BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX VELOCITY W/HEPACOAT UNKNOWN

    MDR report key: 1810478 · Received August 20, 2010

    Report

    Report Number
    9616099-2010-00632
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 1, 2003
    Report Date
    August 5, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ASPIRIN, BIVALIRUDIN, CALCIUM CHANNEL BLOCKERS, CARTIA XT, CLOPIDOGREL, IMDUR, METFORMIN, MONOPRIL, NEXIUM, NITROGLYCERIN, PLAVIX, PRAVACHOL, TOPROL XL, TRICOR, ZETIA. CONCOMITANT DEVICES: TWO XIENCE STENTS. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00307, 3003742446-2010-00308, AND 9616099-2010-00632.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AT THE SAME LESION ON MULTIPLE OCCASIONS. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, PREVIOUS PERCUTANEOUS INTERVENTION, CORONARY ARTERY BYPASS GRAFT SURGERY, MYOCARDIAL INFARCTION AND DIABETES. THE PATIENT HAD A CORDIS HEPACOAT STENT IMPLANTED IN THE PROXIMAL PORTION OF THE RIGHT POSTERIOR DESCENDING ARTERY (PDA) IN 2003. APPROXIMATELY EIGHT MONTHS LATER, THE PATIENT ANOTHER CARDIAC CATHETERIZATION AND A 3.0MM X 18MM CYPHER STENT WAS IMPLANTED IN THE PDA DUE TO RESTENOSIS. APPROXIMATELY SIX YEARS LATER, THE PATIENT RECEIVED TWO XIENCE STENTS. ONE OF THE STENTS WAS PLACED IN THE RIGHT PDA AND THE OTHER IN THE MID RCA. APPROXIMATELY SEVEN YEARS AFTER THE HEPACOAT STENT WAS IMPLANTED, THE PATIENT WAS TREATED WITH A 2.50MM X 23MM CYPHER STENT DUE TO STENOSIS IN THE PROXIMAL PDA. ONE MONTH LATER 2.50MM X 18MM CYPHER WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. APPROXIMATELY THREE MONTHS LATER, THE PATIENT HAD A CYPHER STENT 2.5 X 13 PLACED IN THE PDA DUE TO ANOTHER RESTENOSIS. IT WAS NOTED THAT THE STENT PLACED IN THE LAD DURING THE INDEX PROCEDURE WAS PATENT, ALTHOUGH THE DICTATION DID STATE THAT THERE WAS MILD IN STENT RESTENOSIS IN THE PROXIMAL LAD. THE STERILE LOT NUMBERS FOR THE STENTS ARE UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THERE ARE SOME LESIONS THAT ARE RETICENT TO STENTING AND CONTINUE TO HAVE RESTENOTIC EVENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S EXTENSIVE CORONARY ARTERY DISEASE AND OTHER MEDICAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00307, 3003742446-2010-00308, AND 9616099-2010-00632.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR THE (B)(4) STUDY INDICATED THAT AFTER THE INDEX PROCEDURE THE PATIENT HAD A REVASCULARIZATION DUE TO A PREVIOUS IMPLANTED HEPACOAT STENT RESTENOSIS. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY IN (B)(6) 2010. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT RECEIVED A CORDIS HEPACOAT STENT IN THE RIGHT CORONARY ARTERY (RCA) PROXIMAL POSTERIOR DIAGONAL ARTERY (PDA) IN (B)(6) 2003. THE PATIENT RETURNED IN (B)(6) 2003, HOWEVER NO INTERVENTION WAS PERFORMED. THE HEPACOAT STENT HAD NO IN-STENT RESTENOSIS. IN (B)(6) OF 2003 THE PATIENT HAD ANOTHER CARDIAC CATH. DURING THIS PROCEDURE THE PATIENT RECEIVED A CYPHER STENT 3.0 X 18 INTO THE RCA PROX PDA. APPROXIMATELY SIX YEARS LATER THE PATIENT RECEIVED TWO XIENCE STENTS. ONE OF THE STENTS WAS PLACED IN THE RIGHT PDA AND THE OTHER IN THE MID RCA. IN (B)(6) 2010 THE PATIENT HAD A CYPHER STENT 2.50 X 23 (CXS23250 / LOT UNK) PLACED IN THE PROX PDA DUE TO STENOSIS. ON (B)(6), 2010 A (B)(4) STENT (STUDY STENT) WAS PLACED IN THE PROX LAD. THERE WAS NO STENOSIS OR MALFUNCTION WITH THIS STENT. APPROXIMATELY THREE MONTHS LATER THE PATIENT HAD A CYPHER STENT 2.5 X 13 (CXS13260 / LOT 15140117) PLACED IN THE PDA DUE TO ANOTHER RESTENOSIS. IT WAS NOTED THAT THE STENT PLACED IN THE LAD (STUDY STENT) DURING THE INDEX PROCEDURE WAS PATENT, ALTHOUGH THE DICTATION DID STATE THAT THERE WAS MILD IN STENT RESTENOSIS IN THE PROX LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX VELOCITY W/HEPACOAT UNKNOWN CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R