BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3022141 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01744
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    December 31, 2011
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: STRYKER SL-10, TRANSCEND-14 MICROGUIDE WIRE. GUIDE CATH: 8 FR. SHEATH: 8 FR. DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT, THERAPY DATES, ESTIMATED BASED ON DATE OF PUBLICATION. (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF OCCLUSION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. ADDITIONALLY, IT WAS REPORTED THE ACCULINK WAS USED FOR TREATMENT IN THE CERVICAL CAROTID ARTERY. IT SHOULD BE NOTED THE IFU STATES: THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ABBOTT VASCULAR EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH AND STANDARD RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION. ARTICLE ATTACHED: STENT-ASSISTED ENDOVASCULAR RECANALIZATION OF EXTRACRANIAL INTERNAL CAROTID ARTERY OCCLUSION IN ACUTE ISCHEMIC STROKE.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS NOTED DURING LITERATURE REVIEW: IT WAS REPORTED THAT A RETROSPECTIVE ANALYSIS WAS PERFORMED OF 17 PATIENTS [10 MALES, 7 FEMALES, MEAN AGE OF 62] WHO PRESENTED WITH ACUTE SYMPTOMATIC CAROTID OCCLUSIONS IN THE SETTING OF ACUTE ISCHEMIC STROKE BETWEEN 2006 AND 2011. BALLOON ANGIOPLASTY [VIATRAC BALLOON N=7] AND CAROTID STENTING [ACCULINK N=11] WERE PERFORMED TO REESTABLISH FLOW IN THE CERVICAL CAROTID ARTERY. ADDITIONAL INTRACEREBRAL CIRCULATION ANGIOGRAPHY WAS REPEATED AND A VESSEL OCCLUSION WAS SEEN IN THE INTRACRANIAL CIRCULATION IN 11 OF THE 17 PATIENTS (65%). MECHANICAL THROMBOLYSIS WAS UNDERTAKEN; IF MECHANICAL THROMBOLYSIS WAS UNSUCCESSFUL AND ICTUS WAS WITHIN 8 HOURS, PHARMACOLOGIC THROMBOLYSIS WAS PERFORMED WITH INTRA-ARTERIAL TPA (4 PATIENTS), UROKINASE (1 PATIENT), OR IIB/IIIA RECEPTOR ANTAGONIST, ABCIXIMAB (5 PATIENTS); ADDITIONAL INTRACRANIAL STENTING FOR TANDEM MIDDLE CEREBRAL ARTERY (MCA) OCCLUSIONS WAS PERFORMED IN 2 PATIENTS WITH NON-ABBOTT STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123562 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention