BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APB-6-20-3D-SS

    MDR report key: 6368523 · Received March 1, 2017

    Report

    Report Number
    2029214-2017-00157
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    February 2, 2017
    Report Date
    June 6, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED FOR EVALUATION WITHOUT THE INSTANT DETACHER OR THE PUSHWIRE, AS THEY WERE DISCARDED. A PUSHWIRE OF AN UNKNOWN RETRIEVAL DEVICE WAS FOUND TO BE EXTENDING OUT FROM THE HUB OF AN UNKNOWN MICROCATHETER. NO DAMAGES WERE NOTED ON THE MICROCATHETER HUB OR MICROCATHETER BODY. THE IMPLANT COIL WAS FOUND DAMAGED, STRETCHED AND EXTENDING OUT OF THE DISTAL END OF THE MICROCATHETER. AN ATTEMPT WAS MADE TO ADVANCE THE PUSHWIRE OUT OF THE DISTAL TIP OF THE MICROCATHETER; HOWEVER, THE DEVICES WERE FOUND TO BE STUCK. IT WAS THEN ATTEMPTED TO PULL THE COIL OUT FROM THE DISTAL TIP OF THE MICROCATHETER; HOWEVER, THE IMPLANT COIL AND POLYPROPYLENE FILAMENT BROKE. NO FURTHER TESTING COULD BE CONDUCTED WITH THE RETURNED DEVICES, AND NO OTHER ANOMALIES WERE OBSERVED. ALL COILS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THE ANCILLARY DEVICES WILL NOT BE RETURNED TO THE ORIGINAL MANUFACTURERS AS THE MANUFACTURED IS UNKNOWN, AND THE COIL WAS STUCK WITHIN THE DEVICES. BASED ON THE DEVICE ANALYSIS AND ON THE EVENT DESCRIPTION, THE REPORT OF NON-DETACHMENT COULD NOT BE CONFIRMED, AND THE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE COIL WAS RETURNED ALREADY DETACHED FROM THE PUSHWIRE. THE INSTRUCTIONS FOR USE (IFU), INSTRUCTS THE USER TO REPLACE THE INSTANT DETACHER IF THE IMPLANT COIL FAILS TO DETACH AFTER 3 ATTEMPTS. IN ADDITION, THE USER IS INSTRUCTED TO DETACH THE COIL BY THE MANUAL METHOD (VIA HYPOTUBE) IF ATTEMPTS TO DETACH THE IMPLANT COIL WITH THE 2 INSTANT DETACHERS ARE NOT SUCCESSFUL. PER THE INSTRUCTIONS FOR USE (IFU): IF THE COIL DOES NOT DETACH AFTER 3 ATTEMPTS, DISCARD THE I.D. (INSTANT DETACHER) AND REPLACE WITH A NEW I.D. (INSTANT DETACHER). ALSO, IN THE RARE EVENT THAT THE COIL DOES NOT DETACH AND CANNOT BE REMOVED FROM THE IMPLANT DELIVERY PUSHER, USE THE FOLLOWING STEPS FOR DETACHMENT. A. GRIP THE HYPOTUBE APPROXIMATELY 5 CM DISTAL OF THE POSITIVE LOAD INDICATOR AT THE HYPOTUBE BREAK INDICATOR AND BEND THE IMPLANT DELIVERY PUSHER JUST DISTAL TO THE HBI 180 DEGREES. B. NEXT STRAIGHTEN THE PUSHER BACK, CONTINUE BENDING AND STRAIGHTENING UNTIL THE PUSHER TUBING OPENS EXPOSING THE RELEASE ELEMENT. C. GENTLY SEPARATE THE PROXIMAL AND DISTAL ENDS OF THE OPEN PUSHER. THEN, UNDER FLUOROSCOPY, PULL THE PROXIMAL PORTION OF THE IMPLANT DELIVERY PUSHER APPROXIMATELY 2-3 CM TO CONFIRM IMPLANT DETACHMENT PER IFU. WARNING: "IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD P OSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL. MDR RELATED TO THIS EVENT: 2029214-2017-00157 2029214-2017-00158.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. SUPPLEMENTAL WILL BE FILED WHEN THE EVALUATION IS COMPLETE. MDR RELATED TO THIS EVENT: 2029214-2017-00157, 2029214-2017-00158. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED FOR EVALUATION. THE COIL¿S PUSHWIRE WAS NOT RETURNED. A PUSHWIRE OF AN UNKNOWN RETRIEVAL DEVICE WAS FOUND TO BE EXTENDING OUT FROM THE HUB OF AN UNKNOWN MICROCATHETER. NO DAMAGES WERE NOTED ON THE MICROCATHETER HUB OR MICROCATHETER BODY. THE IMPLANT COIL WAS FOUND TO BE DAMAGED AND STRETCHED AND EXTENDING OUT FROM THE DISTAL END OF THE MICROCATHETER. AN ATTEMPT WAS MADE TO ADVANCE THE PUSHWIRE OUT OF THE DISTAL TIP OF THE MICROCATHETER; HOWEVER, THE DEVICES WERE FOUND TO BE STUCK. AN ATTEMPT WAS MADE TO PULL THE IMPLANT COIL OUT FROM THE DISTAL TIP OF THE MICROCATHETER; HOWEVER, THE IMPLANT COIL AND POLYPROPYLENE FILAMENT BROKE. NO FURTHER TESTING COULD BE CONDUCTED WITH THE RETURNED DEVICES, AND NO OTHER ANOMALIES WERE OBSERVED. ALL COILS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE THE ANCILLARY DEVICES WILL NOT BE RETURNED AS THE MANUFACTURERS OF THE ANCILLARY DEVICES ARE UNKNOWN, AND THE COIL WAS STUCK TO THE DEVICES. BASED ON THE DEVICE ANALYSIS AND ON THE EVENT DESCRIPTION, THE REPORT OF NON-DETACHMENT COULD NOT BE CONFIRMED, AND THE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. THE IMPLANT COIL WAS RETURNED ALREADY DETACHED FROM THE PUSHWIRE. PER THE COIL¿S INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO REPLACE THE INSTANT DETACHER IF THE IMPLANT COIL FAILS TO DETACH AFTER 3 ATTEMPTS. IN ADDITION, THE USER IS INSTRUCTED TO DETACH THE COIL BY THE MANUAL METHOD (VIA HYPOTUBE) IF ATTEMPTS TO DETACH THE IMPLANT COIL WITH THE 2 INSTANT DETACHERS ARE NOT SUCCESSFUL. WARNING: IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT OF IMPLANT COIL FAILURE TO DETACH. UPON RETRIEVAL OF THE COIL, IT STRETCHED, THE COIL MASS MOVE AND 2 COIL LOOPS PROTRUDED INTO THE PARENT ARTERY. THIS ADDED SIGNIFICANT PROCEDURE TIME, FLUOROSCOPY TIME AND MANOEUVERS TO GET THE LOOPS BACK INTO THE ANEURYSM SAC. THIS EVENT ALSO REQUIRED THE PLACEMENT OF A STENT TO KEEP THE COILS WITHIN THE ANEURYSM. THE ANEURYSM WAS IN THE BASILAR TIP, SACCULAR AND WAS UNRUPTURED (7MM MAX WITH 5MM NECK). THE ANATOMY WAS NORMAL. THE PATIENT WAS REPORTED NOT TO HAVE BEEN INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153203 APB-6-20-3D-SS DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE) APB-6-20-3D-SS A324576

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention