BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1933523 · Received December 20, 2010

    Report

    Report Number
    2024168-2010-02839
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THE 2.50X28 MM PROMUS STENT WAS USED IN A 45 MM LENGTH VESSEL. IT SHOULD BE NOTED THE IFU STATES: THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 3.75MM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS, CARDIAC ARREST, CEREBROVASCULAR ACCIDENT/STROKE, AND ADDITIONAL NON-SURGICAL TREATMENT ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU) AND NO FAULT RISK ASSESSMENT MATRIX. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. BALLOON CATHETER: LACROSSE, SAPPHIRE, SAPPHIRE NC, TAZUNA. GUIDE WIRE: RUNTHROUGH, ADVANCE. GUIDING CATHETER: ACCESS. OTHER: ATLANTIS SR PRO2.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY. THE CUSTOMER REPORTED THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT WAS IMPLANTED ON (B)(6), 2010 AND SUBACUTE THROMBOSIS (SAT) OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PRIMARY DISEASE WAS ACUTE MYOCARDICAL INFARCTION. AFTER THE GUIDE WIRE CROSSED, BALLOON ANGIOPLASTY WAS PERFORMED AT THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. SINCE IT WAS A SMALL VESSEL, IT WAS DECIDED TO USE DRUG ELUTING STENTS. THE PROMUS AND XIENCE V STENTS WERE DEPLOYED IN THE DISTAL LAD AND POST DILATATION WAS PERFORMED IN BOTH STENTS. THE PROCEDURE WAS COMPLETED AFTER INTRAVASCULAR ULTRASOUND WAS PERFORMED. HOWEVER, AFTER STENT IMPLANTATION, SUBACUTE THROMBOSIS (SAT) OCCURRED ONLY IN THE PROMUS STENT WHICH WAS TREATED WITH ASPIRATION AND BALLOON ANGIOPLASTY. AFTER THE PATIENT HAD CARDIAC ARREST, CARDIAC COMPRESSION WAS PERFORMED WITH INTUBATION. THEN THE PATIENT HAD CEREBROVASCULAR DAMAGE BUT IS ALIVE. PRE-PROCEDURE TIMI FLOW WAS 0; HOWEVER, POST TIMI FLOW WAS 3. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0072441

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S