BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 22299019 · Received June 20, 2025

    Report

    Report Number
    2124215-2025-40232
    Event Type
    Death
    Date Received
    June 20, 2025
    Date of Event
    May 22, 2025
    Report Date
    December 10, 2025
    Manufacturer
    SILK ROAD MEDICAL
    Product Code
    NTE
    UDI-DI
    00811311021062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH: DATE OF DEATH WAS APPROXIMATED TO (B)(6) 2025, AS THE PATIENT WAS REPORTED TO HAVE EXPIRED OVER THE WEEKEND FOLLOWING THE TCAR PROCEDURE.

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH: DATE OF DEATH WAS APPROXIMATED TO (B)(6) 2025, AS THE PATIENT WAS REPORTED TO HAVE EXPIRED OVER THE WEEKEND FOLLOWING THE TCAR PROCEDURE. UPDATED FIELDS: E1 - INITIAL REPORTER EMAIL.

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH: DATE OF DEATH WAS APPROXIMATED TO (B)(6) 2025, AS THE PATIENT WAS REPORTED TO HAVE EXPIRED OVER THE WEEKEND FOLLOWING THE TCAR PROCEDURE. UPDATED FIELDS: H1 - TYPE OF REPORTABLE EVENT: UPDATED TO DEATH. H6 - EVALUATION METHOD CODES, EVALUATION CONCLUSION CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE 2 HOURS POST TCAR, RESULTING IN ADDITIONAL INTERVENTION, HOSPITALIZATION, AND ULTIMATELY DEATH. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT HAD A TOTAL OCCLUSION OF THE RIGHT SUBCLAVIAN. THE ARTERIAL LINE WAS NOT WORKING WELL, AND WAS MEASURING BLOOD PRESSURE AS FLAT, RANGING FROM 77-87. THE SURGEON ELECTED TO MONITOR BLOOD PRESSURE INSTEAD THROUGH THE BLOOD PRESSURE CUFF. THROUGHOUT THE CASE CUFF READINGS RANGED FROM 125-130. THE ARTERIAL AND VENOUS SHEATHS WERE PLACED, AND FLOW REVERSAL WAS CONFIRMED. A 8MM X 40MM ENROUTE STENT WAS ADVANCED, AND THEN A TCAR TIMEOUT WAS PERFORMED TO TAKE SOME IMAGES. THE SURGEON SUSPECTED THERE WAS A SMALL DISSECTION, AND ELECTED TO PLACE AN ADDITIONAL ENROUTE STENT, 7MM X 30MM, DISTALLY TO THE 8MM X 40MM, OVERLAPPING. FURTHER IMAGING WAS REVIEWED, AND THE SURGEON WAS SATISFIED WITH THE STENT PLACEMENT. THE TCAR PROCEDURE WAS COMPLETED, AND THE ARTERIOTOMY WAS CLOSED. THE PATIENT AWOKE AND WAS UNABLE TO MOVE HIS RIGHT ARM. THE SURGEON ELECTED TO RE-OPEN THE PATIENT AND PERFORM ANOTHER TCAR. HE BELIEVED THE STENTED PORTION NEEDED TO EXTEND INTO THE COMMON CAROTID ARTERY (CCA). THE SURGEON ACCESSED THE CCA, AND REVIEWED THE EXTERNAL AND INTERNAL CAROTID ARTERIES ALONG WITH THE BRAIN FROM IMAGING. HE STATED EVERYTHING LOOKED GOOD, AND THERE WERE NO BLOCKAGES IN THE STENTS OR THE CRANIAL VESSELS. HOWEVER, THE SURGEON DID SUSPECT THERE MIGHT BE A DISSECTION AT THE BIFURCATION OF THE CAROTID. A THIRD STENT WAS PLACED TO COVER THE DISSECTION. SUBSEQUENT IMAGING REVEALED A BLOCKAGE IN THE CRANIUM. A NON-BOSTON SCIENTIFIC THROMBECTOMY VACUUM WAS USED TO SUCTION OUT AND REMOVE THE CLOT. THE PATIENT WOKE UP POST-PROCEDURE, BUT WAS STILL UNABLE TO MOVE HIS RIGHT ARM. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT ULTIMATELY EXPIRED OVER THE WEEKEND. NO FURTHER INFORMATION WAS AVAILABLE DESPITE REQUEST BY BOSTON SCIENTIFIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE 2 HOURS POST TCAR, RESULTING IN ADDITIONAL INTERVENTION, HOSPITALIZATION, AND ULTIMATELY DEATH.AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT HAD A TOTAL OCCLUSION OF THE RIGHT SUBCLAVIAN. THE ARTERIAL LINE WAS NOT WORKING WELL, AND WAS MEASURING BLOOD PRESSURE AS FLAT, RANGING FROM 77-87. THE SURGEON ELECTED TO MONITOR BLOOD PRESSURE INSTEAD THROUGH THE BLOOD PRESSURE CUFF. THROUGHOUT THE CASE CUFF READINGS RANGED FROM 125-130. THE ARTERIAL AND VENOUS SHEATHS WERE PLACED, AND FLOW REVERSAL WAS CONFIRMED. A 8MM X 40MM ENROUTE STENT WAS ADVANCED, AND THEN A TCAR TIMEOUT WAS PERFORMED TO TAKE SOME IMAGES. THE SURGEON SUSPECTED THERE WAS A SMALL DISSECTION, AND ELECTED TO PLACE AN ADDITIONAL ENROUTE STENT, 7MM X 30MM, DISTALLY TO THE 8MM X 40MM, OVERLAPPING. FURTHER IMAGING WAS REVIEWED, AND THE SURGEON WAS SATISFIED WITH THE STENT PLACEMENT. THE TCAR PROCEDURE WAS COMPLETED, AND THE ARTERIOTOMY WAS CLOSED. THE PATIENT AWOKE AND WAS UNABLE TO MOVE HIS RIGHT ARM. THE SURGEON ELECTED TO RE-OPEN THE PATIENT AND PERFORM ANOTHER TCAR. HE BELIEVED THE STENTED PORTION NEEDED TO EXTEND INTO THE COMMON CAROTID ARTERY (CCA). THE SURGEON ACCESSED THE CCA AND REVIEWED THE EXTERNAL AND INTERNAL CAROTID ARTERIES ALONG WITH THE BRAIN FROM IMAGING. HE STATED EVERYTHING LOOKED GOOD, AND THERE WERE NO BLOCKAGES IN THE STENTS OR THE CRANIAL VESSELS. HOWEVER, THE SURGEON DID SUSPECT THERE MIGHT BE A DISSECTION AT THE BIFURCATION OF THE CAROTID. A THIRD STENT WAS PLACED TO COVER THE DISSECTION. SUBSEQUENT IMAGING REVEALED A BLOCKAGE IN THE CRANIUM. A NON-BOSTON SCIENTIFIC THROMBECTOMY VACUUM WAS USED TO SUCTION OUT AND REMOVE THE CLOT. THE PATIENT WOKE UP POST-PROCEDURE BUT WAS STILL UNABLE TO MOVE HIS RIGHT ARM. THE PATIENT WAS SENT TO THE ICU. THE PATIENT ULTIMATELY EXPIRED OVER THE WEEKEND. NO FURTHER INFORMATION WAS AVAILABLE DESPITE REQUEST BY BOSTON SCIENTIFIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EMBOLIC STROKE 2 HOURS POST TCAR, RESULTING IN ADDITIONAL INTERVENTION, HOSPITALIZATION, AND ULTIMATELY DEATH. AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT HAD A TOTAL OCCLUSION OF THE RIGHT SUBCLAVIAN. THE ARTERIAL LINE WAS NOT WORKING WELL, AND WAS MEASURING BLOOD PRESSURE AS FLAT, RANGING FROM 77-87. THE SURGEON ELECTED TO MONITOR BLOOD PRESSURE INSTEAD THROUGH THE BLOOD PRESSURE CUFF. THROUGHOUT THE CASE CUFF READINGS RANGED FROM 125-130. THE ARTERIAL AND VENOUS SHEATHS WERE PLACED, AND FLOW REVERSAL WAS CONFIRMED. A 8MM X 40MM ENROUTE STENT WAS ADVANCED, AND THEN A TCAR TIMEOUT WAS PERFORMED TO TAKE SOME IMAGES. THE SURGEON SUSPECTED THERE WAS A SMALL DISSECTION, AND ELECTED TO PLACE AN ADDITIONAL ENROUTE STENT, 7MM X 30MM, DISTALLY TO THE 8MM X 40MM, OVERLAPPING. FURTHER IMAGING WAS REVIEWED, AND THE SURGEON WAS SATISFIED WITH THE STENT PLACEMENT. THE TCAR PROCEDURE WAS COMPLETED, AND THE ARTERIOTOMY WAS CLOSED. THE PATIENT AWOKE AND WAS UNABLE TO MOVE HIS RIGHT ARM. THE SURGEON ELECTED TO RE-OPEN THE PATIENT AND PERFORM ANOTHER TCAR. HE BELIEVED THE STENTED PORTION NEEDED TO EXTEND INTO THE COMMON CAROTID ARTERY (CCA). THE SURGEON ACCESSED THE CCA, AND REVIEWED THE EXTERNAL AND INTERNAL CAROTID ARTERIES ALONG WITH THE BRAIN FROM IMAGING. HE STATED EVERYTHING LOOKED GOOD, AND THERE WERE NO BLOCKAGES IN THE STENTS OR THE CRANIAL VESSELS. HOWEVER, THE SURGEON DID SUSPECT THERE MIGHT BE A DISSECTION AT THE BIFURCATION OF THE CAROTID. A THIRD STENT WAS PLACED TO COVER THE DISSECTION. SUBSEQUENT IMAGING REVEALED A BLOCKAGE IN THE CRANIUM. A NON-BOSTON SCIENTIFIC THROMBECTOMY VACUUM WAS USED TO SUCTION OUT AND REMOVE THE CLOT. THE PATIENT WOKE UP POST-PROCEDURE, BUT WAS STILL UNABLE TO MOVE HIS RIGHT ARM. THE PATIENT WAS SENT TO THE ICU. THE PATIENT ULTIMATELY EXPIRED OVER THE WEEKEND. NO FURTHER INFORMATION WAS AVAILABLE DESPITE REQUEST BY BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202173 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM EMBOLIC PROTECTION FILTERING GUIDEWIRE NTE SILK ROAD MEDICAL FG12531 0000306636 00811311021062

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death| R| H