BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOTRAP III 5 MM X 37 MM

    MDR report key: 10735000 · Received October 26, 2020

    Report

    Report Number
    3011370111-2020-00076
    Event Type
    Death
    Date Received
    October 26, 2020
    Date of Event
    October 3, 2020
    Report Date
    October 6, 2020
    Manufacturer
    NEURAVI LTD.
    Product Code
    NRY
    UDI-DI
    10886704084570
    PMA / PMN Number
    K193063
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: PC-000781960. THE PURPOSE OF THIS MDR SUBMISSION IS TO MAKE A CORRECTION TO SECTION D: THE SUSPECT MEDICAL DEVICE CATALOG. THE CATALOG IN D.4 HAS BEEN CORRECTED FROM ET309537 TO ET307537. CORRECTED SECTION: D.4. UPDATED SECTIONS: D.4, G.4, G.7, H.2, AND H.10. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO MAKE A CORRECTION TO THE COMMON DEVICE NAME IN SECTION D.2. SECTION D.2 DOCUMENTED THE INCORRECT DEVICE NAME. THE CORRECT DEVICE NAME IS CATHETER, THROMBUS RETRIEVER. CORRECTED SECTION: D.2. UPDATED SECTIONS: D.2, G.4, G.7, H.2, AND H.10. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS MAKE A CORRECTION TO THE INVESTIGATION CONCLUSIONS AND INVESTIGATION FINDINGS. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CORRECTED DATA: INVESTIGATION CONCLUSIONS. INVESTIGATION FINDINGS. IN THIS SUPPLEMENTAL REPORT, THE CODES HAVE BEEN ADDED TO THESE FIELDS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 05 JANUARY 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 05 JANUARY 2021, THE INFORMATION INDICATED THAT THE DATE OF DEATH IS (B)(6) 2020. THE ADDITIONAL INFORMATION ALSO INDICATED THAT THE ANONYMIZED IMAGES/ANGIOGRAPHS OF THE PROCEDURE AND THE LOT NUMBER OF THE DEVICE USED ARE NOT AVAILABLE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS MAKE A CORRECTION TO THE PATIENT CODES. THE PATIENT CODES VESSEL PERFORATION WAS ADDED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. THE PRODUCT LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE INITIAL REPORTER PHONE: (B)(6). THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. [CONCLUSION]: THE EVENT WAS REPORTED FROM THE FIELD THAT A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED WITH A MIDDLE CEREBRAL ARTERY (M1 / M2) OCCLUSION WITH ASSOCIATED STROKE HAD EXPERIENCED A SUBARACHNOID HEMORRHAGE (SAH) DURING THE THROMBECTOMY PROCEDURE. IT WAS REPORTED THAT THE PATIENT ULTIMATELY EXPIRED THE FOLLOWING DAY. TWO PASSES WERE MADE WITH THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / LOT# UNKNOWN). THE CLOT WAS NOT COMPLETELY REMOVED. AFTER THE SECOND PASS, THE PHYSICIAN NOTICED FURTHER SMALLER OCCLUSIONS IN THE SIDE M2 BRANCHES AND DECIDED TO ADMINISTER THROMBOLYTIC DRUG TREATMENT. THE OCCLUSION WAS RESOLVED, AND THE PATIENT WAS REPORTED TO BE DOING FINE; SHE WAS ABLE TO MOVE HER ARM. HOWEVER, THE PHYSICIAN OBSERVED CONTRAST MEDIA FLOWING INTO THE SUBARACHNOID SPACE. COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED 24-HOURS POST-PROCEDURE CONFIRMED THE HEMORRHAGE AND THE PATIENT EXPIRED. NO DEVICE DEFICIENCIES WERE REPORTED. ON 22 OCTOBER 2020, A POWERPOINT PRESENTATION WAS RECEIVED. THE KEY POINTS OF THE CASE WERE SUMMARIZED. THE PATIENT HAD A MEDICAL HISTORY OF POOR HEART FUNCTION (EJECTION RATE: 20% TO 30%), OPIOID ALLERGY, AND SARCOIDOSIS DISEASE. SHE ARRIVED AT THE HOSPITAL 9-10 HOURS AFTER SYMPTOM ONSET; THEREFORE, SHE WAS NOT ELIGIBLE FOR INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA). IT WAS NOTED THAT THE PATIENT WAS ¿MOVING A LOT¿ DURING THE PROCEDURE. DUE TO THE PATIENT¿S BAD HEART FUNCTION, GENERAL ANESTHESIA COULD NOT BE ADMINISTERED. THE DEVICE SET UP CONSISTED OF A 9F MERCI® BALLOON GUIDE CATHETER (STRYKER), 6F SOFIA® INTERMEDIATE CATHETER (MICROVENTION-TERUMO), 0.021¿ PROWLER SELECT PLUS MICROCATHETER (CERENOVUS), AND THE 5MM X 37MM EMBOTRAP III DEVICE. DURING THE FIRST PASS MADE WITH THE EMBOTRAP III, THERE WAS A BYPASS EFFECT AND ¿SOME¿ CLOT WAS RETRIEVED. CONTROL ANGIOGRAPHY DEMONSTRATED PARTIAL REVASCULARIZATION. THERE WAS RE-OPENING OF THE M1 AND A PARTIAL RE-OPENING OF THE M2. THE PHYSICIAN OBSERVED SEVERAL DISTAL CLOT FRAGMENTS IN THE M2, WHICH LED TO THE DECISION TO ADMINISTER 8MG INTRA-ARTERIAL RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RTPA) IN AN EFFORT TO DISSOLVE THE DISTAL CLOT. DURING THE CASE REVIEW DISCUSSION, THE PHYSICIAN SPECIFICALLY MENTIONED ¿MAYBE THIS WAS A MISTAKE.¿ THE EMBOTRAP III WAS THEN DELIVERED TO THE M2 SUPERIOR BRANCH FOR THE SECOND PASS (THE DISTAL PART OF THE DEVICE WAS STILL PROXIMAL TO THE SYLVIAN POINT). A SMALL AMOUNT OF THE CLOT WAS RETRIEVED, BUT AT LEAST TWO BRANCHES (M2 / M3) REMAINED OCCLUDED. A THIRD PASS WAS MADE WITH THE EMBOTRAP III AT THE M2 SUPERIOR BRANCH (DISTAL PART OF DEVICE SLIGHTLY BEYOND SYLVIAN POINT, PERHAPS THE FINAL CAGE AND TIP). THE PHYSICIAN FELT IT WAS SUFFICIENT TO STOP THE PROCEDURE AT THIS POINT DESPITE ¿NOT GREAT¿ RECANALIZATION. HOWEVER, UPON LATER REVIEW OF THE IMAGES, THE CONTROL ANGIOGRAPHY SHOWED SLIGHT CONTRAST EXTRAVASATION NEAR THE SITE OF THE EMBOTRAP III DEPLOYMENT. THE PROCEDURE END TIME WAS 8:10 AM. COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED IMMEDIATELY AFTER THE PROCEDURE REVEALED CONSIDERABLE CONTRAST IN THE SUBARACHNOID SPACE. THE CLINICAL STATUS OF THE PATIENT POST-THROMBECTOMY WAS ¿GOOD, SHE WAS BETTER THAN BEFORE.¿ THE PATIENT WAS UNDERSTANDING WHAT THE PHYSICIAN STATED AND WAS ABLE TO ANSWER QUESTIONS WITH ¿YES¿ OR ¿NO.¿ SHE WAS ABLE TO MOVE HER RIGHT ARM (SHE WAS NOT ABLE TO DO THIS AT BASELINE). SHE HAD A HEADACHE AND RESIDUAL APHASIA. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE STROKE UNIT. APPROXIMATELY FOUR HOURS FOLLOWING THE PROCEDURE (12:00 PM), THE PATIENT¿S CLINICAL CONDITION DETERIORATED. CT SCAN SHOWED SIGNIFICANT BLEEDING WITH COMPRESSION OF PARENCHYMA AND VENTRICLES DUE TO MASS EFFECT, GOING TOWARDS THE BRAINSTEM. THE PATIENT WAS EVALUATED BY A NEUROSURGEON FOR EMERGENCY HEMI-CRANIOTOMY; HOWEVER, SHE ULTIMATELY EXPIRED. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. VESSEL PERFORATION, HEMORRHAGE, AND DEATH ARE WELL-KNOWN EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATIONS ASSOCIATED WITH ENDOVASCULAR MECHANICAL THROMBECTOMY AND ARE LISTED IN THE EMBOTRAP III INSTRUCTIONS FOR USE (IFU) AS SUCH. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE PERFORATION CANNOT BE DETERMINED. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, TORTUOSITY, DEVICE SELECTION, MECHANICAL MANIPULATION OF DEVICES WITHIN THE ARTERY, AND PATIENT MOVEMENT, THAT MAY HAVE CONTRIBUTED. THERE WAS NO REPORT OF A DEVICE MALFUNCTION OR PERFORMANCE ISSUE, SUCH AS RESISTANCE TO WITHDRAWAL, ASSOCIATED WITH THE PERFORATION. WITH THE AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED FROM THE FIELD THAT A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED WITH A MIDDLE CEREBRAL ARTERY (M1 / M2) OCCLUSION WITH ASSOCIATED STROKE HAD EXPERIENCED A SUBARACHNOID HEMORRHAGE (SAH) DURING THE THROMBECTOMY PROCEDURE. IT WAS REPORTED THAT THE PATIENT ULTIMATELY EXPIRED THE FOLLOWING DAY. TWO PASSES WERE MADE WITH THE 5MM X 37MM EMBOTRAP III REVASCULARIZATION DEVICE (ET309537 / LOT# UNKNOWN). THE CLOT WAS NOT COMPLETELY REMOVED. AFTER THE SECOND PASS, THE PHYSICIAN NOTICED FURTHER SMALLER OCCLUSIONS IN THE SIDE M2 BRANCHES AND DECIDED TO ADMINISTER THROMBOLYTIC DRUG TREATMENT. THE OCCLUSION WAS RESOLVED, AND THE PATIENT WAS REPORTED TO BE DOING FINE; SHE WAS ABLE TO MOVE HER ARM. HOWEVER, THE PHYSICIAN OBSERVED CONTRAST MEDIA FLOWING INTO THE SUBARACHNOID SPACE. COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED 24-HOURS POST-PROCEDURE CONFIRMED THE HEMORRHAGE AND THE PATIENT EXPIRED. NO DEVICE DEFICIENCIES WERE REPORTED. ON 22 OCTOBER 2020, A POWERPOINT PRESENTATION WAS RECEIVED. THE KEY POINTS OF THE CASE WERE SUMMARIZED. THE PATIENT HAD A MEDICAL HISTORY OF POOR HEART FUNCTION (EJECTION RATE: 20% TO 30%), OPIOID ALLERGY, AND SARCOIDOSIS DISEASE. SHE ARRIVED AT THE HOSPITAL 9-10 HOURS AFTER SYMPTOM ONSET; THEREFORE, SHE WAS NOT ELIGIBLE FOR INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA). IT WAS NOTED THAT THE PATIENT WAS ¿MOVING A LOT¿ DURING THE PROCEDURE. DUE TO THE PATIENT¿S BAD HEART FUNCTION, GENERAL ANESTHESIA COULD NOT BE ADMINISTERED. THE DEVICE SET UP CONSISTED OF A 9F MERCI® BALLOON GUIDE CATHETER (STRYKER), 6F SOFIA® INTERMEDIATE CATHETER (MICROVENTION-TERUMO), 0.021¿ PROWLER SELECT PLUS MICROCATHETER (CERENOVUS), AND THE 5MM X 37MM EMBOTRAP III DEVICE. DURING THE FIRST PASS MADE WITH THE EMBOTRAP III, THERE WAS A BYPASS EFFECT AND ¿SOME¿ CLOT WAS RETRIEVED. CONTROL ANGIOGRAPHY DEMONSTRATED PARTIAL REVASCULARIZATION. THERE WAS RE-OPENING OF THE M1 AND A PARTIAL RE-OPENING OF THE M2. THE PHYSICIAN OBSERVED SEVERAL DISTAL CLOT FRAGMENTS IN THE M2, WHICH LED TO THE DECISION TO ADMINISTER 8MG INTRA-ARTERIAL RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RTPA) IN AN EFFORT TO DISSOLVE THE DISTAL CLOT. DURING THE CASE REVIEW DISCUSSION, THE PHYSICIAN SPECIFICALLY MENTIONED ¿MAYBE THIS WAS A MISTAKE.¿ THE EMBOTRAP III WAS THEN DELIVERED TO THE M2 SUPERIOR BRANCH FOR THE SECOND PASS (THE DISTAL PART OF THE DEVICE WAS STILL PROXIMAL TO THE SYLVIAN POINT). A SMALL AMOUNT OF THE CLOT WAS RETRIEVED, BUT AT LEAST TWO BRANCHES (M2 / M3) REMAINED OCCLUDED. A THIRD PASS WAS MADE WITH THE EMBOTRAP III AT THE M2 SUPERIOR BRANCH (DISTAL PART OF DEVICE SLIGHTLY BEYOND SYLVIAN POINT, PERHAPS THE FINAL CAGE AND TIP). THE PHYSICIAN FELT IT WAS SUFFICIENT TO STOP THE PROCEDURE AT THIS POINT DESPITE ¿NOT GREAT¿ RECANALIZATION. HOWEVER, UPON LATER REVIEW OF THE IMAGES, THE CONTROL ANGIOGRAPHY SHOWED SLIGHT CONTRAST EXTRAVASATION NEAR THE SITE OF THE EMBOTRAP III DEPLOYMENT. THE PROCEDURE END TIME WAS 8:10 AM. COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED IMMEDIATELY AFTER THE PROCEDURE REVEALED CONSIDERABLE CONTRAST IN THE SUBARACHNOID SPACE. THE CLINICAL STATUS OF THE PATIENT POST-THROMBECTOMY WAS ¿GOOD, SHE WAS BETTER THAN BEFORE.¿ THE PATIENT WAS UNDERSTANDING WHAT THE PHYSICIAN STATED AND WAS ABLE TO ANSWER QUESTIONS WITH ¿YES¿ OR ¿NO.¿ SHE WAS ABLE TO MOVE HER RIGHT ARM (SHE WAS NOT ABLE TO DO THIS AT BASELINE). SHE HAD A HEADACHE AND RESIDUAL APHASIA. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE STROKE UNIT. APPROXIMATELY FOUR HOURS FOLLOWING THE PROCEDURE (12:00 PM), THE PATIENT¿S CLINICAL CONDITION DETERIORATED. CT SCAN SHOWED SIGNIFICANT BLEEDING WITH COMPRESSION OF PARENCHYMA AND VENTRICLES DUE TO MASS EFFECT, GOING TOWARDS THE BRAINSTEM. THE PATIENT WAS EVALUATED BY A NEUROSURGEON FOR EMERGENCY HEMI-CRANIOTOMY; HOWEVER, SHE ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201192 EMBOTRAP III 5 MM X 37 MM EMBOTRAP III REVASCULARIZATION DEVICE NRY NEURAVI LTD. ET309537 10886704084570

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death 0.021¿ PROWLER SELECT PLUS(CERENOVUS)| 6F SOFIA® INTERMEDIATE CATHETER (MICROVENTION)| 9F MERCI® BALLOON GUIDE CATHETER (STRYKER)| 0.021¿ PROWLER SELECT PLUS(CERENOVUS)| 6F SOFIA® INTERMEDIATE CATHETER (MICROVENTION)| 9F MERCI® BALLOON GUIDE CATHETER (STRYKER)