Trevo XP 90185Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00815742001853), received between Mar 16, 2017 and Jan 16, 2024 — classified as 1 death, 32 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (8 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, K150616, 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS USED FOR ACUTE AIS (ACUTE ISCHEMIC STROKE) PROCEDURE, AS THE CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) SHOWED A LONG OCCLUSION AT THE LEFT MCA (MIDDLE CEREBRAL ARTERY). THE OPERATOR-BUILT ACCESS AND THEN USED THE SUBJECT STENT RETRIEVER TO PERFORM A THROMBECTOMY. AFTER THE FIRST ATTEMPT, THE VESSEL WAS NOT COMPLETELY CLEAR, THEREFORE; THE SECOND ATTEMPT WAS MADE, THE BIG RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT STENT RETRIEVER INTO THE RETRIEVER MICROCATHETER. THE SUBJECT STENT RETRIEVER WAS REMOVED FROM THE PATIENT'S ANATOMY AND FOUND THE DISTAL OF THE SUBJECT STENT RETRIEVER PLATINUM COIL WAS DAMAGED. THE OPERATOR REPLACED IT WITH THE CATALYST CATHETER FOR ASPIRATION AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519686 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE THROMBECTOMY PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL HEMORRHAGE. IT IS NOTED THAT THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT STUDY RETRIEVER DEVICE, STROKE (DISEASE UNDER STUDY), UNDERLYING CONDITION, AND THROMBECTOMY PROCEDURE. THE PATIENT PROLONGED HOSPITALIZATION. NO ACTION WAS TAKEN, AND THE EVENT RESOLVED WITH CLINICAL "SEQUELAE". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17132006 ↗
• InjuryJun 6, 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) 2020, 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 RETRIEVER DEVICE, NOT RELATED TO THE STROKE (DISEASE UNDER STUDY) AND TO AN UNDERLYING CONDITION OR DISEASE. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2020 WITHOUT CLINICAL SEQUALAE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 17071434 ↗
• InjuryJun 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 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 THE STROKE (DISEASE UNDER STUDY) AND TO AN UNDERLYING CONDITION OR DISEASE. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2021 WITHOUT CLINICAL "SEQUELAE". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 17054044 ↗
• InjuryMar 25, 2021Adverse 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 PROXIMAL LEFT M1, VESSEL PERFORATION OCCURRED WITH POSSIBLE RELATION TO THE STENT RETRIEVER (SUBJECT DEVICE). THE PHYSICIAN HAD PERFORMED 2 PASSES WITH THE SUBJECT STENT RETRIEVER WHEN THE EVENT OCCURRED. VESSEL DISSECTION AND DEVICE MALFUNCTION WERE NOT REPORTED DURING THE PROCEDURE. PHYSICIAN IS REPORTED TO HAVE COMPLETED THE PROCEDURE SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: Perforation

  MAUDE report 11573033 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBECTOMY FOR LEFT DISTAL INFARCTION WAS PERFORMED USING THE SUBJECT STENT RETRIEVER. FIRST PASS WAS PERFORMED WITH THE SUBJECT STENT RETRIEVER AND ASPIRATION CATHETER. THE MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE IMPROVED TO 3 AFTER FIRST PASS. THERE WAS NO REPORTED PATIENT INJURY SUCH AS VESSEL PERFORATION AND VESSEL DISSECTION. NO DEVICE MALFUNCTION WAS REPORTED DURING PROCEDURE. IMAGING FOLLOW-UP DONE THE NEXT DAY, 25.5 HOURS AFTER THE PROCEDURE REVEALED SUB ARACHNOID HEMORRHAGE (SAH). PATIENT CONDITION AND MEDICAL INTERVENTION DONE DUE TO THE EVENT IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11159019 ↗
• InjuryDec 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, FIRST PASS AND SECOND PASS WERE PERFORMED WITH THE SUBJECT STENT RETRIEVER AND AN ASPIRATION CATHETER. DIFFICULTY WAS ENCOUNTERED DEPLOYING THE SUBJECT STENT RETRIEVER AND THE PHYSICIAN WAS UNABLE TO DEPLOY IT. THEREFORE THE SUBJECT STENT RETRIEVER WAS REMOVED AND PHYSICIAN USED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO COMPLETE THE PROCEDURE AND ACHIEVE REPERFUSION. NO PATIENT INJURY, VESSEL PERFORATION OR VESSEL DISSECTION WAS REPORTED DURING THE PROCEDURE. TWENTY HOURS POST PROCEDURE, FOLLOW UP IMAGING REVEALED INTRACRANIAL HEMORRHAGE. TWENTY FIVE DAYS POST PROCEDURE, THE PATIENT'S CONDITION DETERIORATED DUE TO UNKNOWN CIRCUMSTANCES AND CURRENT CONDITION IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11074484 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED USING THE SUBJECT RETRIEVAL DEVICE TO REMOVE A CLOT IN RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AT M2 SEGMENT. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 7 AND MRS (MODIFIED RANKIN SCORE) OF 0. IT WAS REPORTED THAT DURING STUDY PROCEDURE, INTRACRANIAL HEMORRHAGE NEW SAH (SUBARACHNOID HEMORRHAGE) OCCURRED WITHIN THE RIGHT SYLVIAN FISSURE, NEW 1.2CM INTRAPARENCHYMAL HEMORRHAGE PROBABLY DUE TO IATROGENIC INJURY TO VESSEL. THE PROCEDURE WAS COMPLETED WITH THE FIRST PASS AND AFTER 24 HOURS POST PROCEDURE, THE PATIENT HAD (NIHSS) OF 2. THE EVENT WAS NOT SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) AND IT WAS RESOLVED WITHOUT MEDICAL TREATMENT TO THE PATIENT. THE PATIENT WAS DISCHARGED ON DAY 5-7 WITH NIHSS OF 0 AND MRS OF 1 AND ON DAY 30 WITH MRS OF 1.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 10997330 ↗
• InjuryDec 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER WAS USED DURING TWO TO THREE THROMBECTOMY ATTEMPTS. PHYSICIAN IS REPORTED TO HAVE APPLIED A SIGNIFICANT AMOUNT OF FORCE TO THE PROXIMAL END OF THE SUBJECT RETRIEVER, WHEN A FRACTURE OCCURRED. THE FRACTURE WAS NOTED AT THE PROXIMAL PART OF THE SUBJECT STENT RETRIEVER, WHEN UNSHEATHING FROM THE MICRO CATHETER WHILE INSIDE THE TARGET VESSEL. PHYSICIAN TRIED TO REMOVE THE BROKEN FRAGMENT OF THE SUBJECT STENT RETRIEVER WITH ANOTHER STENT BUT WAS UNSUCCESSFUL. THE CLOT IS REPORTED TO HAVE BEEN PARTIALLY REMOVED THROUGH ASPIRATION. PATIENT WAS GIVEN UNKNOWN ADDITIONAL MEDICATION DUE TO THIS EVENT. PATIENT CONDITION IS A LITTLE BETTER POST PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10932279 ↗
• MalfunctionNov 30, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER WAS DEPLOYED IN THE TARGET VESSEL AND STRONG RESISTANCE WAS ENCOUNTERED WHILE PULLING INTO THE MICRO CATHETER LUMEN. THE SUBJECT RETRIEVER WAS UNABLE TO BE PULLED INTO THE MICRO CATHETER LUMEN AND THEREFORE, BOTH DEVICES WERE SUCCESSFULLY AND COMPLETELY REMOVED FROM THE PATIENT'S ANATOMY. ON REMOVAL OF THE SUBJECT RETRIEVER, CLOTS WERE CONFIRMED AT THE TIP. POST OPERATIVE IMAGING SHOWED IMPROVED PERFUSION WITH THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3. PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924494 ↗
• 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 M1-DISTAL, SUBJECT RETRIEVER WAS USED FOR THE SECOND PASS. PHYSICIAN THEN COMPLETED PROCEDURE USING ANOTHER BRAND 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 10880745 ↗
• InjuryNov 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED WHEN A RETRIEVER (SUBJECT DEVICE) WAS USED DURING THE PROCEDURE. DIAGNOSTIC IMAGING PERFORMED 19 HOURS POST PROCEDURE SHOW DEVELOPMENT OF INTRACEREBRAL HEMORRHAGE (ICH). IT WAS REPORTED THAT THE PATIENT'S MRS SCORE WAS 5. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT AT THE MOMENT.

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

  MAUDE report 10841624 ↗
• 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 10820874 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR CARDIO EMBOLIC DEVELOPED ON THE LEFT CERVICAL-ICA (INTERNAL CAROTID ARTERY) ON (B)(6) 2020, THREE PASSES WERE PERFORMED USING SUBJECT RETRIEVER ALONG WITH MICROCATHTER. PHYSICIAN THEN NOTED THAT THERE WAS VESSEL PERFORATION WITH A POSSIBLE CASUAL RELATIONSHIP OCCURRED DURING PROCEDURE. BEFORE THE PROCEDURE PATIENT MTICI GRADE WAS 0 AND IMMEDIATELY AFTER MTICI GRADE WAS 2A. PATIENT MRS GRADE BEFORE PROCEDURE WAS 0 AND IMMEDIATELY AFTER MRS WAS GRADE 4. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 10797180 ↗
• DeathNov 2, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE SUBJECT DEVICE (RETRIEVER) WAS USED IN THE PROCEDURE WITH OTHER DEVICES TO TREAT OCCLUSION AT M1. THE MEANDERING OF BLOOD VESSELS WAS WEAK. AFTER EASILY REACHING THE BLOCK WITH THE GUIDE WIRE AND CATHETER, THE RESISTANCE WAS ENCOUNTERED WHILE INSERTING THE SUBJECT DEVICE (RETRIEVER) INTO THE CATHETER AND IT GOT STUCK. AFTER THAT, THE PHYSICIAN WAS PUSHING AND PULLING TO MOVE THE SUBJECT DEVICE (RETRIEVER), AND IT WAS SUDDENLY JUMPED OUT OF THE TIP OF THE CATHETER AND FULLY DEPLOYED. AT THAT TIME, THE BLOOD VESSELS OF M2 WERE DAMAGED AND BLEEDING. THE PHYSICIAN INDICATED THAT THE RESISTANCE WAS CAUSED THE BLOOD VESSELS TO SHIFT DOWNWARDS, WHICH CAUSED THEM TO TEAR. THE SUBJECT DEVICE (RETRIEVER) WAS PULLED BUT IT WAS STUCK AND COULD NOT BE STORED IN THE CATHETER. FINALLY, THE SUBJECT DEVICE (RETRIEVER) WAS WITHDRAWN TOGETHER WITH THE CATHETER AND THE SUBJECT DEVICE (RETRIEVER) WAS REMOVED FROM THE CATHETER (THE STENT WAS NOT TRANSECTED). THE BLEEDING AREA WAS TREATED WITH THE CATHETER AND THE PHYSICIAN THOUGHT THE SUBJECT DEVICE (RETRIEVER) WOULD BE EASY TO LIFT BECAUSE IT WAS EASY TO GUIDE THE CATHETER TO THE TREATMENT AREA. IT WAS REPORTED THAT THE PATIENT

  Patient problems: Vascular Dissection

  MAUDE report 10771535 ↗
• InjuryOct 29, 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, PATIENT'S VESSEL WAS PERFORATED BY THE SUBJECT STENT RETRIEVER. THERE WAS NO HEMORRHAGE SEEN IN FOLLOW UP IMAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 10756766 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY 2 MONTHS POST PROCEDURE AT THE RIGHT M1 DISTAL LESION THE PATIENT DEVELOPED AN INTRACRANIAL HEMORRHAGE AND SUBARACHNOID HEMORRHAGE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10738142 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED FOR CARDIO EMBOLIC DEVELOPED ON THE LEFT M1-PROXIMAL. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 0 AND MRS (MODIFIED RANKIN SCORE) OF 0. 4 PASS WAS PERFORMED BY USING THE SUBJECT RETRIEVER AND ASPIRATION CATHETER (CAT6). THEN APPROXIMATELY 8 HOURS LATER, THE SAH (SUBARACHNOID HEMORRHAGE) WAS CONFIRMED AND CEREBRAL HEMORRHAGE (PH-2) WAS CONFIRMED BY CT (COMPUTERIZED TOMOGRAPHY) ON THE NEXT DAY. THE PROCEDURE WAS COMPLETED WITH (TICI) SCORE OF 2A AND MRS SCORE OF 3. IT WAS UNKNOWN IF THE MEDICAL TREATMENT WAS ADMINISTERED TO TREAT THE PATIENT¿S SAH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10734709 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBECTOMY WAS PERFORMED IN THE RIGHT M2 VESSEL. ONE PASS WAS PERFORMED WITH SUBJECT RETRIEVER AND AN ASPIRATION CATHETER. THERE WAS NO VESSEL PERFORATION, VESSEL DISSECTION OR DEVICE MALFUNCTION DURING PROCEDURE. PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE. FOLLOW UP CT SCAN POST PROCEDURE SHOWED INTRACRANIAL AND SUB ARACHNOID HEMORRHAGE. MEDICAL INTERVENTION/TREATMENT DONE FOR THE HEMORRHAGE IS UNKNOWN. PHYSICIAN SUSPECTS THAT HEMORRHAGE WAS CAUSED BY INFARCTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10731568 ↗
• InjuryOct 22, 2020Difficult to Remove; Difficult to Remove

  DURING THE PROCEDURE FOR THROMECTOMY FOR RIGHT M1 DISTAL WAS PERFORMED ON (B)(6) 2020. PRIOR TO PROCEDURE PATIENT MODIFIED RANKIN SCALE (MRS) BEFORE ONSET WAS 0, THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE WAS 0 AND NIH STROKE SCALE (NIHSS) WAS 20. AFTER ONE PASS WAS PREFORMED FINAL TICI SCORE WAS 2B AND POST PROCEDURE NIHSS WAS 12. THE PHYSICIAN DID NOT REALIZE THE VESSEL PERFORATION AND DISSECTION AT THE TIME OF FINISHING THE PROCEDURE. INTRACEREBRAL HEMORRHAGE (ICH) TYPE PH1 WAS OBSERVED IN CT AND MRI FOLLOW-UP AFTER THE PROCEDURE ON (B)(6), THEN PROTAMINE AND TRANSAMIN WAS ADMINISTERED TO THE PATIENT AND HEMOSTASIS WAS OBSERVED. IT WAS NOTED THAT VESSEL PERFORATION AND VESSEL DISSECTION WAS IN RELATION TO THE DIFFICULT REMOVAL OF THE SUBJECT RETRIEVER DURING THE PROCEDURE. ON (B)(6), PATIENT MRS WAS 4 AT TIME OF DISCHARGE.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels; Vascular Dissection

  MAUDE report 10723011 ↗
• InjuryOct 9, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED FOR THE LEFT P1 AND BASILAR. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 1, A NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 7, AND MRS (MODIFIED RANKIN SCORE) OF 0. FIRST, 1 PASS FOR BASILAR WAS PERFORMED WITH SUBJECT DEVICE (RETRIEVER) AND ASPIRATION CATHETER. NEXT, PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) WAS PERFORMED FOR BASILAR. SUBSEQUENTLY, THROMBOLYTIC THERAPY WAS PERFORMED FOR LEFT P2, AND FINALLY, THROMBECTOMY FOR LEFT P1 WAS PERFORMED WITH SUBJECT DEVICE (RETRIEVER) AND ASPIRATION CATHETER. IT WAS REPORTED THAT THERE WERE VESSEL PERFORATION/DISSECTION AND SAH (SUBARACHNOID HEMORRHAGE) OCCURRED DURING PROCEDURE WHICH RELATED TO THE SUBJECT DEVICE (RETRIEVER) AND ALSO OCCURRENCE OF A REMOVAL DIFFICULTY OF THE SUBJECT DEVICE (RETRIEVER). THE PROCEDURE WAS COMPLETED WITH THROMBOLYSIS IN CEREBRAL INFARCTION SCORE (TICI) OF 2B AND NIHSS SCORE OF 40. IT WAS UNKNOWN WHAT MEDICAL TREATMENT WAS ADMINISTERED TO TREAT THE PATIENT¿S VESSEL DISSECTION AND SAH. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels; Vascular Dissection

  MAUDE report 10659848 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED WHEN A RETRIEVER (SUBJECT DEVICE) WAS USED DURING THE PROCEDURE. DIAGNOSTIC IMAGING OF THE PATIENT TAKEN 24 HOURS POST PROCEDURE SHOWED DEVELOPMENT OF SYMPTMATIC SUBARACHNOID HEMORRHAGE (SAH). THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 10603997 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 24 HOURS AFTER THROMBECTOMY FOR CARDIOGENIC CEREBRAL EMBOLISM ON THE LEFT M1 DISTAL INFARCTION, PATIENT EXPERIENCED SUBARACHNOID HEMORRHAGE (SAH) ON IMAGE EVALUATION AFTER THE PROCEDURE HAD COMPLETED. PHYSICIAN CONFIRMED THAT THE SUBJECT RETRIEVER USED PERFORMED AS INTENDED AND DID NOT CAUSE THE REPORTED HEMORRHAGE. HEMORRHAGE WAS TREATED USING ANTIPLATELET MEDICATION AND PATIENT¿S CURRENT STATUS IS STABLE. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) FOR PATIENT WAS GRADE 4 AND POST-PROCEDURE MRS WAS LISTED AS GRADE 4. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10570996 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Unclear Information; Adverse Event Without Identified Device or Use Problem; Unclear Information

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED USING THE SUBJECT RETRIEVAL DEVICE TO REMOVE A CLOT IN MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AT M1 SEGMENT. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 1, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 4 AND MRS (MODIFIED RANKIN SCORE) OF 0. THE TECHNIQUE USED FOR THIS PASS WAS CONSIDERED SUCCESSFUL. AFTER THE STUDY PROCEDURE TO 48 HOURS POST PROCEDURE, THE PATIENT HAD NEUROLOGICAL CHANGES. BECAME APHASIC WITH INCREASED RIGHT SIDED WEAKNESS. NIHSS WENT TO 12 FROM A 1 AT 24 HOURS POST OP. THE PATIENT WENT BACK TO CT (COMPUTED TOMOGRAPHY) SCAN AND RETURNED FOR ANOTHER THROMBECTOMY ¿ RE OCCLUSION OF LEFT M1 SEGMENT AND FOUND TO HAVE AN AREA OF STENOSIS. IT WAS FOUND ANOTHER CLOT IN LEFT M2 SEGMENT. THE PHYSICIAN DID A THROMBECTOMY ON THE CLOTS AND THEN RETURNED TO THE STENOSED AREA IN M1 SEGMENT AND PLACED A STENT. TICI WAS 2B AT 1224. THE PATIENT WENT BACK TO ICU ON VENT. A SERIAL CT SCAN AFTER THE PROCEDURE REVEALED A SUBARACHNOID HEMORRHAGE WITH MIDLINE SHIFT FROM 5 MM TO 9 MM BY THE NEXT MORNING. THE PATIENT HAD TO GO FOR AN EMERGENT DECOMPRESSIVE CRANI

  Patient problems: Muscle Weakness/Atrophy; No Clinical Signs, Symptoms or Conditions; Restenosis; Speech Disorder

  MAUDE report 10558897 ↗
• InjurySep 3, 2020Fracture; Fracture

  ANALYSIS OF THE CATHETER RETURNED CONCLUDED THAT THE METAL PARTS THAT SEEM TO BE PART OF THE PRODUCT COMES OUT WHEN IT WAS BENT WAS NOT FROM THE CATHETER. BASED ON THE ANALYSIS AND INVESTIGATION, THE METAL PARTS MIGHT HAVE BEEN THE PARTS OF A RETRIEVER (SUBJECT DEVICE) THAT BROKE DURING THE PROCEDURE WITH AN AWARENESS DATE OF (B)(6) 2020. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10489049 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132641, K150616, 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-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-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