Solitaire™ Platinum SFR3-6-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00847536034792), received between Nov 27, 2019 and Apr 25, 2024 — classified as 5 deaths, 17 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE RATIONALE FOR RELATING AE TO SYSTEM OR PROCEDURE WAS UPDATED TO STATE THIS COULD BE A LACUNAR INFARCTION CAUSED BY ANGIOGRAPHY. FINAL POST-PROCEDURE MTICI SCORE 2C ; POST-PROCEDURE 24H NIHSS 9 AND OUTCOME OF THE EVENT IS NOT RECOVERED/RESOLVED.

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Nervous System Injury

  MAUDE report 19181230 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT CEREBRAL EDEMA WAS IMPROVED BY HEAD CT AFTER SURGERY, AND MANNITOL WAS DEHYDRATED TO REDUCE BLOOD PRESSURE. THE PATIENT EXPERIENCED LETHARGY, OPEN EYES WHEN CALLING, AND UNCOOPERATIVE SPEECH. ACTIONS TAKEN INCLUDED MANNITOL. THE MRS SCORE WAS 0 AND NIHSS WAS 40. PRE-PROCEDURE MTICI SCORE WAS 0 AND POST PROCEDURE WAS 3. THE OUTCOME WAS RECOVERED/RESOLVED ON (B)(6) 2023. THE EVENT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE EVENT DID NOT RESULT FROM A DEVICE DEFICIENCY. THE SITE ASSESSED AS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE. THE RATIONALE FOR RELATING TO THE PROCEDURE WAS SURGERY INCREASE RISK OF CEREBRAL EDEMA.

  Patient problems: Cerebral Edema; Dysphasia; Lethargy

  MAUDE report 19135572 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT HEAD COMPUTERIZED TOMOGRAPHY (CT) RE-EXAMINATION ON (B)(6) 2023 SHOWED THAT THE RIGHT CEREBRAL HEMISPHERE HAD A LARGE INFARCTION AND THE RIGHT CEREBRAL EDEMA WAS OBVIOUS. CONSIDERING THE FORMATION OF THE CEREBRAL HERNIA. PER PHYSICAL EXAMINATION, THE PATIENT WAS IN SEDATIVE AND ANALGESIC STATE, MECHANICAL VENTILATION, BILATERAL PUPILS WERE ABNORMALLY LARGE, LIGHT REFLUX DISAPPEARED, LIMBS DID NOT MOVE AUTONOMOUSLY. CT RE-EXAMINATION ON (B)(6) 2023 SHOWED THAT THE RIGHT CEREBRAL EDEMA WAS STILL OBVIOUS. MANNITOL DEHYDRATION REDUCED CRANIAL PRESSURE ACCOMPANIED BY CEREBRAL HERNIA. CT RE-EXAMINATION ON (B)(6) 2023 SHOWED CEREBRAL EDEMA WAS STILL OBVIOUS AND MANNITOL DEHYDRATION WAS CONTINUED TO REDUCE CRANIAL PRESSURE. ON (B)(6) 2024 THE PATIENT WAS IN STABLE CONDITION AND WAS DISCHARGED FROM THE HOSPITAL TO CONTINUE INPATIENT REHABILITATION AND EXERCISE TREATMENT. THIS ADVERSE EVENT (AE) WAS NOT A RECURRENT OR NEW STROKE. AE WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY OR AN UNDERLYING CONDITION. THE PATIENT HAS NOT RECOVERED AND THE ISSUE NOT RESOLVED. BASELINE MODIFIED RANKIN SCALE (MRS) SCORE 0, BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCAL

  Patient problems: Cerebral Edema; Decreased Level of Consciousness; Intracranial Hemorrhage; Ischemia Stroke; Nervous System Injury; Thrombosis/Thrombus; Unspecified Nervous System Problem; Ventilator Dependent

  MAUDE report 18896927 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS DISCHARGED WITH A NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE OF 24. 2 023-11-23 AT THE 90-DAY FOLLOW-UP, IT WAS KNOWN THAT THE NIHSS WAS 36 POINTS. THE ADVERSE EVENT (AE) OF NEUROLOGICAL DETERIORATION WAS RECORDED. THE ONSET DATE WAS 2023-11-13 AND THE PATIENT HAS NOT RECOVERED AND THE ISSUE HAS NOT RESOLVED. THIS IS NOT A RECURRENT OR NEW STROKE. THE AE WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE AE DID NOT RESULT FROM DEVICE DEFICIENCY. MODIFIED RANKIN SCALE (MRS) SCORE 0, NIHSS 31. 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 NOT REALTED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSMENT RESULT WAS YES, CHINA SERIOUS ADVERSE EVENT REPORTING. THE PRE-PROCEDURE MTICI SCORE WAS 0, FINAL POST-PROCEDURE SCORE INDETERMINATE.

  Patient problems: Cognitive Changes; Unspecified Nervous System Problem

  MAUDE report 18627510 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A HIGH-DENSITY IMAGE OF THE LEFT BASAL GANGLIA COMPUTERIZED TOMOGRAPHY (CT) ON (B)(6) 2022 REVEALED CONTRAST EXTRAVASATION WITH SMALL AMOUNT OF BLOOD EXTRAVASATION AFTER INFARCTION.  MODIFIED RANKIN SCALE (MRS) SCORE 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE 16. THIS ADVERSE EVENT (AE) WAS NOT RELATED TO THE DISEASE UNDER STUDY. THIS AE WAS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THIS AE WAS NOR RESULT FROM A DEVICE DEFICIENCY. THE RATIONALE FOR RELATING AE TO SYSTEM OR PROCEDURE IS SURGERY INCREASES LIKELIHOOD OF BLEEDING. THIS WAS NOT A RECURRENT OR NEW STROKE. THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE PATIENT IS RECOVERING AND THE ISSUE IS RESOLVING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND STUDY DEVICES UTILIZED. THE LOCATION OF PROXIMAL FACE OF CLOT 1 WAS THE MIDDLE CEREBRAL ARTERY (MCA) M1, LEFT HEMISPHERE. PRE-PROCEDURE MTICI SCORE WAS 0, POST-PROCEDURE MTICI SC

  Patient problems: Extravasation; Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 18498745 ↗
• InjuryJan 10, 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, POST PROCEDURE CT REVEALED A NEW INFARCTION IN THE LEFT PARIETAL INSULAR LOBE AND A NEW INFARCTION IN THE LEFT OCCIPITAL LOBE WITHOUT OBVIOUS SYMPTOMS. THERE WAS NO TREATMENT OR ACTIONS TAKEN. THE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. THE EVENT WAS NOT A RECURRENT OR NEW STROKE AND DIDN'T RESULT FROM A DEVICE DEFICIENCY. THE EVENT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND UNDERLYING CONDITION OR DISEASE. THE MRS SCORE WAS 0 AND NIHSS SCORE WAS 6. PRE-PROCEDURE MTICI WAS INTERMEDIATE AND POST PROCEDURE MTICI SCORE WAS 3. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR PROCEDURE, HOWEVER, THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND DEVICES UTILIZED.

  Patient problems: Ischemia Stroke

  MAUDE report 18486206 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE POST-OPERATIVE COMPUTERIZED TOMOGRAPHY (CT) REVEALED CLINICALLY SIGNIFICANT SUBARACHNOID HEMORRHAGE (SAH). MODIFIED RANKIN SCALE (MRS) SCORE 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 16. THE ONSET DATE WAS (B)(6) 2023 AND THE PATIENT HAS NOT RECOVERED AND THE ISSUE NOT YET RESOLVED. THIS WAS NOT A RECURRENT OR NEW STROKE. THIS ADVERSE EVENT (AE) WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY, NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE, AND NOT RELATED TO A 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 THE EVENT AS NOT RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE STUDY PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS CAUSALLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE SOLITAIRE. PRE-PROCEDURE MTICI SCORE 0, POST-PROCEDURE MTICI SCORE 3. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE FINAL MTICI 3, AT DISCHARGED NIHSS 6. MRS3 ON (B)(6) 2023. NO TREATMENT WAS PROVIDED TO TREAT THIS CONDITION. NO SYMPTOMS WERE REPORTED RELATED TO THE SAH, AT DISCHARGED NEURO

  Patient problems: Cerebral Edema; Intracranial Hemorrhage; Lethargy; Muscle Weakness/Atrophy; Speech Disorder

  MAUDE report 18486074 ↗
• InjuryJan 8, 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 SFR3 SOLITAIRE STENT HAD MULTIPLE NEW CEREBRAL INFARCTION. POSTOPERATIVE MRI ON (B)(6) 2023 SHOWED A NEW CEREBRAL INFARCTION IN THE LEFT BASAL GANGLIA, ADJACENT TO THE LATERAL VENTRICLE, AND PARIETAL LOBE. NIHSS SCORE: 17, MRS SCORE: 0. NO ACTIONS WERE TAKEN. THE EVENT IS RESOLVING. EVENT WAS CONSERVATIVELY ASSESSED AS POSSIBLE RELATED TO PROCEDURE AND DEVICES UTILIZED. PRE-PROCEDURE MTICI SCORE: 0. FINAL POST-PROCEDURE MTICI SCORE: 3.

  Patient problems: Ischemia Stroke

  MAUDE report 18471683 ↗
• InjuryJan 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT POST PROCEDURE, MRI SHOWED NEW CEREBRAL INFARCTION IN THE LATERAL AND RIGHT FRONTOPARIETOTEMPORAL INSULA AND BASAL GANGLIA. THERE WAS NO TREATMENT OR OTHER ACTIONS TAKEN. THE OUTCOME STATUS IS RECOVERING/RESOLVING. THE EVENT IS NOT A RECURRENT OR NEW STROKE AND DID NOT RESULT FROM A DEVICE DEFICIENCY. THE EVENT WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY AND NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. THE MODIFIED RANKIN SCORE (MRS) WAS 0 AND NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS 14. PRE-PROCEDURE MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) WAS 0 AND POST MTICI WAS 2B. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR PROCEDURE, HOWEVER, THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND DEVICES UTILIZED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A CLOT IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M1.

  Patient problems: Ischemia Stroke

  MAUDE report 18461438 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIETN TREATED WITH A REACT-71 CATHETER AND SFR3 STENT HAD NEW INFACRTIONS. POST-OPERATIVE HEAD AND NECK CT PLAIN SCAN ON SEPTEMBER 8, 2023 A NEW INFARCTION IN THE LEFT PARIETAL INSULA WITH NO OBVIOUS SYMPTOMS. NIHSS SCORE: 6, MRS SCORE: 0. NO ACTIONS WERE TAKEN. THE EVENT IS NOT RESOLVED. EVENT WAS ASSESSED AS CAUSALLY RELATED TO STUDY PROCEDURE AND POSSIBLE RELATED TO DEVICES UTILIZED. PRE-PROCEDURE MTICI SCORE: INDETERMINATE FINAL POST-PROCEDURE MTICI SCORE: 3.

  Patient problems: Embolism/Embolus; Ischemia Stroke

  MAUDE report 18433221 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2023 COMPUTERIZED TOMOGRAPHY (CT) OF THE LEFT BASAL GANGLIA, LEFT RADIATIVE CROWN, AND LEFT FRONTAL INFARCT. (B)(6) 2023 CT REVEALED LEFT BASAL GANGLIA, RADIATIVE CROWN, FRONTAL LOBE, AND CEREBRAL HEMISPHERE THE MULTIPLE INFARCTS WERE NEW INFARCTS. MODIFIED RANKIN SCALE (MRS) SCORE 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 8. THIS EVENT DID NOT RESULT IN CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND WAS NOT LIFE THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND THE DEVICES UTILIZED DURING THE PROCEDURE. THE ISSUE HAS NOT BEEN RESOLVED, PATIENT HAS NOT RECOVERED. THE EVENT WAS PROBABLY RELATED TO THE DISEASE UNDER STUDY, NOT RELATED TO AN UNDERLYING CONDITION, AND NOT RELATED TO DEVICE DEFICIENCY.

  Patient problems: Ischemia Stroke

  MAUDE report 18428626 ↗
• DeathDec 27, 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 SOLITAIRE STENT HAD A CEREBRAL INFARCTION WITH MILD OBSTRUCTIVE HYDROPS WHICH LED TO DEATH ON (B)(6) 2022. ON (B)(6) 2022 THE PATIENT UNDERWENT INTERVENTIONAL SURGERY, (B)(6) 2022 THE PATIENT UNDERWENT INTERVENTIONAL SURGERY, POSTOPERATIVE DRUG SEDATION STATE, VENTILATOR ASSISTED VENTILATION, AFTER DRUG WITHDRAWAL. NIHSS SCORE: 5, MRS SCORE: 5. THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. RELATED TO DISEASE UNDER STUDY - INDEX STROKE. THE PATIENT WAS BEING TREATED FOR A CLOT IN THE MIDLINE BASILAR ARTERY. PRE-PROCEDURE MTICI SCORE: 0. FINAL POST-PROCEDURE MTICI SCORE: 2B. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE CEREBRAL INFARCTION. THE PATIENT DIED AT THE TREATING HOSPITAL. THE DEATH WAS NOT RELATED TO ANY MEDTRONIC DEVICE PER THE SITE AND SPONSOR. AT BASELINE MRS 5, ETIOLOGY OF STROKE WAS LARGE ARTERY ATHEROSCLEROSIS - INTRACRANIAL ATHEROSCLEROSIS WITH SUSPECTED LOCAL THROMBOSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT ON 2022-SEP-01, THE PATIENT WAS IN A COMA AFTER DRUG WITHDRAWAL. THE PATIENT'S FAMILY DECIDED TO STOP VENTILATOR ASSISTED VENTILATION, AND

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke; Vascular Dissection

  MAUDE report 18402441 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SITE AND SPONSOR ASSESSED THE EVENTS AS POSSIBLY RELATED TO THE PROCEDURE AND THE SITE ASSESSED POSSIBLY RELATED TO THE STENT RETRIEVER.

  Patient problems: Embolism/Embolus; Hematoma; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 18369754 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT EXPERIENCED NEW CEREBRAL INFARCTS IN THE AREA OF NON-RESPONSIBLE VESSELS. THIS WAS NOT A RECURRENT OR NEW STROKE. RATIONALE FOR RELATING THE ADVERSE EVENT (AE) TO THE SYSTEM OR PROCEDURE WAS COMMON COMPLICATION ASSOCIATED WITH THE STUDY DISEASE. INTERVENTIONS INCLUDED CONCOMITANT TREATMENT, BLOOD PRESSURE CONTROL, ANTIPLATELET THERAPY. THIS AE WAS PROBABLY RELATED TO THE DISEASE UNDER STUDY AND POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE. THIS AE WAS DID NOT RESULT FROM A DEVICE DEFICIENCY. THE SITE ASSESSED THIS AE AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND DEVICES USED (REACT, SOLITAIRE, AND REBAR.) ADDITIONALLY, THE PATIENT EXPERIENCED REPERFUSION AREA SUBARACHNOID HEMORRHAGE (SAH). THIS WAS NOT A RECURRENT OR NEW STROKE. THE RATIONALE FOR RELATING AE TO SYSTEM OR PROCEDURE WAS AFTER REVASCULARIZATION, REPERFUSION OF THE ISCHEMIC AREA OCCURS WITH HEMORRHAGE. THIS AE WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY, AND PROBABLY RELATED TO AN UNDERLYING CONDITION. THIS AE DID NOT RESULT FROM DEVICE DEFICIENCY. THE SITE ASSESSED THIS EVENT AS NO

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 18358285 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION ABOUT A PATIENT WHO UNDERWENT A PROCEDURE IN WHICH A SOLITAIRE STENT AND REACT CATHETER WAS USED. DURING THE OPERATION, IT WAS REPORTED THAT THERE WAS A RUPTURE OF A BRANCH OF THE LEFT ANTERIOR CHOROIDAL ARTERY, WITH BLEEDING BREAKING INTO THE LEFT LATERAL VENTRICLE. FOLLOWING COIL EMBOLIZATION OF THE LEFT ANTERIOR CHOROIDAL ARTERY, THE SUBSEQUENT ANGIOGRAPHY DID NOT SHOW ANY CONTRAST EXTRAVASATION. A REACT 71 CATHETER WAS COAXIALLY ADVANCED BUT COULDN'T PASS THE OPHTHALMIC ARTERY. A SUCTION CATHETER WAS POSITIONED AT THE C4 SEGMENT. 2023-NOV-14 E1 (HCP, REP, FOR, SDY): EVENT DATE OCCURRED 17-JUN-2023 DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THE RUPTURE OCCURRED CAUSING ANTERIOR CHOROIDAL ARTERY HEMORRHAGE. IMMEDIATE ACTION WAS TAKEN TO NEUTRALIZE THE HEPARIN EFFECTS AND THE RUPTURE/HEMORRHAGE WAS ADDRESSED WITH IMPLANTATION OF 2 EMBOLIZATION COILS. BASELINE MRS WAS 5, NIHSS WAS 29, AND MTICI WAS 0. POST-PROCEDURE MTICI WAS 2A. THE EVENT WAS CONSIDERED LIFE-THREATENING BUT DID NOT RESULT IN NEW PATIENT DISABILITY OR PROLONGED HOSPITALIZATION. THE PATIENT WAS NOTED TO BE RECOVERED AND EVENT RESOLVED ON 05-JUL-2023. IT WAS NO

  Patient problems: Intracranial Hemorrhage; Rupture; Ventilator Dependent

  MAUDE report 18212117 ↗
• InjuryNov 20, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLOT WAS LOCATED IN THE C7 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. MRS WAS 5, NIHSS BASELINE WAS 21 AND POSTOPERATIVE WAS 4, TICI BASELINE WAS 0 AND POSTOPERATIVE WAS 3. IV TPA WAS NOT CONTRAINDICATED. VESSEL TORTUOSITY WAS SEVERE. THE DIAMETER OF THE PUNCTURED VESSEL (RIGHT FEMORAL ARTERY) WAS 8MM. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. IT WAS NOTED THAT NO PROBLEM WAS FOUND WHEN THE PRODUCT WAS OPENED. 71 WAS PUSHED UP TO C7 AND THERE WAS NO PRESSURE FOR NEGATIVE PRESSURE SUCTION. AFTER TAKING OUT, IT WAS FOUND THAT THERE WAS A SMALL GAP AT THE POSITION WHERE THE SOFT AND HARD PARTS OF THE CATHETER WERE CONNECTED. AFTER REPLACING WITH THE INTERMEDIATE CATHETER 71, AFTER THE STENT (6/40 PLATINUM) WAS DEPLOYED FOR THE FIRST TIME, IT COULD NOT RECOVER TO THE REBAR MICROCATHETER, REPLACED WITH 4/40 PLATINUM TO COMPLETE THE OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 18170273 ↗
• DeathOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF A PATIENT WHO HAD UNDERGONE A MECHANICAL THROMBECTOMY ON (B)(6) 2023 IN WHICH A SOLITAIRE PLATINUM STENT RETRIEVER WAS USED. THERE WAS NO NOTED DEVICE OR INTRA-OPERATIVE ISSUES. THE PATIENT WAS NOTED TO HAVE STENT/VESSEL OCCLUSION POST-OPERATIVELY WHICH RESULTED IN PATIENT DEATH. THE SITE ASSESSMENT CONCLUDED THE EVENT WAS NOT RELATED TO THE PROCEDURE OR MEDTRONIC DEVICE(S). HOWEVER, THE STUDY SPONSOR ASSESSMENT REPORTS CONSERVATIVELY. THE PATIENT DEATH WAS ON (B)(6) 2023.

  Patient problems: Bradycardia; Cerebral Edema; Coma; Hydrocephalus; Intracranial Hemorrhage; Ischemia; Ischemia Stroke; Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 17851753 ↗
• DeathMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE ONSET DATE WAS 2023-JAN-01. THE PATIENT DID HAVE TREATMENT; SURGICAL PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA; Swelling/ Edema

  MAUDE report 16849840 ↗
• InjuryApr 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE STENT WAS STUCK DURING THE PROCEDURE DURING DELIVERY. IT WAS NOTED THAT THE VESSEL WAS MODERATELY TORTUOUS. RESISTANCE OCCURRED IN THE MIDDLE SECTION OF THE CATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE OF THE INTERNAL CAROTID ARTERY, C7. IV TPA WAS NOT CONTRAINDICATED. THERE WERE 2 PASSES WITH THE DEVICE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. STROKE ONSET TO REPERFUSION TIME WAS 2 HOURS. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT RECOVERING FROM THE PROCEDURE IS IN A LIGHT COMA. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE EVENT. THE CATHETER WAS A MEDTRONIC PRODUCT REBAR27 LOT # B412012. THE PATIENT¿S BASELINE NIHSS SCORE 27. THE PATIENT¿S POST-THROMBECTOMYNIHSS SCORE 20.

  Patient problems: Coma

  MAUDE report 16685497 ↗
• DeathNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT EMBOLIZATION INTO NEW VASCULAR TERRITORIES OCCURRED DURING THE INDEX PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE OF THE ICA BELOW CAROTID T,  MCA M1, MCA M2, ACA A2. NIHSS SCORE BASELINE WAS 27, POST PROCEDURE WAS 25. TICI SCORE BASELINE WAS 0, POST PROCEDURE WAS 3. IV TPA WAS NOT CONTRAINDICATED. REACT-68 IN PASS 2, SOLITAIRE IN PASS 1, REBAR 18 MICROCATHETER IN PASS 1. STROKE ONSET TO REPERFUSION TIME WAS (B)(6) 2022 AT 7:40 TO (B)(6) 2022 AT 14:00. THE PATIENT'S MEDICAL HISTORY INCLUDES DIABETES MELLITUS, HYPERTENSION, CORONARY ARTERY DISEASE, AND CURRENT TOBACCO USER. ANCILLARY DEVICES INCLUDE A REACT-68 GUIDE CATHETER AND A REBAR 18 MICROCATHETER.

  Patient problems: Embolism/Embolus; Ischemia Stroke; Swelling/ Edema

  MAUDE report 15846836 ↗
• MalfunctionNov 8, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN SFR3 SOLITAIRE STENT HAD RESISTANCE IN THE DISTAL SECTION OF THE REBAR-27 CATHETER DURING DEL IVERY. ON (B)(6) 2022, THE PHYSICIAN WAS PERFORMING AN INTERVENTIONAL THROMBECTOMY AND OPENING SURGERY FOR ACUTE LARGE BLOOD VESSEL OCCLUSION. DURING THE SURGERY, AFTER THE GUIDEWIRE WITH MICROCATHETER REBAR-27 WERE INPLACE. UNDER THE CIRCUMSTANCE THAT SFR3-6- 40-10 PRODUCT DID NOT ENTER THE BODY AND AFTER BEING DELIVERED TO THE TAIL OF THE MICROCATHETER BY THE STENT PROTECTIVE SHEATH, IT BECAME STUCK AND IT WAS DIFFICULT TO CONTINUE TO BE DELIVERED. THE SURGEONS IN ORDER TO MAKE THE SURGERY SAFE, AND AFTER TRYING 2 TIMES WITHOUT SUCCESS, THE STENT WAS SELECTED TO BE REPLACED. SINCE THE 6-40 STENT WAS OUT OF STOCK, THE SFR3-4-40-10 STENT WAS CHOSEN TO PERFORM THE SURGERY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS BEING TREATED FOR AN ISCHEMIC STROKE IN THE MIDDLE CEREBRAL ARTERY.  MRS: BASELINE 2. MRS: PROCEDURE 1. NIHSS SCORE: BASELINE 15. NIHSS SCORE: POST PROCEDURE 3. TICI SCORE: BASELINE 0. TICI SCORE: POST PROCEDURE 2B. IV TPA WAS NOT CONTRAINDICATED. 1 PASS WAS MADE WITH THE DEVICE. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755785 ↗
• DeathOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT DIED OF MULTIPLE ORGAN FAILURE DUE TO PULMONARY INFECTION ON (B)(6) 2022. THE EVENT WAS NOT THE RESULT OF A DEVICE DEFICIENCY, AND WAS NOT A NEW OR RECURRING STROKE. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT HAD UNDERGONE TREATMENT FOR A CLOT LOCATED IN THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY. THE PATIENT'S PRE-PROCEDURE MTICI SCORE WAS 0, AND POST-PROCEDURE IT WAS 3. THE PATIENT'S MRS SCORE HAD BEEN 0, AND THEIR NIHSS SCORE WAS 16.

  Patient problems: Intracranial Hemorrhage; Muscle Weakness/Atrophy; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 15598842 ↗
• InjuryNov 27, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE SOLITAIRE PLATINUM SEPARATED AND REMAINED IN THE PATIENT. PRIOR TO THE EVENT, THERE WERE TWO ASPIRATION ONLY ATTEMPTS. AFTER THE ASPIRATION ATTEMPTS, THE SOLITAIRE WAS DEPLOYED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) AND OPENED FOR FIVE MINUTES. UPON PULLING THE STENT OUT OF THE CAVERNOUS INTERNAL CAROTID ARTERY (ICA) AFTER ONE PASS, THE REPORTED EVENT OCCURRED. A STENT WAS DEPLOYED INSIDE THE SOLITAIRE STENT AS INTERVENTION. THE PATIENT WAS UNDERGOING MECHANICAL THROMBECTOMY FOR TREATMENT OF AN ISCHEMIC STROKE LOCATED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT¿S MRS, NIHSS, AND TICI SCORES WERE UNKNOWN. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9386841 ↗