BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1902296 · Received November 11, 2010

    Report

    Report Number
    3004742046-2010-00532
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    June 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. THE LOT NUMBER WAS PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT, PAIN (HEAD) AND NEUROLOGICAL DEFICIT/DYSFUNCTION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS POTENTIAL ADVERSE EFFECTS. THE THERAPY/NON-SURGICAL TREATMENT AND HOSPITALIZATION ARE A RESULT OF THE REPORTED PATIENT 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7 DAYS AFTER THE CAROTID STENTING PROCEDURE USING THE ACCUNET EMBOLIC PROTECTION DEVICE AND A NON-ABBOTT STENT IN THE RIGHT COMMON CAROTID ARTERY, THE PT HAD A LEFT SIDED STROKE WITH RIGHT HEMIPARESIS AND WAS ADMITTED TO THE HOSPITAL. THE CT SCAN SHOWED AN ACUTE INFARCT IN THE LEFT POSTERIOR CEREBRAL ARTERY. ON (B)(6) 2010, THE PT AWOKE FROM HER SLEEP WITH COUGHING, SHORTNESS OF BREATH, SLURRED SPEECH, CONFUSION, HEADACHE, LETHARGY, AND URINARY INCONTINENCE. THE PT WAS GIVEN SUBCUTANEOUS HEPARIN INJECTIONS TO PREVENT DEEP VEIN THROMBOSIS. THE PT WAS ALSO DIAGNOSED WITH DEMENTIA LIKELY SECONDARY TO ISCHEMIA. THE PT WAS TRANSFERRED TO A REHABILITATION FACILITY FOR PHYSICAL AND OCCUPATIONAL THERAPY ON (B)(6) 2010. THE PT WAS DISCHARGED FROM REHABILITATION ON (B)(6) 2010, IN GUARDED CONDITION. FOUR DAYS AFTER THE CAROTID PROCEDURE, THE PT WAS THOUGHT TO HAVE HAD A TRANSIENT NEUROLOGICAL CHANGE, BUT THE PHYSICIAN DETERMINED THAT THERE WAS NO PERMANENT CHANGE AT THAT TIME. THERE WAS NO TREATMENT PROVIDED ON (B)(6) 2010, FOR THIS TRANSIENT NEUROLOGICAL CHANGE. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9101451

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention| S GUIDE WIRE: GLIDEWIRE| STENT: PRECISE RX 8 X 30| SHEATH: 6 FRENCH SHORT SHEATH| OTHER: HEPARIN| VESSEL CLOSURE: PERCLOSE PROGLIDE 6 FRENCH| GUIDE CATH: JB1| PINNACLE 8 FRENCH 10 CM| VITEK