BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2132636 · Received June 17, 2011

    Report

    Report Number
    3003742446-2011-00310
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    March 2, 2010
    Report Date
    May 23, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED AN MI DURING THE INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING DYSLIPIDEMIA AND HYPERTENSION. THE INDICATION FOR THE INDEX PROCEDURE WAS ANGINA. ANGIOGRAPHY REVEALED AN 80% LESION IN THE PROXIMAL LAD, GREATER THAN 30MM IN LENGTH. IN (B)(6) 2010 THE INDEX PROCEDURE WAS DONE FOR THE PROXIMAL LAD LESION. PRE-DILATION, STENT IMPLANTATION X 2 (ONE STUDY STENT AND ONE NON-STUDY STENT) AND POST-DILATION WERE PERFORMED. IVUS WAS USED TO CONFIRM STENT APPOSITION AND VESSEL DIAMETER. ONE STUDY STENT WAS UNABLE TO BE DELIVERED TO THE TARGET LESION AND A NON-CORDIS STENT WAS SUCCESSFULLY IMPLANTED. CORE LAB REPORTED PLACEMENT OF TWO STENTS WITH A 28% RESIDUAL IN-LESION STENOSIS, NO DISSECTION AND TIMI 3 FLOW. PER THE CORE LAB A PRE-PROCEDURE 20% STENOSIS OF A SIDE BRANCH HAD CHANGED TO 99% POST-PROCEDURE. POST PROCEDURE, THE CARDIAC ENZYMES WERE ELEVATED AND AN MI WAS DETERMINED. THE PATIENT WAS; HOWEVER, DISCHARGED THE FOLLOWING DAY ON DUAL ANTI-PLATELET THERAPY. REPEAT ANGIOGRAPHY, IN (B)(6) 2010, REVEALED THE STUDY STENT TO BE PATENT; HOWEVER, THE DISTAL LAD HAD A FOCAL 70-80% LESION. CARDIAC ENZYMES WERE NEGATIVE AT THIS TIME. THE PHYSICIAN NOTED THAT ANGIO-SPASM MAY HAVE CONTRIBUTED TO THE EVENT. THE CORE LAB REPORTED A 31% IN-LESION STENOSIS WITH TIMI 3 FLOW, AND NOTED REMOTE TVR OF MID LAD, STUDY STENT PATENT. ONE STENT WAS IMPLANTED TO TREAT THE MID LAD LESION AND DUAL ANTI-PLATELET THERAPY WAS CONTINUED. IN (B)(6) 2010, THE PATIENT WAS ADMITTED WITH ANGINA, THE CARDIAC ENZYMES WERE NEGATIVE AT THIS TIME. ANGIOGRAPHY REVEALED A 70-80% STENOSIS BETWEEN THE TWO STENTS IN THE MID PORTION OF THE LAD. THE CORE LAB REPORTED A 31% IN-LESION STENOSIS WITH NO THROMBUS AND TIMI 3 FLOW, NOTING REMOTE TARGET VESSEL REVASCULARIZATION. "STUDY STENTS PATENT. REMOTE TVR OF SEGMENT DISTAL TO STUDY STENTS. NEW STENT DEPLOYED OVERLAPPING DISTAL STUDY STENT". DUAL ANTI-PLATELET THERAPY WAS CONTINUED. 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. REVIEW OF LOT 15090701 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THROMBOTIC OR RESTENOSIS EVENTS WHEREIN THE INNER LUMEN OF THE CORONARY ARTERY BECOMES NARROWED AND BLOOD FLOW DECREASED. THE MYOCARDIAL TISSUES ARE STARVED OF OXYGEN AND OTHER NUTRIENTS SECONDARY TO THE DECREASED OR STOPPED BLOOD FLOW AND IT CAUSES PERMANENT CARDIAC DAMAGE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00310 AND 3003742446-2011-00326.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00310 AND 3003742446-2011-00326. SINCE THE STUDY COORDINATOR CONFIRMED THE 2.5X18MM CYPHER STENT WAS PATENT FOUR MONTHS AND NINE MONTHS AFTER THE INDEX PROCURE, THE CODE RESTENOSIS WILL BE REMOVED FROM (B)(4) (MDR REPORT 3003742446-2011-00310). THE CODE RESTENOSIS WILL BE UNREPORTED. INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED ELEVATED ENZYMES AFTER THE INDEX PROCEDURE AND RESTENOSIS OF A NON-STUDY CYPHER STENT AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, HYPERLIPIDEMIA, HYPERTENSION, AND A SULFA ALLERGY. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS DESCRIBED A DE NOVO, 40MM IN LENGTH, MODERATELY CALCIFIED AND 80% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.5MM X 28MM XIENCE STENT. THE STENT DID NOT FULLY COVER THE LESION SO A 2.50MM X 18MM CYPHER STENT WAS THEN IMPLANTED ABUTTING AND PROXIMAL TO THE XIENCE STENT. BOTH STENTS WERE POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. POST PROCEDURE, THE PATIENT EXPERIENCED ELEVATED ENZYMES TWICE THE UNL. ACCORDING TO THE REPORTER THE ELEVATED CARDIAC ENZYMES WERE NOT CLINICALLY SIGNIFICANT. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION. IT WAS REPORTED THAT THE PATIENT HAD AN EXTREMELY LONG LAD DISEASE AND FOR THIS RECEIVED A LONG XIENCE STENT AND CYPHER STENT. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PROBABLE CAUSE FOR ELEVATED CARDIAC ENZYMES WAS DUE TO THE PROCEDURE ITSELF. APPROXIMATELY FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA, ANGIOGRAPHY WAS PERFORMED AND REVEALED A NEW LESION IN THE DISTAL LAD. THE LESION WAS IN A BEND AND WAS DIFFICULT TO FIND, REQUIRING SEVERAL VIEWS. THE LESION WAS ALSO TREATED WITH NITROGLYCERIN WHICH DID NOT HELP THE APPEARANCE, REQUIRING INTERVENTION. THE EVENT WAS TREATED WITH THE IMPLANT OF A 2.5MM X 13MM CYPHER STENT AT 11 ATMS, THE STENT WAS POST-DILATED WITH FINAL EXCELLENT ANGIOGRAPHIC RESULTS. APPROXIMATELY NINE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT AGAIN EXPERIENCED ANGINA, ANGIOGRAPHY WAS PERFORMED AND REVEALED RESTENOSIS IN THE 2.5MM X 13MM CYPHER STENT IMPLANTED FOUR MONTHS POST-INDEX PROCEDURE. THE STUDY COORDINATOR CONFIRMED THAT THE STUDY STENT WAS PATENT AT THE FOUR AND NINE MONTH ANGIOGRAMS AND THAT THE RESTENOSIS WAS WITHIN THE STENT IMPLANTED AT FOUR MONTHS. (B)(4): 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. 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. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND THE LESION BEING IN A BEND. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    CEC ADJUDICATION MINUTES RECEIVED ON NOVEMBER 29, 2011 WERE REVIEWED. THE COMMITTEE AGREES WITH THE CODING OF ARC (PERI-PROCEDURAL PCI), FOR (B)(6) 2010. THE EVENT FOR THE ARC WAS PREVIOUSLY CAPTURED AND AN ELEVATED ENZYME EVENT. HOWEVER, BASED ON THE NEW INFORMATION THAT WAS RECEIVED, THE EVENT WILL NOW BE CAPTURED AS A MYOCARDIAL INFARCTION. THIS CHANGE IS FOR CATALOG NUMBER CWS18250 (LOT NUMBER 15090701) WAS THIS WAS THE ONLY STENT IMPLANTED AT THE TIME OF THE EVENT. (B)(4). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00310 AND 3003742446-2011-00326. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS COMPLIANT WITH ANTI-PLATELET THERAPY. THE CURRENT STATUS OF THE PATIENT WAS ALIVE AND WELL. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED STATING THE ELEVATED CARDIAC ENZYMES WERE NOT CLINICALLY SIGNIFICANT. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION. IT WAS REPORTED THAT THE PATIENT HAD AN EXTREMELY LONG LAD DISEASE AND FOR THIS RECEIVED A LONG XIENCE STENT AND CYPHER STENT. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PROBABLE CAUSE FOR ELEVATED CARDIAC ENZYMES WAS DUE TO THE PROCEDURE ITSELF.

    Description of Event or Problem · 1

    THE STUDY COORDINATOR CONFIRMED THAT THE 2.5X18MM CYPHER STENT IMPLANTED DURING THE INDEX PROCEDURE WAS PATENT FOUR MONTHS AND NINE MONTHS AFTER THE INDEX PROCEDURE. SHE STATED THAT THERE WAS RESTENOSIS OF THE 2.5X13MM CYPHER STENT IMPLANTED FOUR MONTHS AFTER THE INDEX PROCEDURE. SHE CONFIRMED THAT THE RESTENOSIS OCCURRED NINE MONTHS AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT UNDERWENT REVASCULARIZATION OF THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY APPROXIMATELY FOUR MONTHS AND NINE MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LAD. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE LESION WAS DESCRIBED AS DE NOVO, TYPE B2, 40MM IN LENGTH, 80% STENOSED, NON-THROMBOSED, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 2.50MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON CATHETER AND A 2.5X28MM XIENCE STENT WAS IMPLANTED AT 10ATMS. POST-DILATION WAS DONE AND A 2.50X18MM CYPHER CWS STENT WAS IMPLANTED ABUTTING THE XIENCE STENT AT 11ATMS. POST-DILATION WAS DONE WITH AN UNKNOWN BALLOON CATHETER AT 12ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. TEN HOURS POST-PROCEDURE, THE PATIENT'S LABS WERE THE FOLLOWING: CK = 281 (ULN 174), CK-MB = 20.1 (ULN 5.0), AND TROPONIN I = 3.43 (ULN 0.15). EIGHTEEN HOURS AFTER THE INDEX PROCEDURE, THE LABS WERE CK = 277, CK-MB = 19.8, AND TROPONIN I = 3.61. CARDIAC CATHETERIZATION REPORT FROM THE INDEX PROCEDURE CONFIRMED IMPLANTATION OF A XIENCE STENT AND CYPHER CWS STENT IN THE PROXIMAL LAD. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED STENT APPOSITION AND VESSEL DIAMETER. FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND A CARDIAC CATHETERIZATION REVEALED 70-80% STENOSIS OF THE MID TO DISTAL PORTION OF THE LAD. CORONARY SPASM WAS NOT EXCLUDED AS A COMPONENT OF THIS SYNDROME. A 2.5X13MM CYPHER STENT WAS IMPLANTED AT 11ATMS. THE CYPHER STENT AND XIENCE STENT IMPLANTED IN THE PROXIMAL LAD WAS PATENT. NINE MONTHS AFTER THE INDEX PROCEDURE, CARDIAC CATHETERIZATION REVEALED TWO AREAS OF DISCREET NARROWING OF ABOUT 75-80% BETWEEN THE XIENCE AND CYPHER STENTS IN THE MID PORTION OF THE LAD. A 2.25X23MM CYPHER STENT WAS IMPLANTED. POST-DILATION WAS DONE AND RESIDUAL STENOSIS WAS 0%.

    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 15090701

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R