIDE BRANCH PATENCY. THIS IS AN INHERENT RISK OF THE PROCEDURE. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ARE AT RISK TO CAUSE A SIDE BRANCH OCCLUSION. COMMON TECHNIQUES TO PREVENT OCCLUSIONS DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. THE ELEVATED ENZYMES EXPERIENCED BY THE PATIENT POST PROCEDURE ARE LIKELY TO BE RELATED TO THE SIDE BRANCH OCCLUSION LEADING TO THE MYOCARDIAL INFARCTION DIAGNOSIS. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE PATIENT, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00122, 3003742446-2011-00123, 3003742446-2011-00124, 3003742446-2011-00125, AND 3003742446-2011-00126.

    Additional Manufacturer Narrative · 1

    TWO DAYS POST INDEX PROCEDURE, A STAGED PROCEDURE WAS PERFORMED WITH THE PLACEMENT IF THREE CYPHER STENTS. PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS23350/ LOT 15031284) STENT WAS PERFORMED IN THE DISTAL RCA. BALLOON ANGIOPLASTY WAS PERFORMED IN THE MID RCA WITH SUBSEQUENT PLACEMENT OF ONE CYPHER (CXS33350/ LOT 15049639) STENT, OVERLAPPING THE INITIAL STENT TO FULLY COVER THE LESION. THIS WAS FOLLOWED BY POST-STENT BALLOON ANGIOPLASTY. THE THIRD LESION IN THE PROXIMAL RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS28300/ LOT 15031274) STENT OVERLAPPING THE NEXT INITIAL STENT TO FULLY COVER THE LESION. THE SITE REPORTED A 0% FINAL RESIDUAL TARGET LESION STENOSIS WITH NO DISSECTION IN ALL THREE LESIONS WITH FINAL TIMI 3 FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTIPLATELET THERAPY. CARDIAC ENZYMES COLLECTED THREE DAYS POST INDEX PROCEDURE INDICATED THAT THE CKMB WAS THREE TIMES ELEVATED ABOVE THE UPPER NORMAL LIMIT (UNL), AND THE TROPONIN WAS OVER 2.0. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FIVE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00122, 3003742446-2011-00123, 3003742446-2011-00124, 3003742446-2011-00125, AND 3003742446-2011-00126.

    Description of Event or Problem · 1

    THE (B)(4) DATABASE INDICATED THAT THE CARDIAC ENZYMES (CKMB 10.8 - UNL 2.4) REPORTED ON (B)(6) 2009 (INDEX WAS CONDUCTED ON (B)(6) 2009) WERE 3 TIMES ELEVATED, AND THE TROPONIN (3.52 - UNL 0.399) WAS OVER 2.0. THE PATIENT IS A (B)(6) WOMAN WITH A HISTORY OF MI, MOST RECENT IN (B)(6) 1998, ONE PCI IN (B)(6) 1998 IN THE TARGET VESSEL WITH PLACEMENT OF A STENT, DYSLIPIDEMIA, HYPERTENSION, CHF WITH LVEF LESS THAN 30%, AND SMOKING, WHO PRESENTED WITH A 80% STENOSIS IN THE DISTAL LAD, A 95% STENOSIS IN THE 1ST OBTUSE MARGINAL (OM1), A 70% LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) (LESION LENGTH 20 MM), A 70% LESION IN THE MID RCA (LESION LENGTH GREATER THAN 30 MM), AND A 80% STENOSIS IN THE DISTAL RCA (BIFURCATING LESION, LENGTH 25 MM BY VISUAL ESTIMATE). NO ANGINA WAS REPORTED. ON (B)(6) 2009, THE PATIENT UNDERWENT THE INDEX PROCEDURE TREATMENT OF TWO TARGET LESIONS. THE FIRST TARGET LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) WAS TREATED WITH PRE-STENT BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS23350/ LOT 15045472) STENT. THE SITE REPORTED A 0% FINAL RESIDUAL TARGET LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE SECOND TARGET LESION IN THE 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF ONE CYPHER (CXS13225/ LOT 15053568) STENT. THE SITE REPORTED A 0% FINAL RESIDUAL TARGET LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. DUE TO EXCESSIVE DYE, THE STAGED PROCEDURE WITH TREATMENT OF THREE TARGET LESIONS IN THE RCA WAS PLANNED.

    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 15031284

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L