Sofia DA6125ST-ASP-US-ODRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00842429108475), received between Apr 6, 2022 and Jun 18, 2025 — classified as 1 death, 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE AXIOM RESTORE STUDY: SUBARACHNOID HEMORRHAGE. (HEMORRHAGIC TRANSFORMATION) CT FINDINGS LIKELY FOUND HEMORRHAGIC TRANSFORMATION OF PRIOR INFARCT. TREATMENT FOR THIS INCLUDED REVERSING THE INR WITH VITAMIN K & AC WAS HELD WITH. CT WAS PERFORMED AND SHOWED STABLE HEMORRHAGE. NO OTHER INTERVENTION NEEDED. DATE OF SURGERY: (B)(6) 2024, RESOLVED WITHOUT SEQUELAE ON (B)(6) 2024. DIAGNOSTIC PROCEDURE PERFORMED FOLLOWING THE EVENT: SERIAL CT, NO FURTHER AE. SITE REPORTED EVENT RELATED TO: STUDY DISEASE RELATIONSHIP TO SOFIA: POSSIBLY. RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE: POSSIBLY RELATIONSHIP TO STUDY DISEASE: DEFINITELY. RELATIONSHIP TO CONCURRENT CONDITION / TREATMENT: POSSIBLY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22257247 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A RESTORE CLINICAL STUDY, THE PATIENT HAD SUBARACHNOID HEMORRHAGE POST THE MECHANICAL THROMBECTOMY PROCEDURE USING AN ASPIRATION CATHETER. THE PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE NOTED ON CT SCAN AND WAS DESCRIBED AS MILD, AND ASYMPTOMATIC. THERE WAS NO INTERVENTION PERFORMED. SPONTANEOUSLY, THE EVENT OUTCOME RESOLVED WITHOUT SEQUELAE BY (B)(6)2024. THE RELATIONSHIP TO THE DEVICE IS CONSIDERED POSSIBLY. THE RELATIONSHIP TO THE MECHANICAL THROMBECTOMY PROCEDURE IS CONSIDERED DEFINITELY. THE RELATIONSHIP TO THE STUDY DISEASE IS CONSIDERED POSSIBLY. THE RELATIONSHIP TO THE CONCURRENT CONDITION/TREATMENT IS CONSIDERED POSSIBLY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22180362 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY SOFAST / RESTORE: EVENT SUMMARY: 81 YEAR OLD MALE WITH PATIENT MEDICAL HISTORY (PMH) SIGNIFICANT FOR HTN, DM AND CAD S/P STENT (THE PATIENT HAS A HISTORY OF HYPERTENSION (HTN), DIABETES MELLITUS (DM), AND CORONARY ARTERY DISEASE (CAD), AND HAS HAD A STENT PLACED) WHO PRESENTED TO BMC ON 9/26 FOR UNRESPONSIVENESS/SPACING OUT, FOLLOWED BY LEFT WEAKNESS AND NEGLECT. CAT HEAD/NECK WITH RIGHT MCA M1 OCCLUSION. SUBJECT UNDERWENT THROMBECTOMY WITH RECANALIZATION. 24 HOURS POST TNK (TNK - TENECTEPLASE MEDICATION) CT HEAD ON (B)(6) DEMONSTRATING DIFFUSE BILATERAL IPH, SAH AND IVH IN B/L VENTRICLES. ECASS PH2 . (IPH - INTRAPARENCHYMAL HEMORRHAGE, SAH -SUBARACHNOID HEMORRHAGE, IVH-INTRAVENTRICULAR HEMORRHAGE, B/L - BILATERAL & ECASS PH2 - CLASSIFICATION OF HEMORRHAGE) EVENT NUMBER: 33-012-004 . EVENT NAME: SUBARACHNOID HEMORRHAGE. EVENT: NEUROLOGICAL. EVENT DATE: 27/SEP/2024 . WERE ANY DIAGNOSTIC PROCEDURES PERFORMED FOLLOWING THE EVENT? YES PLEASE DESCRIBE DIAGNOSTIC PROCEDURES AND PROVIDE INTERPRETATION: HEAD CT SEVERITY: MODERATE SAE?: NO UADE / USADE?: NO ACTION REQUIRED - AE: HOSPITALIZATION HOSPITALIZATION ADMISSION DATE: (B)(6) 2024 WAS THE PATIEN

  Patient problems: Altered State of Consciousness; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Obstruction/Occlusion; Paresis

  MAUDE report 22137698 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE (B)(6) STUDY THAT ROUTINE FOLLOW UP CT DUAL ENERGY IMAGING DONE POST PROCEDURE SHOWS NEW ACUTE SUBARACHNOID HEMORRHAGE WITHIN THE LEFT SYLVIAN FISSURE AND SCATTERED THROUGH THE LEFT CEREBRAL CORTICAL SULCI. MRI COMPLETED SHORTLY AFTER SHOWS BILATERAL SUBARACHNOID HEMORRHAGE LEFT > RIGHT. ADDITIONAL IMAGING SHOWS NO ADDITIONAL HEMORRHAGE AND THEN DECREASING AMOUNTS. ANTICIPATED EVENT DISCUSSED WITH PATIENT AND FAMILY PRIOR TO THROMBOLYTIC ADMINISTRATION. SAH IMPROVED ON SUBSEQUENT CT SCANS, AND NIHSS IMPROVED 2 DAYS POST PROCEDURE. THE PATIENT RECEIVED THROMBOLYTIC IMMEDIATELY PRIOR TO PROCEDURE. THE SITE REPORTED THAT THE EVENT IS: POSSIBLY RELATED TO (B)(6). POSSIBLY RELATED TO STUDY DISEASE. POSSIBLY RELATED TO CONCURRENT CONDITION / TREATMENT. DEFINITELY RELATED TO MECHANICAL THROMBECTOMY PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 21684783 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST CLINICAL TRIAL: PERSISTENT OCCLUSION AND NON-PACIFICATION OF THE RIGHT CERVICAL ICA. DIAGNOSTIC PROCEDURE PLANNED FOR RIGHT ICA STENT FOLLOWING THE EVENT. SEVERITY OF EVENT CLASSIFIED AS MILD. RESIDUAL RIGHT ICA OCCLUSION SEEN ON MRI. PATIENT WENT BACK AND HAD A RIGHT ICA STENT PLACED THE NEXT DAY. CAROTID STENT PLANNED IN 6 WEEKS FOR INTRALUMINAL THROMBUS/DISSECTION (AFTER ANTICOAGULATION MEDICATION) BUT NOT PLACED YET, NO SERIOUS ADVERSE EVENT AS OF DISCHARGE. CAROTID STENTING INTERVENTION WAS PERFORMED SIX WEEKS LATER, RESOLVED WITHOUT SEQUELAE. THE ADVERSE EVENT WAS ADJUDICATED BY AN INDEPENDENT REVIEWING COMMITTEE AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND SOFIA DEVICE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21342305 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH "SOFAST CLINICAL STUDY", A CT HEAD(B)(6)2024 00:39 WITH "EVOLVING RIGHT MCA TERRITORY INFARCT WITH LOCOREGIONAL MASS EFFECT ON THE ADJACENT SULCI AND MILD LEFTWARD MIDLINE SHIFT OF APPROXIMATELY 1 MM. CHRONIC INFARCTS IN THE LEFT PARIETAL LOBE AND RIGHT CEREBELLUM. NO HYDROCEPHALUS. NO ABNORMAL ARTERIAL-PHASE ENHANCEMENT. PARANASAL SINUSES ARE ESSENTIALLY CLEAR. CTA REVEALS OCCLUSION OF THE PROXIMAL RIGHT M1 MCA. THE REMAINDER THE VASCULATURE IS PATENT. MILD-MODERATE ATHEROSCLEROSIS WITH ASSOCIATED NARROWING OF THE CAVERNOUS PORTIONS OF THE INTERNAL CAROTID ARTERIES BILATERALLY. NO ANEURYSM." ALERT RELATIONSHIP POSSIBLE RELATED TO SOFIA. MANAGED FOR HYPERTENSION, TYPE 2 DIABETES MELLITUS, ONGOING MEDICAL OPTIMIZATION AS SECONDARY STROKE PREVENTION. SUBJECT WAS DISCHARGED ON (B)(6)2024 TO A SKILLED NURSING HOME IN STABLE CONDITION. SUBJECT HAD 90 DAY FOLLOW UP VISIT IN CLINIC ON (B)(6)2024, AT THAT TIME SUBJECT IS LIVING AT HOME WITH PROFESSIONAL HELP REQUIRED FOR DAILY ACTIVITIES. ON NEUROLOGICAL EVALUATION, NIHSS WAS 21, MRS WAS 5, NO AE WAS REPORTED AT THE TIME OF FOLLOW UP. SUBJECT EXITED THE STUDY ON THE SAME DAY (B)(6)2024. NO TREATMENT WAS GIVEN FOR AE AS

  Patient problems: Obstruction/Occlusion

  MAUDE report 20659731 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST CLINICAL TRIAL, ACUTE INFARCTS (ISCHEMIC STROKE) IN RIGHT MCA AND ACA TERRITORY REPORTED 2 DAYS POST SURGERY. MRI BRAIN ON (B)(6) 2024 SHOWED PUNCTUATE AND CURVILINEAR FOCI OF SUSCEPTIBILITY, LIKELY REPRESENTING PETECHIAL HEMORRHAGE AND ACUTE INFARCTS ON RIGHT MCA AND ACA TERRITORIES. RECURRENT ISCHEMIC STROKE WAS REPORTED 10 DAYS POST SURGERY. THE PATIENT PRESENTED TO THE HOSPITAL WITH GENERALIZED WEAKNESS AND STROKE LIKE SYMPTOMS, WHICH STARTED ON (B)(6) 2024. CT ANGIOGRAPHY PERFORMED, PREVIOUSLY RIGHT ICA HAS RECANALIZED, 60% STENOSIS IMMEDIATELY PROXIMAL TO AN ECSTATIC SEGMENT, WHICH REACHES 1MM DIAMETER, NO LEFT CAROTID STENOSIS, NO VERTEBRAL ARTERY STENOSIS OF DISSECTION. PATIENT'S SEVERITY OF SYMPTOMS WERE MILD. MANAGED WITH MEDICATIONS: ASPIRIN, PLAVIX AND HIGH INTENSITY STATINS. NURSING AND OCCUPATIONAL THERAPY HAVE BOTH REPORTED SOME IMPULSIVITY. EVALUATION ON (B)(6) 2024 NOTED GENERALIZED WEAKNESS IMPROVING, CONTINUES TO HAVE IMPULSIVITY, LEFT SIDED STRENGTH DEFICITS, COGNITIVE DEFICITS. ON (B)(6) 2024 SUBJECT WAS DISCHARGED TO LONG TERM CARE FACILITY. PATIENT HAD FOLLOW-UP VISIT IN CLINIC ON (B)(6) 2024 AND QUALITY OF LIFE ASSESSMENT WAS P

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 20317845 ↗
• DeathJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SOFAST CLINICAL TRIAL, THAT THE ASPIRATION CATHETER STUDY DEVICE WAS USED IN A THROMBECTOMY PROCEDURE. THERE WAS ¿ACUTE SUBARACHNOID HEMORRHAGE FILLING THE LEFT SYLVIAN FISSURE AND ALONG THE LEFT CEREBRAL CONVEXITY¿ NOTED ON MRI AND CT DIAGNOSTIC INTERPRETATION. ¿PROBABLE TRACE INTRAVENTRICULAR HEMORRHAGE SECONDARY TO REDISTRIBUTION. NIHSS 19 AT BASELINE, 26 POST PROCEDURE ACCOMPANIED BY SAH/IVH.¿ THE CAROTID CAVERNOUS FISTULA WAS ASSESSED AS DEFINITELY RELATED TO THE INITIAL THROMBECTOMY AND POSSIBLY TO THE STUDY DEVICE. REPORTEDLY, ONE DAY POST PROCEDURE, THE PATIENT DEVELOPED A STROKE WITH CEREBRAL ISCHEMIA THAT RESULTED IN PATIENT DEATH 10 DAYS LATER. AS REPORTED TO MICROVENTION¿S CLINICAL SAFETY SPECIALIST, ¿THE PATIENT WAS INITIALLY INTUBATED AND SUBSEQUENTLY EXTUBATED ON (B)(6) 2023. HOWEVER, PATIENT MENTAL STATUS DID NOT IMPROVE. REPEAT CT AND MRI BRAIN SHOWED LARGE ACUTE STROKE IN THE LEFT MCA VASCULAR TERRITORY WITH MASS EFFECT AND MINIMAL RIGHTWARD MIDLINE SHIFT. PATIENT WAS STARTED ON 3% NAA IV INFUSION WITHOUT ANY POSITIVE EFFECT. FAMILY MEETING WAS HELD WITH THE NEXT OF KIN, WHO MADE THE DECISION TO PURSUE COMFORT CARE. PATIENT WAS PLACED O

  Patient problems: Dyspnea; Fistula; Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 19666694 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENROLLED IN THE SOFAST CLINICAL STUDY DEVELOPED DYSARTHRIA. CTA SHOWED RE-OCCLUSION OF LEFT VERTEBRAL ARTERY. THE PATIENT WAS STABLE AND HAD A LOW NIHSS SCORE AND NON-DISABLING SYMPTOMS, SO A REPEAT THROMBECTOMY WAS DEFERRED. ON MRI AND CT, THERE WAS NO EVIDENCE OF NEW INFARCTION OR HEMORRHAGE. GIVEN MRI RESULTS WHICH WERE REASSURING AGAINST LARGE STROKE BURDEN AND MASS EFFECT, THE PATIENT WAS TRANSITIONED FROM HEPARIN TO APIXABAN 5MG BID WITH PLAN TO REPEAT IMAGING IN 3 MONTHS.

  Patient problems: Obstruction/Occlusion; Speech Disorder

  MAUDE report 19218979 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE (B)(4) CLINICAL STUDY, DISTAL EMBOLI, OCCURRED ON DAY OF PROCEDURE THAT WAS ASSESSED AS RELATED TO INITIAL THROMBECTOMY AND POSSIBLY TO THE STUDY DEVICE. A CATHETER-RELATED VASOSPASM OCCURRED UPON REMOVING THE CATHETER FROM THE RIGHT ICA. THIS SPASM LIMITED REPERFUSION OF THE RIGHT MCA AND ACA, AND MULTIPLE DISTAL EMBOLI APPEARED IN THE SUPERIOR AND POSTERIOR MCA DIVISIONS. ORIGINAL MTICI SCORE OF 3 LOWERED TO 2B. OUTCOME WAS A TECHNICALLY SUCCESSFUL ASPIRATION THROMBECTOMY. EMBOLI ARE ONGOING, BUT PATIENT SHOWS NO CLINICAL CONSEQUENCES. POST OPERATIVE DAY 1, NIHSS IS REDUCED TO 2 FROM PRE-PROCEDURE SCORE OF 9; MRS IS 3. POST OPERATIVE DAY 7 NIHSS IS REDUCED TO 2 FROM PRE-PROCEDURE SCORE OF 9; MRS IS 2.

  Patient problems: Embolism/Embolus; Vasoconstriction

  MAUDE report 19193391 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE RESTORE CLINICAL STUDY: CTA HEAD SHOWED OCCLUSION OF THE CERVICAL, PETROUS, AND CAVERNOUS LEFT ICA, WITH PATENT CLINOID AND SUPRAGLENOID SEGMENTS. OCCLUSION OF THE LEFT CAROTID ARTERY PROXIMAL TO THE RECENTLY PLACED LEFT ICA STENT, EXTENDING FROM THE LEFT COMMON CAROTID ARTERY, TREATED WITH SELECTIVE CATHERIZATION OF LEFT COMMON CAROTID ARTERY. PATIENT EXPERIENCED CAROTID STENT THROMBOSIS, DELAYING THE 2ND PROCEDURE FOR RECANALIZATION, WHICH WAS ATTEMPTED BUT FAILED. NO KNOWN CLINICAL WORSENING. THE EVENT WAS ASYMPTOMATIC NEUROLOGICAL EVENT. THE STUDY SITE STATED THAT THE EVENT IS RELATED TO THE STUDY DISEASE. THE STUDY INDEPENDENT REVIEWER RELATED THE EVENT AS DEFINITELY RELATED TO THE STUDY DISEASE, POSSIBLY TO CONCURRENT CONDITION AND POSSIBLY RELATED TO THE STUDY DEVICE AND MECHANICAL THROMBECTOMY STUDY PROCEDURE. THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19093952 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE RESTORE CLINICAL STUDY: PATIENT WAS BROUGHT IN EMERGENTLY FOR IMAGING, WHICH REVEALED EARLY ISCHEMIC CHANGES IN THE R MCA TERRITORY, R ICA OCCLUSION, AND PERFUSION MISMATCH. PATIENT WAS EXPERIENCING RECURRENT ISCHEMIC STROKE. THROMBECTOMY WAS ATTEMPTED, INCLUDING MULTIPLE PASSES, BUT WAS UNSUCCESSFUL. NO HEMORRHAGIC TRANSFORMATION ON F/U CT. HEMOSIDERIN STAINING UNCLEAR IF PREEXISTING OR NOT. A DHC WAS LATER PERFORMED WITH NO COMPLICATIONS. PATIENT PASSED AWAY TWO DAYS LATER. DIAGNOSTICS PROCEDURES: HCT DAY OF, ACUTE INFARCT IN RIGHT MCA TERRITORY, ASPECTS 6, NO ICH OR MASS. INTERVENTION: EVT AND DHC. AS REPORTED BY THE HOSPITAL: PATIENT MADE A COMPLETE RECOVERY AFTER THE INITIAL THROMBECTOMY (RM1 EMBOLECTOMY). MRI SHOWED SMALL STROKES AND HIS NIHSS WAS 0. PATIENT WAS TRANSFERRED TO THE NEUROLOGY SERVICE FOR THE REMAINDER OF HIS STROKE WORKUP BUT ON DAY 3 OF HOSPITAL STAY, HE HAD A NEURO EXAM CHANGE C/W COMPLETE R MCA SYNDROME. CODE STROKE WAS CALLED ON THE FLOOR AND PATIENT WAS FOUND TO HAVE A COMPLETE R ICA OCCLUSION. HE WENT AGAIN FOR A SECOND THROMBECTOMY, HOWEVER WITH 9 ATTEMPTS, THE SUSTAINED RECANALIZATION WAS NOT ACHIEVED D/T SIGNIFICANT CLOT BURDEN. LATE

  Patient problems: Ischemia Stroke

  MAUDE report 19093921 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESTORE CLINICAL STUDY THAT 100 DAYS POST THROMBECTOMY PROCEDURE, A CTA DEMONSTRATED PROGRESSIVE STENO-OCCLUSIVE PROCESS OF RM1 SEGMENT OF THE MCA. THE PATIENT WAS KEPT ON DAPT AND SENT FOR AN ANGIOGRAM THREE DAYS LATER, WHICH DEMONSTRATED COMPLETE OCCLUSION OF THE RIGHT MCA. THE DISTAL BRANCHES WERE FILLED VIA ACA COLLATERALS AND THERE WAS ALSO SOME COLLATERALIZATION FROM LENTICULOSTRIATE BRANCHES. IT WAS PLANNED FOR THE PATIENT TO CONTINUE ASA AND ATORVASTATIN INDEFINITELY. THE PATIENT WAS STILL ASYMPTOMATIC 109 DAYS FROM THE SURGERY DURING A FOLLOW UP VISIT. IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS DEFINITELY RELATED TO THE STUDY DISEASE, POSSIBLY RELATED TO THE THROMBECTOMY PROCEDURE, AND POSSIBLY RELATED TO THE ASPIRATION CATHETER.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19081115 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM THE RESTORE CLINICAL STUDY, THE PATIENT PRESENTED WITH STENOSIS WITH LEFT M1 CVA WITH TERMINAL ICA OCCLUSION. PATIENT WAS GIVEN TNKASE AND UNDERWENT ENDOVASCULAR ATTEMPT AT REVASCULARIZATION VIA A MECHANICAL THROMBECTOMY WITH ONLY PARTIAL SUCCESS. PATIENT WAS INTUBATED AND TRANSFERRED TO ICU POST PROCEDURE. MRI SHOWED LARGE LEFT MCA TERRITORY INFARCT WITH NO HEMORRHAGIC CONVERSION, SMALL DISTAL LEFT ACA TERRITORY INFARCT AND 5MM OF LEFT-TO-RIGHT SUBFALCINE SHIFT. PATIENT'S NEUROLOGIC STATUS FURTHER DETERIORATED, AND THE PATIENT MADE NO SIGNIFICANT MEANINGFUL RECOVERY. A REPEAT CT HEAD SCAN 3 DAYS POST INDEX PROCEDURE SHOWED EVOLUTION OF INFARCTS WITH APPROXIMATELY 9 MM OF LEFT-TO-RIGHT SUBFALCINE SHIFT. ISCHEMIC STROKE WAS DIAGNOSED 8 DAYS POST INDEX PROCEDURE. NEUROSURGICAL INTERVENTION WAS OFFERED TO THE FAMILY AND DECLINED PER CRITICAL CARE NOTE. PATIENT'S FAMILY DECIDED TO PLACE PATIENT ON COMFORT CARE ONLY. THE PATIENT WAS EXTUBATED, PROTECTING AIRWAY BUT REMAINED WITHOUT MEANINGFUL NEUROLOGIC IMPROVEMENT. DUE TO LACK OF RECOVERY, THE PATIENT PASSED AWAY, 10 DAYS POST INDEX PROCEDURE. THE HOSPITAL COURSE WAS COMPLICATED BY FINDING OF MSSA BACTEREMIA FOR WHICH

  Patient problems: Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 18856477 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE SEE SECTION H10 FOR INVESTIGATION CONCLUSION.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18222242 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY SOFAST (RESTORE) CLINICAL STUDY: POST THROMBECTOMY, A MORE DISTAL LEFT MCA DISTAL M2 SUPERIOR DIVISION BRANCH OCCLUSION WAS NOTED BY DISTAL THROMBOEMBOLISM. CONTINUED ANGIOGRAPHY TO DELINEATE THE SITE OF DISTAL OCCLUSION. MANAGED BY STENT-RETRIEVER THROMBECTOMY. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023. THIS MAY HAVE BEEN PRE-EXISTING OR FROM FRAGMENTED THROMBOEMBOLISM FROM THE MORE PROXIMALLY ASPIRATED OCCLUSION. IT IS NOTED OVERNIGHT (B)(6) 2023, THE PATIENT HAD A BRADYCARDIC CARDIAC ARREST SECONDARY TO COMPLETE HEART BLOCK, ALSO EPISODE OF ATRIAL FIBRILLATION. THE PATIENT HAS SINCE BEEN DISCHARGED TO A SKILLED NURSING FACILITY. IT IS NOTED THIS INCIDENT WAS POSSIBLY RELATED TO STUDY DEVICE.

  Patient problems: Atrial Fibrillation; Bradycardia; Thromboembolism

  MAUDE report 17897203 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED AS REPORTED THROUGH THE CLINICAL STUDY SOFAST, SITE NAME 07 - SAHLEIN (SOFIA ASPIRATION CATHETER). IT WAS REPORTED THAT POST TRANSCATHETER ENDOVASCULAR THROMBECTOMY FOR TREATMENT OF ACUTE ISCHEMIC STROKE. POST THROMBECTOMY, THERE WERE NO COMPLICATIONS, AND THE PATIENT TOLERATED THE PROCEDURE WELL. LATER THE SAME DAY, ON (B)(6) 2022 A CT SCAN NOTED A NEW SMALL VOLUME LEFT SYLVIAN SUBARACHNOID HEMORRHAGE. AS OF (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT CONTINUED TO DO WELL NEUROLOGICALLY. NO NEW NEUROLOGIC EVENTS WITH OBSERVES RESOLUTION OF ORIGINAL DEFICITS. NEUROLOGICAL FOLLOW-UP EVERY 4 HOURS WAS ORDERED. ON (B)(6) 2022, AN MRI WAS PERFORMED, AND IT WAS NOTED THAT THE HEMORRHAGE HAD RESOLVED WITHOUT SEQUELAE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15900383 ↗
• MalfunctionApr 6, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING ASPIRATION IN A STROKE CASE, THE SOFIA ASPIRATION CATHETER BROKE BETWEEN THE HUB AND CATHETER WHEN BEING PULLED. THE PHYSICIAN REMOVED THE CATHETER AND CONFIRMED NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14032664 ↗