Solitaire PlatinumRecalls & reported problems across all models

We found 4 models of Solitaire Platinum by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2019 and Jul 12, 2024 — classified as 15 deaths, 44 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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. 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 Solitaire Platinum problems

Solitaire Platinum models

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

• Solitaire™ Platinum SFR3-4-40-10

  Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
  10 deaths39 reports
• Solitaire™ Platinum SFR3-6-40-10

  Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
  5 deaths23 reports
• Solitaire™ Platinum SFR3-4-20-05

  Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
  1 report
• Solitaire™ Platinum SFR3-4-20-10

  Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
  1 report

Recent Solitaire Platinum adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED MULTIPLE SUBACUTE CEREBRAL INFARCTS IN THE LEFT CEREBRAL HEMISPHERE REGION. THE CAUSE OF THIS IS THAT THE LEFT MIDDLE CEREBRAL ARTERY REMAINS STENOTIC AND THERE IS REMNANT APPENDAGE EMBOLIZATION. ON REVIEW AT TIME OF DISCHARGE, THE HYPERDENSE SHADOW WAS REDUCED, THEN THE SUBJECT WAS DISCHARGED AS THE REQUIREMENT OF THE FAMILY. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE IS 0, BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 15. THIS IS NOT A RECURRENT OR NEW STROKE. THE ADVERSE EVENT (AE) IS NOT RELATED TO THE SYSTEM OR PROCEDURE AND NOT RELATED TO UNDERLYING PATIENT CONDITION. AE DID NOT RESULT FROM DEVICE DEFICIENCY. THE ONSET DATE WAS 2023-04-06, AND THE ISSUE RECOVERED/RESOLVED ON 2023-04-10. PER SITE, 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 DEVICE. PRE-PROCEDURE MTICI SCORE 0, FINAL POST-PROCEDURE MTICI 3. ANCILLARY DEVICES INCLUDE A ZHO

  Patient problems: Embolism/Embolus; Ischemia Stroke; Stenosis

  MAUDE report 18995715 ↗
• 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 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 ↗
• 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 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 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 ↗

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