Solitaire™ Platinum SFR3-4-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00847536034761), received between Feb 26, 2020 and Jul 12, 2024 — classified as 10 deaths, 26 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT HAD MILD CEREBRAL EDEMA. HEMATOMA WITHIN ISCHEMIC FIELD WITH MILD SPACE-OCCUPYING EFFECT INVOLVING = 30% OF THE INFARCTED AREA (PH1). THE PATIENT'S FAMILY REQUESTED TO BE DISCHARGED FROM THE HOSPITAL, AND THE SITUATION WILL CONTINUE TO BE FOLLOWED UP AT THE 90 DAY FOLLOW-UP VISIT. NIHSS SCORE AVAILABLE: 35, MRS SCORE: 0. EVENT IS ASSESSED AS POSSIBLE RELATED TO STUDY PROCEDURE. THE EVENT IS RESOLVING. PRE-PROCEDURE MTICI SCORE: 0 FINAL POST-PROCEDURE MTICI SCORE: 3. ADDITIONAL INFORMATION WAS RECEIVED REPORTING SYMPTOMS WERE NOT REPORTED IN THE AE DESCRIPTION, HOWEVER BASELINE NIHSS 35 REMAINED SAME ON THE 24-H POST-PROCEDURE ON (B)(6) 2024 AND AT DISCHARGE VISIT ON (B)(6) 2024. THERE WAS NO HOSPITALIZATION, NO TREATMENT, AND NO ACTIONS TAKEN TO RESOLVE THE HEMATOMA. ADDITIONAL INFORMATION RECEIVED REPORTED SITE ALSO ADDED AE DESCRIPTION OF HEMORRHAGIC TRANSFORMATION STROKE PH1

  Patient problems: Hematoma; Hemorrhagic Stroke; Nervous System Injury

  MAUDE report 19734106 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A SOLITAIRE SFR3 STENT HAD COMPLICATIONS. THE HEAD CT POST-OPERATIVE REVEALED CEREBRAL INFARCTION IN THE LEFT MIDDLE CEREBRAL ARTERY M2 SEGMENT. NIHSS SCORE AVAILABLE: 9, MRS SCORE: 0. NO ACTION WERE TAKEN TO RESOLVE THE EVENT. THE EVENT RESOLVED ON 2024-JUN-28. THE EVENT WAS POSSIBLY RELATED TO STUDY PROCEDURE AND DEVICES UTILIZED.  PRE-PROCEDURE MTICI SCORE: 1 FINAL POST-PROCEDURE MTICI SCORE: 3.

  Patient problems: Ischemia Stroke

  MAUDE report 19667512 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A MECHANICAL THROMBECTOMY PROCEDURE ON (B)(6) 2023 IN WHICH A SOLITAIRE PLATINUM (SFR3) STENT RETRIEVER WAS USED. THE PATIENT'S PRE-PROCEDURE MRS WAS 1 AND THE NIHSS WAS 21. THERE WAS NO REPORTED DEVICE MALFUNCTION OR INTRA-OPERATIVE ISSUE. THE DAY AFTER THE PROCEDURE, ON (B)(6) 2023, HEMORRHAGIC TRANSFORMATION (PH2) OF THE STROKE AREA WAS OBSERVED. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING. HOWEVER, THE EVENT DID REQUIRE HOSPITALIZATION/PROLONGED HOSPITALIZATION AND WAS NOTED TO HAVE OUTCOME OF "RECOVERED/RESOLVED WITH SEQUELAE" ON (B)(6) 2024 THOUGH IT WAS NOTED THE EVENT DID NOT RESULT IN PATIENT DISABILITY. IT WAS NOTED THE EVENT WAS POSSIBLY RELATED TO THE PATIENT DISEASE UNDER STUDY/INDEX STROKE AND/OR AN UNDERLYING PATIENT CONDITION. THE SITE ASSESSMENT CONCLUDED THE EVENT WAS NOT RELATED TO THE PROCEDURE OR THE DEVICES. HOWEVER, THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19550497 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED PERCUTANEOUS INTERVENTION WAS REQUIRED TO TREATED THE EVENT. MRS SCORE: 0.

  Patient problems: Embolism/Embolus

  MAUDE report 19220707 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT DISCHARGE VISIT FOLLOW-UP IMAGING COMPUTERIZED TOMOGRAPHY (CT) ON (B)(6) 2024 SHOWS INFARCT IN NEW VASCULAR TERRITORY. THE WAS NO ALLEGED PRODUCT ISSUE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR MT TREATMENT OF A ISCHEMIC STROKE  IN THE BASILAR ARTERY. MODIFIED RANKIN SCALE (MRS) SCORE BASELINE WAS 0, PROCEDURE 5. NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) BASELINE 19, POST PROCEDURE 6. TICI SCORE BASELINE 0, POST-PROCEDURE 3. IV TPA WAS CONTRAINDICATED. THERE WAS 1 PASS WITH THE DEVICE. STROKE ONSET: 03:30 ON (B)(6) 2024 - REPERFUSION TIME: 08:50 ON (B)(6) 2024. THE ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: Ischemia Stroke

  MAUDE report 18690565 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD UNDERGONE A MECHANICAL THROMBECTOMY ON (B)(6) 2023 IN WHICH A SOLITAIRE PLATINUM STENT RETRIEVER WAS USED. POST-OPERATIVE MTICI 3 WAS NOTED. THERE WAS NO REPORTED DEVICE MALFUNCTION/DEFICIENCY NOR ANY INTRA-OPERATIVE PATIENT ISSUES. IT WAS REPORTED THAT POST-OPERATIVELY ON (B)(6) 2023, A NEW CEREBRAL INFARCTION, CONTRALATERAL TO THE INDEX LESION, WAS OBSERVED AND WAS NOT TREATED. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING, DID NOT RESULT IN OR PROLONG PATIENT HOSPITALIZATION, DID NOT RESULT IN PATIENT DISABILITY, AND DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION. IT WAS NOTED THAT THE EVENT WAS POSSIBLY RELATED TO AN UNDERLYING PATIENT CONDITION. BOTH THE SITE AND MEDTRONIC STUDY SPONSOR ASSESSMENTS CONCLUDED THE EVENT WAS NOT RELATED TO SOLITAIRE OR TO THE PROCEDURE. AS THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PATIENT ADVERSE EVENT WAS NOT RELATED TO THE DEVICE(S) OR PROCEDURE, THE EVENT DOES NOT MEET THE DEFINITION OF A COMPLAINT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE SPONSOR ASSESSMENT WAS UPDATED. ON 2024-FEB-06 THE CEC ADJUDICATED THIS EVENT AS NON-SERIOUS, CAUSAL TO THE STUDY PROCEDURE, AND PO

  Patient problems: Ischemia Stroke

  MAUDE report 18658090 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED NEUROLOGICAL DETERIORATION AT 24 HOURS WAS NOTED AS (BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 14 WORSENED TO NIHSS 25). IT IS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT OR ANY MEDICAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS WAS MADE BY THE INVESTIGATOR, SPONSOR, OR CEC. REFER TO MANUFACTURER REPORT 2029214-2024-00235 FOR RELATED DEVICE.

  Patient problems: Cognitive Changes; Ischemia Stroke; Unspecified Nervous System Problem

  MAUDE report 18645611 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT NO SYMPTOMS WERE REPORTED, HOWEVER, BASELINE NIHSS WAS 24 AND 24 HOURS POST PROCEDURE ON (B)(6) 2022 NIHSS WAS 20. THERE WAS NO CAUSE REPORTED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DISEASE UNDER STUDY OR UNDERLYING CONDITION.

  Patient problems: Ischemia Stroke

  MAUDE report 18522090 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT ON 2023-SEP-08, A NEW INFARCTION OCCURRED IN THE RIGHT FRONTAL LOBE AND GUIDE LOBE, WITH NO OBVIOUS SYMPTOMS. THE MODIFIED RANKIN SCALE (MRS) SCORE 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE 5. THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND DEVICES USED. THE LOCATION OF PROXIMAL FACE OF CLOT 1 WAS MIDDLE CEREBRAL ARTERY (MCA) AND FINAL POST-PROCEDURE MTICI SCORE WAS 2B. THIS ADVERSE EVENT (AE) WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE PATIENT HAS NOT RECOVERED AND THE ISSUE IS NOT RESOLVED.

  Patient problems: Ischemia Stroke

  MAUDE report 18479339 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT EXPERIENCED POSTOPERATIVE CEREBRAL INFARCTION WITH AN ONSET DATE OF (B)(6) 2023. MODIFIED RANKIN SCALE (MRS) SCORE 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 21. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST SHOWED CLINICALLY SIGNIFICANT LEFT BASAL GANGLIA PARAVENTICULAR CEREBRAL INFARCTION. CT SHOWED LEFT MEDIAL TEMPORAL LOBE, INSULA LOBE, BASAL GANGLIA AREA, NEW CEREBRAL INFARCT. THIS ADVERSE EVENT (AE) WAS NOT RELATED TO THE DISEASE UNDER STUDY, AN UNDERLYING CONDITION OR DISEASE, OR DEVICE DEFICIENCY. THIS EVENT DID NOT RESULT IN CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE. PRE-PROCEDURE MTICI SCORE: 0, FINAL POST-PROCEDURE MTICI SCORE: 3. ADDITIONAL INFORMATION RECEIVED REPORTED. OTHER FINDINGS FROM THE HEAD CT COMPLETED 19-OCT NOTED "CONTRAST AGENT EXUDATION WITH A SMALL AMOUNT OF BLEEDING." NO ASSOCIATED PATIENT SYMPTOMS WERE REPORTED. THE SITE REPORTED BOTH OBSERVED EVENTS WERE NOT CONSIDERED LIFE-THREATENING, DID NOT REQUIRE ADDITIONAL INTERVENTION OR RESULT IN PATIENT DISA

  Patient problems: Intracranial Hemorrhage; Ischemia; Ischemia Stroke

  MAUDE report 18451191 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A SOLIATIRE SFR3 STENT HAD A NEW INFARCTION OF THE LEFT CEREBELLUM. POSTOPERATIVE CT EXAMINATION SHOWED PONTINE INFARCTION AND LEFT CEREBELLAR INFARCTION. NIHSS SCORE: 6, MRS SCORE: 0. NO ACTIONS WERE TAKEN. THE EVENT WAS NOT RESOLVED. THE EVENT WAS ASSESSED AS RELATED TO THE PROCEDURE AND DEVICES USED. LOCATION OF PROXIMAL FACE OF CLOT 1: LOCATION: BASILAR ARTERY. HEMISPHERE: MIDLINE. PRE-PROCEDURE MTICI SCORE: 0. LOCATION OF PROXIMAL FACE OF CLOT 2: LOCATION: MIDDLE CEREBRAL ARTERY (MCA), M2. HEMISPHERE: RIGHT. PRE-PROCEDURE MTICI SCORE: 0.  LOCATION OF PROXIMAL FACE OF CLOT 3: LOCATION: POSTERIOR CEREBRAL ARTERY (PCA), P2. HEMISPHERE: LEFT. PRE-PROCEDURE MTICI SCORE: 0. FINAL POST-PROCEDURE MTICI SCORE: 3.

  Patient problems: Ischemia Stroke; Unspecified Nervous System Problem

  MAUDE report 18450916 ↗
• DeathJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED PULMONARY EMBOLISM POST PROCEDURE. ACTIONS TAKEN INCLUDED SUBCUTANEOUS INJECTION OF LOW MOLECULAR WEIGHT HEPARIN. THE OUTCOME WAS FATAL ON (B)(6) 2023. THE EVENT WAS NOT A RECURRENT OR NEW STROKE. THE EVENT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND CAUSALLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.  THE MRS SCORE WAS 0 AND NIHSS WAS 19. PRE-PROCEDURE MTICI WAS 1 AND FINAL WAS 3. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR PROCEDURE, HOWEVER, THE SPONSOR ASSESSMENT WAS UNCLEAR.

  Patient problems: Intracranial Hemorrhage; Pulmonary Embolism

  MAUDE report 18449488 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT ON 2023-05-31 MRI SHOWED BILATERAL PONTINE ARMS, PONS, LEFT PEDUNCLE, AND LEFT TEMPORO-OCCIPITAL PARIETAL LOBE THERE ARE MULTIPLE RELATIVELY NEW LACUNAR INFARCTS ON THE LEFT SIDE OF THE PRESSING PART OF THE CORPUS CALLOSUM. THE PATIENT HAD NO OBVIOUS SYMPTOMS. THERE WERE NO ACTIONS TAKEN TO RESOLVE THE ISSUE. THE PATIENT HAD NOT RECOVERED AND THE ISSUE HAD NOT RESOLVED AT THE TIME OF THIS REPORT. THIS EVENT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY, NOT RELATED TO AN UNDERLYING CONDITION, AND NOT RESULTING FROM A DEVICE DEFICIENCY. MODIFIED RANKIN SCALE (MRS) SCORE 2, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 18. THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EV ENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND STUDY DEVICES UTILIZED. THE PRE-PROCEDURE MTICI SCORE 0, FINAL POST-PROCEDURE MTICI SCORE 3.

  Patient problems: Ischemia Stroke

  MAUDE report 18428409 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE FOLLOWING OUTCOMES FOR THE PATIENT: 24H POST-PROCEDURE NIHSS 4, AT DISCHARGE NIHSS 2 ON (B)(6) 2023 AT DAY 90 NIHSS 2, MRS 2. HOWEVER, IT WAS NOTED THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE OBSERVED POST-OPERATIVE NEW INFARCTION. THE PATIENT'S CONSCIOUSNESS WAS CLEAR LIMB WEAKNESS WAS SIGNIFICANTLY IMPROVED. THE PATIENT HAD NO OBVIOUS LIMB NUMBNESS AT TIME OF DISCHARGE.

  Patient problems: Ischemia Stroke

  MAUDE report 18383067 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THE EVENT. NIHSS WAS 25 AT 24 HOURS POST PROCEDURE AND 14 AT 7 DAYS POST. THERE WAS NO NEUROLOGIC DETERIORATION AT THE TIME OF THE EVENT. AT DAY 90, MRS 1 WAS REPORTED. IT WAS NOTED THAT THE EVENT DID NOT RESULT IN PATIENT DISABILITY.

  Patient problems: Ischemia Stroke

  MAUDE report 18348370 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD FULL RECANALIZATION WITH MTICI3 AT THE END OF PROCEDURE, AT DISCHARGE ON (B)(6) 2023, NIHSS 12AT EXIT ON DAY 90 FU VISIT, MRS4, NIHSS 13. NO ADDITIONAL TREATMENT WAS NEEDED. THE PATIENT CONTINUED SEDATION AND ANALGESIA AND HER VITAL SIGNS WERE STABLE. ON (B)(6) 2023, THE PATIENT'S CONSCIOUSNESS IMPROVED AND HE WILL BE DISCHARGED FOR REHABILITATION.

  Patient problems: Intracranial Hemorrhage; Paralysis; Shock; Thrombosis/Thrombus

  MAUDE report 18286868 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT EXPERIENCED NEUROLOGICAL DETERIORATION GREATER THAN OR EQUAL TO4 POINTS. WORSENING FROM BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 17 TO NIHSS 40 WAS IDENTIFIED BY THE SITE AT THE  24 HOUR POST-PROCEDURE VISIT PERFORMED ON 22-AUG-2023. IT IS UNKNOWN IF AN ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS WAS MADE BY THE INVESTIGATOR, SPONSOR, OR CEC. IT IS UNKNOWN IF THERE WERE ANY IMPACTS TO THE PATIENT. IT IS UNKNOWN IF THERE WAS ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. AS OF 2023-NOV-08 THE SITE HAD NOT REPORTED THE ASSOCIATED ADVERSE EVENT (AE) OF NEUROLOGICAL DECLINE AND QUERY WAS STILL IN PROGRESS, AT THAT TIME, SITE HAD RESPONDED AS FOLLOWS "DUE TO GENERAL ANESTHESIA DURING THE OPERATION, THE EFFICACY DID NOT END, NISS SCORE COULD NOT BE PERFORMED AT DISCHARGE, AND AE DID NOT NEED TO BE RECORDED AFTER CONFIRMATION WITH THE INVESTIGATOR" AND "IT HAS BEEN CONFIRMED THAT THE PATIENT IS UNDER GENERAL ANESTHESIA, BUT THE NISS SCORE CAN STILL BE PERFORMED WITHOUT MODIFICATION." ADDITIONAL INFORMATION WAS RECEIVED REPORTING A PERCUTANEOUS INTRACRANIAL ARTERY THROMBECTOMY WA

  Patient problems: Cognitive Changes; Coma; Ischemia Stroke; Unspecified Nervous System Problem

  MAUDE report 18212383 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE FINAL POST-PROCEDURE MTICI SCORE WAS 2A.

  Patient problems: Hematoma; Intracranial Hemorrhage

  MAUDE report 18192925 ↗
• DeathNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT POST PROCEDURE CT ON (B)(6) 2022 SHOWED HIGH DENSITY IMAGING AROUND THE FOURTH VENTRICLE OF THE MEDULLA OBLONGATA AND THE LEFT CEREBELLAR HEMISPHERE. THE EVENT WAS NOT A RECURRENT OR NEW STROKE AND DID NOT RESULT FROM A DEVICE DEFICIENCY. THE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY OR AN UNDERLYING CONDITION OR DISEASE. THE MRS SCORE WAS 4 AND NIHSS SCORE WAS 17. PRE-PROCEDURE MTICI WAS 0 AND POST-PROCEDURE WAS 2B. NO TREATMENT OR OTHER ACTIONS WERE TAKEN. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE DEVICES, HOWEVER, THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY DEVICE UTILIZED AND THE PROCEDURE.

  Patient problems: Aspiration Pneumonitis; Coma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18174055 ↗
• DeathNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED DURING INDEX HOSPITALIZATION ¿THE SUBJECT DEVELOPED CENTRAL RESPIRATORY AND CIRCULATORY FAILURE, FAILED TO RECOVER SPONTANEOUS RESPIRATION AFTER RESCUE, AND WAS PRONOUNCED DEAD AT 3:18 ON (B)(6) 2023.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhagic Stroke; Respiratory Failure

  MAUDE report 18091662 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT DEVELOPED CONTRAST EXTRAVASATION WITH BLEEDING IN THE LEFT BASAL AREA AFTER THROMBECTOMY. CONTRAST MEDIA EXTRAVASATION WAS CONSIDERED AFTER CEREBRAL INFARCTION IMAGING. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST THERE WAS LEFT FRONTOTEMPORAL PARIETAL LOBE WAS PATCHY WITH HIGH DENSITY THAT WAS CLINICALLY SIGNIFICANT. THERE WAS NO TREATMENT OR OTHER ACTIONS TAKEN. THE OUTCOME STATUS IS RECOVERING/RESOLVING. THE EVENT WAS NOT A RECURRENT OR NEW STROKE. THE EVENT IS NOT RELATED TO THE DISEASE UNDER STUDY OR AN UNDERLYING DISEASE OR CONDITION. THE EVENT DID NOT RESULT FROM A DEVICE DEFICIENCY. PRE-PROCEDURE AND POST-PROCEDURE MTICI WAS INTERMEDIATE. MRS SCORE WAS 4. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE DEVICES.

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17835972 ↗
• MalfunctionAug 11, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE STENT COULD NOT BE PUSHED SMOOTHLY (RESISTANCE) DURING THE PUSHING PROCESS IN THE MICROCATHETER, AND IT WAS FOUND THAT THE CONNECTION BETWEEN THE STENT BODY AND THE PUSH ROD WAS BROKEN WHEN IT WAS TAKEN OUT OF THE BODY. THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER.  NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE STENT WAS PREPARED AS INDICATED IN THE IFU.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE OF THE MIDDLE CEREBRAL ARTERY. THE BASELINE MRS SCORE WAS 4 AND THE PROCEDURE MRS SCORE WAS 4. THE BASELINE NIHSS SCORE WAS 10 AND THE POST PROCEDURE NIHSS SCORE WAS 5. THE BASELINE TICI SCORE WAS 0 AND THE POST PROCEDURE TICI SCORE WAS 2B. IV TPA WAS NOT CONTRAINDICATED. THERE WERE 0 PASSES WITH THE DEVICE.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE STROKE ONSET TO REPERFUSION TIME WAS 40 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509648 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A SFR3 SOLITAIRE HAD AN INTRAVENTRICULAR HEMORRHAGE (IVH). UNSCHEDULED FOLLOW UP VISIT ON (B)(6) 2023, (B)(6) 2023 AND (B)(6) 2023 BRAIN CT IMAGING OBSERVATION OF ¿INTRAVENTRICULAR HEMORRHAGE¿ WAS REPORTED BY SITE. NO OTHER PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD UNDERGONE A MECHANICAL THROMBECTOMY WITH A SOLITAIRE PLATINUM (SFR3) STENT RETRIEVER TO TREAT ISCHEMIC STROKE. THE PATIENT'S PRE-PROCEDURE MRS WAS 5, NIHSS WAS 14, AND TICI WAS 2A. THERE WAS NO DEVICE MALFUNCTION OR DEFICIENCY REPORTED AND TICI 3 WAS ACHIEVED WITH THE PROCEDURE. THE DAY AFTER THE PROCEDURE, COMPUTED TOMOGRAPHY (CT) SHOWED REPERFUSION INJURY OR INTRACEREBRAL HEMORRHAGE WITH PARTIAL NECROSIS OF BRAIN TISSUE. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) MEDICATIONS FOR ANTI-PLATELET AGGREGATION. THE PATIENT OUTCOME WAS NOTED AS "NOT RECOVERED/NOT RESOLVED." THE EVENT WAS NOTED TO BE A REPERFUSION INJURY WHICH IS A COMMON POST-OPERATIVE STROKE COMPLICATION. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING AND DID NOT RESULT IN NEW PATIENT DISABILITY. NO ADDITIONAL SURGICAL INTERVENTION W

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 17338648 ↗
• DeathJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS A POTENTIAL COMPLAINT OF DISTAL EMBOLIZATION IN THE SAME TREATED VASCULAR TERRITORY DURING PROCEDURE TO RIGHT MCA-1 FOR WHICH SECOND PASS WAS PERFORMED.

  Patient problems: Embolism/Embolus; Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 17238510 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION HAD LEFT CAROTID ARTERY OCCLUSION AFTER THE OPERATION. AFTER THE OPERATION, THROMBOSIS OCCURRED IN THE IMPLANTED STENT, AND THE PATIENT WAS TREATED WITH DRUG BLOOD RETURN AND ANTICOAGULANT THERAPY. IT WAS NOT RELATED TO THE STUDY PRODUCT DURING THE RECOVERY PERIOD, THE FAMILY ASKED TO BE DISCHARGED. NIHSS SCORE AVAILABLE: 4 AFTER THE OPERATION, THE STENT WAS IMPLANTED WITHOUT DRUG COATING, AND THE THROMBUS WAS HARD AND RETRACTED. NO HOSPITALIZATION OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT RECEIVED PHYCIAL THERAPY AND THE EVENT IS RESOLVING. LOCATION OF PROXIMAL FACE OF CLOT: PRE-PROCEDURE MTICI SCORE: INDETERMINATE. FINAL POST-PROCEDURE MTICI SCORE: 3. THE EVENT HAD A POSSIBLE RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17158541 ↗