BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOTRAP III 5 MM X 37 MM

    MDR report key: 12274259 · Received August 4, 2021

    Report

    Report Number
    3011370111-2021-00067
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 16, 2021
    Report Date
    July 20, 2021
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). SECTION B5: ADDITIONAL INFORMATION RECEIVED ON 23-AUG-2021 INDICATED THAT POST-PROCEDURAL FLAT PANEL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THE SAB. THUS, THE SAB WAS A PERI-INTERVENTIONAL EVENT. THERE WAS NO ACTIVE BLEEDING SEEN ON INTRAPROCEDURAL ANGIOGRAPHY. THE TREATING PHYSICIAN COMMENTED THAT EXTREME VESSEL STRESS IN THE DISTAL PART OF THE M2 BRANCH CAUSED THE SAB. THE INTERACTION BETWEEN THE VESSEL, THROMBUS, AND THE EMBOTRAP III AND 5F SOFIA WAS CONSIDERED THE CAUSE OF THE EVENT. THE SAB WAS NOT TREATED. THE PATIENT WAS DISCHARGED ON DAY 14 WITH A NIHSS SCORE OF 0 AND MODIFIED RANKIN SCALE (MRS) SCORE OF 1. THERE WERE NO ALLEGED PRODUCT MALFUNCTIONS ASSOCIATED WITH THE EMBOTRAP III. THREE PASSES WERE MADE IN AN ATTEMPT TO RETRIEVE THE CLOT. THE EMBOVAC ASPIRATION CATHETER (UNKNOWN PRODUCT CODE & LOT NUMBER) WAS REPLACED WITH THE 5F SOFIA FOR THE LAST PASS FOR MORE DISTAL ASPIRATION (M2 BRANCH). ANTIPLATELET EFFECTIVENESS WAS NOT TESTED PRIOR TO THE PROCEDURE. PRE-PROCEDURAL MEDICATIONS INCLUDED THE FOLLOWING: 75MG CLOPIDOGREL AND ACTILYSE 68ML (14:57 BOLUS, 7ML + 60-MINUTE INFUSION). HEPARIN WAS NOT ADMINISTERED DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. COMPLAINT CONCLUSION: A REPORT FROM THE FIELD INDICATED THAT THE PATIENT SUFFERED FROM A SUBARACHNOID BLEED (SAB) AFTER USE OF A 5MM X 37MM EMBOTRAP III (ET307537/21B084AV) REVASCULARIZATION DEVICE. THE PATIENT INITIALLY PRESENTED WITH A MIDDLE CEREBRAL ARTERY (M2 SEGMENT) OCCLUSION AND THE EMBOTRAP DEVICE WAS USED FOR A TOTAL OF THREE PASSES. THE EVENT DID NOT RESULT IN A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH). THE PATIENT¿S BASELINE NIHSS SCORE HAD IMPROVED FROM 5 TO 1. THE MEDICAL IMAGING RECEIVED WAS WAS REVIEWED BY AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT, NEUROVASCULAR SURGEON. THE ASSESSMENT READS AS FOLLOWS: "A REPORT OF SUBARACHNOID HEMORRHAGE AFTER DEPLOYMENT OF A 5 MM X 37 MM EMBOTRAP III IN THE RIGHT MCA M2 IS MADE. THE REPORT IS ACCOMPANIED BY THREE ANGIOGRAPHIC IMAGES. NO OTHER DETAILS ACCOMPANY THE REPORT. THE FIRST IMAGE DEMONSTRATES A MICROCATHETER IN THE RIGHT MCA M2 THE SECOND AND THIRD IMAGES DEMONSTRATE AN EMBOTRAP IN THE RIGHT MCA DISTAL M2 AND AN ASPIRATION CATHETER IN THE MCA M1 SEGMENT. THERE IS NO SIGNIFICANT VESSEL TORTUOSITY. NO CT SCAN IS AVAILABLE. BY REPORT THERE IS SUBARACHNOID HEMORRHAGE BUT NO SICH. PER REPORT THE PATIENT IMPROVED FROM AN NIHSS OF 5 TO 1. POST THROMBECTOMY HEMORRHAGES (ICH AND SAH) ARE KNOWN COMPLICATIONS OF MECHANICAL THROMBECTOMY. THE RISK OF HEMORRHAGE INCREASES WITH REPEAT MANEUVERS AND MORE DISTAL POSITIONING OF DEVICES. ONE POSSIBLE MECHANISM FOR SUCH BLEEDS IS SMALL PERFORATING VESSEL TEARS AS A RESULT OF SHEARING FORCES GENERATED DURING DEVICE MANIPULATIONS." ADDITIONAL INFORMATION RECEIVED ON 23-AUG-2021 INDICATED THAT POST-PROCEDURAL FLAT PANEL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THE SAB. THUS, THE SAB WAS A PERI-INTERVENTIONAL EVENT. THERE WAS NO ACTIVE BLEEDING SEEN ON INTRAPROCEDURAL ANGIOGRAPHY. THE TREATING PHYSICIAN COMMENTED THAT EXTREME VESSEL STRESS IN THE DISTAL PART OF THE M2 BRANCH CAUSED THE SAB. THE INTERACTION BETWEEN THE VESSEL, THROMBUS, AND THE EMBOTRAP III AND 5F SOFIA WAS CONSIDERED THE CAUSE OF THE EVENT. THE SAB WAS NOT TREATED. THE PATIENT WAS DISCHARGED ON DAY 14 WITH A NIHSS SCORE OF 0 AND MODIFIED RANKIN SCALE (MRS) SCORE OF 1. THERE WERE NO ALLEGED PRODUCT MALFUNCTIONS ASSOCIATED WITH THE EMBOTRAP III. THREE PASSES WERE MADE IN AN ATTEMPT TO RETRIEVE THE CLOT. THE EMBOVAC ASPIRATION CATHETER (UNKNOWN PRODUCT CODE & LOT NUMBER) WAS REPLACED WITH THE 5F SOFIA FOR THE LAST PASS FOR MORE DISTAL ASPIRATION (M2 BRANCH). ANTIPLATELET EFFECTIVENESS WAS NOT TESTED PRIOR TO THE PROCEDURE. PRE-PROCEDURAL MEDICATIONS INCLUDED THE FOLLOWING: 75MG CLOPIDOGREL AND ACTILYSE 68ML (14:57 BOLUS, 7ML + 60-MINUTE INFUSION). HEPARIN WAS NOT ADMINISTERED DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 21B084AV PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. HEMORRHAGE SECONDARY TO VESSEL TRAUMA OR INJURY IS A WELL-KNOWN EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION ASSOCIATED WITH THE EMBOTRAP III REVASCULARIZATION DEVICE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS SUCH AS VESSEL CHARACTERISTICS, CLOT BURDEN/CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND MECHANICAL MANIPULATION OF DEVICES WITHIN THE ARTERY THAT MAY HAVE CONTRIBUTED. THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED OR THAT IT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. SINCE THE RELATIONSHIP OF THE EMBOTRAP DEVICE TO THE REPORTED EVENT CANNOT BE CLEARLY ESTABLISHED, THE EVENT MEETS MDR REPORTING CRITERIA WITH THE CLASSIFICATION OF ¿SERIOUS INJURY¿. THE EMBOVAC ASPIRATION CATHETER WILL NOT BE CAPTURED IN ASSOCIATION WITH THE SAB AS THE TREATING PHYSICIAN REPORTED THAT THE EVENT WAS SECONDARY TO EXTREME VESSEL STRESS IN THE DISTAL M2 BRANCH. THE EMBOVAC WAS NOT USED IN THE DISTAL M2 BRANCH. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE MEDICAL IMAGING WAS REVIEWED BY AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT, NEUROVASCULAR SURGEON ON 29-JUL-2021. THE ASSESSMENT READS AS FOLLOWS: "A REPORT OF SUBARACHNOID HEMORRHAGE AFTER DEPLOYMENT OF A 5 MM X 37 MM EMBOTRAP III IN THE RIGHT MCA M2 IS MADE. THE REPORT IS ACCOMPANIED BY THREE ANGIOGRAPHIC IMAGES. NO OTHER DETAILS ACCOMPANY THE REPORT. THE FIRST IMAGE DEMONSTRATES A MICROCATHETER IN THE RIGHT MCA M2 THE SECOND AND THIRD IMAGES DEMONSTRATE AN EMBOTRAP IN THE RIGHT MCA DISTAL M2 AND AN ASPIRATION CATHETER IN THE MCA M1 SEGMENT. THERE IS NO SIGNIFICANT VESSEL TORTUOSITY. NO CT SCAN IS AVAILABLE. BY REPORT THERE IS SUBARACHNOID HEMORRHAGE BUT NO SICH. PER REPORT THE PATIENT IMPROVED FROM AN NIHSS OF 5 TO 1. POST THROMBECTOMY HEMORRHAGES (ICH AND SAH) ARE KNOWN COMPLICATIONS OF MECHANICAL THROMBECTOMY. THE RISK OF HEMORRHAGE INCREASES WITH REPEAT MANEUVERS AND MORE DISTAL POSITIONING OF DEVICES. ONE POSSIBLE MECHANISM FOR SUCH BLEEDS IS SMALL PERFORATING VESSEL TEARS AS A RESULT OF SHEARING FORCES GENERATED DURING DEVICE MANIPULATIONS." THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 21B084AV PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT THE PATIENT SUFFERED FROM A SUBARACHNOID BLEED (SAB) AFTER USE OF A 5MM X 37MM EMBOTRAP III (ET307537/21B084AV) REVASCULARIZATION DEVICE. THE PATIENT INITIALLY PRESENTED WITH A MIDDLE CEREBRAL ARTERY (M2 SEGMENT) OCCLUSION AND THE EMBOTRAP DEVICE WAS USED FOR A TOTAL OF THREE PASSES. THE EVENT DID NOT RESULT IN A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH). THE PATIENT¿S BASELINE NIHSS SCORE HAD IMPROVED FROM 5 TO 1. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, MEDICAL IMAGING WAS PROVIDED AND FORWARDED TO AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT, NEUROVASCULAR SURGEON FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170980 EMBOTRAP III 5 MM X 37 MM CATHETER, THROMBUS RETRIEVER NRY NEURAVI LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1