BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1944337 · Received January 3, 2011

    Report

    Report Number
    3003742446-2011-00007
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    April 27, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE (B)(4) STUDY INDICATED THAT CORONARY ARTERY OCCLUSION AND DISSECTION OCCURRED DURING THE INDEX PROCEDURE. THE FOLLOWING DAY, THE PATIENT WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION. THE PATIENT WAS A (B)(6) OLD MALE DIAGNOSED WITH THREE-VESSEL DISEASE NOT AMENABLE TO CORONARY BYPASS GRAFTING. THERE WERE 3 TARGET LESIONS TREATED DURING THIS PROCEDURE: BIFURCATION OF THE DISTAL CIRCUMFLEX WITH THE 1ST OBTUSE MARGINAL (OM) AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE DISTAL CIRCUMFLEX WAS 2.5MM IN DIAMETER AND 10MM LONG. LESION CLASSIFICATION WAS B2. THE LESION WAS DE NOVO AND THROMBUS-CONTAINING. PRE-PROCEDURE STENOSIS WAS 99%. THE 1ST OBTUSE MARGINAL (OM) WAS 2.8MM IN DIAMETER AND 15MM LONG. LESION CLASSIFICATION WAS B1. THE LESION WAS DE NOVO AND THROMBUS CONTAINING. PRE-PROCEDURE STENOSIS WAS 95%. THE LESIONS WERE PRE-DILATED WITH A 2.5 X 20MM FIRESTAR BALLOON AT 11ATM BEFORE THE IMPLANTATION OF A 2.5X13MM CYPHER AT 14ATM IN THE DISTAL CIRCUMFLEX. THE OBTUSE MARGINAL BRANCH WAS OVERLAPPING THE ORIGIN OF THE DISTAL CIRCUMFLEX. A 2.75X23MM CYPHER WAS IMPLANTED IN THE OM BRANCH. THE CATH LAB REPORT INDICATED THAT AFTER DEPLOYMENT OF THE STENT IN THE OM BRANCH, THERE WAS ABRUPT CLOSURE OF THE DISTAL CIRCUMFLEX. SEVERAL WIRES WERE USED TO TRY TO RE-CROSS. THE PATIENT WAS HAVING SOME CHEST PAIN DURING OCCLUSION OF THE ORIFICE OF THE DISTAL CIRCUMFLEX. FINALLY, A PILOT WIRE WAS ABLE TO CROSS IN THE STENT STRUTS AND ORIGIN OF THE DISTAL CIRCUMFLEX AND POST-DILATION WAS SUCCESSFUL CONDUCTED WITH A 2.5MM BALLOON. THE GUIDEWIRE WAS THEN REDIRECTED INTO THE LAD. THE PROXIMAL LAD WAS 3MM IN DIAMETER AND LESION LENGTH WAS 25MM. LESION CLASSIFICATION WAS B1 AND THE LESION WAS DE NOVO. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 2.5 X 20MM FIRESTAR BALLOON AT 14ATM. BEFORE A 3.0X28MM CYPHER WAS DEPLOYED AT THE LESION AT 16ATM. POST STENT DEPLOYMENT, A DISTAL DISSECTION WAS NOTED. A 2.75X13MM CYPHER WAS DEPLOYED TO TREAT THE DISSECTION AND WAS OVERLAPPING WITH THE 1ST STENT. THE FOLLOWING DAY THE PATIENT HAD ELEVATED CARDIAC ENZYMES AND WAS DIAGNOSED WITH MYOCARDIAL INFARCTION. THE ELEVATED ENZYMES WERE RELATED BY THE STUDY CONTACT TO THE ABRUPT CLOSURE OF THE CIRCUMFLEX POST-STENT DEPLOYMENT IN THE OM. THE EVENT WAS MEDICALLY MANAGED ONLY AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. 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. THE IFU STATES THAT PLACEMENT OF A STENT HAS THE POTENTIAL TO COMPROMISE SIDE BRANCH PATENCY. THIS IS AN INHERENT RISK OF THE PROCEDURE. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ARE AT RISK TO CAUSE A SIDE BRANCH OCCLUSION. COMMON TECHNIQUES TO PREVENT OCCLUSIONS DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ASPIRIN, CHONDROITIN, FISH OIL, LOPRESSOR, NIACIN, NITROGLYCERIN, PRASUGREL, PRILOSEC, PRINIVIL, PROVENTIL, THROMBIN. THIS IS ONE OF 4 PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00005, 3003742446-2011-00006, AND 3003742446-2011-00008. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT WAS A (B)(6) MALE. THERE WERE 3 TARGET LESIONS (DIST CX, 1ST OB MARG, AND PROX LAD). THE DISTAL CX WAS 2.5MM IN DIAMETER AND 10MM LONG. LESION CLASSIFICATION WAS B2. THE LESION AS DE NOVO AND THROMBUS-CONTAINING. PRE-PROCEDURE STENOSIS WAS 99%. THE LESION WAS PRE-DILATED WITH A 2.5 X 20MM FIRESTAR BALLOON AT 11ATM. A CXS13250 WAS DEPLOYED AT 14ATM. THE STENT WAS POST-DILATED, BECAUSE OF THE BIFURCATION, WITH A 2.5 X 20MM BALLOON AT 18ATM. AN ABRUPT CLOSURE OCCURRED. POST-PROCEDURE STENOSIS WAS 20%. THE 1ST OBTUSE MARGINAL (OM) WAS 2.8MM IN DIAMETER AND 15MM LONG. LESION CLASSIFICATION WAS B1. THE LESION WAS DE NOVO AND THROMBUS CONTAINING. PRE-PROCEDURE STENOSIS WAS 95%. THE LESION WAS PRE-DILATED WITH A FIRESTAR 2.5 X 20MM BALLOON AT 10ATM. A CXS23275 WAS DEPLOYED AT 12ATM. A SIDE BRANCH OCCLUSION OCCURRED. POST-PROCEDURE STENOSIS WAS 0%. THE PROXIMAL LAD WAS 3MM IN DIAMETER AND LESION LENGTH WAS 25MM. LESION CLASSIFICATION WAS B1 AND THE LESION WAS DE NOVO. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS PRE-DILATED WITH A 2.5 X 20MM FIRESTAR BALLOON AT 14ATM. A CXS28300 WAS DEPLOYED AT THE LESION AT 16ATM. POST STENT DEPLOYMENT A DISTAL DISSECTION WAS NOTED. A CXS13275 WAS DEPLOYED TO TREAT THE DISSECTION AND WAS OVERLAPPING WITH THE 1ST STENT. POST-PROCEDURE STENOSIS WAS 0%. POST-PROCEDURE THE PATIENT HAD A RIGHT GROIN HEMATOMA (PSEUDOANEURYSM). IT WAS MEDICALLY MANAGED AND RESOLVED WITHOUT SEQUELAE. THE FOLLOWING DAY THE PATIENT HAD ELEVATED CARDIAC ENZYMES(DIAGNOSIS - MI) RELATED TO THE ABRUPT CLOSURE OF THE CIRCUMFLEX POST-STENT DEPLOYMENT. THE EVENT WAS MEDICALLY MANAGED ONLY. PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    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 58 YR Life Threatening FIRESTAR BALLOON 2.5 X 20MM