BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1973136 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00527
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    May 16, 2008
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. RESTENOSIS IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DIL CATH: 5.5 X 20 AND 4.5 X 20 VIATRAC. EMBOLIC PROTECTION: RX ACCUNET (1011334-75, LOT # 7041251); (1011334-75, LOT # 8032051). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE STENT REMAINS INSIDE THE PATIENT. HYPOTENSION AND OCCLUSION ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE DEPLOYMENT OF THE RX ACCUNET, DISTAL TO THE TARGET LESION IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED HYPOTENSION. THE PATIENT WAS STARTED ON A NEOSYNEPHRINE INFUSION FOR ONE DAY AND THE PATIENT'S CONDITION RESOLVED 3 DAYS LATER. AFTER THE 7 X 30 RX ACCULINK STENT WAS IMPLANTED IN THE TARGET LESION, ANGIOGRAPHY SHOWED SOME DISTAL NARROWING DUE TO A NEW LESION DISTAL TO THE STENT. THE 6 X 30 RX ACCULINK WAS IMPLANTED OVERLAPPING THE 7 X 30 RX ACCULINK AND SUCCESSFULLY OPENED UP THE NEW TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ON (B)(6) 2011, AN ANGIOGRAM FOUND A 50% IN-STENT RESTENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY THAT WAS TREATED WITH BALLOON ANGIOPLASTY. A NEW LESION WAS FOUND DISTAL TO THE IN-STENT RESTENOSIS THAT WAS TREATED WITH A SECOND ACCULINK STENT. THE IN-STENT RESTENOSIS WAS REDUCED TO 10%. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 8042351

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R STENT: 6-8X30 RX ACCULINK ((B)(4))