Trevo 90183Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00815742001839), received between Oct 3, 2018 and Mar 24, 2025 — classified as 1 death, 24 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K132641, K203219); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 23, 2024Open, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1902-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE SUBJECT STENT RETRIEVER WAS PULLED OUT AFTER ONE PULL, PHYSICIAN SAW THAT THERE WAS A LOOSE THREAD AT THE END OF THE SUBJECT STENT RETRIEVER. IT MAY APPEAR THAT PARTS OF THE SUBJECT STENT RETRIEVER HAVE COME LOOSE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. UPDATE: THE SUBJECT STENT RETRIEVER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED, AND IT WAS DISCOVERED THAT THE REPORTED EVENT OF THE SUBJECT STENT RETRIEVER BEING BROKEN/FRACTURE DURING USE WAS NOT CONFIRMED. THE SUBJECT RETRIEVER INSERTION TOOL WAS NOTED TO BE KINKED/BENT, COILS WERE DAMAGED, AND A FOREIGN MATERIAL WAS NOTED WRAPPED AROUND THE DISTAL END OF THE RETRIEVER SHAPED SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678659 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE ON (B)(6) 2020, THE PATIENT SUFFERED FROM HEMORRHAGIC TRANSFORMATION-BLOOD BRAIN BARRIER RUPTURE. IT WAS REPORTED THERE WAS A POSSIBLE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND SUBJECT RETRIEVER DEVICE USED IN THE PROCEDURE. IT WAS REPORTED THE STROKE (DISEASE UNDER STUDY) AND THE THROMBECTOMY PROCEDURE WERE RELATED TO THE ADVERSE EVENT. THE EVENT RESOLVED WITH UNKNOWN CLINICAL SEQUALAE ON (B)(6) 2020. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446220 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A THROMBECTOMY PROCEDURE, THE PATIENT EXPERIENCED SPASM WHICH WAS TREATED WITH THE MEDICATION. IT IS NOTED THAT THE ADVERSE EVENT (SPASM) HAS POSSIBLY RELATIONSHIP TO THE THROMBECTOMY PROCEDURE AND THE SUBJECT STUDY DEVICE RETRIEVER, NOT RELATED TO STROKE (DISEASE UNDER STUDY) AND TO AN UNDERLYING CONDITION. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED WITHOUT CLINICAL SEQUALAE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 17080602 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE ON (B)(6) 2020, THE PATIENT EXPERIENCED HEMORRHAGE AS IDENTIFIED AS PARENCHYMATOUS HEMATOMA 2. IT IS NOTED THAT THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT CATALYST DEVICE. NO FURTHER INFORMATION IS AVAILABLE. UDATED: FURTHER REVIEWING FROM MEDICAL SAFETY TEAM INDICATED THAT THE PATIENT EXPERIENCED SUB ARACHNOID HEMORRHAGE (SAH) AT THE LEFT SYLVIAN. ADDITIONALLY, THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT STUDY RETRIEVER DEVICE AS THE EVENT HAD NO RELATION TO THE CATALYST DEVICE AS PREVIOUSLY REPORTED. THIS REPORT REFERS TO THE SUBJECT STUDY RETRIEVER DEVICE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage

  MAUDE report 17078152 ↗
• DeathJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE FIRST TREATMENT STRATEGY FROM A THROMBECTOMY PROCEDURE ON (B)(6) 2021, THE PATIENT SUFFERED VESSEL PERFORATION /RUPTURE ON STENOSED ARTERY AND HIV WHICH WERE TREATED WITH THE MEDICATION AND SUBSEQUENTLY THERE WAS PATIENT DEATH. IT IS NOTED THAT THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT STUDY RETRIEVER DEVICE, THROMBECTOMY PROCEDURE, DISEASE UNDER STUDY AND TO AN UNDERLYING CONDITION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels; Viral Infection

  MAUDE report 17052823 ↗
• MalfunctionJun 28, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT MECHANICAL THROMBECTOMY VIA SR (STENT RETRIEVER) COMBINATION TECHNIQUE WAS PERFORMED FOR AIS (ACUTE ISCHEMIC STROKE). SUBJECT RETRIEVER STENT WAS ADVANCE TO THE TARGETED SITE AND STENT WAS DEPLOYED SUCCESSFULLY WITH FULL OPENING OF THE SHAPE SECTION OF THE RETRIEVER WAS ACHIEVED. AFTER CLOT INTEGRATION WHEN THE PHYSICIAN TRIED TO WITHDRAW THE SUBJECT RETRIEVER, RESISTANCE WAS ENCOUNTERED AND IT GOT STUCK INTO THE SUPRACLINOID SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY). CONSTANT TENSION HAS BEEN APPLIED ON THE STENT DELIVERY WIRE TO LOOSE THE STENT AND THEN THE STENT RETRIEVER WAS REMOVED WITH THE CAPTURED CLOT FROM THE PATIENT VASCULATURE. THE SURGICAL DELAY WAS NOTED AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THE SUBJECT DEVICES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081653 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT TREVO RETRIEVER WAS USED IN THE STUDY PROCEDURE TO TREAT THE CLOT AT THE RIGHT MCA (MIDDLE CEREBRAL ARTERY)-M3 EXTENDING IN ICA (INTERNAL CAROTID ARTERY - CERVICAL (NOT T), ACA (ANTERIOR COMMUNICATING ARTERY)-A3. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 0. DURING THE STUDY PROCEDURE 3RD PASS, PRESUMED DISSECTION OF THE M3 OCCLUDED BRANCH WITH RE-OCCLUSION OF THE VESSEL. FOLLOW-UP WITH CT (COMPUTED TOMOGRAPHY) SCAN AFTER THE STUDY PROCEDURE REVEALED SAH (SUBARACHNOID HEMORRHAGE) WITH THE TICI OF 0. THERE WAS NO TREATMENT ADMINISTERED DUE TO THE EVENT AND THE OUTCOME OF THE ADVERSE EVENT IS STILL ON GOING . BASED ON THE PHYSICIAN¿S OPINION THAT THE ADVERSE EVENT WAS RELATED TO AN INDEX STROKE, INDEX PROCEDURE, AND THE SUBJECT DEVICE (TREVO RETRIEVER). NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11279271 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT DEVICE RETRIEVER WAS USED TO REMOVE THE PROXIMAL FACE OF CLOT LOCATED AT THE RIGHT MCA (MIDDLE CEREBRAL ARTERY) M1 EXTENDING TO M2. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 0 AND NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 18 AND MRS (MODIFIED RANKIN SCORE) OF 1. IT WAS REPORTED THAT DURING PROCEDURE, SAH (SUBARACHNOID HEMORRHAGE) OCCURRED. THERE WERE NO SERIOUS ADVERSE EVENT OR NEUROLOGICAL DETERIORATION REPORTED DUE TO THE SAH AND NO MEDICAL MANAGEMENT WAS ADMINISTERED IN RESPONSE TO THE PATIENT HEMORRHAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT¿S NEUROLOGICAL ASSESSMENT SHOWED TICI OF 3 AND NIHSS OF 15 AFTER 24 HOURS PROCEDURE. THE PATIENT WAS DISCHARGED APPROXIMATELY 5-7 DAYS POST PROCEDURE WITH NIHSS OF 15 AND MRS OF 4. NO OTHER INFORMATION WAS PROVIDED. UPDATE INFORMATION: RECEIVED ON ADDITIONAL ON 19-JAN-2021 INDICATED THAT THE PATIENT¿S CURRENT CONDITION IS ONGOING. THE STENT AND PATIENT¿S ANATOMY WERE THE CAUSE OF THE SUBARACHNOID HEMORRHAGE. THE PATIENT ANATOMY WAS NOTED TO BE MODERATE TORTUOUS .THERE WERE NO DIFFICULTIES ENCOUN

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11135885 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT RETRIEVER ALONG WITH OTHER DEVICES WERE USED TO REMOVE THE CLOT FROM LEFT M2 LESION. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 13 AND MRS (MODIFIED RANKIN SCORE) OF 0. ASPECTS BEFORE PROCEDURE WAS 10. THE TICI WAS IMPROVED TO 2B AFTER THE FIRST PASS. HOWEVER, THE VESSEL PERFORATION OCCURRED DURING THE PROCEDURE WHICH WAS ALLEGEDLY NOT RELATED TO THE SUBJECT RETRIEVER. THERE WAS NO OTHER PATIENT INJURY SUCH AS VESSEL DISSECTION OR DEVICE MALFUNCTION DURING PROCEDURE. 24 HOURS POST PROCEDURE COMPUTER TOMOGRAPHY (CT) CONFIRMED THE INTRACRANIAL HEMORRHAGE (ICH). 7 DAYS POST PROCEDURE, THE NIHSS OF 17 AND THE MRS SCORE BECAME WORSE TO 4. THE MRS SCORE OF 4 WAS RECONFIRMED POST 50 DAYS PROCEDURE. THE PHYSICIAN STATED THAT PATIENT'S M2 INFARCTION WAS "CARDIO EMBOLISM" ACCORDING TO TOAST CLASSIFICATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 11078401 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE FOR RIGHT M2 ON (B)(6) 2020 SUBJECT RETRIEVER AND ASPIRATION CATHETER WAS USED FOR TWO PASSES. VESSEL PERFORATION NOT RELATED TO SUBJECT RETRIEVER OCCURRED DURING THE PROCEDURE. CT SCAN FOLLOW-UP AFTER PROCEDURE SHOWED SAH (SUBARACHNOID HEMORRHAGE). PATIENT MRS (MODIFIED RANKIN SCALE) BEFORE ONSET WAS 0. THE PRE-PROCEDURE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE WAS 0 AND FINAL TICI WAS 2B. PRE-PROCEDURE NIHSS (NATIONAL INSTITUTES OF HEALTH STROKE SCALE) SCORE WAS NOTED AT 15 AND FINAL NIHSS WAS 15. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 10849233 ↗
• MalfunctionNov 10, 2020Difficult to Remove; Difficult to Remove

  DURING THE THROMBOLYSIS PERFORMED FOR RIGHT M2, PASSES WERE DONE WITH SUBJECT RETRIEVER. THERE WERE NO VESSEL PERFORATION OR VESSEL DISSECTION, BUT PHYSICIAN NOTED DIFFICULTY REMOVING SUBJECT RETRIEVER OCCURRED DURING PROCEDURE. FINAL TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE WAS 2B AND NO HEMORRHAGE OBSERVED IN FOLLOW-UP CT AND MRI AFTER PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820873 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED DURING PROCEDURE WE BUT IT WAS NOT RELATED TO THE REPORTED RETRIEVER. DIAGNOSTIC IMAGING TAKEN 24 HOUR POST PROCEDURE SHOWED DEVELOPMENT OF INTRACEREBRAL HEMORRHAGE (ICH) IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10709198 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT RETRIEVER WAS USED TO REMOVE CLOT FROM THE RIGHT MCA M1 PORTION ON (B)(6) 2020. AFTER THE 1ST PASS, EMBOLIZATION TO NEW TERRITORY (ENT) OCCURRED IN RIGHT A2 SEGMENT, THEN AN ADDITIONAL PASS WAS PERFORMED TO REMOVE M2 CLOT. THROMBECTOMY WAS PERFORMED TO TREAT THE DISTAL NEW TERRITORY EMBOLUS (ENT). PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 17 AND MRS (MODIFIED RANKIN SCORE) OF 0. ACCORDING TO THE SURGEON, VESSEL PREFORMATION OCCURRED DURING THE PROCEDURE BUT WAS NOT DUE TO STRYKER RETRIEVER. 24 HOURS POST PROCEDURE COMPUTER TOMOGRAPHY (CT) CONFIRMED, INTRACRANIAL HEMORRHAGE (ICH) WAS OBSERVED. IT IS UNKNOWN IF THE ICH WAS TREATED. NO ADDITIONAL INFORMATION WAS RECEIVED. POST PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THAT THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) REPERFUSION GRADE WAS 2B, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 21 AND MRS (MODIFIED RANKIN SCORE) OF 5, THREE DAYS POST PROCEDURE.

  Patient problems: Embolism/Embolus; Intracranial Hemorrhage

  MAUDE report 10584291 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN THE RIGHT DISTAL M1 AND M2 VESSELS, THE PHYSICIAN MADE THREE SUCCESSFUL PREVIOUS PASSES USING ANOTHER RETRIEVER, SUBJECT STENT RETRIEVER AND ASPIRATION CATHETER. A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A WAS ACHIEVED. DURING THE FOURTH PASS WITH THE SUBJECT STENT RETRIEVER, THE CLOT MOVED TO THE RIGHT DISTAL M1. ASPIRATION THROMBECTOMY WAS PERFORMED DURING THE LAST PASS TO SUCCESSFULLY REMOVE THE CLOT, AND THE FINAL TICI SCORE WAS 1. THE PHYSICIAN REPORTED DIFFICULTY DEPLOYING THE SUBJECT STENT RETRIEVER DUE TO UNKNOWN REASONS. THE PATIENT DEVELOPED SYMPTOMATIC SUB-ARACHNOID HEMORRHAGE AFTER THE PROCEDURE WITHOUT ANY RELATED VESSEL PERFORATION OR DISSECTION. 24 HOURS AFTER THE PROCEDURE, IMAGING SHOWED INTRA-CRANIAL HEMORRHAGE. PHYSICIAN'S OPINION ON WHAT CAUSED THE HEMORRHAGE WAS NOT PROVIDED. PATIENT CONDITION AND MEDICAL TREATMENT ADMINISTERED FOR THE HEMORRHAGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism/Embolus; Embolus; Intracranial Hemorrhage

  MAUDE report 10505835 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THROMBECTOMY PROCEDURE FOR LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 DISTAL AND M2. PROCEDURE INCLUDED 3 PASSES IN TOTAL PERFORMED WITH THE SUBJECT RETRIEVER. PATIENT PRE-PROCEDURE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) SCORE WAS 0 AND HAD NIHSS (NIH STROKE SCALE/SCORE) 24. FOLLOWING PROCEDURE COMPLETION, PATIENT WAS NOTED TO HAVE POST PROCEDURE TICI SCORE OF 2B AND NIHSS SCORE OF 13. PHYSICIAN REPORTED NO VESSEL PERFORATION, VESSEL DISSECTION AND DEVICE MALFUNCTION DURING PROCEDURE WHICH WAS COMPLETED SUCCESSFULLY. 24 HOURS POST-PROCEDURE, IMAGING RESULTS SHOWED INTRACEREBRAL HEMORRHAGE AND SUBSEQUENTLY PATIENT DEVELOPED SICH (SPONTANEOUS INTRACEREBRAL HEMORRHAGE) AND SYMPTOMATIC SAH (SUBARACHNOID HEMORRHAGE) TWO DAYS POST PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10492435 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020 FOR LEFT P2 CARDIOGENIC CEREBRAL EMBOLISM IN WHICH THE SUBJECT RETRIEVER WAS USED, A CAUSATIVE VASCULAR DISSECTION WAS OBSERVED. FOLLOWING COMPLETED PROCEDURE ON (B)(6) 2020, PATIENT EXPERIENCED INTRACRANIAL HEMORRHAGE PH-1 (PARENCHYMAL HEMATOMA TYPE 1). PATIENT HAD PREOPERATIVE MRS (MODIFIED RANKIN SCALE) OF GRADE 0 AND A MRS GRADE OF 3 DATED 26-FEB-2020. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intracranial Hemorrhage; Vascular Dissection

  MAUDE report 10287053 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT OF THROMBOSIS IN LEFT M2, THE SUBJECT RETRIEVER WAS USED TO REMOVE THE THROMBOSIS. THE PATIENT MRS (MODIFIED RANKIN SCALE) PRE PROCEDURE WAS UNKNOWN. PREPROCEDURE PATIENT HAD A MODIFIED TREATMENT IN CEREBRAL ISCHEMIA (MTICI) GRADE OF 0 AND A POST OPERATION MTICI GRADE OF 2A WAS ACHIEVED. IT WAS REPORTED THAT SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SAH) OCCURRED TWOS DAYS AFTER PROCEDURE. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. PHYSICIAN NOTED THAT SUBJECT DEVICE DID NOT CAUSE SAH IN PATIENT, RATHER THE PATIENT SAH WAS LIKELY DUE TO POOR CONDITION AT TIME OF TRANSPORTATION AND TARGET BLOOD VESSELS WAS THIN. NO ADDITIONAL FOLLOW-UP PROCEDURE TO TREAT PATIENT SAH IS PLANNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 10221488 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE FOR RIGHT M1 DISTAL WAS PERFORMED USING A COMBINATION TECHNIQUE WITH A RETRIEVER (SUBJECT DEVICE) AND A CATHETER. IT WAS REPORTED THAT SUBJECT RETRIEVER MIGHT HAVE CONTRIBUTED IN DEVELOPMENT OF VESSEL PERFORATION DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Perforation of Vessels

  MAUDE report 10164108 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS DONE AT LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY WITH THE USE OF THE SUBJECT STENT RETRIEVER AND AN ASPIRATION CATHETER. THE PATIENT'S VESSEL DISSECTION WAS CONFIRMED DURING PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 10117521 ↗
• InjuryJun 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT RETRIEVER BROKE 3CM PROXIMAL TO THE STENT PORTION AND REMAINED WITHIN PATIENT¿S VESSEL. PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. PATIENT PASSED AWAY DUE TO PREEXISTING COMORBIDITIES. PHYSICIAN STATED PATIENT DEATH WAS NOT DUE TO SUBJECT DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10107312 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE USING THE SUBJECT DEVICE (RETRIEVER) ALONG WITH OTHER DEVICES (DISTAL ACCESS CATHETER AND LONG SHEATH), THE PATIENT'S VESSEL RUPTURE D IN M2 BRANCH AND LED TO HEMORRHAGE IN WHICH RESULTING IN A SERIOUS INJURY AND REQUIRED MEDICAL INTERVENTION. NO OTHER INFORMATION WAS PROVIDED. UPDATE ADDITIONAL INFORMATION. RECEIVED ADDITIONAL INFORMATION FROM THE SITE ON 19-JUNE-2020 INDICATED THAT THE CAUSE OF THE VESSEL RUPTURE IS NOT KNOWN. FIRST, THERE WAS A HIGH FRICTION DURING THROMBECTOMY, MOST LIKELY CAUSE BY THE UNDERLYING VESSEL DISEASE, PRESUMABLY DUE TO HARD THROMBUS. SECOND, IT WAS TECHNICALLY NOT POSSIBLE TO NAVIGATE THE INTERMEDIATE SUBJECT CATHETER INTO THE M1-SEGMENT, SO THAT DURING THE THROMBECTOMY, IT WAS POSITIONED WITHIN THE CAVERNOUS SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY). THIS CAUSED A SUBOPTIMAL ANGLE OF FORCE DURING THE PULLING OF THE STENT RETRIEVER. THESE TWO REASONS MIGHT HAVE FACILITATED THE RUPTURE. THE RUPTURE WAS TREATED BY OCCLUDING THE M1/M2 SEGMENT OF THE ICA WITH BALLOON CATHETER AND RESOLVED AFTER 10 MINUTES NO MORE ACTIVE EXTRAVASATION WAS OBSERVED. THE HEMORRHAGE WAS STABLE IN POST-INTERVENTIONAL CONTROL IMAGING. T

  Patient problems: Hemorrhage, Cerebral; Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 10023195 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMEBCTOMY PROCEDURE AT RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY(MCA), VESSEL PERFORATION OCCURRED INSIDE THE PATIENT'S ANATOMY. TWO PASSES WERE PERFORMED DURING THE PROCEDURE, 1ST PASS WAS PERFORMED WITH THE SUBJECT RETRIEVER IN CONJUNCTION WITH OTHER COMPANY'S CATHETER AND THE 2ND PASS WAS PERFORMED WITH UNKNOWN ASPIRATION CATHETER. IT IS UNKNOWN AT WHAT STAGE VESSEL PERFORATION OCCURRED AND WHAT DEVICES WERE RELATED TO THE EVENT. THE PHYSICIAN DENIED RELATIONSHIP TO THE SUBJECT RETRIEVER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation

  MAUDE report 9892313 ↗
• InjuryMar 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE FOR BASILAR ARTERY, THE PATIENT'S VESSEL WAS PERFORATED. THE EVENT IS NOT RELATED TO THE SUBJECT RETRIEVER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 9833037 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE, THE PATIENT'S VESSEL PERFORATED AT THE RIGHT MIDDLE CEREBRAL ARTERY(MCA) INSIDE THE PATIENT'S ANATOMY. THE MEDICAL TREATMENT/INTERVENTION TAKEN DUE TO THE REPORTED EVENT IS UNKNOWN. THE NEXT DAY AFTER THE PROCEDURE, COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND ASYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) WAS NOTED IN PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 9803157 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ¿DELAYED REBLEEDING FROM PSEUDOANEURYSM AFTER MECHANICAL THROMBECTOMY USING STENT RETRIEVER DUE TO SMALL ARTERY AVULSION CONFIRMED BY OPEN SURGERY¿ ARTICLE STATES THAT THE PATIENT WAS PRESENTED WITH RIGHT HEMIPLEGIA AND GLOBAL APHASIA. IMAGING REVEALED OCCLUSION OF THE M2 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY WITH SUBTLE ACUTE ISCHEMIC CHANGE IN THIS TERRITORY. INTRAVENOUS THROMBOLYSIS WAS GIVEN AND MECHANICAL THROMBECTOMY WERE PERFORMED WITH THE SUBJECT STENT RETRIEVER. SUCCESSFUL REVASCULARIZATION WAS FINALLY ACHIEVED WITH A SINGLE PASS OF THE STENT RETRIEVER. DURING RETRIEVAL OF THE STENT RETRIEVER FROM THE PATIENT¿S BODY, SIGNIFICANT DEVIATION OF THE VESSEL OCCURRED AROUND MIDDLE CEREBRAL ARTERY INSIDE THE PATIENT'S ANATOMY. ANTI- COAGULATION WAS INITIATED AFTER CONFIRMING RESOLUTION OF A SMALL AMOUNT OF POST-PROCEDURAL SUB ARACHNOID HEMORRHAGE 1 DAY AFTER THE PROCEDURE. HOWEVER, 4 DAYS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF HEADACHE AND COMPUTED TOMOGRAPHY AND ANGIOGRAPHY REVEALED A MASSIVE SYLVIAN HEMATOMA WITH DE NOVO FORMATION OF A SMALL PSEUDOANEURYSM AT THE SITE WHERE THE STENT RETRIEVER WAS DEPLOYED. OPEN SURGERY BY CRANIOTOMY AND SUPERFICIAL TEMPORAL AR

  Patient problems: Headache; Hematoma; Hemorrhage, Subarachnoid; Pseudoaneurysm; Vascular Dissection

  MAUDE report 9587134 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132641, K203219. One submission often covers many models, so check the product and lot details in each record.

• Z-0347-2018 · Nov 28, 2017 · Terminated
  Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
• Z-0276-2018 · Nov 3, 2017 · Terminated
  Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Acc
• Z-0275-2018 · Nov 3, 2017 · Terminated
  Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.0
• Z-0277-2018 · Nov 3, 2017 · Terminated
  Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention