BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2141672 · Received June 27, 2011

    Report

    Report Number
    3003742446-2011-00336
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 4, 2010
    Report Date
    May 16, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR. REPORT #S 3003742446-2011-00335, 00336 AND 00337.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY AND THE CEC MINUTES INDICATE THAT A PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE AN EJECTION FRACTION OF 30-39% AND REMOTE HISTORY OF SMOKING. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. THE INDEX TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS 40MM IN LENGTH, HEAVILY CALCIFIED, DE NOVO AND 90% STENOSED. THE LESION WAS DIRECT STENTED WITH A 2.5MM X 23MM CYPHER STENT AT 16ATMS. THAT WAS FOLLOWED BY THE IMPLANT OF A 2.75MM X 23MM CYPHER STENT AT 14 ATMS, OVERLAPPING AND DISTAL TO THE FIRST STENT. THE STENTS WERE NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY THE PATIENT UNDERWENT A STAGED PROCEDURE TO TREAT THE PROXIMAL CIRCUMFLEX (CFX) AND THE FIRST AND SECOND OBTUSE MARGINALS (OM). THE PROXIMAL CFX WAS DESCRIBED AS DE NOVO AND 90% STENOSED. THE LESION WAS DIRECT STENTED WITH A 3.5MM X 13MM CYPHER STENT AT 18ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE CHARACTERISTICS OF THE OM1 WERE NOT PROVIDED, BUT THE LESION WAS TREATED WITH A 3.0MM X 18MM CYPHER STENT AT 10ATMS. THE STENT WAS NOT POST-DILATED. THE OM2 WAS DESCRIBED AS DE NOVO AND 80% STENOSED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 2.75MM X 13MM CYPHER STENT AT 6ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. THE CARDIAC ENZYMES 16-24 HOURS AFTER THE STAGED PROCEDURE WERE ELEVATED. THE CEC ADJUDICATED THIS AS AN MI RELATED TO DEVICE AND PROCEDURE. THE ENZYMES WERE NOT ELEVATED AFTER THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE STAGED PROCEDURE. 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. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PLANNED STAGED PROCEDURE, THE FIRST PART ON (B)(6) 2010, AND THE 2ND PART ON (B)(6) 2010. 2 CYPHER STENTS WERE IMPLANTED IN THE MID LAD ON (B)(6) 2010, AND 3 MORE CYPHER STENTS WERE IMPLANTED ON (B)(6) 2010: ONE EACH IN THE PROXIMAL CX, 1ST OM, AND 2ND OM. ALL 5 STENTS WERE IMPLANTED WITHOUT DIFFICULTY. THE EVENING OF (B)(6) 2010, THE PATIENT'S CARDIAC ENZYMES WERE FOUND TO BE HIGH. ON THE (B)(6) THEY HAD RISEN EVEN MORE. HOWEVER, THE PATIENT NEVER HAD CHEST PAIN AND WAS ASYMPTOMATIC. NO INTERVENTION OR TREATMENT WAS PERFORMED, AND THE PATIENT WAS DISCHARGED (B)(6) 2010. AS PER THE PHYSICIAN, THE PATIENT DID NOT HAVE AN MI, OR ANY OTHER ADVERSE EVENT, ONLY ELEVATED ENZYMES. THE (B)(6) WERE RECEIVED ON (B)(6) AND REVIEWED, ADJUDICATION STATUS-FINAL REPORT. THE COMMITTEE DISAGREES WITH STENT THROMBOSIS, WHICH IS CONSISTENT WITH THE FACT THAT IT HAS NOT BEEN REPORTED. THE COMMITTEE DOES AGREE WITH PROTOCOL DEFINED NON-Q-WAVE MI, RELATED TO DEVICE AND PROCEDURE, AND ARC PERI-PROCEDURAL PCI RELATED TO DEVICE AND PROCEDURE (WHICH IS DEFINED AS A PERI-PROCEDURAL MI) DURING THE STAGED PROCEDURE.

    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 15120307

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR