BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1071574 · Received July 7, 2008

    Report

    Report Number
    9616099-2008-01680
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    November 7, 2007
    Report Date
    June 13, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT RECEIVED FROM THE STUDY INDICATED THAT A PATIENT EXPERIENCED A TYPE B DISSECTION WHILE HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR PRIOR PCI TO THE TARGET VESSEL BUT NOT THE LESION, HYPERTENSION, HYPERLIPIDEMIA, PRIOR TOBACCO ABUSE, DIABETES, MYOCARDIAL INFARCTION AND PERIPHERAL VASCULAR DISEASE. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET VESSEL WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) BIFURCATING WITH THE FIRST DIAGONAL (DX). THE LAD LESION WAS DESCRIBED AS DE NOVO, GREATER THAN 45 DEGREES OF ANGULATION, 70% STENOSED AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED WITH A 2.5MM X 20MM BALLOON AT 12 ATMS, FOLLOWED BY THE DEPLOYMENT OF A 3.0MM X 33MM CYPHER SELECT (CS) STENT AT 12 ATMS. THE STENT WAS POST-DILATED WITH KISSING BALLOON TECHNIQUE WITH A 3.0MM X 15MM BALLOON AT 12 ATMS. A TYPE B DISSECTION OCCURRED IN THE LEFT MAIN ARTERY (LM) WHEN WITHDRAWING THE STENT DELIVERY SYSTEM BALLOON. THE SITE INDICATES THAT IT WAS CAUSED BY THE "DEEP INTUBATION" OF THE GUIDE CATHETER IN THE VESSEL. THE SITE ALSO INDICATED THERE WAS SOME DIFFICULTY WITHDRAWING THE BALLOON DUE TO THE HEAVY CALCIFICATION. THE LM DISSECTION WAS DIRECT STENTED WITHIN A 3.5MM X 33MM CS STENT AT 16 ATMS FOLLOWED BY POST-DILATION WITH A 4.0MM X 10MM BALLOON AT 20 ATMS. THE EVENT RESOLVED WITHOUT FURTHER SEQUEL. THE 1ST DX WAS A 90% STENOSED, DE NOVO AND OSTIAL LESION AT THE BIFURCATION WITH THE LAD. THE LESION WAS PRE-DILATED WITH A 2.5MM X 20MM BALLOON AT 10 ATMS FOLLOWED BY THE DEPLOYMENT OF A 2.3MM X 33MM CS STENT AT 10 ATMS. THE STENT WAS NOT POST-DILATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DISSECTIONS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THE IFU CAUTIONS THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION. THE ACT OF CORONARY STENTING IN A BIFURCATION IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ASIDE FROM THE INHERENT RISK OF THE PROCEDURE THAT, VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS IS AN INITIAL AND FINAL REPORT. NOTIFICATION WAS RECEIVED FROM THE REGISTRY INDICATING THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD A TYPE B DISSECTION IN THE LEFT MAIN CORONARY ARTERY AND WAS STENTED WITH ANOTHER CYPHER STENT WITHOUT ANY CONSEQUENCE. THE DISSECTION WAS CAUSED BY DEEP INTUBATION OF A MEDTRONIC EBU GUIDE CATHETER DURING WITHDRAWAL OF THE 1ST STENT'S BALLOON. THERE WERE NO ECG CHANGES OR CHEST PAIN. THE VESSEL WAS HEAVILY CALCIFIED AND ALTHOUGH PASSING THE STENT WAS NOT VERY DIFFICULT, BALLOON REMOVAL WAS DIFFICULT AS SOMETIMES HAPPENS IN VERY CALCIFIED VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT - NIQ NIQ CORDIS DE MEXICO NA 13240726

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 6F GUIDING CATHETER| 4.0X10MM BALLOON CATHETER| 3.0X15MM BALLOON CATHETER| 2.5X20 BALLOON CATHETER