LVIS 213025-LVIS-D-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429100950), received between Oct 12, 2021 and Sep 11, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS STUDY: AE NAME: P1 OCCLUSION. EVENT ONSET DATE: 8-APR-2022. EVENT DESCRIPTION: POD 1 PATIENT¿S STENT ASSISTED COIL EMBOLIZATION WAS COMPLICATED BY STENT OCCLUSION. UNDERWENT MECHANICAL THROMBECTOMY ON (B)(6) 2022. DECREASED LEVEL OF CONSCIOUSNESS PRIOR TO PROCEDURE, SYMPTOMS RESOLVED (MINUS RLE WEAKNESS-WHICH WAS POA) AFTER PROCEDURE. RELATEDNESS: STUDY PROCEDURE-RELATED, STUDY DEVICE-RELATED. DATE REPORTED TO THE SPONSOR: 18-AUG-2025. DATE OF INDEX PROCEDURE: ON (B)(6) 2022. IS THE EVENT A SERIOUS ADVERSE EVENT? YES. OUTCOME: RESOLVED WITHOUT SEQUELAE. DOES THE EVENT MEET CRITERIA FOR AN UNANTICIPATED ADVERSE DEVICE EFFECT? NO. ADDITIONAL INFORMATION: EVENT SUMMARY FOR AE#2 ISCHEMIC STROKE: NEURO EVALUATION ON (B)(6) 2023 (POD 298) SHOWED CHRONIC RIGHT LOWER EXTREMITY WEAKNESS BUT NEW FACE AND ARM WEAKNESS. PATIENT WAS OUTSIDE WINDOW FOR TPA AND HAS NO MOTOR DEFICIT SO WOULD NOT REALLY BE THROMBECTOMY CANDIDATE AS LARGE VESSEL OCCLUSION WAS NOT SUSPECTED. BRAIN MRI REVEALED A TINY ACUTE SMALL VESSEL ISCHEMIA IN THE SUBCORTICAL WHITE MATTER OF THE POSTERIOR LEFT PARIETAL LOBE AND LEFT OCCIPITAL LOBE. MRA SHOWED PUNCTATE AREAS OF ACUTE SMALL VESSEL I

  Patient problems: Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 23033994 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY. AN AE HAS BEEN REPORTED FOR SUBJECT (B)(6) AT SITE USA-19. AE NAME : INTRAOPERATIVE ANEURYSM RUPTURE, EVENT ONSET DATE : JUN 26, 2019, EVENT DESCRIPTION : INTRAOPERATIVE ANEURYSM RUPTURE, SPECIFY THE EVENT LOCATION: IPSILATERAL TO TARGET LESION, WAS THE EVENT A STROKE?: YES, RELATEDNESS : STUDY DEVICE-RELATED , SPECIFY CLINICAL OUTCOME" SUBARACHNOID HEMORRHAGE, DATE REPORTED TO THE SPONSOR : (B)(6) 2025, DATE OF INDEX PROCEDURE : (B)(6) 2018 , IS THE EVENT A SERIOUS ADVERSE EVENT?: YES , OUTCOME: RESOLVED WITH SEQUELAE . ADDITIONAL INFORMATION RECEIVED STATED THAT THE CEC ADJUDICATED AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED. BASED ON CEC REVIEW IT WAS MINOR INTRAOPERATIVE RUPTURE WITH MINOR CONSEQUENCE. DUE TO THE ADJUDICATION THE SITE REPORTED AS DISEASE-RELATED. CEC ADJUDICATED AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED. CT OBTAINED (B)(6) 2019 (POD 1) SHOWED SMALL AMOUNT OF SUBARACHNOID HEMORRHAGE AND MILD CEREBRAL EDEMA. TREATED WITH MANNITOL, DECADRON AND OXYTOCIN. HEADACHE, NAUSEA, VOMITING IMPROVED ON (B)(6) 2019. TOLERATING LOW DOSE NIMODIPINE. SUBJECT HAD SOME PERSONAL ISSUES WITH CAR ACCIDENT AND HOME BROK

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 22986594 ↗
• InjuryOct 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT AN LVIS D STENT WAS IMPLANTED TO TREAT A RUPTURED BASILAR TIP ANEURYSM. AFTER DEPLOYING THE STENT, THE BASILAR TIP ANEURYSM WAS COILED SUCCESSFULLY. AN ANGIOGRAM WAS THEN PERFORMED, WHICH SHOWED THE RIGHT END OF LVIS STENT IN THE PCA NOT FULLY DEPLOYED AND THAT THE RIGHT PCA WAS OCCLUDED. A SCEPTER XC WAS ADVANCED UNDER FLUOROSCOPY AND INFLATED. AN ANGIOGRAM PERFORMED POST INFLATION SHOWED A PCA RUPTURE WITH EXTRAVASATION. THE RIGHT PCA WAS COILED TO ADDRESS THE HEMORRHAGE. AFTERWARDS, AN ANGIOGRAM SHOWED LIMITED FLOW IN THE BASILAR ARTERY AND BRAIN EDEMA. THE PATIENT IS IN CRITICAL CONDITION AND INTUBATED. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED DURING THE SAME PROCEDURE REFERENCED IN MFR. REPORT # 2032493-2021-00414.

  Patient problems: Cerebral Edema; Extravasation; Hemorrhage/Blood Loss/Bleeding; Ischemia; Rupture

  MAUDE report 12616271 ↗