BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2933698 · Received January 29, 2013

    Report

    Report Number
    2024168-2013-00465
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLOPIDOGREL, ASPIRIN. EMBOLIC PROTECTION: RX ACCUNET. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF EMBOLISM AND INFECTION ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 6-8 X 40 MM ACCULINK STENT IN THE MILDLY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS RE-HOSPITALIZED WITH SEPTIC EMBOLI TO THE RIGHT LOWER EXTREMITY, CAUSING CELLULITIS WITH AN ABSCESS. MEDICATIONS WERE PROVIDED, INCLUDING ANTIBIOTICS. ON (B)(6) 2012, DRAINAGE AND DEBRIDEMENT OF THE ABSCESS WAS PERFORMED TO THE RIGHT GROIN, THIGH AND CALF. ON (B)(6) 2013, THE PATIENT UNDERWENT PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER AND THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2013 WITH OUTPATIENT INTRAVENOUS (IV) ANTIBIOTIC THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED ON (B)(6) 2013, ADDITIONAL INFORMATION INDICATES THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39130 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2100561

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R CONCOMITANT MEDICAL DEVICES.