BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1931393 · Received December 17, 2010

    Report

    Report Number
    3003742446-2010-00461
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    September 5, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #S 3003742446-2010-00461, 3003742446-2010-00462, AND 3003742446-2010-00463. THE (B)(6) MALE PATIENT FROM THE (B)(4) STUDY EXPERIENCED CHEST PAIN AND ELEVATED TROPONINS POST IMPLANTATION OF THREE CYPHER STENTS. THE CEC ADJUDICATION AGREED WITH A POSSIBLE STENT THROMBOSIS PER ARC GUIDELINES APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE WHEN THE PATIENT DIED. THE SITE REPORTED THAT THE CAUSE OF DEATH WAS NON-CARDIAC DUE TO SEPSIS. PAST MEDICAL HISTORY INCLUDED ANGINA (WITHIN PAST 6 WEEKS), POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA (WITHIN PAST 6 WEEKS), PREVIOUS CABG, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, AND HISTORY OF ALLERGY. THE TARGET LESIONS WERE THE LEFT MAIN AND THE PROXIMAL CIRCUMFLEX. BOTH LESIONS WERE DE NOVO AND VERY CALCIFIED. THE LESION IN THE PROXIMAL CIRCUMFLEX WAS BIFURCATED WITH A SIDE BRANCH. A 2.25 X 23MM CYPHER STENT HAD DIFFICULTY DELIVERING TO THE LESION REQUIRING SEVERAL DILATIONS AND THE BUDDY-WIRE TECHNIQUE. THE STENT WAS EVENTUALLY IMPLANTED. A 2.5 X 13MM CYPHER STENT WAS ALSO IMPLANTED IN THE PROXIMAL CIRCUMFLEX, OVERLAPPING THE PREVIOUSLY IMPLANTED STENT. THE PATIENT ALSO RECEIVED A 3.0 X 08MM CYPHER STENT IN THE LEFT MAIN. POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. POST-PROCEDURE COURSE WAS COMPLICATED BY ANGINA AND ENZYMES WERE ELEVATED ABOVE THE UPPER NORMAL LIMIT POST-PROCEDURE. A CATH LAB REPORT PERFORMED THE FOLLOWING DAY WAS RECEIVED INDICATING A LEFT HEART CATH, CORONARY ANGIOGRAPHY, LEFT VENTRICULOGRAM AND BYPASS GRAFTS INJECTIONS WERE PERFORMED. NO INTERVENTION WAS CONDUCTED. PATIENT'S POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. AN ANGIOGRAM WAS PERFORMED BUT NO INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT WAS DISCHARGED THREE DAYS LATER. THE DEATH CERTIFICATE REPORTED THAT IMMEDIATE CAUSE OF DEATH WAS ENDOCARDITIES WITH INTERVAL BETWEEN ONSET AND DEATH OF THREE DAYS. THE SITE REPORTED THAT THE CAUSE OF DEATH WAS NON-CARDIAC DUE TO SEPSIS. NO AUTOPSY WAS PERFORMED. THE CEC ADJUDICATION AGREED WITH POSSIBLE STENT THROMBOSIS (ARC). THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION CAN EXHIBIT ITSELF AS CHEST PAIN, EKG CHANGES AND CARDIAC ENZYMES INCREASE. THROMBOSIS IS KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE CEC ADJUDICATION, POSSIBLE THROMBOSIS PER ARC GUIDELINES WAS CODED. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT. THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #S 3003742446-2010-00461, 3003742446-2010-00462, & 3003742446-2010-00463.

    Description of Event or Problem · 1

    THE (B)(6) MALE PATIENT WAS PART OF (B)(4) STUDY IN ORDER TO TREAT LESIONS IN THE LEFT MAIN AND THE PROXIMAL CIRCUMFLEX. BOTH LESIONS WERE DE NOVO AND VERY CALCIFIED. THE LESION IN THE PROXIMAL CX WAS BIFURCATED WITH A SIDE BRANCH. A 2.25 X 23MM CYPHER STENT HAD DIFFICULTY DELIVERING TO THE PROXIMAL CX, REQUIRING SEVERAL DILATIONS AND THE BUDDY-WIRE TECHNIQUE. THE STENT WAS EVENTUALLY IMPLANTED. A 2.5 X 13MM CYPHER STENT WAS ALSO IMPLANTED IN THE PROXIMAL CX, OVERLAPPING THE PREVIOUSLY IMPLANTED STENT. THE PATIENT ALSO RECEIVED A 3.0 X 08MM CYPHER STENT IN THE LEFT MAIN. FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE DEATH WAS RULED AS NON-CARDIAC AND DUE TO SEPSIS. THE EVENT WAS GRADED AS UNRELATED TO BOTH THE INDEX PROCEDURE AND THE IMPLANTED CYPHER STENTS. THE (B)(4) MINUTES OF (B)(4) 2010 WERE REVIEWED. THE ADJUDICATION AGREES WITH THE INITIAL REPORT OF NON-CARDIOVASCULAR DEATH OF SEPSIS UNRELATED TO THE DEVICE AND THE DRUG. THEY ALSO DISAGREE WITH THE ARC AND PROTOCOL DEFINITION OF STENT THROMBOSIS WHICH IS CONSISTENT WITH THE FACT THAT A THROMBOTIC EVENT WAS NOT REPORTED. THE MINUTES DO INDICATE, HOWEVER THAT THE POST-PROCEDURE COURSE WAS COMPLICATED BY ANGINA AND THAT THE CARDIAC ENZYMES WERE ELEVATED ABOVE THE UPPER NORMAL LIMIT POST-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 15095729

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death ASPIRIN, CLOPIDOGREL