Sofia DA6131ST-ASP-US-ODRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00842429108482), received between Oct 19, 2023 and Jun 24, 2025 — classified as 22 injuries.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RESTORE CLINICAL STUDY: CEC ADJUDICATED- ADVERSE EVENT RELATED TO INITIAL THROMBECTOMY PROCEDURE, SUBARACHNOID HEMORRHAGE; BRAIN PARENCHYMA/EXTRA-AXIAL SPACES: UNCHANGED LARGE RIGHT MCA TERRITORY INFARCTION WITH HYPER ATTENUATION COMPATIBLE WITH CONTRAST STAINING AND/OR HEMORRHAGIC CONVERSION. POSSIBLY RELATED TO THE STUDY DEVICE. CLOSE INTERVAL FOLLOW-UP IS RECOMMENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22324499 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RESTORE CLINICAL TRIAL, THE PATIENT PRESENTED TO THE HOSPITAL WITH RIGHT SIDED FACIAL DROOP, RIGHT SIDED HEMIPARESIS, AND WORSENING EXPRESSIVE APHASIA. THE PATIENT WAS TREATED WITH A MECHANICAL THROMBECTOMY AND WAS DISCHARGED TO HOME SELF-CARE THREE DAYS POST PROCEDURE. AT THAT TIME NIHSS WAS SIX, NOTABLE FOR DISORIENTATION, SLIGHT FACIAL DROOP, SEVERE APHASIA, AND MILD DYSARTHRIA. SHORTLY AFTER PATIENT RETURNED HOME THE SPOUSE NOTED RIGHT SIDED WEAKNESS, INCREASED GLOBAL APHASIA, AND INCREASED FACIAL DROOP. THE PATIENT PRESENTED BACK TO THE EMERGENCY DEPARTMENT ON (B)(6) 2024. CTA PERFORMED DEMONSTRATING DISTAL LEFT M1 OCCLUSION. NEURO CONTACTED AND ANOTHER CTA PERFORMED SHOWING DISTAL LEFT MCA M1 OCCLUSION WITH A 6ML CORE AND 80ML PENUMBRA. LYTIC NOT ADMINISTERED DUE TO BEING OUT OF WINDOW. DECISION MADE TO PROCEED TO ANOTHER MECHANICAL THROMBECTOMY FOR TREATMENT. IR-CEREBRAL ANGIOGRAM PERFORMED BY THE PHYSICIAN START TIME ON (B)(6) 2024. COMBINED MECHANICAL THROMBECTOMY PERFORMED WITH A FINAL MTICI SCORE OF 2B. THIS WAS COMPLICATED BY AN ANTERIOR M2-3 CONTRAST EXTRAVASATION/SUBARACHNOID HEMORRHAGE REQUIRING COIL EMBOLIZATION OF ANTERIOR BRANCH OF LEFT M2.

  Patient problems: Facial Paralysis; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Obstruction/Occlusion; Speech Disorder

  MAUDE report 22116391 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST/RESTORE CLINICAL STUDY: NEW IMAGING EVIDENCE OF SUBARACHNOID HEMORRHAGE. THE ROUTINE POST-THROMBECTOMY NONCONTRAST HEAD CT REVEALED TRACE SUBARACHNOID HEMORRHAGE THAT WAS UNCHANGED ON SUBSEQUENT HEAD CTS AND REQUIRED NO FURTHER INTERVENTION. INDEX PROCEDURE WAS PERFORMED THE DAY PRIOR. THERE WAS NO HEMORRHAGIC TRANSFORMATION. NO DIAGNOSTICS PROCEDURES WERE PERFORMED FOLLOWING THE EVENT. THE EVENT WAS NEUROLOGICAL AND ASYMPTOMATIC. SEVERITY WAS MILD. THE EVENT WAS RESOLVED WITHOUT SEQUELAE SIX DAYS LATER. EVENT WAS ADJUDICATED AS POSSIBLY RELATED TO THE SOFIA DEVICE, STUDY DISEASE, AND CONCURRENT CONDITION/TREATMENT. THE EVENT WAS ADJUDICATED AS DEFINITELY RELATED TO THE MECHANICAL THROMBECTOMY PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22116154 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A RESTORE CLINICAL STUDY, THE INDEX THROMBECTOMY WAS PERFORMED ON (B)(6) 2024 WITH AN ASPIRATION THROMBECTOMY OF THE RIGHT ICA. ON (B)(6) 2024, A CTA SHOWED A NON-FLOW-LIMITING DISSECTION FLAP IN THE RIGHT HIGH CERVICAL ICA. THIS WAS NOT SEEN ON THE FINAL ANGIOGRAM AND PRESUMABLY DEVELOPED SOMETIME BETWEEN (B)(6) 2024. THIS DID NOT APPEAR TO BE SYMPTOMATIC. THE PATIENT REMAINED CLINICALLY ASYMPTOMATIC FROM THE RIGHT ICA DISSECTION AND A CT HEAD STUDY FROM (B)(6) 2024 SHOWED NO NEW RIGHT-SIDED EVIDENCE OF STROKE. NO FURTHER FOLLOW-UP WAS PERFORMED. THE EVENT OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE RELATIONSHIP TO SOFIA DEVICE IS POSSIBLY, RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE IS DEFINITELY, RELATIONSHIP TO STUDY DISEASE IS POSSIBLY AND RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT IS POSSIBLY.

  Patient problems: Vascular Dissection

  MAUDE report 21759141 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY RESTORE: RE-OCCLUSION OF INDEX VESSEL IS STATED TO BE POSSIBLE RELATED TO SOFIA STUDY DEVICE AND PROCEDURE. EVENT SUMMARY: SUBJECT (B)(6) WAS ENROLLED IN THE RESTORE STUDY (B)(6) 2024 AFTER A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED BY DR. (B)(6) ON (B)(6) 2024 TO REMOVE A RIGHT M1 OCCLUSION. SHE WAS DISCHARGED HOME ON (B)(6) 2024 WITH A NIHSS OF 0 AND AN MRS OF 1. SHE HAD RESIDUAL MILD LEFT-SIDED WEAKNESS AT DISCHARGE AND WAS TAKING ASPIRIN 325MG PO DAILY & ATORVASTATIN 80 MG PO DAILY AT HOME. SUBJECT PRESENTED AT OUTSIDE HOSPITAL (B)(6) 2024 WITH REGRESSION OF HER SYMPTOMS; PROGRESSIVE WORSENING OF LEFT SIDED WEAKNESS (UPPER AND LOWER EXTREMITIES), SLIGHT LEFT FACIAL DROOP, AND SLURRED SPEECH THAT SHE REPORTS BEGAN ON (B)(6) 2024. IMAGING PERFORMED AT OUTSIDE HOSPITAL INCLUDING CT, CTA AND MRI SHOWED RE-OCCLUSION OF RIGHT MCA. (B)(6) WAS CONSULTED, AND SUBJECT WAS GIVEN CLOPIDOGREL (PLAVIX) 600MG PO FOR A RECURRENT ACUTE ISCHEMIC STROKE IN THE RIGHT MCA TERRITORY. PATIENT TRANSFERRED TO (B)(6) (B)(6) 2024 AND UNDERWENT A MECHANICAL THROMBECTOMY AND ATLAS STENT PLACEMENT AT M1 STENOSIS WITH DR. (B)(6). NIHSS SCORE 3 PRIOR TO THROMBECTO

  Patient problems: Facial Paralysis; Ischemia Stroke; Paresis; Speech Disorder

  MAUDE report 21398343 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY RESTORE (SOFAST):AE WAS ADJUDICATED BY INDEPENDENT REVIEWER (CEC) AS POSSIBLY RELATED TO SOFIA DEVICE. EVENT NAME: DISTAL EMBOLI/THROMBI (DISTAL EMBOLI INDEX TERRITORY). EVENT: NEUROLOGICAL ASYMPTOMATIC. EVENT SUMMARY: DISTAL MIGRATION OF CLOT AFTER FRAGMENTATION FROM THE FIRST PASS. TREATED SUCCESSFULLY WITH INTRA-ARTERIAL TPA. DATE OF SURGERY: (B)(6)2024. DAYS FROM SURGERY: 0. WERE ANY DIAGNOSTIC PROCEDURES PERFORMED FOLLOWING THE EVENT? NO. SEVERITY: MILD. SAE? NO. UADE / USADE? NO. ACTION REQUIRED - AE: MEDICATION ONLY. MEDICATION - PLEASE SPECIFY: TPA. OUTCOME - AE: RESOLVED WITHOUT SEQUELAE. DATE OF RESOLUTION: (B)(6)2024. RELATED TO: INITIAL THROMBECTOMY. RELATIONSHIP TO STUDY DEVICE: UNRELATED. IS THE EVENT A STUDY-DEFINED ADVERSE EVENT? YES. EVENT OUTCOME: RESOLVED. RELATIONSHIP TO SOFIA DEVICE: POSSIBLY. RELATIONSHIP TO ERIC DEVICE: NOT RELATED. RELATIONSHIP TO BOBBY BGC DEVICE: NOT RELATED. RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE: DEFINITELY. RELATIONSHIP TO STUDY DISEASE: POSSIBLY. RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT: POSSIBLY. SEVERITY: MODERATE. IS THE EVENT AN SAE? NO. HEMORRHAGIC TRANSFORMATION? NO. STUDY E

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21132101 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED, PLEASE SEE H6 & H11.

  Patient problems: Intracranial Pressure Increased

  MAUDE report 20719694 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY RESTORE: ON (B)(6) 2024, THERE WAS AN ADVERSE EVENT # (B)(6); CAROTID DISSECTION RELATED TO STUDY DEVICE. EVENT SUMMARY: DURING THE THROMBECTOMY PROCEDURE IT WAS NOTED THAT A CAROTID DISSECTION OCCURRED AND WAS TREATED WITH PED. NO NEUROLOGICAL SYMPTOMS WERE NOTED POST OPERATIVE. THE GUIDEWIRE WAS SUSPECTED. CAROTID DISSECTION LIKELY RELATED TO BALLOON GUIDE CATHETER 8F QAPEL, HOWEVER CANNOT EXCLUDE THAT SOFIA MAY HAVE CAUSED INITIAL DISSECTION IF IT CROSSED THE REGION. INTERVENTION OF CAROTID REPAIR WITH PED COMPLETED. ANTIPLATELET MEDICATION BRILINTA 90MG, BID PRESCRIBED AND ONGOING. RELATIONSHIP TO SOFIA DEVICE: POSSIBLY. RELATIONSHIP TO ERIC DEVICE: NOT RELATED. RELATIONSHIP TO BOBBY BGC DEVICE: NOT RELATED. RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE: DEFINITELY. RELATIONSHIP TO STUDY DISEASE: POSSIBLY. RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT: POSSIBLY. EVENT ADJUDICATION STATUS: COMPLETE. IT IS NOTED THE PATIENT HAS A HISTORY OF DVT/PE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 20364448 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST STUDY, A PATIENT ENROLLED IN THE STUDY EXPERIENCED A TRANSIENT ISCHEMIC ATTACK POST PROCEDURE. THE PATIENT BECAME APHASIC WITH FASCIAL SYMPTOMS. A CT WAS PERFORMED AND WAS NEGATIVE. THE SYMPTOMS RESOLVED WITHOUT SEQUELAE AND BLOOD PRESSURE MANAGEMENT WAS ORDERED.

  Patient problems: Muscle Weakness/Atrophy; Speech Disorder; Transient Ischemic Attack

  MAUDE report 20032456 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST CLINICAL STUDY: DURING THE FIRST ANGIOGRAPHIC IMAGING OF THE OCCLUSION, A DISTAL LEFT MCA M3 OCCLUSION WAS SEEN THAT PERSISTED AFTER THE SUCCESSFUL MECHANICAL THROMBECTOMY OF THE LEFT MCA M1 THROMBUS. THIS WAS TOO DISTAL TO MECHANICALLY ACCESS. A CALCIUM-CHANNEL BLOCKER MEDICATION WAS ADMINISTERED TO HELP RELAX THE DISTAL LEFT MCA M3 OCCLUDED VESSEL. THIS DID NOT RESULT IN RECANALIZATION OF THE PERSISTENT LEFT MCA M3 DISTAL OCCLUSION, BUT THE OVERALL REPERFUSION WAS TICI 2C. THERE WERE NO OBSERVED SEQUELAE OF THIS OCCLUSION. AT 24 HOUR FOLLOW UP EVALUATION, NIHSS REDUCED TO 9 FROM PRE-PROCEDURE SCORE OF 26, MRS IS 3. SUBJECT¿S PREMORBID MRS WAS 0. 4 DAYS AFTER THE FOLLOW UP EVALUATION, NIHSS WAS 2, MRS WAS 1. NEUROLOGICAL EXAM NOTED MIXED APHASIA, RECEPTIVE MORE THAN EXPRESSIVE APHASIA, IMPROVED SINCE TRANSFER TO FLOOR. UNABLE TO ANSWER ORIENTATION QUESTIONS. DOES APPROPRIATELY ANSWER YES/NO QUESTIONS ABOUT LOCATION. NOT ABLE TO FOLLOW COMMANDS CONSISTENTLY, BUT DOES FOLLOW SOME INSTRUCTIONS. SUBJECT WAS EAGER TO GO HOME. SUBJECT WAS DISCHARGED TO GO HOME. THE EVENT WAS ASSESSED BY AN INDEPENDENT REVIEWING COMMITTEE AS RELATED POSSIBLY TO THE SOFIA DE

  Patient problems: Dysphasia

  MAUDE report 20027737 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE SOFAS STUDY THAT THE SUBJECT PRESENTED WITH THE LEFT MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION AND SEVERE STENOSIS AT THE LEFT INTERNAL CAROTID ARTERY (ICA) ON MAY 3RD, 2023. HE WAS ADMINISTERED TENECTEPLASE AND MECHANICAL THROMBECTOMY. ON 8-MAY-2023 AROUND 5PM EXPERIENCED TRANSIENT APHASIA [TRANSIENT ISCHEMIC ATTACK], AND THE ABILITY TO SPEAK HAD IMPROVED OVER NIGHT AND HE DENIED ANY OTHER SYMPTOM. CONCURRENT CONDITION/ TREATMENT: INTRACRANIAL STENOSIS RESOLVED WITHOUT SEQUELAE: 08/MAY/2023 DATE OF SURGERY: (B)(6) 2023 RELATIONSHIP TO SOFIA DEVICE: POSSIBLY RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE: POSSIBLY RELATIONSHIP TO STUDY DISEASE: POSSIBLY RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT: POSSIBLY.

  Patient problems: Dysphasia; Transient Ischemic Attack

  MAUDE report 19721340 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST CLINICAL STUDY: BELOW EVENT WAS REVIEWED BY INDEPENDENT REVIEWER (CEC) AND WAS REPORTED TO BE REPEAT ISCHEMIC STROKE IS INDICATED AS POSSIBLY RELATED TO THE THROMBECTOMY PROCEDURE AND THE STUDY DEVICE, SOFIA. EVENT TERM: RECURRENT STROKE INDEX TERRITORY. EVENT # (B)(6). DATE STARTED: (B)(6) 2024. HOSPITALIZATION ADMISSION DATE (B)(6) 2024. HOSPITALIZATION DISCHARGE DATE (B)(6) 2024. DATE OF SURGERY (B)(6) 2024. DAYS FROM SURGERY 24. EVENT DESCRIPTION: POST INDEX THROMBECTOMY, PATIENT DEVELOPED SPONTANEUOUS ABDOMINAL HEMATOMA REQUIRING CHANGE OF ANTICOAGULATION TO LOVENOX. SHE RETURNED TO HOSPITAL WITH A REPEART LARGE VESSEL OCCLUSION AND WAS TAKEN FOR THROMBECTOMY WITH GOOD OUTCOMES. F/U DESCRIPTION: PATIENT IS IN REHAB, NOW DAY 10. MINIMAL RIGHT FACIAL DROOP AND APHASIA. PARTICIPATING IN OT. HOSPITAL DISCHARGE NIHSS OF 2 FOR MILD APHASIAL FACIAL DROOP. RELATIONSHIP TO SOFIA DEVICE: POSSIBLY. RELATIONSHIP TO ERIC DEVICE NOT RELATED. RELATIONSHIP TO BOBBY BGC DEVICE NOT RELATED. RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE: POSSIBLY. RELATIONSHIP TO STUDY DISEASE: POSSIBLY. RELATIONSHIP TO CONCURRENT CONDITION /TREATMENT POSSIBLY. SAE CRITERIA SER

  Patient problems: Ischemia Stroke; Speech Disorder

  MAUDE report 19592202 ↗
• InjuryJun 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD A 90 DAY FOLLOW UP TELEMEDICINE VISIT, AND THE MRS SCORE WAS 1 AFTER EXITING THE STUDY. NIHSS WAS NOT DONE. THERE WAS NO AE NOTED.

  Patient problems: Stroke/CVA

  MAUDE report 19543878 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE SOFAST STUDY THAT A PATIENT DEVELOPED A CEREBRAL HEMORRHAGE ON (B)(6) 2023 DUE TO THEIR INITIAL THROMBECTOMY. ANTIPLATELETS WERE HELD, AND IT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023. ACTION REQUIRED - AE: INTERVENTION. INTERVENTION - HELD ANTIPLATELETS. OUTCOME - AE: RESOLVED WITHOUT SEQUELAE. DATE OF RESOLUTION: (B)(6) 2023. RELATED TO: INITIAL THROMBECTOMY. EVENT OUTCOME: RESOLVED. RELATIONSHIP TO SOFIA DEVICE: POSSIBLY. RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE: POSSIBLY. RELATIONSHIP TO STUDY DISEASE: DEFINITELY. RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT: POSSIBLY. CHARACTERIZE HEMORRHAGIC TRANSFORMATION: PH2: HEMATOMA IN > 30% OF INFARCTED AREA WITH SUBSTANTIAL SPACE OCCUPYING EFFECT.

  Patient problems: Hematoma; Intracranial Hemorrhage

  MAUDE report 18899701 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE RESTORE CLINICAL STUDY, CEREBRAL EDEMA (AE-001). CT HEAD: EVOLVING LEFT MCA TERRITORY INFARCTION WITH SIGNIFICANT INTERVAL CEREBRAL EDEMA AND SWELLING, 15 MM MIDLINE SHIFT AND HERNIATION. SMALL AREA OF INTRAPARENCHYMAL HEMORRHAGE IN THE LEFT BASAL GANGLIA COMPATIBLE WITH HEMORRHAGIC CONVERSION. REQUIRES INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT OF BODY FUNCTION OR BODY FUNCTION. INTERVENTION- EMERGENT DECOMPRESSIVE HEMICRANIECTOMY PERFORMED. THE AE IS INDICATED TO BE POSSIBLY RELATED TO THE SOFIA DEVICE AND TO THE THROMBECTOMY PROCEDURE. DEFINITELY RELATED TO THE STUDY DISEASE. ADDITIONAL INFORMATION INDICATED: PATIENT STATUS: SUBJECT S/P INDEX PROCEDURE ON (B)(6) 2023, EXITED THE STUDY ON (B)(6) 2023 DUE TO PROGRESSION OF INDEX ISCHEMIC STROKE (-002). EVENT ISCHEMIC STROKE HAS BEEN ADJUDICATED AS NOT RELATED TO DEVICE OR PROCEDURE, BUT RELATED TO THE STUDY DISEASE. HEMORRHAGIC CONVERSION (AE-003): INTERVENTION, DECOMPRESSIVE HEMICRANIECTOMY. DECREASE IN MASS EFFECT HOWEVER ULTIMATELY, SHE DIED ON (B)(6) 2023 DUE TO MULTISYSTEM FAILURE (MULTIFOCAL ACUTE PNEUMONIA, CARDIOMEGALY, ATHEROSCLEROSIS, EMPHYSEMA). THE EVENT I

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18812884 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE SOFAST/RESTORE, THAT ON THE DAY OF INDEX THROMBECTOMY PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE ADVERSE EVENTS. VASOSPASM OBSERVED INVOLVING ACCESSED VASCULAR TREE WAS NOTED. ISSUE RESOLVED THE SAME DAY WITHOUT SEQUELAE. THERE WAS DISTAL EMBOLI/CLOT MIGRATION IN M1 THAT REQUIRED INTERVENTION WITH REPEAT THROMBECTOMY, WHICH RESOLVED THE NEXT DAY WITHOUT SEQUELAE, AND ASSESSED AS POSSIBLY RELATED TO STUDY DEVICE, STUDY DISEASE, AND DEFINITELY TO THROMBECTOMY PROCEDURE. REPORTEDLY, DISTAL EMBOLI/CLOT MIGRATION RESOLVED. "IR STROKE ANGIOGRAM", "RIGHT INTERNAL CAROTID CEREBRAL ANGIOGRAM #2 (DURING THROMBECTOMY). THIS ANGIOGRAM WAS PERFORMED IN AP AND LATERAL PROJECTION. THIS ANGIOGRAM WAS PERFORMED IMMEDIATELY AFTER FIRST PASS VIA SOFIA 6 FRENCH REPERFUSION CATHETER. SEVERE VASOSPASM OF THE RIGHT M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY; HOWEVER, GOOD DISTAL PERFUSION WAS SEEN. SMALL CLOT WAS SEEN IN THE ANGULAR BRANCH OF THE INFERIOR DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY. THIS WOULD CLASSIFY AS TIC I 2C REPERFUSION. THE PATIENT ALSO EXPERIENCED EMBOLIZATION TO A NEW TERRITORY THAT WAS RESOLVED WITHOUT SEQUELAE WITH MEDICATION, ASSESSED AS POSSIBLY RELA

  Patient problems: Embolism/Embolus; Vascular Dissection; Vasoconstriction

  MAUDE report 18379064 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED FROM THE SOFAST STUDY, THE PATIENT EXPERIENCED A RIGHT ACA INFARCT, AE # 001. MRA SHOWED SMALL INFARCT IN POSTERIOR DISTAL BRANCHES OF RIGHT ACA. INTERVENTION WAS ACA THROMBECTOMY. PATIENT PRESENTED AS DIRECT ADMIT FROM OSH FOLLOWING STEMI WITH PLACEMENT OF DES IN LAD SAME DAY. ON ARRIVAL PATIENT HAD NIHSS OF 18 WITH MUTISM, LEFT HEMIPLEGIA AND RIGHT HEMIPARESIS. RIGHT MCA SUPERIOR DIVISION OCCLUSION WAS FOUND AS WELL AS A LEFT MCA INFERIOR STENOSIS, AND DEVELOPING HYPO DENSITY. PATIENT WAS TAKEN FOR THROMBECTOMY. REPORTED PRIOR MEDICAL HISTORY INCLUDED PREVIOUS STROKE AND RESIDUAL SPEECH DEFICITS. HOSPITAL COURSE WAS FURTHER COMPLICATED BY PNEUMONIA THAT CONTRIBUTED TOWARDS PATIENT'S DEPENDENCE ON VENTILATION, AND NONOCCLUSIVE THROMBOSIS FOUND IN THE LEFT COMMON FEMORAL. ON (B)(6) 2023 THE PATIENT'S WIFE ASKED FOR PATIENT TO BE TRANSITIONED TO INPATIENT HOSPICE. THE PATIENT PASSED AWAY (B)(6) 2023. SUBJECT 17-008 AE # 001-RIGHT ACA INFARCT WAS DETERMINED "POSSIBLY RELATED TO THE SOFIA DEVICE. " INDEX PROCEDURE WAS (B)(6) 2023. PLEASE NOTE, IT IS DOCUMENTED "EVENT PNEUMONIA EVENT NUMBER # 17-008-003 ON POST OPERATIVE DAY 2, WITH OUTCOME OF DEATH, NOT RELATED TO PROCEDUR

  Patient problems: Stroke/CVA

  MAUDE report 18303253 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST THROMBECTOMY ON (B)(6) 2023 THERE IS RESULTANT TICI 2C REPERFUSION. THERE IS EVIDENCE OF DISTAL EMBOLI. IT WAS SUBSEQUENTLY ASPIRATED. SITE REPORTED IT AS MILD, NON-SERIOUS, RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023.

  Patient problems: Aspiration/Inhalation

  MAUDE report 18279897 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SOFAST CLINICAL TRIAL, THE REPORTED DISTAL EMBOLIZATION IS INDICATED TO BE RELATED TO THE INITIAL THROMBECTOMY AND POSSIBLY RELATED TO THE STUDY DEVICE, SOFIA. NO ACTION WAS REQUIRED, AND THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Embolism/Embolus

  MAUDE report 18222918 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST CLINICAL STUDY, THE NEXT DAY FOLLOWING MECHANICAL THROMBECTOMY PROCEDURE THAT USED THE SOFIA ASPIRATION CATHETER, THE PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE NOTED ON CT OF THE HEAD AND DESCRIBED AS MILD, ASYMPTOTIC, NO CHANGE IN NIHSS. TH PATIENT WAS ADMINISTERED IV HEPARIN, INTRA-ARTERIAL TPA AND RESOLVED WITH SEQUELAE. THE EVENT IS ASSESSED AS POSSIBLY RELATED TO THE SOFIA DEVICE, DEFINITELY RELATED TO THE MECHANICAL THROMBECTOMY PROCEDURE, AND POSSIBLY RELATED TO THE STUDY DISEASE AND CONCURRENT CONDITION/TREATMENT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18166010 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE SOFAST/RESTORE CLINICAL STUDY, IN-STENT THROMBOSIS. DURING INDEX THROMBECTOMY, RIGHT ICA UNDERWENT BALLOON ANGIOPLASTY AND STENT PLACEMENT (XACT). ANGIOGRAPHIC RUNS AFTER PLACEMENT SHOWED THAT THE STENT IS OCCLUDED. ASPIRATION WAS COMPLETED WITH THE SOFIA AND FOLLOW UP RUNS COMPLETED WITHOUT NOTING ANY THROMBUS. EVENT OUTCOME, RESOLVED. THE RELATIONSHIP TO THE SOFIA DEVICE IS INDICATED AS, POSSIBLE AND DEFINITELY RELATED TO THE MECHANICAL THROMBECTOMY PROCEDURE. THE EVENT OUTCOME IS REPORTED RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18145649 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE SOFAST CLINICAL STUDY, PROCEDURAL DYNA CT WITH CONTRAST INJECTION IN THE LEFT ICA IN ADDITION TO A DYNA CT WITHOUT CONTRAST DEMONSTRATED POSSIBLE AREAS OF SUBARACHNOID HEMORRHAGE ALONG THE LEFT SYLVIAN FISSURE AND INTRAPARENCHYMAL HEMORRHAGE OF THE POSTERIOR ASPECT OF THE LEFT PARIETAL LOBE ON (B)(6) 2023. EVOLUTION OF A LEFT DISTAL MCA TERRITORY INFARCT WITH TINY PETECHIAL HEMORRHAGE, AS WELL AS A SMALL FOCUS OF LEFT FRONTAL SUBARACHNOID HEMORRHAGE WAS NOTED ON CT HEAD/BRAIN W/O CON ON (B)(6) 2023. NO SUBARACHNOID HEMORRHAGE WAS NOTED IN CT CONDUCTED ON (B)(6) 2023. NO ACTION WAS REQUIRED, AND THE EVENT WAS RESOLVED WITHOUT SEQUELAE. THE SAH WAS STATED TO BE POSSIBLY RELATED TO THE SOFIA DEVICE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17967296 ↗