BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1923765 · Received December 14, 2010

    Report

    Report Number
    3003742446-2010-00453
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    April 27, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: BETA BLOCKERS, BIVALIRUDIN, CALCIUM CHANNEL BLOCKERS, CLOPIDOGREL, GLYBURIDE, HMG; DEVICES: VOYAGER BALLOON. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00450, 3003742446-2010-00451, AND 3003742446-2010-00452. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION POST DEPLOYMENT OF SEVERAL CYPHER STENTS . PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDES OBESITY, ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION, HYPERLIPIDEMIA, DIABETES, RENAL INSUFFICIENCY, RENAL FAILURE (PATIENT ON DIALYSIS), ALLERGY TO LIPITOR, AND HISTORY OF KIDNEY CANCER. FOUR LESIONS WERE TREATED DURING THE INDEX PROCEDURE. ALL THE LESIONS WERE HEAVILY CALCIFIED AND DE NOVO. THE 1ST TARGET LESION WAS THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL DIAMETER WAS 2.25MM AND THE LESION LENGTH WAS 12MM. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 2 X 12MM VOYAGER BALLOON AT 15ATM. A CXS(B)(4) WAS DEPLOYED AT 16ATM. THE 2ND TARGET LESION WAS THE MID LAD. VESSEL DIAMETER WAS 3.0MM AND LESION LENGTH WAS 20MM. PRE-PROCEDURE STENOSIS WAS 70%. A CXS(B)(4) WAS DEPLOYED AT 16ATM. THE 3RD TARGET LESION WAS THE PROXIMAL LAD. VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 10MM. PRE-PROCEDURE STENOSIS WAS 80%. A CXS(B)(4) WAS DEPLOYED AT 16ATM, OVERLAPPING THE PREVIOUS STENT. THE STENT WAS POST-DILATED WITH A DURASTAR BALLOON BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-PROCEDURE STENOSIS WAS 0%. THE 4TH TARGET LESION WAS THE DISTAL CIRCUMFLEX. THE LESION WAS HEAVILY CALCIFIED AND DENOVO. PRE-PROCEDURE STENOSIS WAS 80%. A CXS(B)(6) WAS DEPLOYED AT 16ATM. PRE-PROCEDURE CARDIAC ENZYMES MEASURED AS FOLLOWS: CK WAS 166 (NL 232, RATIO <1) WITH A CKMB OF 2.3 (NL 3.6, RATIO <1) AND A TROPONIN I OF 0.04 (NL 0.07, RATIO <1). POST-PROCEDURE, THE CK WAS 160 (RATIO <1) WITH A CKMB OF 6.6 (RATIO 1.833) AND A TROPONIN I OF 1.22 (RATIO 17.43). CARDIAC ENZYMES THE FOLLOWING DAY WERE AS FOLLOWS: CK WAS 166 (RATIO <1) WITH A CKMB OF 9.4 (RATIO 2.6) AND THE TROPONIN I WAS NOT TESTED. THE ECG CORE LAB REPORTED NO NEW ST-T ABNORMALITIES AND NO NEW Q WAVES AND THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. THE CEC ADJUDICATION MINUTES AGREE WITH A PERI-PROCEDURAL MYOCARDIAL INFARCTION AND IT IS THEREFORE REPORTED. THE PATIENT RETURNED THE NEXT DAY AFTER DISCHARGE WITH A NON ST-ELEVATED MYOCARDIAL INFARCTION. THE PATIENT WAS TREATED WITH STENT IN THE RCA. THERE WAS NO RESTENOSIS OR THROMBOSIS IN THE INDEX PROCEDURE STENTS. THE EVENT WAS NOTED AS NOT RELATED TO THE INDEX PROCEDURE OR THE CYPHER STENTS IMPLANTED DURING THE INDEX PROCEDURE. 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 THAT MAY LEAD TO A DIAGNOSIS OF MYOCARDIAL INFARCTION. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ALMOST INEVITABLY CAUSES PLAQUE REDISTRIBUTION IN THE SIDE BRANCHES. COMMON TECHNIQUES TO PREVENT PLAQUE SHIFTING DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. INFLATION OF BALLOONS OVER THE RECOMMENDED RATED BURST PRESSURE MAY ALSO LEAD TO EXCESSIVE INTIMAL DAMAGE AND HIGHER POTENTIAL FOR PLAQUE SHIFTING. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE VESSEL FACTORS (MULTIPLE LESIONS TREATED AND RCA LESION LEFT UNTREATED) AND INHERENT RISK OF PROCEDURE FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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.

    Description of Event or Problem · 1

    THE REPORT IS FROM (B)(4) STUDY. ALL THE LESIONS WERE HEAVILY CALCIFIED AND DE NOVO. THE 1ST TARGET LESION WAS THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL DIAMETER WAS 2.25MM AND THE LESION LENGTH WAS 12MM. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 2 X 12MM VOYAGER BALLOON AT 15ATM. A CXS13225 WAS DEPLOYED AT 16ATM. THE 2ND TARGET LESION WAS THE MID LAD. VESSEL DIAMETER WAS 3.0MM AND LESION LENGTH WAS 20MM. PRE-PROCEDURE STENOSIS WAS 70%. A CXS23300 WAS DEPLOYED AT 16ATM. THE 3RD TARGET LESION WAS THE PROX LAD. VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 10MM. PRE-PROCEDURE STENOSIS WAS 80%. A CXS13350 WAS DEPLOYED AT 16ATM, OVERLAPPING THE PREVIOUS STENT. THE STENT WAS POST-DILATED WITH A DURASTAR BALLOON BECAUSE THE STENT WAS NOT FULLY EXPANDED. POST-PROCEDURE STENOSIS WAS 0%. THE 4TH TARGET LESION AS THE DISTAL CIRCUMFLEX. VESSEL DIAMETER WAS 2.5 X 10MM BALLOON. THE LESION AS HEAVILY CALCIFIED AND DENOVO. PRE-PROCEDURE STENOSIS WAS 80%. A CXS13250 WAS DEPLOYED AT 16ATM. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ADDITIONAL INFORMATION RECEIVED 11/17/2010: REVIEW OF THE ADJUDICATION MINUTES REVEAL THAT THE (B)(4) ADJUDICATES A MYOCARDIAL INFARCTION OCCURRING ON THE DAY OF THE INDEX PROCEDURE ((B)(6) 2010) BASED ON INCREASED CARDIAC ENZYMES.

    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 15115514

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R MEDICATIONS: ASPIRIN