BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2141697 · Received June 27, 2011

    Report

    Report Number
    3003742446-2011-00338
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 3, 2010
    Report Date
    May 4, 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

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR REPORT #S 3003742446-2011-00338 AND 00339.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY ADJUDICATIONS MINUTES INDICATED THAT A PATIENT EXPERIENCED A PERI-PROCEDURAL MI AND CHEST PAIN AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, AN UNKNOWN ALLERGY AND BORDERLINE DYSLIPIDEMIA. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). OF NOTE AN 80% STENOSIS WAS ALSO NOTED IN THE PROXIMAL CIRCUMFLEX AND A 90% LESION IN THE FIRST OBTUSE MARGINAL. THE LAD WAS DESCRIBED AS DE NOVO, HEAVILY CALCIFIED, COMPLEX AND 80% STENOSED. THE LESION WAS DIRECT STENTED WITH A 3.5MM X 33MM CYPHER STENT AT 12 ATMS, THIS WAS FOLLOWED BY THE IMPLANT OF A 3.5MM X 23MM CYPHER STENT AT 16ATMS, PROXIMAL AND OVERLAPPING THE FIRST ONE. BOTH STENTS WERE POST-DILATED FOR OPTIMAL EXPANSION AND THE REPORTED RESIDUAL STENOSIS WAS 0%. FOLLOWING THE PROCEDURE THE TROPONIN WENT FROM .18 ON THE (B)(6) AT 2202, TO .91 ON (B)(6) AM 0456 WITH COMPLAINTS OF C/P, SO THAT'S WHEN THEY DID THE PROX CIRC. THE UNL WAS 0.01. THIS WAS ADJUDICATED TO BE A PERI-PROCEDURAL MI RELATED TO THE DEVICE AND THE PROCEDURE. THE PATIENT ALSO CONTINUED TO EXPERIENCE CHEST PAIN, SO A STAGED PROCEDURE WAS PERFORMED THE FOLLOWING DAY TO TREAT THE PROXIMAL CIRCUMFLEX WITH THE IMPLANT OF A BARE METAL STENT. THE PATIENT ALSO EXPERIENCED CHEST PAIN THREE DAYS AFTER THE STAGED PROCEDURE THAT WAS MEDICALLY MANAGED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS 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. CHEST PAIN IS ALSO ASSOCIATED WITH THE IMPLANT OF STENTS, THE PROGRESSION OF DISEASE AND RESIDUAL DISEASE LEFT UNTREATED. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE INHERENT RISK AND/OR UNTREATED DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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

    THIS (B)(6) MALE PATIENT UNDERWENT SUCCESSFUL STENTING OF THE MID AND PROXIMAL LAD WITH 2 OVERLAPPING CYPHER STENTS ON (B)(6) 2010. NO PROCEDURAL DIFFICULTIES WERE NOTED. AT THE TIME OF INDEX PROCEDURE, THE PROXIMAL CIRCUMFLEX WAS NOTED TO BE 80% OCCLUDED, BUT THE PHYSICIAN FELT THE LAD WAS THE PRIMARY LESION ON THAT DAY. IT WAS NOTED THAT THE PATIENT CONTINUED TO HAVE CHEST PAIN AND POSITIVE TROPONINS AFTER THE INDEX PROCEDURE. THEREFORE, REVASCULARIZATION OF THE PROXIMAL CIRCUMFLEX WAS PERFORMED THE FOLLOWING MORNING AS PART OF A STAGED PROCEDURE. AN UNKNOWN DES WAS IMPLANTED IN THE PROXIMAL CIRC. THE PATIENT'S CHEST PAIN RESOLVED AFTER THE PROXIMAL CIRCUMFLEX WAS TREATED. THE CEC MINUTES OF (B)(4) WERE RECEIVED ON (B)(4) AND REVIEWED, ADJUDICATION STATUS-FINAL REPORT. THE COMMITTEE AGREES WITH ARC (PERI-PROCEDURAL PCI) ON (B)(6) 2010 FOLLOWING THE INDEX PROCEDURE WHERE TWO STUDY STENTS WERE IMPLANTED IN OVERLAPPING FASHION. THIS EVENT HAS BEEN CAPTURED AS AN MI ON BOTH INDEX STENTS.

    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 15109105

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR