SofiaRecalls & reported problems across all models

We found 3 models of Sofia by Microvention, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2022 and Jun 24, 2025 — classified as 1 death, 40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Sofia problems

Sofia models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sofia DA6131ST-ASP-US-OD

  CATHETER, THROMBUS RETRIEVER
  22 reports
• Sofia DA6125ST-ASP-US-OD

  CATHETER, THROMBUS RETRIEVER
  1 death18 reports
• Sofia DA6115ST-GC-OD

  Catheter, intravascular, diagnostic
  2 reports

Recent Sofia adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN A RESTORE CLINICAL STUDY, THE NEXT DAY FOLLOWING THE MECHANICAL THROMBECTOMY PROCEDURE THAT WAS PERFORMED USING WITH THE SOFIA ASPIRATION CATHETER, THE PATIENT EXPERIENCED SUBARCHNOID HEMORRHAGE, AND THIS EVENT WAS SUMMARIZED AS A LEFT POSTERIOR INSULA WEDGE-SHAPED HYPODENSITY, REPRESENTING ACUTE/SUBACUTE CVA. THERE WAS NO TREATMENT PROVIDED, AS THE PATIENT WAS ONLY OBSERVED. NIHSS SCORE WAS NOTED TO BE 3 AND MRS SCORE WAS AT 4. ALTHOUGH REQUESTED, THERE WAS NO OTHER PATIENT INFORMATION PROVIDED BY THE SITE AT THIS TIME. IT WAS NOTED THAT THE RELATIONSHIP TO SOFIA DEVICE IS CONSIDERED POSSIBLY, THE RELATIONSHIP TO MECHANICAL THROMBECTOMY PROCEDURE IS CONSIDERED DEFINITELY, THE RELATIONSHIP TO STUDY DISEASE IS CONSIDERED POSSIBLY, AND THE RELATIONSHIP TO CONCURRENT CONDITION/TREATMENT IS CONSIDERED POSSIBLY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22155645 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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