BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3062040 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02342
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF HYPOTENSION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT 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 AN ACCCULINK STENT WAS IMPLANTED IN A DE NOVO, HEAVILY CALCIFIED, 90% STENOSED, LEFT INTERNAL CAROTID ARTERY VIA FEMORAL ACCESS AND THE PATIENT WAS DISCHARGED HOME THE NEXT DAY, ON (B)(6) 2013. WHEN THE PATIENT WAS HOME, THAT NIGHT, ON (B)(6) 2013, THE PATIENT EXPERIENCED A NEAR SYNCOPE EPISODE (DIZZINESS USED BECAUSE THERE WAS NO LOSS OF CONSCIOUSNESS) AND FELL BACK HITTING THE BACK OF HIS HEAD. THE PATIENT DID NOT LOSE CONSCIOUSNESS. THE NEAR SYNCOPE EPISODE (DIZZINESS) WAS RELATED TO POSTURAL HYPOTENSION. REPORTEDLY, THE PATIENT WAS INSTRUCTED TO TAKE IT EASY BUT HE DID NOT DO SO. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2013 FOR OBSERVATION. THE PATIENT'S ORTHOSTATIC BLOOD PRESSURES WERE 203/82 WHILE LYING DOWN AND 89/51 WHILE STANDING. THE PATIENT'S NORMAL PROSCAR, FLOMAX, AND HYPERTENSIVE MEDICATIONS WERE NOT GIVEN. MIDORINE AND FLUDOCORTISONE ACETATE MEDICATION WERE GIVEN AS TREATMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013, BUT WILL CONTINUE TO BE FOLLOWED-UP VERY CLOSELY WITH THE PHYSICIAN. THE NEAR SYNCOPE (DIZZINESS) IS LISTED AS CONTINUING AND THIS WAS REPORTED AS A SERIOUS ADVERSE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYNCOPE RESOLVED WITHOUT AN ADVERSE PATIENT SEQUELA ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163517 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2082261

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R