BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1930416 · Received December 16, 2010

    Report

    Report Number
    3004742046-2010-00609
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 23, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. CONCOMITANT MEDICAL PRODUCTS: EMBOLIC PROTECTION: RX ACCUNET (1011649-55 LOT # 0022551); DILATATION CATHETER: 6 X 20 VIATRAC; OTHER: HEPARIN; VESSEL CLOSURE: 8-FRENCH ANGIO-SEAL LEFT GROIN; PERCLOSE DEVICE X 2 RIGHT GROIN (LOT 920436H, 920126H). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE RX ACCUNET (1011649-55, LOT 0022551) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY REMOVING A FILTER AND RECOVERY CATHETER INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION WITH THE ANATOMY/LESION OR PREVIOUSLY DEPLOYED STENTS, DAMAGE TO THE WIRE/FILTER/RECOVERY CATHETER, OR IF THE FILTER IS NOT FULLY CAPTURED IN THE RECOVERY CATHETER. IT IS LIKELY THAT INTERACTION WITH THE IMPLANTED ACCULINK STENT CONTRIBUTED TO THE REPORTED DIFFICULTIES TO REMOVE AND SUBSEQUENTLY RESULTED IN THE DETACHMENT OF THE FILTER BASKET. IT SHOULD BE NOTED THAT OCCLUSION, HYPOTENSION, CEREBROVASCULAR ACCIDENT (STROKE), EMBOLISM, HEMORRHAGE, ISCHEMIA AND SEIZURES ARE LISTED IN THE ACCUNET INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. THE REPORTED DETACHMENT OF THE FILTER BASKET, DIFFICULTY TO REMOVE AND INTERACTION WITH THE STENT AND FILTER BASKET APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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. AS PART OF MANUFACTURING QUALITY PROCESS, ALL CATHETERS ARE INSPECTED DURING THE FINAL INSPECTION TO ENSURE THE PRODUCT STRUCTURE AND INTEGRITY. IN ADDITION, SAMPLES FROM EACH LOT ARE VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT AFTER POST DILATATION OF THE ACCULINK STENT IN THE LEFT INTERNAL CAROTID ARTERY USING A VIATRAC BALLOON, THE PATIENT EXPERIENCED VERY SLUGGISH FLOW IN THE CAROTID ARTERY AND HAD AN EMBOLIC STROKE IN THE LEFT MAIN CEREBRAL ARTERY WITH RIGHT SIDED HEMIPARESIS AND APHASIA. THE PATIENT ALSO HAD JERKING MOVEMENTS ON THE LEFT SIDE THAT REQUIRED INTUBATION AND SEDATION AND INTRAVENOUS PROPHYLACTIC SEIZURE MEDICATION. DURING REMOVAL OF THE ACCUNET, THE ACCUNET FILTER BASKET COULD ONLY BE PARTIALLY COLLAPSED WITH THE RECOVERY CATHETER AND WHILE RETRIEVING, THE FILTER CAUGHT ON THE EDGE OF THE ACCULINK STENT AND THE ACCUNET FILTER BASKET SHEARED OFF OF THE GUIDE WIRE. THE ACCUNET ALSO PULLED DOWN THE ACCULINK STENT. BOTH THE ACCUNET AND THE ACCULINK WERE REMOVED FROM THE COMMON CAROTID ARTERY WITH A SNARE DEVICE. ANOTHER ACCUNET WAS INSERTED AND A SECOND ACCULINK WAS IMPLANTED. THE PATIENT WAS THEN FOUND TO HAVE GOOD ANGIOGRAPHIC RESULT WITH NORMAL FLOW IN THE CAROTID ARTERY. THE PATIENT WAS STARTED ON PLAVIX. THE CT SCAN TEN DAYS POST PROCEDURE INDICATED THAT THE PATIENT'S INITIALLY EMBOLIC INFARCT PROGRESSED TO A HEMORRHAGIC STROKE WITH RIGHT SIDED HEMIPARESIS AND APHASIA. WHILE THE PATIENT DOES REMAIN HOSPITALIZED, HIS CONDITION HAS IMPROVED. 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-VS 0060761

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R