LVIS 212525-LVIS-D-HDERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00812636022192), received between Apr 21, 2025 and Feb 19, 2026 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE CLINICAL STUDY LVIS PAS: AE FOR LVIS SUBJECT WAS ADJUDICATED BY CEC 02-FEB-2026, AS STUDY PROCEDURE-RELATED AND STUDY DEVICE-RELATED. AE NAME: NECK REMNANT VS. RECANALIZATION DATE OF INDEX PROCEDURE: ON (B)(6) 2017. EVENT ONSET DATE: 6-SEP-2018. EVENT DESCRIPTION: FROM CTA NECK ON (B)(6) 2018: STATUS POST STENT ASSISTED COILING OF PREVIOUSLY DEMONSTRATED ANEURYSMS ARISING FROM THE RIGHT POSTERIOR CEREBRAL ARTERY AT THE P2-P3 SEGMENTS. THERE IS A SMALL AREA OF RECANALIZATION VERSUS NECK REMNANT JUST SUPERIOR TO THE COIL MASS ON SERIES 5 IMAGE 110 MEASURING 3 MM DIAMETER. DURING FOLLOW UP VISIT ON (B)(6) 2018 THE PHYSICIAN REVIEWED HIS CTA FROM EARLIER TODAY. THERE IS A SMALL, 2 MM, RESIDUAL SEEN AT THE NECK OF THE PROXIMAL ANEURYSM AND THE DISTAL ANEURYSM IS NO LONGER SEEN. THE PATIENT IS NOT EXPERIENCING ANY SYMPTOMS. NEUROLOGIST RECOMMENDED CONTINUED XARELTO. DEVICE REMAINS IMPLANTED. SITE REPORTED RELATEDNESS: DISEASE-RELATED IS THE EVENT A SERIOUS ADVERSE EVENT? NO. OUTCOME: RESOLVED WITHOUT SEQUELAE. DOES THE EVENT MEET CRITERIA FOR AN UNANTICIPATED ADVERSE DEVICE EFFECT? NO. NO OTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aneurysm expansion

  MAUDE report 24396465 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: EVENT SUMMARY: FIVE DAYS AFTER THE INDEX PROCEDURE, MRI BRAIN REVEALED SIGNS OF LEFT CEREBRAL PEDUNCLE STROKE. THERE IS AN INTRAPARENCHYMAL HEMATOMA IN THE RIGHT FRONTAL LOBE; THIS IS UNCHANGED FROM THE RECENT CT EXAMINATION. PNEUMOCEPHALUS WITH AIR BUBBLES IN BOTH LATERAL VENTRICLES IS PRESENT. BASED ON NEUROSURGERY CONSULT, MRI FINDINGS WERE FOUND AS NOT ACUTELY CONCERNING, AND REQUIRED NO CHANGE IN MANAGEMENT. PATIENT REMAINS SEDATED, INTUBATED AND MECHANICALLY VENTILATED. ADDITIONALLY, WITH NO EVIDENCE OF VASOSPASM ON DAILY TRANS CRANIAL DOPPLERS AND CEREBRAL ANGIOGRAM, WAS GIVEN THE OKAY TO BEGIN NORMALIZING BP, AND BEGIN SPONTANEOUS BREATHING TRIALS FOR EXTUBATING. REPEAT MRI, NINE DAYS AFTER THE INDEX PROCEDURE, DEMONSTRATED MULTIPLE SMALL EMBOLIC CVAS. EVENT WAS RESOLVED WITHOUT SEQUELAE. THE EVENT WAS ADJUDICATED AS STUDY DEVICE-RELATED, DISEASE-RELATED AND MEDICATION-RELATED. INDEX PROCEDURE: PATIENT PRESENTED TO ED WITH SAH AND BASILAR ARTERY ANEURYSM, UNDERWENT CEREBRAL ANGIOGRAM WITH STENTING OF BASILAR ARTERY BIFURCATION, COIL EMBOLIZATION OF BASILAR ARTERY ANEURYSM, AND PLACEMENT OF EVD. PATIENT DID SHOW SOME IMPROVEME

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 23307975 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED IN THE LVIS PAS CLINICAL STUDY, AN AE HAS BEEN REPORTED FOR SUBJECT (B)(6) AT SITE USA-18. AE NAME: STASIS OVER THE DISTAL ACA EVENT ONSET DATE: 21-JUL-2020 EVENT DESCRIPTION: DURING RETREATMENT PROCEDURE ON (B)(6) 2020, "DELAYED IMAGING SHOWED STASIS OVER THE DISTAL ACA.INTEGRILIN BOLUS WAS EMERGENTLY GIVEN AND INFUSION STARTED. FOLLOW UP IMAGES OBTAINED AFTER INFUSION HAD BEEN STARTED SHOW RESOLVING STASIS AND BETTER FLOW INTO THE DISTAL ANTERIOR CEREBRAL ARTERY." RELATEDNESS : DISEASE-RELATED DATE OF INDEX PROCEDURE : (B)(6) 2018 IS THE EVENT A SERIOUS ADVERSE EVENT? : NO OUTCOME : RESOLVED WITHOUT SEQUELAE DOES THE EVENT MEET CRITERIA FOR AN UNANTICIPATED ADVERSE DEVICE EFFECT? : NO ADJUDICATION RECEIVED ON (B)(6) 2025, BELOW AE FOR LVIS PAS SUBJECT (B)(6) WAS ADJUDICATED AS STUDY DEVICE-RELATED, STUDY PROCEDURE-RELATED. AWARENESS DATE: 18AUG2025 ADJUDICATED ADVERSE ENTER TERM: DISTAL ACA STASIS EVENT CATEGORY: AE SERIOUS ADVERSE EVENT: NO SEVERITY: GRADE 2 MODERATE- MINIMAL, LOCAL, OR NONINVASIVE INTERVENTION INDICATED AE RELATEDNESS: STUDY DEVICE RELATED AE CATEGORY" NEUROLOGIC NEUROLOGICAL DEFICIT- NO EVENT LOCATION: IPSILATERAL TO TARGET LESION STASIS IN DISTAL

  Patient problems: Obstruction/Occlusion

  MAUDE report 22925890 ↗
• InjuryAug 28, 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, BASED ON THE REVIEW OF MEDICAL RECORD, REPEAT ANGIOGRAM ON DECEMBER 2018 SHOWED MINIMAL RESIDUAL ANEURYSM FILLING. ANGIOGRAM ON (B)(6) 2019 (POD 550) SHOWED INCREASED FILLING BETWEEN COILS, WITHOUT SIGNIFICANT COIL COMPACTION. TREATED WITH SURGERY OF REPEAT STENTING AND COIL EMBOLIZATION ON (B)(6) 2020. CURRENT PATIENT STATUS DESCRIBED AS: PATIENT HAD BEEN WITHOUT HEADACHE OR OTHER SYMPTOMS CONCERNING FOR RUPTURE. RESOLVED WITHOUT SEQUELAE.

  Patient problems: Aneurysm

  MAUDE report 22919516 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: PATIENT HAD AN ISCHEMIC STROKE AFTER LVIS PROCEDURE, PATIENT HAD FACIAL DROOP AND SOME SENSATION CONCERNS. THE EVENT IS RELATED TO THE STUDY DEVICE RELATED. THE PATIENT WAS EVALUATED WITH CT ON (B)(6) 2017, BUT NO ACUTE FINDINGS WERE DETECTED. WAS STARTED ON BRILLENTA FOR STROKE PREVENTION. ON (B)(6) 2017 MEDICATIONS INCLUDING VALIUM AND MECLIZINE PRN WERE GIVEN FOR SYMPTOMS MANAGEMENT. NO TREATMENT WAS GIVEN. OCCURRED 1 DAY AFTER. INDEX PROCEDURE WAS ON (B)(6) 2017. NO OTHER RELATEDNESS, ADJUDICATED AS DEVICE RELATED AND MEDICATION RELATED.

  Patient problems: Facial Paralysis; Ischemia Stroke

  MAUDE report 22561969 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE CLINICAL STUDY LVIS PAS AND ADJUDICATED AS STUDY DEVICE-RELATED AND STUDY PROCEDURE-RELATED. AE NAME: PERSISTENT LEFT INTERNAL CAROTID ARTERY ANEURYSM DATE OF INDEX PROCEDURE: (B)(6) 2018 - THE LVIS WAS IMPLANTED ON (B)(6) 2018 AND IS CONSIDERED THE INDEX PROCEDURE EVENT ONSET DATE: (B)(6) 2020 ¿ DATE OF RE-TREATMENT / 2ND PROCEDURE EVENT DESCRIPTION: TREATED FOR A LEFT ICA ANEURYSM WITH ENDOVASCULAR FLOW DIVERTING STENT PLACEMENT RELATEDNESS: DISEASE-RELATED IS THE EVENT A SERIOUS ADVERSE EVENT? YES ADJUDICATED INFORMATION NOTES: AE TERM: TARGET ANEURYSM RETREATMENT WITH EVENT LOCATION: IPSILATERAL TO TARGET LESION AE CATEGORY: NEUROLOGIC GRADE 3: SEVERE (SAE) ¿ SEVERE OR MEDICALLY SIGNIFICANT BUT NOT IMMEDIATELY LIFE-THREATENING; HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION INDICATED REASONS FOR SERIOUSNESS: MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION WAS THE EVENT ASSOCIATED WITH A NEUROLOGICAL DEFICIT? NO WAS THE EVENT A TRANSIENT ISCHEMIC ATTACK (TIA)? NO WAS THE EVENT A STROKE? NO WAS THERE A TARGET ANEURYSM REBLEED? NO DOES THIS EVENT QUALIFY AS A C

  Patient problems: Aneurysm expansion

  MAUDE report 22549570 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THOUGH AN LVIS PAS CLINICAL STUDY, A RETREATMENT OF A TARGET ANEURYSM OCCURRED ON THE IPSILATERAL TO TARGET LESION. THE STENT FAILED TO PROVIDE ADEQUATE FLOW DIVERSION EFFECT. THIS RETREATMENT TOOK PLACE 140 DAYS AFTER THE INITIAL IMPLANTATION. FOLLOWING THE RETREATMENT SURGERY, THE PATIENT WAS MONITORED IN THE ICU AND REMAINED STABLE OVERNIGHT, LEADING TO THEIR DISCHARGE HOME. SEVEN MONTHS LATER, A CTA SHOWED THAT THE ANEURYSM WAS STABLE WITH NO ACUTE FINDINGS. THE PATIENT EXITED THE STUDY AFTER THE RETROSPECTIVE COLLECTION OF 5-YEAR FOLLOW-UP DATA. THE ADVERSE EVENT IS CONSIDERED RELATED TO THE STUDY DEVICE AND THE STUDY PROCEDURE. THE EVENT IS CATEGORIZED AS NEUROLOGIC. HOWEVER, IT IS IMPORTANT TO NOTE THAT THIS EVENT DID NOT RESULT IN ANY NEUROLOGICAL DEFICITS. IT IS NOT CLASSIFIED AS A TRANSIENT ISCHEMIC ATTACK (TIA) OR A STROKE, AND THERE WAS NO TARGET ANEURYSM REBLEED. THIS EVENT QUALIFIES AS A CLINICAL OUTCOME, SPECIFICALLY TARGET ANEURYSM RETREATMENT. THE EVENT ADJUDICATION STATUS IS COMPLETE.

  Patient problems: Aneurysm expansion

  MAUDE report 22516622 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE LVIS PAS CLINICAL STUDY: SUBJECT WITH RECURRENT GIANT RIGHT ANTERIOR CEREBRAL A2 SEGMENT ANEURYSM TREATED ON WITH ELECTIVE INDEX PROCEDURE OF SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION. DID WELL OVERNIGHT AND WAS DISCHARGED HOME. SUBSEQUENT FOLLOW UP MRA ON EVENT DATE, 645 DAYS POST-OP INDEX PROCEDURE, SHOWED PROGRESSIVE INCREASE IN THE SIZE AND PERSISTENT FILLING OF GIANT RIGHT ANTERIOR CEREBRAL ARTERY A1-2 JUNCTION ANEURYSM. DIAGNOSED WITH PROGRESSIVE INCREASE IN THE SIZE OF RECANALIZED TARGET ANEURYSM WHICH IS CAUSED BY COMPACTION OF THE PREVIOUSLY PLACED COIL MASS, THE PREVIOUSLY PLACED LVIS STENT WAS PATENT. HE DOES NOT COMPLAIN OF ANY SYMPTOMS. HE UNDERWENT ENDOVASCULAR RETREATMENT OF THE TARGET ANEURYSM WITH IR INTRACRANIAL STENT, 9 MONTHS AFTER THE MRA. OUTCOME WAS RESOLVED WITHOUT SEQUELAE. EVENT WAS NOT A TRANSIENT ISCHEMIC ATTACK (TIA) OR STROKE. THERE WAS NO TARGET ANEURYSM REBLEED. THE LOCATION WAS IPSILATERAL TO TARGET LESION. EVENT WAS ADJUDICATED AS RELATED TO THE STUDY DEVICE, STUDY PROCEDURE, AND DISEASE.

  Patient problems: Aneurysm expansion

  MAUDE report 22401325 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING DEVELOPMENT OF A SMALL RIGHT FRONTAL SUBDURAL HYGROMA LIKELY DUE TO SMALL DEFECT IN THE ARACHNOID. PATIENT IS ASYMPTOMATIC AND UNDERWENT SUBDURO-PERITONEAL. EVENT RESOLVED WITHOUT SEQUELAE AND WAS ADJUDICATED BY CEC AS STUDY DEVICE AND STUDY PROCEDURE RELATED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21878559 ↗