BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA COIL SYSTEM

    MDR report key: 7991803 · Received October 22, 2018

    Report

    Report Number
    3009698517-2018-00012
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 10, 2018
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    PMA / PMN Number
    K172390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS THE DEVICE WAS IMPLANTED AND REPORTED UNAVAILABLE. THE PHYSICIAN NOTED THAT THERE WERE NO COMPLICATIONS DEPLOYING THE COILS DURING THE PROCEDURE. HOWEVER, IT WAS ALSO NOTED THAT THE PHYSICIAN WOULD BRING THE PATIENT BACK AT A LATER TIME TO INSERT A PIPELINE, THUS IMPLYING THE NECK OF ANEURYSM WAS WIDE. ON (B)(6) 2018, A CTA FOLLOW UP WAS DONE SHOWING THE COILS STILL INTACT. ON (B)(6) 2018 THE PATIENT HAD A STROKE AND THE MD SUSPECTED WAS THE RESULT OF A SIGNIFICANT AMOUNT OF THE PROXIMAL COIL BEING DISPLACED INTO THE PARENT ARTERY. COIL PROLAPSE INTO THE PARENT ARTERY IS A WELL-CHARACTERIZED COMPLICATION OF ENDOVASCULAR TREATMENT. COILS THAT PROTRUDE INTO THE PARENT VESSEL AFTER DEPLOYMENT CAN BE CARRIED INTO DISTAL VESSELS WITH THE POTENTIAL TO CREATE A THROMBOGENIC MASS. BASED ON STUDIES REPORTING LARGE SERIES OF PATIENTS, COIL PROLAPSE (ALSO CALLED PROTRUSION, HERNIATION, OR DISPLACEMENT) OCCURS IN UP TO 4.5% (112/2497) OF PATIENTS TREATED WITH ANY COIL DEVICE. COIL PROLAPSE MAY RESULT FROM A VARIETY OF CAUSES, INCLUDING SIZE MISMATCH BETWEEN THE COILS AND ANEURYSM, INADEQUATE POSITION OF THE MICROCATHETER, COIL INSTABILITY AFTER DETACHMENT, EXCESSIVE EMBOLIZATION, MICROCATHETER OR STENT RELATED PROBLEMS, OR FROM BEING PUSHED BY SUBSEQUENT COIL EMBOLIZATION. PROLAPSE OCCURRED IN ANEURYSMS WITH WIDE OR "LOOSE" NECKS IN 15 STUDIES. THUS, THE CAUSE IS TYPICALLY NOT ASSOCIATED WITH THE COIL ITSELF, BUT RATHER DUE TO PROCEDURAL OR OPERATOR-RELATED COMPLICATIONS, INCLUDING PLACEMENT OF MULTIPLE COILS, WHICH HAS THE POTENTIAL TO DISPLACE ONE OR MORE COILS INTO THE PARENT ARTERY. ROOT CAUSE IN THIS CASE IS BELIEVED TO BE AN INHERENT PROCEDURAL COMPLICATION, NOTABLY DUE TO THE REPORTED WIDE NECK OF THE TREATMENT SITE. LACK OF IMMEDIATE SUPPORT IN THE FORM OF A PIPELINE FURTHER INCREASED THE RISK OF PROXIMAL COIL DISPLACEMENT INTO THE PARENT ARTERY. LACK OF DEVICE RETURN PREVENTED DEEPER EVALUATION OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "DR. (B)(6) HAD HIS FIRST OPTIMA CASE ON (B)(6) 2018. IT WAS A SAH OFF THE ICA WHICH HE WAS TRYING TO PLACE SOME COILS TO PROTECT THE DOME AND THEN BRING HER BACK TO PLACE A PIPELINE. HE PLACED THE FOLLOWING COILS IN ORDER 8X27 CS10 / 6X20 CS10 / 4X10 CS10 / 3X6 CS10. ALL WERE DEPLOYED WITHOUT INCIDENT. THE PATIENT WENT HOME ON (B)(6) 2018 AFTER HAVING A CTA DONE WHICH SHOWED ALL COILS STILL INTACT. ON (B)(6) 2018, THE PATIENT HAD A STROKE WHICH THE MD SUSPECTED WAS THE RESULT OF A SIGNIFICANT AMOUNT OF THE PROXIMAL COIL BEING DISPLACED INTO THE PARENT ARTERY AND DOWN INTO THE PCOM. I HAVE ATTACHED PICTURES OF THE ANGIOGRAM TAKEN ON (B)(6) 2018. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834214 OPTIMA COIL SYSTEM OPTIMA COIL HCG BALT USA, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening