BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2063404 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02744
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. NEUROLOGICAL EVENTS MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE, NEUROLOGICAL EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. INFORMATION AVAILABLE IN THE CASE DESCRIPTION IS NOT SUFFICIENT TO DETERMINE A RELATIONSHIP BETWEEN THE EVENT AND THE ABBOTT VASCULAR PRODUCT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    NEUROLOGICAL EVENT, BRADYCARDIA, STROKE, WEAKNESS AND PAIN (HEAD) MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTIONS FOR USE ARE KNOWN OBSERVED AND POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BRADYCARDIA AND HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE AND AS LISTED IN THE INSTRUCTION FOR USE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THE PRODUCT. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, UPDATED INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT HAD A VASOVAGAL RESPONSE OF BRADYCARDIA WITH BRIEF ASYSTOLE DURING THE PROCEDURAL POST-DILATATION ((B)(6) 2011) WHICH LASTED A FEW SECONDS AND RESOLVED WITH COUGHING AND BALLOON DEFLATION. HYPOTENSION OCCURRED DURING THE PROCEDURE, TREATED WITH MEDICATIONS. THE PATIENT HAD RIGHT SIDE WEAKNESS AND NUMBNESS AND WORD FINDING PROBLEM WHICH LASTED GREATER THAN 24 HOURS, HOWEVER, IT WAS NOT DIAGNOSED AS STROKE. THERE WAS NO MEDICATION PRESCRIBED FOR THIS EVENT. CLINIC VISIT ON (B)(6) 2011 NOTED 2 EPISODES OF CHEST PAIN OVER THE LAST WEEK THAT WERE REFRACTORY TO SUBLINGUAL NITROGLYCERINE; THE PATIENT FELT BETTER AFTER VOMITING ONCE. THE PHYSICIAN SUSPECTED THAT THE SYMPTOMS WERE DUE TO GASTROINTESTINAL ETIOLOGY BUT HAD FURTHER TESTING ORDERED. ON (B)(6) 2011, THE PATIENT STATED HE HAS NOT FELT WELL SINCE HIS PROCEDURE AND COMPLAINED OF HEADACHES AND LEFT SIDED SINUS PAIN, UNCHANGED SINCE BEFORE THE PROCEDURE, AND NUMBNESS IN THE FIRST THREE DIGITS OF THE RIGHT HAND AND DIFFICULTY WRITING. BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED SEVERE CHRONIC SMALL-VESSEL ISCHEMIC CHANGES NOTED THROUGHOUT THE CEREBRAL WHITE MATTER, OLD DEEP WHITE MATTER INFARCTION ON THE RIGHT WITH INFERIOR EXTENSION INTO THE LATERAL RIGHT BASAL GANGLIA, SUSPECTED 6-MM SUBACUTE LACUNAR-TYPE INFARCTION IN THE LEFT FRONTOPARIICTAL REGION, AND NO EVIDENCE OF A MAJOR TERRITORY INFARCTION, HEMORRHAGE OR MASS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION RECEIVED INDICATES THIS NEUROLOGIC EVENT WAS A MINOR, IPSILATERAL, ISCHEMIC STROKE. ADDITIONALLY THERE IS NO INDICATION THE PATIENT EXPERIENCED HYPOTENSION TREATED WITH MEDICATION DURING THIS PROCEDURE AS REPORTED ON THE PREVIOUS MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT POST UNEVENTFUL STENTING PROCEDURE OF THE LEFT INTERNAL CAROTID ARTERY ON (B)(6) 2011, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT OF RIGHT SIDED NUMBNESS. THERE WAS NO REPORTED TREATMENT AND THE PATIENT WAS DISCHARGED (B)(6) 2011. THE PATIENT CONDITION WAS REPORTED AS CONTINUING IMPROVEMENT. 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 9040251

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S EMBOLIC PROTECTION: RX ACCUNETOTHER: HEPARIN