Trevo XP 90186Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00815742001860), received between May 15, 2018 and Aug 2, 2023 — classified as 1 death, 23 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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, K143077, 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 31 reports, in the reporter's own words as published by the FDA.

• 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 17447286 ↗
• 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 STUDY RETRIEVER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17078367 ↗
• MalfunctionNov 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS ADVANCED THROUGH THE MICROCATHETER AND WHEN THE PHYSICIAN TRIED TO RETURN THE PUSHERWIRE, THE SUBJECT STENT RETRIEVER BROKE. THERE WAS A SURGICAL DELAY OF UNKNOWN DURATION DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890985 ↗
• InjuryMay 19, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE SUBJECT SENT DEVICE (TREVO XP) WAS USED ON ONE RIGHT MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM CASE. PUNCTURED THROUGH RIGHT FEMORAL ARTERY AND PLACED 8F CODIS GUIDE CATHETER, SOFIA ASPIRATION CATHETER, PRO-18 MICROCATHETER AND SYNCHRO GUIDEWIRE TO BUILD ACCESS AND PLACED MIDDLE CATHETER AND MICROCATHETER TO THE LOCATION. PREPARED TO USE A SUBJECT DEVICE SYENT. CHECKED IT AND FLUSHED IT NORMALLY AND THEN DELIVERED IT INTO PRO18 MICROCATHETER. AFTER IT WAS PLACED TO THE LOCATION, DEPLOYED IT AND WITHDREW IT NORMALLY. FOR THE FIRST TIME TO WITHDRAW, NO THROMBUS WAS OBSERVED. SO THE OPERATOR DELIVERED IT TO DEPLOY AGAIN AND WHEN WITHDRAWING THE SUBJECT STENT, BIG RESISTANCE WAS ENCOUNTERED AND THE SUBJECT STENT COULD NOT BE RETRACTED. TRIED SEVERAL TIMES THE SUBJECT STENT WAS SEPARATED AND LEFT IT IN THE VESSEL AND COULD NOT BE TAKEN OUT WITH A SNARE. THE OPERATOR COMMUNICATED WITH THE PATIENT AND FINALLY WITHDREW THE REST OF THE DEVICES AND FINISHED THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14438248 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMBECTOMY FOR RIGHT CERVICAL- ICA (INTERNAL CAROTID ARTERY) WAS PERFORMED ON PATIENT WITH MODIFIED RANKING SCALE: MRS SCORE: 3 (SCALE +3: MODERATE DISABILITY; REQUIRING SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE) AND ALBERTA STROKE PROGRAM EARLY CT SCORE: ASPECTS BEFORE PROCEDURE WAS (B)(6) 2020. FIRST PASS AND SECOND PASS WERE PERFORMED WITH RETRIEVER (SUBJECT DEVICE) AND ASPIRATION CATHETER. HOWEVER, THROMBOLYSIS IN CEREBRAL INFARCTION SCALE: TICI WAS STILL 0: NO PERFUSION AFTER 2 PASS. IN ADDITION, VESSEL DISSECTION OCCURRED DURING PROCEDURE, WHICH WAS ALLEGEDLY RELATED TO RETRIEVER. THERE WERE NO VESSEL PERFORATION, OR DEVICE MALFUNCTION DURING PROCEDURE. MRI FOLLOW-UP 12.5 HOURS AFTER THE PROCEDURE ON (B)(6) 2020 REVEALED ICH (INTRACRANIAL HEMORRHAGE). MODIFIED RANKING SCALE: MRS SCORE BECAME WORSE TO +4 (MODERATELY SEVERE DISABILITY; UNABLE TO WALK AND ATTEND TO BODILY NEEDS WITHOUT ASSISTANCE) THOUGH NATIONAL INSTITUTES OF HEALTH STROKE SCALE: NIHSS WAS CHANGED FROM 14 TO 13 ON OCT 26TH, 2020. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IT IS UNDER CONFIRMATION WHY THE PROCEDURE WAS FINISHED THOUGH TICI WAS 0 AFTER 2ND

  Patient problems: Intracranial Hemorrhage; Vascular Dissection

  MAUDE report 10893175 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOR A THROMBECTOMY PROCEDURE FOR RIGHT INTERNAL CAROTID TERMINUS AND RIGHT DISTAL M1, SUBJECT RETRIEVER WAS USED FOR ONE PASS, FOLLOWED BY SECOND DIFFERENT SIZE STENT RETRIEVER, AND COMPLETED PROCEDURE WITH THIRD STENT RETRIEVER AND ASPIRATION CATHETER. THERE WAS NO REPORTED VESSEL PERFORATION, VESSEL DISSECTION OR DEVICE MALFUNCTION DURING PROCEDURE. PATIENT MRS (MODIFIED RANKIN SCALE) BEFORE ONSET WAS 0 AND PRE-PROCEDURE ASPECTS (THE ALBERTA STROKE PROGRAM EARLY CT) SCORE WAS 5. PATIENT PRE-PROCEDURE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE WAS 0 AND FINAL TICI WAS 2B. PRE-PROCEDURE NIHSS (NIH STROKE SCALE/SCORE) WAS NOTED TO BE 17 AND POST NIHSS WAS 38. PATIENT HAD FOLLOW UP COMPUTED TOMOGRAPHY (CT) SAME DAY AFTER PROCEDURE AND SHOWED SICH (SYMPTOMATIC INTRACRANIAL HEMORRHAGE)-PH2 (PARENCHYMATOUS HEMATOMA 2). FIVE DAYS FOLLOWING PROCEDURE, PATIENT HAD PASSED DUE TO EXACERBATION OF CEREBRAL INFARCTION. CAUSE OF EXACERBATED CEREBRAL INFARCTION IS UNKNOWN. NO OTHER INFORMATION PROVIDED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10880802 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBECTOMY WAS PERFORMED ON THE LEFT M1 DISTAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY. FIRST AND SECOND PASS WERE PERFORMED WITH SUBJECT STENT RETRIEVER AND ASPIRATION CATHETER. VESSEL DISSECTION OCCURRED DURING PROCEDURE, WHICH THE PHYSICIAN CONFIRMED WAS NOT RELATED TO THE SUBJECT STENT RETRIEVER. IMAGING DONE FIVE HOURS POST PROCEDURE REVEALED SUB ARACHNOID HEMORRHAGE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10872791 ↗
• MalfunctionNov 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT RETRIEVER FELL APART FROM ATTACHMENT POINT TO THE WIRE WHEN PULLED BACK INTO CATHETER ALONG WITH THE MICROCATHETER. THE SUBJECT RETRIEVER LEFT IN THE ARTERY, AND PARTIALLY IN THE CATHETER THEN IT WAS PULLED BACK SLOWLY. THE SUBJECT RETRIEVER WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY IN THE END. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10870269 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED IN THE RIGHT INTERNAL CAROTID TERMINUS. ONE PASS WAS PERFORMED WITH THE SUBJECT RETRIEVER. THERE WAS NO REPORTED VESSEL PERFORATION, VESSEL DISSECTION OR DEVICE MALFUNCTION DURING PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. IMAGING DONE ONE DAY POST PROCEDURE SHOWED SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH). PHYSICIAN OPINION IS THAT THE SICH WAS CAUSED BY HEMORRHAGIC INFARCTION. THE PATIENT WAS DISCHARGED 23 DAYS LATER WITH MRS OF 5 AND APPROXIMATELY 2 MONTHS FINAL FOLLOW UP WITH MRS OF 5. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10857666 ↗
• InjuryNov 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE SUBJECT STENT RETRIEVER WAS USED IN COMBINATION WITH A CATHETER. DURING DELIVERY OF THE SUBJECT STENT RETRIEVER IN THE INTERNAL CAROTID TERMINUS TO M1 SEGMENT, ITS DELIVERY WIRE FRACTURED AT THE DISTAL PART. THE PHYSICIAN DID NOT APPLY SIGNIFICANT FORCE DURING MANEUVER. THE SUBJECT STENT RETRIEVER FRAGMENT WAS LEFT INSIDE THE PATIENT'S ANATOMY WITH NO OTHER PLANS TO REMOVE IT. PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE WITH NO ADDITIONAL MEDICATION DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10845126 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT RETRIEVER WAS USED FOR TWO PASSES. THE PHYSICIAN NOTED THAT THE M2 VESSEL WAS INJURED AND BLEEDING AND HAD OCCURRED DURING THE FIRST PASS. THE PROCEDURE WAS NOT COMPLETED AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. NO ADDITIONAL TREATMENT WAS GIVEN FOR THE VESSEL BLEEDING AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT PROBLEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 10837719 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE RETRIEVER ALONG WITH OTHER DEVICES WERE USED TO REMOVE THE PROXIMAL FACE OF CLOT ON THE RIGHT M2 MIDDLE CEREBRAL ARTERY (MCA). PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION SCORE (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 25 AND MRS (MODIFIED RANKIN SCORE) OF 0. DURING STUDY PROCEDURE, THE SUBARACHNOID HEMORRHAGE (BLEEDING) OCCURRED AT LANDING SITE OF THE SUBJECT DEVICE RETRIEVER; THEREFORE, 5 COILS WERE USED TO TREAT THE OCCLUSION OF THE BLEEDING ARTERIAL SITE. THERE WERE NO SERIOUS ADVERSE EVENT OR NEUROLOGICAL DETERIORATION REPORTED TO THE PATIENT. 24 HOURS POST PROCEDURE, THE PATIENT¿S (TICI) OF 3 AND NIHSS SCORE OF 24. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10816810 ↗
• MalfunctionNov 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT RETRIEVER WAS USED DURING THROMBECTOMY PROCEDURE FOR THE DISTAL RIGHT M1 AND RIGHT CERVICAL- INTERNAL CAROTID ARTERY (ICA) OCCLUSION. THE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND ALBERTA STROKE PROGRAM EARLY CT SCORE (ASOECTS) WAS 3 BEFORE THE PROCEDURE. DURING THE FIRST PASS IN THE M1- DISTAL, THE SUBJECT RETRIEVER WAS BROKEN. THERE WERE NO VESSEL DISSECTION OR VESSEL PERFORATION DURING THE PROCEDURE. NO HEMORRHAGE AFTER THE PROCEDURE WAS CONFIRMED. NON-STRYKER RETRIEVER AND ASPIRATION CATHETER WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. A STENT WAS DEPLOYED IN THE CERVICAL -ICA AFTER TREATING M1-DISTAL OCCLUSION. SUCCESSFUL RECANALIZATION WITH TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3 WAS ACHIEVED. NO CLINICAL CONSEQUENCES WERE REPROVED DUE TO THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10814336 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBECTOMY WAS PREFORMED ON THE RIGHT PROXIMAL M1 VESSEL. FIRST PASS WAS DONE WITH THE SUBJECT STENT RETRIEVER AND AN ASPIRATION CATHETER. 2ND AND THIRD PASS WERE DONE WITH NON-STRYKER DEVICES. THERE WAS NO REPORTED VESSEL PERFORATION, VESSEL DISSECTION OR DEVICE MALFUNCTION DURING PROCEDURE. PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE BUT 24 HOURS LATER, CT FOLLOW UP SCANS SHOWED INTRACEREBRAL HEMORRHAGE AND SUB ARACHNOID HEMORRHAGE. MEDICAL INTERVENTION IN RESPONSE TO THE HEMORRHAGE IS UNKNOWN. IN THE PHYSICIAN'S OPINION, THE HEMORRHAGE WAS CAUSED BY HEMORRHAGIC INFARCTION. THE PATIENT IS REPORTED TO HAVE PASSED AWAY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10744674 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE FOR THE LEFT M1-PROXIMAL, LEFT M2 AND LEFT M3 WERE PERFORMED ON (B)(6) 2020 USING THE SUBJECT RETRIEVER AND THE FINAL TICI SCORE WAS 2B. THERE WERE NO VESSEL PREFORMATION AND VESSEL DISSECTION RELATED TO THE SUBJECT RETRIEVER. 24 HOURS POST FOLLOW UP MIR SHOWED SUBARACHNOID HEMORRHAGE (SAH) AND INTRACEREBRAL HEMORRHAGE (ICH). NO CLINICAL CONSEQUENCES WERE NOT REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10723687 ↗
• InjurySep 23, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING REMOVAL OF A CLOT IN M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE PHYSICIAN PULLED THE SUBJECT STENT RETRIEVER IN AN ATTEMPT TO WITHDRAW IT AND FELT RESISTANCE. THE SUBJECT STENT RETRIEVER FRACTURED AT THE DISTAL DELIVERY WIRE, JUST PROXIMAL TO THE RETRIEVER WHILE IT WAS INSIDE PATIENT'S ANATOMY. THE PATIENT ANATOMY WAS NOTED TO BE TORTUOUS AND THE PHYSICIAN MADE NO FURTHER ATTEMPTS TO REMOVE THE SUBJECT DEVICE FRAGMENT OR THE UN-RETRIEVED CLOT. SURGICAL DELAY OCCURRED BUT DURATION IS UNKNOWN. ADDITIONAL MEDICATION GIVEN DUE TO EVENT IS ALSO UNKNOWN. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND PATIENT CONDITION REMAINS THE SAME AS AT ADMISSION AS THE CLOT WAS NOT ABLE TO BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10577535 ↗
• InjurySep 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO REMOVE THE SUBJECT STENT RETRIEVER BUT THE JUNCTION BETWEEN THE STENT AND THE WIRE BROKE AS SOON AS IT WAS PULLED. ANOTHER RETRIEVER WAS USED TO RETRIEVE THE BROKEN PART, BUT IT WAS UNABLE TO BE REMOVED AND LEFT INSIDE THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED, AND PATIENT HAD NO OTHER ABNORMAL SYMPTOMS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10483481 ↗
• MalfunctionAug 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT (SUBJECT DEVICE) GOT DETACHED FROM THE DELIVERY WIRE AND REMAINED INSIDE THE SUPPORT CATHETER USED DURING THE PROCEDURE. THE CORE WIRE OF THE SUBJECT DEVICE WAS DAMAGED. BOTH THE DETACHED SUBJECT STENT AND THE CATHETER WERE SUCCESSFULLY REMOVED FROM THE PATIENT'S ANATOMY. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10437586 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THROMBECTOMY PROCEDURE, THE FIRST PASS WAS PERFORMED WITH THE SUBJECT DEVICE RETRIEVER ON THE LEFT ICA (INTERNAL CAROTID ARTERY) TERMINUS. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 21 AND MRS (MODIFIED RANKIN SCORE) OF 0. THE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) AND STENTING WERE PERFORMED FOR LEFT M1 PROXIMAL NOT FOR EMBOLIZATION TO NEW TERRITORY (ENT) EVEN THOUGH THE OCCURRENCE OF ENT WAS OBSERVED BUT WAS DENIED BY THE PROCEDURE. IT WAS REPORTED THAT THERE WAS VESSEL DISSECTION OCCURRED DURING PROCEDURE. FOLLOW-UP WITH CT (COMPUTED TOMOGRAPHY) SCAN AND MRI (MAGNETIC RESONANCE IMAGING) WITHIN 24 HOURS AFTER THE PROCEDURE SHOWED SYMPTOMATIC INTRACRANIAL HEMORRHAGE SICH (HI-2) WITH NIHSS OF 21. IT WAS UNKNOWN WHAT MEDICAL TREATMENT WAS ADMINISTERED TO TREAT THE PATIENT¿S SICH. THE PATIENT WAS DISCHARGED APPROXIMATELY 33 DAYS POST PROCEDURE WITH MODIFIED RANQUIN SCALE (MRS) OF 5 AND TICI SCORE OF 3. ACCORDING TO THE PHYSICIAN, THE EVENT VESSEL DISSECTION RELATED TO SUBJECT DEVICE RETRIEVER. NO FURTHER INFORMATION WAS AVAILABLE UPDATE INFORMATION: REC

  Patient problems: Embolism/Embolus; Embolus; Intracranial Hemorrhage; Vascular Dissection

  MAUDE report 10359327 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DURING A THROMBECTOMY PROCEDURE FOR LEFT IC TERMINUS, SUBJECT RETRIEVER WAS USED. THE PATIENT HAD AN MRS (MODIFIED RANKIN SCALE) OF 0, A MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) GRADE OF 0 AND NIHSS (NATIONAL INSTITUTES OF HEALTH STROKE SCALE) OF 24 PRIOR TO PROCEDURE. AFTER TWO PASSES WITH THE SUBJECT RETRIEVER, PATIENT EXPERIENCED ENT (EMBOLIZATION TO NEW TERRITORY) THAT WAS RESOLVED USING ANOTHER DEVICE. THE FINAL MTICI SCORE WAS 2B. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE, THE PATIENT EXPERIENCED VESSEL PERFORATION RELATED TO THE SUBJECT RETRIEVER USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism; Perforation of Vessels

  MAUDE report 10242907 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMBECTOMY IN THE RIGHT CERVICAL INTERNAL CAROTID ARTERY (ICA), PROXIMAL RIGHT M1 - THE SUBJECT STENT RETRIEVER WAS USED IN COMBINATION WITH A CATHETER. EMBOLIZATION TO NEW TERRITORY FROM RIGHT M1 TO M2 OCCURRED AFTER ONE PASS. THROMBECTOMY FOR RIGHT M2 WAS PERFORMED WITH A NON-STRYKER STENT RETREIVER AND ASPIRATION CATHETER AND IT RESOLVED. IT WAS ALSO REPORTED THAT VESSEL PERFORATION OCCURRED DURING PROCEDURE, BUT IT WAS NOT RELATED TO THE SUBJECT STENT RETRIEVER. PATIENT STATUS REPORTED AS MRS:4. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Embolism

  MAUDE report 10216213 ↗
• InjuryMay 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN USED INFINITY, ACE 68 AND VELOCITY CATHETER . PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER AND UPON RETRIEVAL, THE STENT OF THE SUBJECT STENT RETRIEVER BROKE FROM THE DELIVERY WIRE. THE PHYSICIAN USED A SECOND STENT RETRIEVER AS A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE BROKEN STENT FROM THE PATIENT'S MIDDLE CEREBRAL ARTERY. THE PHYSICIAN REPLACED IT WITH A NEW RETRIEVER AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10054655 ↗
• InjuryApr 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE ON STROKE PATIENT (CLOT WAS IN ICA-INTERNAL CAROTID ARTERY AND M1), THE STENT RETRIEVER (SUBJECT DEVICE) DETACHED. MULTIPLE ATTEMPTS WERE MADE BY SURGEON TO SNARED IT OUT, BUT RETRIEVER WAS LEFT IN PATIENTS BRAIN IN M1 VASCULATURE. MEDICATION WAS ADMINISTERED TO THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AND THE CLOT WAS NOT ABLE TO BE REMOVED (CLOT STILL IN M1). ACCORDING TO THE PHYSICIAN, THE ISSUES WERE RELATED TO THE SUBJECT DEVICE . THE PATIENT CLINICAL CONDITION IS NOT GOOD, EXPERIENCING SYMPTOMS RELATED TO THE CLOT AND THE ACUTE NATURE OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9935762 ↗
• DeathMar 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT CAME WITH A STROKE DUE TO A THROMBUS IN INTERNAL CAROTID ARTERY, C1 SEGMENT AND MIDDLE CEREBRAL ARTERY M1 RIGHT SEGMENT. NEUROLOGICAL ASSESSMENT WAS NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) OF 15. THROMBECTOMY WITH THE SUBJECT STENT RETRIEVER WAS INDICATED WITH LOCAL ANESTHESIA. DURING REMOVAL, THE SUBJECT STENT CAME OFF WITHOUT RESISTANCE AND REMAINED IN M1 VESSEL. ATTEMPT TO RECOVER THE STENT WITH LASSO FAILED AND THE ICA SIPHON SECTION WAS PERFORATED. THE PATIENT SUFFERED A MAJOR INTRACRANIAL HYPERTENSION AND SUB ARACHNOID HEMORRHAGE, WAS TRANSFERRED TO A NEURO TRAUMATIC RESUSCITATION UNIT, BUT PASSED AWAY FEW HOURS POST-PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Death; Device Embedded In Tissue or Plaque; Hemorrhage, Subarachnoid; High Blood Pressure/ Hypertension; Perforation of Vessels

  MAUDE report 9826527 ↗
• InjuryFeb 11, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE SUBJECT DEVICE WAS DONE FOR RIGHT M1-DISTAL CARDIO EMBOLIC AND THE VESSEL DISSECTION OCCURRED WHICH RELATED TO THE SUBJECT DEVICE. WHEN USING THE SUBJECT DEVICE, THE DOCTOR FELT THE DIFFICULTY DEPLOYING AND WITHDRAWAL. THE SUBJECT DEVICE WAS FINALLY REMOVED AND COMPLETED THE PROCEDURE. AFTER THAT, THE BLEEDING WAS CONFIRMED AS HI TYPE 1 BASED ON EUROPEAN COOPERATIVE ACUTE STROKE STUDY (ECASS) CLASSIFICATION. 19 DAYS POST PROCEDURE ASSESSED HAVING A MODIFIED RANKIN SCALE (MRS) OF 3. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 9696242 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132641, K143077, 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-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
• 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