BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NESTER PLATINUM EMBOLIZATION COIL

    MDR report key: 9726618 · Received February 19, 2020

    Report

    Report Number
    1820334-2020-00401
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    December 20, 2018
    Report Date
    June 2, 2020
    Manufacturer
    COOK INC
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON FURTHER INVESTIGATION, THIS EVENT IS NOT REPORTABLE. BASED ON THE DESCRIPTION OF EVENT, FEEDBACK FROM THE FIELD, AND DISCUSSIONS WITH THE GLOBAL PRODUCT MANAGER, IT IS APPARENT THAT THE MIGRATED DEVICE WAS NOT A COOK DEVICE, BUT INSTEAD THE RUBY COIL (PENUMBRA INC, ALAMEDA, CALIFORNIA) DESCRIBED IN THE ARTICLE. NO FOLLOW UP INFORMATION WILL BE SUBMITTED FOR THIS REPORT.

    Description of Event or Problem · 0

    SEE H10.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: 4MM X 14CM NESTER COIL OR MICROCOIL. CONCOMITANT MEDICAL PRODUCTS: 2.8F X 110CM PROGEAT MICROCATHETER AND MICROWIRE (TERUMO MEDICAL CORP), FOUR ADDITIONAL 4-MM X 14-CM NESTER COILS (COOK MEDICAL), ONE 6-MM X 20-CM DETACHABLE RUBY COIL (PENUMBRA INC). PMA/510(K) #: PREAMENDMENT OR K153778. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BELOW DESCRIPTION OF A NESTER PLATINUM EMBOLIZATION COIL MIGRATION WAS TAKEN FROM THE FOLLOWING ARTICLE: CHEN ET AL., ¿ENDOVASCULAR RETRIEVAL OF A MIGRATED COIL IN THE RIGHT HEPATIC ARTERY WITH A SOLITAIRE DEVICE.¿ JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY 30.1 (2019); 30: 122-124. THE FOLLOWING IS STATED IN THE ARTICLE: "A (B)(6) YEAR-OLD WOMAN WHO HAD A SPLENECTOMY FOLLOWING TRAUMA PRESENTED WITH PERSISTENT HEMORRHAGE WITHIN THE SPLENIC BED AS WELL AS PELVIC FRACTURES AND POSSIBLE ACTIVE PELVIC HEMORRHAGE FOR ARTERIOGRAPHY AND EMBOLIZATION. ANGIOGRAPHY OF THE CELIAC AXIS DEMONSTRATED ACTIVE EXTRAVASATION ARISING FROM THE DISTAL ASPECT OF THE SPLENIC ARTERY OR POSSIBLY FROM THE PROXIMAL ASPECTS OF SHORT GASTRIC ARTERIES WITHIN THE SPLENIC BED. AFTER SELECTIVE CATHETERIZATION AND ANGIOGRAM OF THE SPLENIC ARTERY, A 2.8-F X 110-CM (MICROCATHETER AND MICROWIRE OF ANOTHER MANUFACTURER) WERE ADVANCED INTO THE MIDASPECT OF THE SPLENIC ARTERY. COIL EMBOLIZATION OF THE SPLENIC ARTERY WAS THEN PERFORMED USING FIVE 4-MM X 14-CM NESTER COILS (COOK MEDICAL, BLOOMINGTON, INDIANA) AND ONE 6-MM X 20-CM DETACHABLE (COIL FROM ANOTHER MANUFACTURER). HOWEVER, ANGIOGRAPHY PERFORMED AFTER EMBOLIZATION DEMONSTRATED RETROGRADE MIGRATION OF THE FINAL COIL INTO THE RIGHT HEPATIC ARTERIAL CIRCULATION (FIG 2). THEREFORE, A (CATHETER AND ANGLED GUIDEWIRE OF ANOTHER MANUFACTURER) WERE ADVANCED TOGETHER INTO THE PROPER HEPATIC ARTERY. THE MICROCATHETER AND MICROWIRE WERE THEN ADVANCED THROUGH THE EXISTING CATHETER DISTALLY INTO A BRANCH OF THE RIGHT HEPATIC ARTERY CONTAINING THE LARGEST PORTION OF THE EMBOLIZATION COIL OUT TO THE MOST DISTAL ASPECT OF THE COIL. A 6-MM X 30-MM STENTRIEVER DEVICE WAS ADVANCED THROUGH THE MICROCATHETER 4 MM DISTAL TO THE MIGRATED COIL AND UNSHEATHED ACROSS THE COIL. THE DEVICE WAS THEN USED TO ENSNARE AND SECURE THE COIL BY RETRIEVING THE DEVICE WIRE AND ADVANCING THE MICROCATHETER. THE DEVICE, MICROCATHETER, AND COIL WERE THEN RETRACTED AND SECURED AS A UNIT AT THE CATHETER TIP. THE COIL WAS RETRIEVED INTACT IN A SINGLE PASS WITHOUT DIFFICULTY. REPEATED ANGIOGRAPHY OF THE RIGHT HEPATIC ARTERY DEMONSTRATED NO EVIDENCE OF ARTERIAL DISSECTION OR OCCLUSION (FIG 3)." "FINAL DIGITAL SUBTRACTION ANGIOGRAM AFTER COIL RETRIEVAL DEMONSTRATES PATENCY OF THE RIGHT HEPATIC ARTERY WITHOUT EVIDENCE OF VESSEL INJURY." NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192051 NESTER PLATINUM EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention