BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS L

    MDR report key: 2885351 · Received December 19, 2012

    Report

    Report Number
    2183460-2012-00027
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A PATIENT ALLEGEDLY EXPERIENCING A DISTAL EMBOLIZATION DURING A JETSTREAM PROCEDURE. THE PATIENT IS A FEMALE OF UNKNOWN AGE AND MEDICAL HISTORY. THE PATIENT PRESENTED WITH A CONCENTRIC 2 CM / 70% OCCLUSION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) AS WELL AS 2CM / 95% OCCLUSION IN THE MID SFA. THE PATIENT WAS HEPARINIZED TO AN ACTIVATED CLOTTING TIME (ACT) OF GREATER THAN 270 SECONDS. THE PHYSICIAN RAN THE JETSTREAM NAVITUS L ATHERECTOMY CATHETER OVER A SPIDER FILTER WIRE. THE NAVITUS L DEVICE DID NOT EXPERIENCE MUCH BOG DOWN WITH BLADES UP OR DOWN DURING ACTIVATION. THE NAVITUS WAS REMOVED OVER THE SPIDER FILTER WIRE AND ANGIOGRAM WAS PERFORMED. THE ANGIOGRAM SHOWED GREAT TREATMENT RESULTS; HOWEVER, A DISTAL EMBOLI WAS OBSERVED TO BE SITTING ON TOP OF THE TIBIO PERINEAL (TP) TRUNK. THE PHYSICIAN THEN REMOVED THE SPIDER FILTER WIRE WITHOUT INCIDENCE AND ANOTHER ANGIOGRAM WAS PERFORMED. THIS ANGIOGRAM SHOWED THE EMBOLUS WAS STILL SITTING IN TOP OF THE TP TRUNK. THE PHYSICIAN USED AND JETSTREAM G3 SF (1.85MM) ATHERECTOMY CATHETER IN AN ATTEMPT TO REMOVE THE EMBOLI. THIS PROCEDURE WAS UNSUCCESSFUL TO REMOVE THE EMBOLI. THE PHYSICIAN THEN USED KISSING BALLOON TECHNIQUE IN THE ANTERIOR TIBIAL (AT) AND TP TRUNK IN AN ATTEMPT TO TREAT THE EMBOLI. THIS PROCEDURE WAS ALSO UNSUCCESSFUL. THE PHYSICIAN THEN THROMBOLYSED THE PATIENT OVERNIGHT WITH TPA. THE NEXT DAY THERE WAS NO CHANGE IN THE EMBOLI SO THE PHYSICIAN HAD THE EMBOLI SURGICALLY REMOVED. THE EMBOLECTOMY PROCEDURE WAS SUCCESSFUL WITH GREAT RESULTS. THE JETSTREAM NAVITUS INSTRUCTIONS FOR USE (IFU) CAUTIONS AND NOTES THE USER: "USE ONLY COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM NAVITUS L SYSTEM. USE OF ANY SUPPLIES NOT LISTED COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM NAVITUS L SYSTEM." "DO NOT TREAT WHEN THE CATHETER TIP IS POSITIONED RETROGRADE TO THE BLOOD FLOW (AGAINST THE FLOW OF BLOOD). THIS CAN POTENTIALLY COMPROMISE THE INFUSION AND ASPIRATION CAPABILITIES OF THE JETSTREAM NAVITUS L SYSTEM." IN THIS CASE THE SPIDER FILTER WIRE IS NOT LISTED IN THE JETSTREAM NAVITUS IFU AS A COMPATIBLE DEVICE. HOWEVER, THERE WAS NO ADVERSE INTERACTION BETWEEN THE JETSTREAM NAVITUS L DEVICE AND THE SPIDER FILTER WIRE IN THIS CASE. THIS EVENT IS REPORTABLE SINCE THE ASSOCIATION BETWEEN THE JETSTREAM NAVITUS L DEVICE AND THE SUBSEQUENT NOTED DISTAL EMBOLIZATION WHICH REQUIRED INTERVENTION TO TREAT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    PATIENT HAD DISEASE IN PROXIMAL SFA 2CM CONCENTRIC DISEASE 70% OCCLUDED. MID SFA DISEASE CONCENTRIC 2CM 95% OCCLUDED. RAN THE NAVITUS L OVER A SPIDER FILTER. DID NOT HAVE MUCH BOG DOWN BLADES UP AND BLADES DOWN. WE HEPARINIZED THE PATIENT TO AN ACT OF 270+. NO WIRE STICK ON THIS CASE. SHOT AN ANGIOGRAM, GREAT RESULT DISTAL EMBOLI SITTING ON TOP OF TP TRUNK. REMOVED FILTER SAFELY. SHOT ANOTHER ANGIOGRAM AND EMBOLI WAS STILL SITTING ON TOP OF TP TRUNK. USED 1.85MM G3 SF TO SUCK OUT EMBOLI. NO DIFFERENCE IN RESULT POST 1.85 SF. USED KISSING BALLOONS IN AT AND TP TRUNK. NO DIFFERENCE IN RESULT. THROMBOLYSED OVERNIGHT WITH TPA. NO DIFFERENCE IN RESULT. SURGEON TOOK PATIENT TO OPERATING ROOM TO REMOVE EMBOLI. GREAT RESULT POST EMBOLECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS L JETSTREAM NAVITUS L MCW BAYER INTERVENTIONAL, INC. 031005-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention