Trevo NXT 90314Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327299946), received between Jul 14, 2020 and Nov 26, 2025 — classified as 1 death, 15 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K192207, K200117, K203219, K210502, K223305); 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. 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE STENT RETRIEVER (SUBJECT DEVICE) WAS USED IN THE THROMBUS RETRIEVAL PROCEDURE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE THROMBUS; HOWEVER, THE THROMBUS COULD NOT BE RETRIEVED, NOR THE ASPIRATION CATHETER COULD BE RAISED TO THE TARGET SITE DUE TO THE TORTUOSITY. THE PHYSICIAN ATTEMPTED TO PULL THE MICROCATHETER WITH EXCESSIVE FORCE RESULTING IN FRACTURE TO THE SHAPED SECTION OF THE STENT AND THE DISTAL TIP OF THE STENT DELIVERY WIRE THAT REMAINED INTRACRANIAL. THE PROCEDURE COULD NOT BE COMPLETED HOWEVER THE PATIENT WAS REPORTED TO BE DOING FINE AFTER THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23659461 ↗
• MalfunctionJan 3, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE THROMBECTOMY PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS PLACED. UPON REMOVAL OF THE STENT, IT WAS OBSERVED THAT THE DISTAL MESH OF THE STENT WAS DEFORMED. THE PHYSICIAN SUSPECTED THAT THERE MIGHT BE A BREAK IN THE MESH. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074117 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER GOT STUCK IN THE INTERNAL CAROTID ARTERY AND A CAROTID-CAVERNOUS FISTULA WAS CREATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fistula

  MAUDE report 19578411 ↗
• InjuryOct 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT STENT RETRIEVER DELIVERY WIRE BROKE OFF DURING THIRD PASS AND PART OF THE STENT AND DELIVERY WIRE REMAINED IN THE PATIENT'S MIDDLE CEREBRAL ARTERY (M2-M1). AN ATTEMPT WAS MADE TO RETRIEVE IT WITH A SNARE DEVICE, BUT IT COULD NOT BE RETRIEVED. RECANALIZATION WAS NOT OBTAINED, AND THE PROCEDURE WAS COMPLETED LEAVING THE REMAINED BROKEN/FRACTURED DEVICES. THE PATIENT'S CONDITION IS STABLE SO FAR. THE PATIENT WAS ABLE TO SPEAK AFTER THIS EVENT. ANTIPLATELET DRUGS WERE ADDED. PHYSICIAN FELT THAT THE ANATOMY AND/OR LOCATION OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17866471 ↗
• InjuryJul 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE FOR LEFT MCA MIDDLE CEREBRAL ARTERY ACUTE CEREBRAL INFARCTION, SUBJECT RETRIEVER PASSED THROUGH ANY STENTED ARTERIES AND 2 RETRIEVAL ATTEMPTS WERE MADE. WHILE RETRIEVING THE THROMBUS THE CORE WIRE OF THE SUBJECT STENT RETRIEVER WAS BROKEN OFF FROM THE DELIVERY WIRE IN THE PATIENT'S BODY. THE BROKEN FRAGMENT REMAINS IN PLACE WITHOUT RETRIEVAL. UNKNOWN MEDICATION IS ADDED. THE PATIENT IS CURRENTLY IN HOSPITAL, HEALTH CONDITION IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17313676 ↗
• InjuryMay 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE AT BASILAR ARTERY IN A STROKE PATIENT, THE SUBJECT STENT RETRIEVER GOT STUCK IN THE CATHETER AND THE CORE WIRE OF THE SUBJECT STENT RETRIEVER FRACTURED INSIDE THE PATIENT VASCULATURE. THE FRACTURED FRAGMENT WAS TRIED TO BE RETRIEVED USING A SNARE DEVICE BUT RUPTURED THE VESSEL SO THE PHYSICIAN HAD TO TAKE DOWN THE VERTEBRAL ARTERY WITH COILS. IT WAS REPORTED THAT THE RUPTURE OF THE VESSEL WAS CAUSED BY THE SNARE DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE. PATIENT'S ANATOMY WAS VERY TORTUOUS AND THE PHYSICIAN FEELS THAT THIS ANATOMY MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 17028737 ↗
• InjuryApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT RETRIEVER (SUBJECT DEVICE) BROKE OFF IN THE PATIENT. THE RETRIEVER WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT. THERE WAS AN UNKNOWN SURGICAL DELAY AS A RESULT OF THE EVENT. LIFELONG ANTIPLATELET MEDICATIONS ARE LIKELY REQUIRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16778164 ↗
• MalfunctionJan 31, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE WHEN THE SUBJECT RETRIEVER STENT WAS STORED IN A TRAY , SOMETHING LIKE COATING SUBSTANCE WAS FOUND FLOATING IN THE SALINE SOLUTION IN THE TRAY. IT IS UNCLEAR AT WHAT POINT IN TIME THIS OCCURRED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269963 ↗
• DeathJan 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT DEVICE WAS DETACHED AND WAS LEFT BEHIND IN A PATIENT ANATOMY, RESULTING SURGICAL DELAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16131881 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR THROMBECTOMY PROCEDURE IN A PATIENT WITH STROKE AT RIGHT MIDDLE CEREBRAL ARTERY (MCA) M2, AFTER THE FIRST PASS WHEN THE SUBJECT STENT RETRIEVER WAS PULLED OUT OF THE VESSEL, THE VESSEL RUPTURED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 15581859 ↗
• InjuryApr 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE CAT 7 CATHETER, MARKSMAN (MEDTRONIC MICROCATHETER), (B)(4) (ASAHI INTEC. GUIDEWIRE) WERE USED TO PLACE A MICROCATHETER INTO M1 AND ADVANCED CAT 7 CATHETER. HOWEVER, BECAUSE OF SEVERE MEANDERING ANATOMY, THE PRODUCT WAS WORN OUT, THUS A NEW CAT 7 + PHENOM 27 (MEDTRONIC MICROCATHETER) + (B)(4) WERE USED. NO ALLEGATIONS AGAINST CAT 7 CATHETER. CAT 7 CATHETER COULD NOT BE ADVANCED MUCH, BUT PHENOM 27 MICROCATHETER COULD BE ADVANCED TO THE PERIPHERY, SO THE STENT (SUBJECT DEVICE) WAS DEPLOYED FROM THERE. AT THIS TIME, THE STENT (SUBJECT DEVICE) DEPLOYED NORMALLY, AND THERE WAS NO FEELING OF ANY STUCK NOR RESISTANCE. THE STENT (SUBJECT DEVICE) WAS INSERTED INTO THE PHENOM 27 MICROCATHETER AND WAS ABLE TO ADVANCE TO THE LESION WITHOUT ANY PARTICULAR RESISTANCE, SO IT WAS UNSHEATHED THERE. LEAVING THE STENT (SUBJECT DEVICE) IN PLACE, AN ATTEMPT WAS MADE TO REMOVE THE PHENOM 27 MICROCATHETER, HOPING THAT BY REMOVING THE PHENOM 27 MICROCATHETER, CAT 7 CATHETER WOULD BE ADVANCED, AND REMOVED THE PHENOM 27 MICROCATHETER AS USUAL. WHEN PHENOM 27 MICROCATHETER WAS REMOVED AS USUAL WITHOUT ANY RESISTANCE, THERE WAS NO WIRE THAT WAS SUPPOSED TO COME OUT, AND W

  Patient problems: Foreign Body In Patient

  MAUDE report 14061949 ↗
• MalfunctionMar 18, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE MIDDLE CEREBRAL ARTERY CLOT RETRIEVAL PROCEDURE, THE DISTAL ACCESS CATHETER AND MICROCATHETER COAXIALLY ADVANCED DISTAL TO THE LESION NAVIGATED BY THE GUIDEWIRE. THE SUBJECT DEVICE WAS PASSED THROUGH THE STENTED ARTERY AND DEPLOYED INSIDE THE PATIENT'S ANATOMY. DURING THE FIRST PASS, RECANALIZATION WAS NOT ACHIEVED. THEREFORE, A SECOND PASS WAS PERFORMED AS SAME AS THE FIRST PASS. WHILE RETRIEVING THE SUBJECT RETRIEVER, IT'S GOT STUCK IN THE PATIENT'S ANATOMY AND NOT ABLE TO BE REMOVED. THE PHYSICIAN ADVANCED THE DISTAL ACCESS CATHETER TO COVER THE SUBJECT RETRIEVER AND REMOVED TOGETHER 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

  MAUDE report 13803586 ↗
• MalfunctionNov 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED IN A PATIENT WITH ACUTE CEREBRAL INFARCTION IN MCA (MIDDLE COMMUNICATING ARTERY) WITH VERY TORTUOUS VASCULAR ANATOMY. DURING THE PROCEDURE, THE LEFT M1 DISTAL THROMBUS WAS RETRIEVED WITH THE SUBJECT RETRIEVER STENT AND MICROCATHETER. WHEN THE THIRD PASS WAS COMPLETED AND THE SUBJECT STENT RETRIEVER WAS STUCK INSIDE THE MICROCATHETER. PHYSICIAN TRIED TO MOVE THE DELIVERY WIRE BACK AND FORTH BUT ONLY THE SUBJECT RETRIEVER STENT DELIVERY WIRE CAME OUT. WHEN THE LOCATION OF THE STENT WAS CHECKED UNDER FLUOROSCOPY, IT WAS CONFIRMED THAT THE SUBJECT RETRIEVER STENT WAS STUCK AT THE TIP, INSIDE THE MICROCATHETER. THE SUBJECT RETRIEVER STENT ALONG WITH THE MICROCATHETER WERE RETRIEVED OUT OF THE PATIENT'S VASCULAR ANATOMY. PTA (PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY) WAS PERFORMED USING BALLOON CATHETER AND 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 12884190 ↗
• InjuryNov 18, 2021Fracture; Fracture

  IT WAS REPORTED THAT A MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR ACUTE CEREBRAL ISCHEMIA, IN LEFT MIDDLE CRANIAL ARTERY DISTAL OCCLUSION IN A PATIENT. DURING THE PROCEDURE, RECANALIZATION COULD NOT BE OBTAINED IN THE FIRST PASS USING THE SUBJECT RETRIEVER STENT, THUS A SECOND PASS WAS MADE WITH THE SUBJECT RETRIEVER STENT. THE SUBJECT STENT GOT PREMATURELY DEPLOYED BETWEEN M2 AND M1 DURING THE SECOND PASS. THE OPERATOR ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT BY ASPIRATING IT THROUGH THE BACK LOCK SYRINGE, WITHOUT REMOVING THE MICROCATHETER. THE OPERATOR WAS ABLE TO RETRIEVE ONLY THE SUBJECT RETRIEVER STENT DELIVERY WIRE OUT, LEAVING THE SUBJECT RETRIEVER STENT INSIDE THE PATIENT'S VASCULAR ANATOMY AS THE SUBJECT STENT WAS FRACTURED AT THE JUNCTION BETWEEN THE STENT AND THE DELIVERY WIRE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT (CONFIRMED ON (B)(6), 2021 BY THE DOCTOR). NO FURTHER INFORMATION IS AVAILABLE ON THE CURRENT CONDITION OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12837227 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE SURGEON TRIED TO INSERT THE RETRIEVER (SUBJECT DEVICE) INTO THE MICROCATHETER, A STRONG RESISTANCE WAS FELT AT THE CATHETER SHAFT AND IN THE MIDDLE OF THE MICROCATHETER, IT WAS DIFFICULT TO ADVANCE. WHEN THE SURGEON REMOVED THE RETRIEVER (SUBJECT DEVICE) AND THE MICROCATHETER FROM BODY THERE WAS RESISTANCE AS WELL. 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 12230161 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING PROCEDURE TO PERFORM ACUTE BLOOD CIRCULATION RECANALIZATION THERAPY FOR M2 OBSTRUCTION, A MICROCATHETER AND SUBJECT RETRIEVER WAS GUIDED USING GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS WHICH CAUSED DIFFICULTY IN ADVANCING THE DEVICES TO THE TARGET SITE. SUBJECT DEVICE WAS ABLE TO CROSS THE OBSTRUCTION SITE AND WAS DEPLOYED. ACCOMPANYING MICROCATHETER WAS REMOVED AND A DIFFERENT CATHETER WAS PLACED ALONG THE SUBJECT RETRIEVER WIRE. PHYSICIAN CONFIRMED BLEEDING FROM THE LESION SITE VIA IMAGING IMMEDIATELY AFTER INDUCTION, INTEGRATION WITH THE STENT RETRIEVER AND REMOVAL FROM THE BODY. A BALLOON CATHETER WAS EXPANDED AND WAITED FOR SEVERAL MINUTES UNDER BLOOD COLLECTION BLOCKAGE, BUT HEMOSTASIS WAS NOT OBTAINED. THE PHYSICIAN THEN GUIDED ANOTHER MICROCATHETER AND VASCULAR EMBOLIZATION WAS PERFORMED USING 3 COILS AND NBCA (N-BUTYL CYANOACRYLATE). AFTER THE PROCEDURE PATIENT WAS NOTED TO HAVE PARALYSIS AND APHASIA. PREOPERATIVE CONDITION OF THE PATIENT IS UNKNOWN AND IT IS UNABLE TO CONFIRM WHETHER THE SYMPTOM HAVE WORSENED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dysphasia; Hemorrhage/Blood Loss/Bleeding; Paralysis

  MAUDE report 11457750 ↗
• MalfunctionFeb 23, 2021Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT RETRIEVER WAS RETURNED FOR ANALYSIS ON 19-NOV-2020 AND DEVICE INVESTIGATION REVEALED THAT THE LAMINATION OF THE DELIVERY WIRE OF THE SUBJECT RETRIEVER WAS PEELED DURING THE PROCEDURE. THEREFORE THIS EVENT MEETS REPORTING CRITERIA WITH AN AWARENESS DATE OF 28-JAN-2021. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11367205 ↗
• InjuryJan 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOW UP ANGIOGRAM TAKEN POST PROCEDURE, WHERE A RETRIEVER (SUBJECT DEVICE) WAS USED, SHOWED VESSEL EXTRAVASATION. PATIENT SUFFERED A REPERFUSION HEMORRHAGE POST PROCEDURE AND THE RUPTURED VESSEL WAS EMBOLIZED WITH LIQUID EMBOLIC AGENT. IT WAS REPORTED THAT THE PATIENT'S HEALTH PROGNOSIS IS DIRE. NO OTHER CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 11256753 ↗
• InjuryJan 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOW UP ANGIOGRAPHIC IMAGES TAKEN POST PROCEDURE, WHERE A RETRIEVER (SUBJECT DEVICE) WAS USED, SHOWED EXTRAVASATION IN PATIENT'S ANATOMY. THE PHYSICIAN EMBOLIZED THE EXTRAVASATION WITH LIQUID EMBOLIC AGENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Extravasation

  MAUDE report 11256610 ↗
• MalfunctionJan 25, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING WITHDRAWN FROM THE PATIENT'S VESSEL DURING THE PROCEDURE. THE SUBJECT RETRIEVER EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER WHILE BEING 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

  MAUDE report 11227209 ↗
• MalfunctionJan 25, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING WITHDRAWN FROM THE PATIENT'S VESSEL DURING THE PROCEDURE. THE SUBJECT RETRIEVER EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER WHILE BEING 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

  MAUDE report 11227208 ↗
• InjuryDec 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN A TRUNCATED OCCLUDED RIGHT MIDDLE CEREBRAL ARTERY, THE SUBJECT RETRIEVER FRACTURED AT THE JUNCTION AND WAS UNABLE TO BE REMOVED FROM THE PATIENT ANATOMY. PATIENT ANATOMY WAS NOT TORTUOUS AND RESISTANCE DURING THE PROCEDURE WAS NOT REPORTED. THE PHYSICIAN TRIED TO REMOVE THE FRAGMENT FOR TWO HOURS WITH A SNARE AND ADDITIONAL STENT RETRIEVER WHICH WAS DEPLOYED DISTALLY TO TRY AND LATCH BUT WAS NOT SUCCESSFUL. PATIENT WAS REPORTED TO BE ALIVE AND ADDITIONAL IMAGING WAS REQUIRED TO DETERMINE IF ADDITIONAL MEDICATION WOULD BE GIVEN DUE TO THIS EVENT. THE CLOT WAS PARTIALLY REMOVED AND PERFUSION SCORE OF THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 2B WAS ACHIEVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10947273 ↗
• InjuryOct 20, 2020Fracture; Fracture

  DURING THROMBECTOMY PROCEDURE, THE SUBJECT RETRIEVER WAS USED TO REMOVE BLOOD CLOT FROM THE LEFT MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 18 AND MRS (MODIFIED RANQUIN SCALE) OF 0. IT WAS REPORTED THAT DURING RETRIEVAL OF SECOND PASS AT ICA (INTERNAL CAROTID ARTERY) TERMINUS, THE SUBJECT RETRIEVER BROKE INSIDE PATIENT¿S VESSEL POSSIBLY WEAKENED JUNCTION AFTER FIRST PASS AND THE RESISTANCE ENCOUNTERED DURING ADVANCEMENT. THE PHYSICIAN TRIED TO REMOVE THE FRACTURED SUBJECT RETRIEVER WITH A SNARE DEVICE, BUT IT WAS UNSUCCESSFUL. THEREFORE, THE FRACTURED SUBJECT RETRIEVER WAS RETAINED IN VASCULATURE. THE PROCEDURE WAS COMPLETED WITH A NEW RETRIEVER DEVICE (NON-STRYKER) WITH THIRD PASS AND THE CLOT WAS SUCCESSFULLY REMOVED AND RESTORED THE BLOOD FLOW. THE ASPIRIN AND CLOPIDOGREL WERE PROVIDED TO THE PATIENT FROM CAROTID STENT. THE PATIENT HAS NO EXPERIENCED OR COMPLICATION DUE TO THE RETRIEVED FRAGMENT. THE PATIENT WAS DISCHARGED TO REHAB AND ASSESSED HAVING A NIHSS OF 2 AND MRS OF 2.

  Patient problems: Foreign Body In Patient

  MAUDE report 10709062 ↗
• MalfunctionSep 11, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS HARD TO SEE UNDER FLOURSCOPY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THE EVENT AND THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10525527 ↗
• InjuryJul 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THIRD PASS FOR THROMBOLYTIC PROCEDURE, THE SUBJECT RETRIEVER HAD DETACHED WITHIN PATIENT ANATOMY. PHYSICIAN WAS UNABLE TO RETRIEVE THE DETACHED SUBJECT DEVICE AND SUBSEQUENTLY COMPLETED THE PROCEDURE. PATIENT WAS PROVIDED DAPT (DUAL ANTI-PLATELET THERAPY) MEDICATION DUE TO THE SUBJECT DEVICE LEFT BEHIND. PHYSICIAN REPORTED NO ANOMALIES REGARDING DEVICE USAGE PRIOR TO DETACHMENT DURING THIRD PASS. PHYSICIAN LATER REPORTED PATIENT HAD PASSED AWAY DUE TO HEMORRHAGE. PHYSICIAN CONFIRMED THAT PATIENT DEATH WAS NOT DUE TO SUBJECT DEVICE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Intracranial Hemorrhage

  MAUDE report 10273875 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192207, K200117, K203219, K210502, K223305. One submission often covers many models, so check the product and lot details in each record.

• Z-1905-2024 · Apr 23, 2024 · Open, Classified
  Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK