LVIS 214035-LVIS-D-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429100974), received between Jan 21, 2020 and Aug 28, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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.

• InjuryAug 28, 2025Activation Problem; Activation Problem

  IT WAS REPORTED FOR A PATIENT ENROLLED IN THE LVIS PAS STUDY THAT THERE WAS AN INCOMPLETE OPEN OF THE LVIS DEVICE PROXIMAL TO THE ANEURYSM. ONCE COILING WAS COMPLETED, WE COMPLETELY DEPLOYED LVIS BLUE. THE MICROCATHETER WAS REMOVED. IT WAS NOTICED THAT LVIS BLUE DID NOT OPEN WELL PROXIMALLY. LVIS BLUE WAS ANGIOPLASTIED PROXIMALLY. NO ASSOCIATED AE TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919765 ↗
• InjuryMay 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL REPORTING FOR THE PATIENT ENROLLED IN THE LVIS PAS STUDY THAT THERE WAS A RECURRENCE OF THE TARGET MIDLINE BASILAR ANEURYSM ELEVEN MONTHS POST INDEX PROCEDURE. DURING THE OPERATIVE PROCEDURE TO TREAT THE MIDLINE BASILAR TARGET ANEURYSM RECURRENCE, DUE TO EXTREME FRAGILITY OF THE ANEURYSMAL WALL, THE TARGET ANEURYSM RUPTURED. THE SURGEONS COULD NOT RECONSTRUCT THE WALL AND CLIP THE ANEURYSM IN ORDER TO STOP THE BLEEDING AND PREVENT FATAL BLOOD LOSS. THE LUMEN OF THE ANEURYSM WAS PACKED WITH COTTONOIDS AND CLIPS WERE APPLIED ON THE WALLS OF THE ANEURYSM TO CLIP COTTONOID IN PLACE. THE PATIENT PASSED AWAY SHORTLY AFTER THIS PROCEDURE. THE MIDLINE BASILAR ANEURYSM RECURRENCE WAS ADJUDICATED BY THE SITE AS DISEASE RELATED, STUDY DEVICE, AND STUDY PROCEDURE RELATED. TARGET ANEURYSM RETREATMENT WAS ADJUDICATED BY THE SITE TO BE STUDY DISEASE RELATED. DURING OPERATIVE PROCEDURE TO TREAT THE ANEURYSM RECURRENCE, AN INTRA-OPERATIVE ANEURYSM RUPTURE OCCURRED; THE ANEURYSM CHARACTERISTICS CONTRIBUTED TO THE RUPTURE THAT LED TO THE PATIENT DEATH WAS ADJUDICATED BY THE SITE TO BE DISEASE RELATED.

  Patient problems: Aneurysm expansion; Cerebral Edema; Diplopia/Double Vision; Facial Paralysis; Muscle Weakness/Atrophy; Ruptured Aneurysm

  MAUDE report 21955876 ↗
• MalfunctionJan 21, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY DISSECTION. AFTER MECHANICAL THROMBECTOMY WITH A STENT RETRIEVER WAS COMPLETED, THE LVIS STENT WAS DEPLOYED; HOWEVER, IT DID NOT FULLY OPEN AT THE DISTAL END. AN EFFORT WAS MADE TO OPEN THE STENT FURTHER WITH THE WIRE, BUT IT WAS NOT SUCCESSFUL. BLOOD FLOW WAS PRESENT IN THE INTERNAL CAROTID ARTERY WHERE THE STENT WAS PLACED. THERE WAS NO REPORTED ADVERSE CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613543 ↗