BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET HELICAL NANO 1MM X 2CM

    MDR report key: 4922573 · Received July 17, 2015

    Report

    Report Number
    3008853977-2015-00305
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 26, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK (MDR)
    Product Code
    HCG
    PMA / PMN Number
    K113412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE EVENT DESCRIPTION STATED THAT AFTER SUCCESSFUL PLACEMENT INSIDE THE ANEURYSM, BOTH COILS PROLAPSED FROM THE ANEURISM SACK INTO THE PARENT VESSEL AND OCCLUDED IT. IT IS LIKELY THAT SOME PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE FIRST COIL FOLLOWED BY THE SECOND COIL (SUBJECT DEVICE) WERE SUCCESSFULLY IMPLANTED INSIDE THE RUPTURED RIGHT WIDE-NECK ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM; HOWEVER, BOTH COILS PROLAPSED FROM THE ANEURYSM SACK INTO THE PARENT VESSEL AND OCCLUDED IT. BLOOD FLOW TO THE CONTRALATERAL SIDE WAS MINIMAL. A STENT WAS SUCCESSFULLY PLACED FROM CONTRALATERAL A2 ANTERIOR CEREBRAL ARTERY (ACA), ACROSS THE ACOM, AND DOWN TO THE A1 (ACA). IMMEDIATELY AFTER THE STENT PLACEMENT COILS WERE PUSHED BACK INSIDE THE ANEURYSM AND ALL THE VESSELS WERE FULLY PATENT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    THE FIRST COIL FOLLOWED BY THE SECOND COIL (SUBJECT DEVICE) WERE SUCCESSFULLY IMPLANTED INSIDE THE RUPTURED RIGHT WIDE-NECK ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM; HOWEVER, BOTH COILS PROLAPSED FROM THE ANEURYSM SACK INTO THE PARENT VESSEL AND OCCLUDED IT. BLOOD FLOW TO THE CONTRALATERAL SIDE WAS MINIMAL. A STENT WAS SUCCESSFULLY PLACED FROM CONTRALATERAL A2 ANTERIOR CEREBRAL ARTERY (ACA), ACROSS THE ACOM, AND DOWN TO THE A1 (ACA). IMMEDIATELY AFTER THE STENT PLACEMENT COILS WERE PUSHED BACK INSIDE THE ANEURYSM AND ALL THE VESSELS WERE FULLY PATENT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464734 TARGET HELICAL NANO 1MM X 2CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK (MDR) 18248768

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention