Artemis AP28-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00814548017877), received between Nov 14, 2017 and Dec 31, 2025 — classified as 4 deaths, 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THE CASE WAS NEARLY COMPLETE WHEN THE ARTEMIS BECAME CLOGGED AFTER APPROXIMATELY NINETY MINUTES OF USE. AT THAT POINT, THE PHYSICIAN REALIZED THEY WERE ON THE WRONG TRAJECTORY AND NOTICED A VESSEL INJURY TO THE RIGHT A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). THE CLOGGED ARTEMIS WAS REMOVED AND REPLACED WITH A NEW DEVICE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. TO ADDRESS THE VESSEL INJURY, THE PHYSICIAN PERFORMED IRRIGATION AND ELECTRO-CAUTERY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT STATUS.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 23936906 ↗
• DeathJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A MICRO NEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). ON (B)(6) 2023, WE RECEIVED A NOTIFICATION FROM THE CLINICAL TEAM THAT AN INTRAOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A RIGHT THALAMIC POSTERIOR LIMB INTERNAL CAPSULE HEMORRHAGE. A NEW BLEED WAS ALSO NOTICED IN THE OPPOSITE HEMISPHERE FROM SURGICAL SITE. THE PATIENT EXPIRED ON (B)(6) 2023. THE HEMORRHAGE AND DEATH WERE REPORTED TO HAVE A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17330250 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT A MICRO NEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS NO SUCTION AND THAT THE ARTEMIS HAD BECOME CLOGGED AFTER FIVE MINUTES OF USE. THEREFORE, THE ARTEMIS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. ON (B)(6) 2023, A SECOND NOTIFICATION WAS RECEIVED FROM THE CLINICAL TEAM REPORTING THAT AN INTRAOPERATIVE COMPUTERIZED TOMOGRAPHY (CT) SCAN TAKEN ON (B)(6) 2022 REVEALED A RECURRENT HEMORRHAGE LARGER THAN THE PRIOR HEMORRHAGE. THE CRANIOTOMY WAS THEN EXTENDED, AND NAVIGATION WAS USED FOR A NEW ENTRY POINT AND CRANIOTOMY DEFECT WAS ENLARGED. A FULL 3CM CRANIOTOMY WAS PERFORMED. THE ENTRY POINT WAS THE SUPERIOR FRONTAL SULCUS. SUCTION WAS ADVANCED INTO THE CLOT AND USED TO REMOVE THE CLOT. BIPOLAR CAUTERY WAS USED FOR HEMOSTASIS. THE RECURRENT HEMORRHAGE WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16339687 ↗
• DeathJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 23-MAR-2021, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING ARTEMIS NEURO EVACUATION DEVICE. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2021, THE PATIENT¿S POST-PROCEDURE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED INTRAVENTRICULAR HEMORRHAGE (IVH) IN THE BILATERAL FRONTAL HORNS, THALAMIC ICH, AND RIGHT SYLVIAN SUBARACHNOID HEMORRHAGE (SAH). ON (B)(6) 2021, A FOLLOW UP CT HEAD SCAN DEMONSTRATED STABLE RESIDUAL IVH. ON (B)(6) 2021, UPON USAGE OF EXTERNAL VENTRICULAR DRAIN (EVD), A CT SCAN SHOWED REDEMONSTRATION OF BLOOD PRODUCTS ALONG THE ROUTE OF A PREVIOUS VENTRICULOSTOMY CATHETER. BLOOD PRODUCTS ADJACENT TO THE LEFT THALAMUS AND A SMALL VOLUME OF IVH OF THE LEFT OCCIPITAL HORN WERE ALSO FOUND. ON (B)(6) 2021, AFTER THE INDEX PROCEDURE, THE PATIENT IMPROVED AND WAS MEDICALLY AND NEUROSURGICALLY CLEARED FOR DISCHARGE TO ACUTE NURSING REHABILITATION WITH PLANS TO CONTINUE LOVENOX (ENOXAPARIN) TO COUMADIN BRIDGE. ON (B)(6) 2021, THE PATIENT WAS FOUND TO BE IN RESPIRATORY DISTRESS WITH SEPSIS AND SEPTIC SHOCK. THE PATIENT WAS INTUBATED, TREATED WITH VASOPRESSORS AND ANTIBIOTICS, AND A CT HEAD WAS SUGGESTIVE FOR MASSIV

  Patient problems: Intracranial Hemorrhage

  MAUDE report 14692161 ↗
• DeathDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MINIMALLY INVASIVE SURGERY (MIS) PROCEDURE IN THE RIGHT PARIETAL AND OCCIPITAL LOBES USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THE ULTRASOUND DURING THE PROCEDURE SHOWED GOOD EVACUATION OF THE HEMORRHAGE, AND NO PROCEDURAL COMPLICATIONS WERE REPORTED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND REMAINED INTUBATED AND SEDATED WHILE BEING TRANSFERRED FOR A ROUTINE POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD. THE CT SCAN REVEALED A LARGE RE-HEMORRHAGE AT THE SAME SITE WITH EXTENSION INTO THE RIGHT VENTRICLE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM (OR) AND UNDERWENT A RIGHT CRANIOTOMY, EVACUATION OF THE RE-HEMORRHAGE, AND INSERTION OF AN EXTERNAL VENTRICULAR DRAIN (EVD). THE PATIENT WAS THEN TRANSFERRED TO THE NEUROLOGICAL CRITICAL CARE UNIT (NCCU). ON (B)(6) 2021, THE PATIENT DEMONSTRATED A WORSENING IN HIS NEUROLOGICAL EXAMINATION. IMMEDIATELY FOLLOWING THIS, THE PATIENT HAD A CT DEMONSTRATING NEW AREAS OF HEMORRHAGE AND EXTENSIVE EDEMA LATERAL TO THE PRIMARY HEMORRHAGE WITHIN THE PARIETAL LOBE WITH MARKED ASSOCIATED MIDLINE SHIFT. THE PATIENT WAS TRANSFERRED TO THE OR FOR ANOTHER CRANIOTOMY AND HEMOR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12981477 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MICRO NEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE. ON (B)(6) 2021, THE COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED POST MIS PROCEDURE REVEALED A TINY AMOUNT OF BLOOD WITHIN THE DEPENDENT PORTIONS OF THE LATERAL VENTRICLES. THERE WAS RIGHTWARD DISPLACEMENT AND COMPRESSION OF THE LATERAL AND 3RD VENTRICLES. IT SHOULD BE NOTED THAT NO ACTION WAS TAKEN TO TREAT THE INTRAVENTRICULAR HEMORRHAGE (IVH). HOWEVER, THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021 AND THE PATIENT WAS DISCHARGED TO SKILLED NURSING FACILITY ON (B)(6) 2021 FOR MEDICAL MANAGEMENT. THE CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THE INTRAVENTRICULAR HEMORRHAGE (IVH) AS AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX INTRACEREBRAL HEMORRHAGE (ICH) AND THE INDEX PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 12840804 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). ON 18-MAY-2021, THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN INTERVAL INCREASE IN SIZE OF RIGHT BASAL GANGLIA HEMATOMA AND INCREASED ASSOCIATED MASS EFFECT COMPARED TO THE (B)(6) 2021 EXAM, WITH SUSPECTED INTERVAL REBLEEDING. IT SHOULD BE NOTED THAT A FOLLOW-UP CT SCAN WAS DONE ON (B)(6) 2021 AND THE INTERVAL REBLEEDING WAS RESOLVED. INCREASE IN SIZE OF RIGHT BASAL GANGLIA HEMATOMA WAS ADJUDICATED TO BE AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX PROCEDURE, THE INDEX INTRACEREBRAL HEMORRHAGE (ICH) AND TO THE COMORBIDITY BY THE CLINICAL EVENTS COMMITTEE (CEC). ON 02-NOV-2021, WE RECEIVED AN UPDATE INDICATING THAT THE CLINICAL EVENTS COMMITTEE (CEC) DETERMINED THE INTRACRANIAL HEMORRHAGE TO BE AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX PROCEDURE AND THE INDEX INTRACEREBRAL HEMORRHAGE (ICH).

  Patient problems: Hematoma

  MAUDE report 12110517 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2021, THE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A WORSENING OF THE INTRAVENTRICULAR HEMORRHAGE (IVH). IT SHOULD BE NOTED THAT NO ACTION WAS TAKEN TO TREAT THE WORSENING OF THE IVH. ON (B)(6) 2021, THE PATIENT EXPIRED DUE TO CARDIOPULMONARY ARREST. THE PATIENT''S DEATH WAS REPORTED TO BE UNRELATED TO THE ARTEMIS. THE WORSENING OF THE IVH WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND INDEX PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11901154 ↗
• MalfunctionMay 13, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO TREAT THE RIGHT FRONTAL INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE ARTEMIS BIDENT WAS NO LONGER TURNING AND THAT THERE WAS NO INDICATOR SOUND COMING FROM THE ARTEMIS. THEREFORE, THE ARTEMIS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821524 ↗
• MalfunctionMay 4, 2021Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ARTEMIS WAND WAS ADVANCED THROUGH THE ENDOSCOPE TO THE HEMATOMA AND CLOT EVACUATION WAS INITIATED. SUBSEQUENTLY, SIGNIFICANT ARTERIAL BLEEDING WAS ENCOUNTERED. IRRIGATION WAS CONTINUED AND SEVERAL ATTEMPTS TO CAUTERIZE THE BLEED WERE PERFORMED; HOWEVER, THE BLEEDING CONTINUED. THE ARTEMIS THEN BECAME CLOGGED AND WOULD NOT ASPIRATE. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. WHILE USING THE NEXT TWO CONSECUTIVE ARTEMIS DEVICES THEY BECAME CLOGGED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WANDS; THEREFORE, THEY WERE REMOVED FROM THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION FOR AN OPEN CRANIOTOMY. DURING THE OPERATION, THE PHYSICIAN DETERMINED THAT THE HEMORRHAGE WAS A RUPTURED ARTERIOVENOUS MALFORMATION (AVM). ATER OPERATING FOR SOME TIME, ADEQUATE HEMOSTASIS WAS ACHIEVED AND THE OPERATION WAS ENDED. ON (B)(6) 2021, THE SITE DECIDED THAT THE AVM RUPTURE WAS A SERIOUS ADVERSE EVENT THAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769818 ↗
• MalfunctionMay 4, 2021Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ARTEMIS WAND WAS ADVANCED THROUGH THE ENDOSCOPE TO THE HEMATOMA AND CLOT EVACUATION WAS INITIATED. SUBSEQUENTLY, SIGNIFICANT ARTERIAL BLEEDING WAS ENCOUNTERED. IRRIGATION WAS CONTINUED AND SEVERAL ATTEMPTS TO CAUTERIZE THE BLEED WERE PERFORMED; HOWEVER, THE BLEEDING CONTINUED. THE ARTEMIS THEN BECAME CLOGGED AND WOULD NOT ASPIRATE. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. WHILE USING THE NEXT TWO CONSECUTIVE ARTEMIS DEVICES THEY BECAME CLOGGED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WANDS; THEREFORE, THEY WERE REMOVED FROM THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION FOR AN OPEN CRANIOTOMY. DURING THE OPERATION, THE PHYSICIAN DETERMINED THAT THE HEMORRHAGE WAS A RUPTURED ARTERIOVENOUS MALFORMATION (AVM). ATER OPERATING FOR SOME TIME, ADEQUATE HEMOSTASIS WAS ACHIEVED AND THE OPERATION WAS ENDED. ON (B)(6) 2021, THE SITE DECIDED THAT THE AVM RUPTURE WAS A SERIOUS ADVERSE EVENT THAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769806 ↗
• MalfunctionMay 4, 2021Obstruction of Flow; Suction Failure; Obstruction of Flow; Suction Failure

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) AND A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). DURING THE PROCEDURE, THE ARTEMIS WAND WAS ADVANCED THROUGH THE ENDOSCOPE TO THE HEMATOMA AND CLOT EVACUATION WAS INITIATED. SUBSEQUENTLY, SIGNIFICANT ARTERIAL BLEEDING WAS ENCOUNTERED. IRRIGATION WAS CONTINUED AND SEVERAL ATTEMPTS TO CAUTERIZE THE BLEED WERE PERFORMED; HOWEVER, THE BLEEDING CONTINUED. THE ARTEMIS THEN BECAME CLOGGED AND WOULD NOT ASPIRATE. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. WHILE USING THE NEXT TWO CONSECUTIVE ARTEMIS DEVICES THEY BECAME CLOGGED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WANDS; THEREFORE, THEY WERE REMOVED FROM THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN STABLE CONDITION FOR AN OPEN CRANIOTOMY. DURING THE OPERATION, THE PHYSICIAN DETERMINED THAT THE HEMORRHAGE WAS A RUPTURED ARTERIOVENOUS MALFORMATION (AVM). ATER OPERATING FOR SOME TIME, ADEQUATE HEMOSTASIS WAS ACHIEVED AND THE OPERATION WAS ENDED. ON (B)(6) 2021, THE SITE DECIDED THAT THE AVM RUPTURE WAS A SERIOUS ADVERSE EVENT THAT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769805 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED. ON (B)(6) 2020, THE PATIENT DISPLAYED A SLIGHT INCREASED PROMINENCE OF THE LATERAL VENTRICLES AND AN INTRAVENTRICULAR RE-HEMORRHAGE IN THE OCCIPITAL HORNS WAS NOTED. HOWEVER, THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2020. ON (B)(6) 2020 WE WERE MADE AWARE THAT THE CEC ADJUDICATED THE RE-HEMORRHAGE TO BE A SERIOUS ADVERSE EVENT RELATED TO ARTEMIS, TO THE PROCEDURE, TO THE PATIENT¿S COMORBIDITY, AND TO THE INDEX INTRACRANIAL HEMORRHAGE (ICH). ON (B)(6) 2021, WE WERE MADE AWARE THAT THE PATIENT SUFFERED HYDROCEPHALUS ON (B)(6) 2020. THE COMPUTED TOMOGRAPHY SCAN (CT) REVEALED WORSENING EXTRA-AXIAL COLLECTION AND LEFT CEREBRAL CONVEXITY, AS WELL AS WORSENING MIDLINE SHIFT AND VENTRICULAR DILATATION. IT WAS ALSO NOTED THAT THERE WAS PROBABLY TRANSEPENDYMAL FLOW CEREBROSPINAL FLUID (CSF). A MEDICAL PROCEDURE WAS PERFORMED TO TREAT THE HYDROCEPHALUS AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2020. THE CEC ADJUDICATED THE HYDROCEPHALUS TO BE A SERIOUS ADVERSE EVENT RELATED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hydrocephalus

  MAUDE report 11412685 ↗
• MalfunctionNov 20, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO EVACUATE A HEMATOMA USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, WHILE ATTEMPTING TO USE THE ARTEMIS WITHIN THE PATIENT, THE PHYSICIAN NOTICED THE ARTEMIS ASPIRATION WAS WEAK. THE PHYSICIAN RESET THE ARTEMIS TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE ARTEMIS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10880250 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A MEDICAL PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). AFTER BLOOD EVACUATION WITH THE ARTEMIS, EVIDENCE OF A NEW ISCHEMIC STROKE WAS DETERMINED ON COMPUTERIZED TOMOGRAPHY (CT) SCANS. POSTOPERATIVE SEIZURES WERE LIKELY DUE TO THIS STROKE. IN ADDITION, HOLOCEPHALIC LEFT SUBDURAL HEMATOMA WAS LIKELY THE CAUSE OF THE LEFT HEMISPHERIC FOCAL STATUS EPILEPTICUS. THE EVENTS WERE CONSIDERED UNRESOLVED AT THE TIME OF THE STUDY. ON (B)(6) 2019, THE PATIENT EXPIRED FROM SEPSIS IN THE SETTING OF THE ICH. THE PATIENT'S DEATH WAS UNRELATED TO THE ARTEMIS. THE ISCHEMIC STROKE WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX ICH, THE INDEX PROCEDURE, AND COMORBIDITY. THE SUBDURAL HEMATOMA WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT RELATED TO THE ARTEMIS AND INDEX PROCEDURE.

  Patient problems: Hematoma; Ischemia Stroke

  MAUDE report 10830888 ↗
• MalfunctionMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WAS NO REPORT OF DEVICE MALFUNCTION DURING THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT STARTED ON HEPARIN DRIP FOR THE TREATMENT OF BILATERAL PULMONARY EMBOLISM (PE). ON (B)(6) 2020 AT 04:37, A COMPUTED TOMOGRAPHY SCAN (CT SCAN) SHOWED STABLE EXAMINATION. ON (B)(6) 2020 AT 17:16, A CT SCAN SHOWED ACUTE 7.6 CENTIMETERS INTRAPARENCHYMAL HEMATOMA (IPH) IN THE RIGHT BASAL GANGLIA WITH ASSOCIATED VASOGENIC EDEMA AND 10 MILLIMETERS LEFTWARD SHIFT. THE PATIENT WAS ASYMPTOMATIC AND THE RE-BLEED WAS AN INCIDENTAL FINDING ON THE CT SCAN. ALL ANTICOAGULANT/ANTIPLATELET TREATMENT WAS IMMEDIATELY DISCONTINUED, AND PROTAMINE WAS GIVEN. ON (B)(6) 2020, A CT SCAN SHOWED STABLE IPH. AS OF (B)(6) 2020, THE EVENT IS STILL ONGOING AND THE PATIENT IS UNDER STANDARD OF CARE TREATMENT PLAN. THE ACUTE IPH WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND THE INDEX PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10102190 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY. ON (B)(6) 2020, THE PATIENT WAS NOTICED TO BEGIN EXPERIENCING SEIZURE-LIKE ACTIVITY. THE PATIENT¿S EYES WOULD ROLL BACK, THEIR BODY WOULD SHAKE, AND THE PATIENT WOULD TAKE SEVERAL DEEP BREATHS. THESE SYMPTOMS WOULD LAST FOR A FEW SECONDS BEFORE RESOLVING AND WOULD REOCCUR EVERY THIRTY MINUTES. ON (B)(6) 2020, WHILE UNDERGOING PHYSICAL THERAPY, THESE SYMPTOMS WERE NOTICED TO REOCCUR EVERY TWO MINUTES. THE PATIENT WOULD CLAMP THEIR EYES SHUT. UPON OPENING THEIR EYES, THE PATIENT¿S EYES WOULD ROLL BACK. IT WAS UNKNOWN IF THE PATIENT WAS EXPERIENCING SEIZURES OR IF THE PATIENT WAS HAVING PULMONARY EMBOLISM. ON (B)(6) 2020, THE PATIENT WAS SENT TO THE EMERGENCY ROOM REGARDING THESE SYMPTOMS FOR FURTHER EVALUATION AND TREATMENT; SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED. COMPUTED TOMOGRAPHY (CT) SCANS FOR THE BRAIN AND CHEST, AN ELECTROENCEPHALOGRAM (EEG) AND VENTILATION-PERFUSION SCAN OF THE LUNG WERE PERFORMED

  Patient problems: Brain Injury; Seizures; Tissue Damage

  MAUDE report 10040873 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). ON (B)(6) 2019, A FOLLOW UP 24-HOUR COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A SMALL AMOUNT OF HEMORRHAGE WAS NOTED IN THE VENTRICLES; HOWEVER, THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019. THE INTRAVENTRICULAR HEMORRHAGE (IVH) WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE ARTEMIS AND THE INDEX PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9885407 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO EVACUATE A RIGHT PRIMARILY DEEP INTRACEREBRAL HEMORRHAGE USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WAS NO REPORTED COMPLICATION OR DEVICE MALFUNCTION DURING THE PROCEDURE. HOWEVER, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED 24 HOURS POST-PROCEDURE INDICATED THE PRESENCE OF TRACE INTRAVENTRICULAR BLOOD. ON (B)(6) 2020, THE PATIENT WAS REPORTEDLY IMPROVING AND WAS DISCHARGED TO THE GENERAL MEDICAL/SURGICAL WARD. THE INTRAVENTRICULAR BLOOD WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE ARTEMIS AND INDEX PROCEDURE.

  Patient problems: Hemorrhage, Intraventricular

  MAUDE report 9851259 ↗
• MalfunctionFeb 6, 2020Complete Blockage; Complete Blockage

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, IT WAS REPORTED THAT THE ARTEMIS BECAME CLOGGED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677966 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE TO TREAT AN INTRACEREBRAL HEMORRHAGE (ICH) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). FOLLOWING THE PROCEDURE, A COMPUTED TOMOGRAPHY SCAN (CT SCAN) SHOWED A RE-HEMORRHAGE OF 8 CC IN VOLUME INTO THE TISSUE BED WITH MASS EFFECT, MIDLINE SHIFT AND, RIGHT UNCAL HERNIATION. THE RE-HEMORRHAGE WAS TREATED WITH STANDARD MEDICAL MANAGEMENT. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2019 IN STABLE CONDITION AND NO MEDICATIONS, BLOOD TRANSFUSION AND MEDICAL PROCEDURE WERE REQUIRED TO ADDRESS THE RE-HEMORRHAGE INTO THE TISSUE BED. THE RE-HEMORRHAGE INTO THE TISSUE BED WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX ICH, THE INDEX PROCEDURE, AND TO THE COMORBIDITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9100051 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A MICRONEUROSURGERY PROCEDURE PRIMARILY IN THE LOBAR SYSTEM USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). THERE WAS NO REPORTED COMPLICATION DURING THE PROCEDURE. HOWEVER, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AFTER THE PROCEDURE ON (B)(6) 2019 AND INDICATED A POSTSURGICAL BRAINSTEM BLEED WITH BLOOD PRODUCTS TRACKING INTERIORLY INTO THE POSTERIOR LIMB OF THE RIGHT INTERNAL CAPSULE, CEREBRAL PEDUNCLE, AS WELL AS THE DORSAL MIDBRAIN AND PONS. IT WAS REPORTED THAT THERE WAS A STABLE 6 MM MIDLINE SHIFT AND INTERVAL DECREASE IN THE SIZE OF THE LEFT LATERAL VENTRICLE. SUBSEQUENTLY, CONTINUOUS ELECTROENCEPHALOGRAPHY (CEEG) MONITORING WAS PERFORMED FOR A 24-HOUR PERIOD AND IT WAS NOTED THAT THE PATIENT'S CLINICAL EXAM RESULTS DECREASED. THE PATIENT DID NOT FOLLOW COMMANDS, FLEXED IN BILATERAL LOWER EXTREMITIES (B/L LE), EXTENDED IN BILATERAL UPPER EXTREMITIES (B/L UE), AND HAD A WEAK COUGH. THE BRAINSTEM BLEED WAS CONSIDERED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO BOTH THE ARTEMIS AND TO THE INDEX PROCEDURE. ON (B)(6) 2019, THE PATIENT SUFFERED A RIGHT OCCIPITAL LOBE STROKE. SUBSEQUENTLY, ANOTHER CT SCAN WA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8880394 ↗
• DeathJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT A RIGHT FRONTAL INTRACEREBRAL HEMORRHAGE (ICH), USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS) ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT DEVELOPED DELIRIUM. THE PHYSICIAN; THEREFORE, ADMINISTERED MEDICATION FOR AGITATION AND FLUCTUATING LEVELS OF ALERTNESS. ADDITIONAL INFORMATION WAS RECEIVED ON 28-AUG-2018 INDICATING THAT THE PRINCIPLE INVESTIGATOR (PI) UPDATED HIS OPINION ON THIS EVENT AND REPORTED IT TO BE NOT RELATED TO ARTEMIS. APPROXIMATELY EIGHT MONTHS LATER, AN UPDATE WAS RECEIVED ON (B)(6) 2019 INDICATING THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED SUBDURAL HYGROMA. THE SUBDURAL HYGROMA WAS ADJUDICATED TO BE AN ADVERSE EVENT RELATED TO THE ARTEMIS, INDEX INTRACEREBRAL HEMORRHAGE (ICH), THE INDEX PROCEDURE AND UNRELATED TO THE COMORBIDITY. AN UPDATE RECEIVED ON 05-MAY-2019 INDICATED THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED INCREASED RESPIRATORY DISTRESS AND BECAME UNRESPONSIVE. THEREFORE, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND WAS INTUBATED. AFTER DISCUSSION WITH THE FAMILY, IT WAS FELT THAT THE PATIENT WOULD NOT WANT TO CONTINUE AGGRESSIVE MEDICAL CARE, GIVEN HIS PROTRACTED RECOVERY TO DATE, AN

  Patient problems: Death; Hemorrhage, Subarachnoid; Respiratory Distress

  MAUDE report 8666312 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A MINIMALLY INVASIVE SURGERY (MIS) USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). IT WAS REPORTED THAT THE CT SCAN SHOWED THE PATIENT HAD A RE-BLEEDING INTRACEREBRAL HEMORRHAGE (ICH). THEREFORE, THE PATIENT UNDERWENT ANOTHER MIS WITH AN ARTEMIS. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2019. THIS RE-BLEEDING ICH WAS ADJUDICATED TO BE AN ADVERSE EVENT RELATED TO THE ARTEMIS, THE INDEX ICH, THE INDEX PROCEDURE, AND TO THE COMORBIDITY WITH THE ATRIAL FIBRILLATION WHICH REQUIRED TREATMENT WITH ELIQUIS.

  Patient problems: Hemorrhage, Subdural

  MAUDE report 8660813 ↗
• MalfunctionApr 9, 2019Complete Blockage; Complete Blockage

  THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE IN A VENTRICLE IN THE BRAIN USING AN ARTEMIS NEURO EVACUATION DEVICE (ARTEMIS). DURING THE PROCEDURE, THE PHYSICIAN WAS TREATING A HEMORRHAGE USING THE ARTEMIS AND REPORTED THAT THE ARTEMIS WAND BECAME CLOGGED AFTER EVACUATING HALF OF THE CLOT. IT WAS ALSO REPORTED THAT THE CLOT WAS VERY TOUGH AND ORGANIZED. THE PHYSICIAN WAS UNABLE TO UNCLOG THE ARTEMIS WAND AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ARTEMIS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8498030 ↗