BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1662758 · Received April 20, 2010

    Report

    Report Number
    3003742446-2010-00114
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    January 29, 2010
    Report Date
    March 24, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION CODES HAVE BEEN INCLUDED.

    Additional Manufacturer Narrative · 1

    UPDATED TO INCLUDE LAB RESULTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00114 AND 3003742446-2010-00115.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00114 AND 3003742446-2010-00115. A PATIENT FROM THE (B)(6) EXPERIENCED A MYOCARDIAL INFARCTION DUE TO STENT THROMBOSIS APPROXIMATELY FOUR DAYS AFTER IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, HYPERTENSION, TYPE 1 DIABETES MELLITUS, SMOKING, PULMONARY FIBROSIS, INTERSTITIAL PNEUMONITIS, GASTROESOPHAGEAL REFLUX DISEASE, HYPOXIA, ARTHRITIS, AND DEPRESSION. DURING THE INDEX PROCEDURE TWO LESIONS WERE TREATED: THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE MID RIGHT CORONARY ARTERY (RCA). THE PROXIMAL LAD LESION WAS DESCRIBED AS 95% STENOSED, 24MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED AND A 2.5X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED. THE CYPHER RX STENT WAS POST-DILATED AT 18ATMS. PRE AND POST PROCEDURE TIMI FLOW WAS 3. RESIDUAL STENOSIS WAS 0%. THERE WAS NO THROMBUS NOTED PRE AND POST PROCEDURE. THE MID RCA LESION WAS DESCRIBED AS 95% STENOSED, DE NOVO, 10MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED AND A 3.0X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED. THE CYPHER RX STENT WAS POST-DILATED AT 24ATMS. PRE AND POST PROCEDURE TIMI FLOW WAS 3. RESIDUAL STENOSIS WAS 0%. MEDICATIONS USED DURING THE PROCEDURE INCLUDED INTEGRILLIN AND HEPARIN. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED PLAVIX AND TICLOPIDINE. FOUR DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH A NON-Q WAVE MYOCARDIAL INFARCTION. THERE WAS ALSO EVIDENCE OF A STENT THROMBUS. THERE WAS NO POSSIBILITY OF A DISSECTION. THE RCA HAD A PROMINENT THROMBUS WITHIN THE MID RCA. THE LAD HAD RESIDUAL THROMBUS FORMATION IN THE DISTAL PORTION OF THE STENT. THROMBUS ASPIRATION WAS CONDUCTED AND THE RCA WAS THEN DILATED WITH A HIGH-PRESSURE BALLOON, SHOWING EXCELLENT RESULTS. LOVENOX WAS ADMINISTERED AND LATER SUBSTITUTED FOR COUMADIN. PLAVIX RESPONSE TEST PERFORMED AND SHOWED A GOOD RESPONSE TO PLAVIX, HOWEVER IT WAS DECIDED TO DISCONTINUE PLAVIX AND SWITCH TO EFFIENT 10MG DAILY. 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. THROMBOTIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. THROMBUS FORMATION DECREASES THE AMOUNT OF BLOOD FLOW TO THE CARDIAC MUSCLE INDUCING AN MYOCARDIAL INFARCTION (MI). REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES WERE UNKNOWN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00114 AND 3003742446-2010-00115. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RESULTS FOR A SINGLE PATIENT SAMPLE OBTAINED FROM A VITROS 5,1 FS CHEMISTRY SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT. THE INCORRECT PATIENT NAME WAS IDENTIFIED BY THE CUSTOMER, SO NO ERRONEOUS RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE (B) (4) STUDY, APPROXIMATELY FOUR DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH A NON-Q WAVE MYOCARDIAL INFARCTION (MI). THERE WAS ALSO EVIDENCE OF STENT THROMBOSIS. THE TARGET LESIONS WERE LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE MID RIGHT CORONARY ARTERY (RCA). THE PROXIMAL LAD LESION WAS DESCRIBED AS 95% STENOSED, 24MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED AND A 2.5X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED. THE CYPHER RX STENT WAS POST-DILATED AT 18ATMS. PRE AND POST PROCEDURE TIMI FLOW WAS 3. RESIDUAL STENOSIS WAS 0%. THERE WAS NO THROMBUS NOTED PRE AND POST PROCEDURE. THE MID RCA LESION WAS DESCRIBED AS 95% STENOSED, DE NOVO, 10MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED AND A 3.0X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED. THE CYPHER RX STENT WAS POST-DILATED AT 24ATMS. PRE AND POST PROCEDURE TIMI FLOW WAS 3. RESIDUAL STENOSIS WAS 0%. THERE WAS NO THROMBUS NOTED PRE AND POST PROCEDURE. FOUR DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH A NON-Q WAVE MYOCARDIAL INFARCTION. THERE WAS ALSO EVIDENCE OF A STENT THROMBUS. THERE WAS NO POSSIBILITY OF A DISSECTION. THE THROMBUS WAS LOCATED IN THE MID RCA AND THERE WAS RESIDUAL THROMBUS FORMATION IN THE LAD. TREATMENT FOR THE THROMBUS INCLUDED A THROMBECTOMY WITH THROMBOLYTIC THERAPY. REPEAT ANGIOGRAM CONFIRMED THAT BOTH THE STENTS WERE PATENT. ACCORDING TO THE INVESTIGATOR, THE EVENTS WERE RELATED TO CORDIS PRODUCT.

    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) 15047847

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R