BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOS ENDOVASCULAR DEVICE, 135X30CM

    MDR report key: 25246656 · Received May 21, 2026

    Report

    Report Number
    2124215-2026-27323
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QEY
    UDI-DI
    00191506011024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER STATE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE REQUIRING INTERVENTION. APPROXIMATELY 1 MONTH AGO, SHE UNDERWENT ENDOVASCULAR RECANALIZATION OF THE OCCLUDED RIGHT ILIAC VEIN VIA A JUGULAR VEIN APPROACH. AN EDGE STENOSIS WAS IDENTIFIED AT THE MOST CAUDAL ASPECT OF THE PREVIOUSLY PLACED STENTS, AND SHE UNDERWENT ADDITIONAL STENTING OF THE COMMON FEMORAL AND ILIAC VEINS. SHE HAD COMPLETE RESOLUTION OF HER SYMPTOMS FOR APPROXIMATELY 10 DAYS THEN STARTED TO EXPERIENCE RECURRENT PAIN AND SWELLING. FIVE DAYS LATER, SHE PRESENTED AND WAS FOUND TO HAVE RECURRENT OCCLUSION OF HER STENTS. THE SHARED DECISION WAS THEN MADE BETWEEN THE PATIENT AND DR. FRESA TO PERFORM REVASCULARIZATION WITH CATHETER DIRECTED THROMBOLYSIS. THE PATIENT'S LAB VALUES WERE NORMAL. HER BASELINE FIBRINOGEN LEVEL WAS 5.2 G/L. SHE WAS TREATED WITH LOW MOLECULAR WEIGHT HEPARIN 1 MG/KG TWICE DAILY AND ASPIRIN 81 MG. ON (B)(6) 2026, THE PATIENT UNDERWENT CATHETER DIRECTED THROMBOLYSIS USING A EKOS ENDOVASCULAR DEVICE, 135X30CM PLACED VIA THE JUGULAR VEIN FROM THE ILIAC THROUGH DEEP FEMORAL VEIN WITH ACTILYSE 1 MG/HR. THE LOW MOLECULAR WEIGHT HEPARIN 1 MG/KG TWICE DAILY AND ASPIRIN 81 MG WAS CONTINUED. THE PATIENT'S LABS VALUES REMAINED NORMAL (CBC, PLATELETS). HER ANTI-XA LEVEL WAS IN THE THERAPEUTIC RANGE. SHE WAS CONTINUOUSLY MONITORED IN THE INTENSIVE CARE UNIT AND REPORTEDLY ALL LABORATORY VALUES WERE NORMAL. HER REPEAT FIBRINOGEN WAS 3.2 G/L. ALL OTHER LABS WERE NORMAL AND HER ANTI-XA LEVEL REMAINED IN THE THERAPEUTIC RANGE. ALSO NOTABLE IS THAT HER BLOOD PRESSURE REMAINED IN THE NORMAL RANGE THROUGHOUT THE INFUSION. AFTER 24 HOURS ((B)(6) 2026) OF INFUSION, THAT DECISION WAS MADE TO PERFORM REPEAT VENOGRAPHY. THE THROMBOLYTIC INFUSION CONTINUED FOR ANOTHER 3 1/2 HOURS UNTIL THE CATH LAB WAS AVAILABLE. PRIOR TO RETURNING TO THE CATH LAB, THE PATIENT EXPERIENCED ACUTE ONSET OF NEUROLOGIC SYMPTOMS ON THE LEFT SIDE WITH APHASIA AND RIGHT HEMIPARESIS. THE PATIENT UNDERWENT CT IMAGING WHICH REVEALED A LEFT INTRACEREBRAL HEMORRHAGE. HER ANTICOAGULATION WAS REVERSED AND THE TPA HAD ALREADY BEEN DISCONTINUED. A REPEAT CT SCAN DEMONSTRATED INCREASING SIZE OF HER ICH. SHE WAS INTUBATED AND UNDERWENT NEUROSURGICAL DECOMPRESSION SURGERY. AS OF (B)(6) 2026, THE PATIENT HAS BEEN EXTUBATED WITH NO CHANGE IN HER NEUROLOGIC EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500339 EKOS ENDOVASCULAR DEVICE, 135X30CM MECHANICAL THROMBOLYSIS CATHETER QEY BOSTON SCIENTIFIC CORPORATION 00191506011024

    Patients

    Seq Age Sex Outcome Treatment
    1