LVIS 212517-LVIS-D-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429100875), received between Dec 4, 2024 and Mar 9, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY, AN ADVERSE EVENT OF THE PATIENT EXPERIENCING SOME RESIDUAL NECK AND PROXIMAL DOME FILLING OF THE ANEURYSM BASE BETWEEN THE COILS. THE DATE OF INDEX PROCEDURE WAS (B)(6) 2021. THE EVENT WAS RESOLVED BY DECIDING TO OBSERVE BY ROUTINE SURVEILLANCE ANGIOGRAPHY. THE PATIENT OUTCOME IS THAT THEY HAD ANOTHER DIAGNOSTIC CEREBRAL ANGIOGRAPHY ON (B)(6) 2023, WHICH SHOWED STABLE OCCLUSION OF THE LEFT VERTEBRAL ARTERY ANEURYSM WITH A WIDE, 5MM NECK ARISING FROM THE LEFT VERTEBRAL ARTERY JUST PROXIMAL TO THE VERTEBROBASILAR JUNCTION, WHERE THERE IS A FENESTRATION, BUT WITH SOME RESIDUAL FILLING OF THE ANEURYSM BASE THROUGH THE COILS, RAYMOND 2A.

  Patient problems: Aneurysm

  MAUDE report 24553404 ↗
• InjuryOct 15, 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 WAS ADJUDICATED AS TARGET ANEURYSM RETREATMENT. CEC COMMENT: RUPTURED ACOMM ORIGINALLY CLIPPED AND TREATED WITH LVIS AS INDEX PROCEDURE. RETREATED IN 2022 WITH A STENT. DATE OF INDEX PROCEDURE: (B)(6) 2019 OUTCOME: RESOLVED WITHOUT SEQUELAE. THE PATIENT WAS RETREATED WITH A STENT ON (B)(6) 2022. POST PROCEDURE EVALUATION ON (B)(6) 2022 PATIENT WAS DOING WELL AND NEUROLOGICALLY INTACT, WAS DISCHARGED HOME. PATIENT HAS A HISTORY OF RIGHT FILLING ACOM AND UNDERWENT SURGICAL CLIPPING FOR (B)(6) IN 2006.

  Patient problems: Aneurysm expansion; Headache; Neuropathy

  MAUDE report 23294873 ↗
• InjuryMay 20, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY, THERE WAS INCOMPLETE OPEN OF THE INTRALUMINAL SUPPORT SENT DEVICE PROXIMAL TO THE ANEURYSM. ON FOLLOW-UP ANGIOGRAPHY, THE PROXIMAL STENT WAS NOTED NOT TO BE FULLY OPENED. GIVEN THAT NO ALTERATION IN FLOW WAS NOTED, FURTHER PUSHING ON THE PARTIALLY OPEN STENT WAS NO PERFORMED. THE PATIENT DID NOT REQUIRE OTHER TREATMENT/INTERVENTION AS A RESULT OF THE MALFUNCTION. THIS TECHNICAL EVENT IS NOT ASSOCIATED WITH ANY ADVERSE EVENT AND DID NOT LEAD TO A SERIOUS ADVERSE DEVICE EFFECT (SADE).

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion

  MAUDE report 22057377 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS RETROSPECTIVE STUDY THAT 39 DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED ACUTE SYMPTOMS OF SLURRED SPEECH, RIGHT FACIAL DROOP AND SENSATION OF "THICK" TONGUE, PROMPTING EMERGENCY DEPARTMENT VISIT WHERE IMAGING SHOWED ISCHEMIC PONTINE INFARCT. SYMPTOMS TREATED WITH MEDICAL MANAGEMENT. THE EVENT WAS DESCRIBED AS ISCHEMIC STROKE, CANNOT BE ASCERTAINED THE LOCATION OF STROKE WITH RESPECT TO THE TARGET VESSEL. THE ADVERSE EVENT RESOLVED WITHOUT SEQUALAE ON DAY 50 POST PROCEDURE. THE PATIENT EXITED THE STUDY ON (B)(6) 2024 AFTER RETROSPECTIVE 5 YEAR FOLLOW-UP WAS COMPLETED. THE ADVERSE EVENT WAS ASSESSED AS RELATED TO THE STUDY DEVICE AND PROCEDURE. THE PATIENT PREVIOUSLY UNDERWENT ENDOVASCULAR EMBOLIZATION WITH A FLOW-DIVERTING STENT OF A RECURRENT BASILAR TIP ANEURYSM ON (B)(6) 2019. PATIENT WAS READMITTED (B)(6) 2019 WITH DYSARTHRIA, TONGUE NUMBNESS, BILATERAL FACE NUMBNESS (R>L) AND BILATERAL HAND NUMBNESS (R>L). MRI SHOWED A SMALL PERFORATOR INFARCT IN THE LEFT PARAMEDIAN PONS ADJACENT TO THE PROXIMAL ASPECT OF THE STENT CONSTRUCT WITHIN THE BASILAR ARTERY. THE STENT CONSTRUCT EXTENDS INTO THE LEFT POSTERIOR CEREBRAL ARTERY AND IS PATENT. THE STE

  Patient problems: Facial Paralysis; Ischemia Stroke; Speech Disorder

  MAUDE report 20848151 ↗