LVIS Jr. 172020-LVISJ-C-HDERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812636020143), received between Apr 12, 2016 and Jun 8, 2018 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2018Separation Failure; Material Deformation; Separation Failure; Material Deformation

  IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION TREATMENT OF AN ANEURYSM WAS ATTEMPTED. AFTER POSITIONING THE LVIS JR STENT AT THE TREATMENT SITE, THE STENT DID NOT DEPLOY PROPERLY. DURING RETRACTION OF THE DELIVERY WIRE, THE STENT WAS STILL ATTACHED AND THE STENT INVERTED ON ITSELF. AFTER MULTIPLE ATTEMPTS WERE MADE, THE STENT WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. THE PROCEDURE WAS RESCHEDULED FOR TREATMENT THE FOLLOWING DAY. FINAL ANGIOGRAPHIC IMAGES DEMONSTRATED NO EVIDENCE OF THROMBUS IN THE VESSEL AND GOOD INTRACRANIAL FLOW. THE PATIENT RETURNED THE NEXT DAY AND TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7584449 ↗
• InjurySep 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED FOR A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM ON (B)(6) 2017. UNDER DIRECT FLUOROSCOPIC ROADMAP ASSISTANCE USING COAXIAL MICROCATHETER TECHNIQUE, THE MICROCATHETER WAS POSITIONED WITHIN THE MCA ANEURYSM AND ANCHORED WITH PARTIAL DEPLOYMENT OF HYDROCOIL. THE LVIS JR. STENT SUPPORT WAS THEN EXTENDED FROM THE RIGHT MIDDLE CEREBRAL ARTERY JUST DISTAL TO THE ANEURYSM ORIGIN EXTENDING PROXIMALLY. USING INTRALUMINAL SUPPORT, COIL EMBOLIZATION WAS THEN PERFORMED WITH INTERMITTENT ARTERIOGRAM. COMPLETION ARTERIOGRAM DEMONSTRATED A WELL-POSITIONED COIL MASS, MINIMAL COIL FILLING AND WIDELY PATENT STENTS, NO EVIDENCE OF DISTAL EMBOLIZATION OF CONTRAST EXTRAVASATION. THE CATHETER WAS REMOVED. THERE WERE NO IMMEDIATE COMPLICATIONS OR PATIENT COMPLAINTS. THE PATIENT REMAINED ON ASPIRIN AND PLAVIX. ON (B)(6) 2017 THE PATIENT WAS FOUND TO HAVE HAD AN EPISODE OF VENTRICULAR TACHYCARDIA. THE PATIENT DID NOT HAVE ANY CHEST PAIN. DUE TO THE PATIENT'S RISK FOR STROKE DUE TO STENT -ASSISTED COIL EMBOLIZATION, THE DUAL ANTIPLATELET THERAPY WAS UNABLE TO BE DISCONTINUED EVEN IN THE PRESENCE OF THE GI BLEED. THE PATIENT REMAINED ON ASPIRIN

  Patient problems: Infarction, Cerebral; Weakness

  MAUDE report 6906622 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION WAS ATTEMPTED FOR A LEFT MCA BIFURCATION SACULAR ANEURYSM. THE LVIS JR. STENT WAS IMPLANTED WITHOUT ISSUE AND A MICROCATHETER WAS JAILED IN THE ANEURYSM. AFTER UNSUCCESSFUL ATTEMPTS WERE MADE TO POSITION TWO COILS IN THE ANEURYSM, A FOCAL AREA OF ACUTE THROMBUS BEGAN TO FORM ON THE STENT, WHICH WAS SUCCESSFULLY TREATED WITH REOPRO. THE PROCEDURE WAS ABORTED IN FAVOR OF COMPLETING THE PROCEDURE AT A LATER DATE. THE PATIENT EXPERIENCED NON-SPECIFIC NEUROLOGICAL DEFICITS 24 HOURS POST-PROCEDURE, PER THE PHYSICIAN.

  Patient problems: Thrombus

  MAUDE report 6632629 ↗
• DeathJun 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO BE A (B)(6) FEMALE PRESENTING WITH ANTRA COMMUNICATING ARTERIES, 7X5XX4MM ANEURYSM. THE PATIENT WAS ELECTIVELY ADMITTED FOR TREATMENT OF THE WIDE NECK ANEURYSM. THE PATIENT WAS PREPPED, BILATERAL GROINS WERE PREPPED IN USUAL FASHION. ACCESS WAS MADE USING ULTRASOUND GUIDANCE. PREVIOUSLY SELECTED COILING VIEWS WERE SELECTED. AN ATTEMPT TO CROSS THE IPSILATERAL A2 SEGMENT WITH A BALLOON CATHETER AND MICROCATHETER WAS UNSUCCESSFUL. ACCESS THE CONTRALATERAL A2 AND DEPLOYED A LVIS STENT. A MICROCATHETER WAS ADVANCED INTO THE ANEURYSM AND THE MICROWIRE WAS REMOVED. ANGIOGRAPHIC RUNS WERE USED TO VERIFY THE POSITION OF THE SYSTEM. AN ATTEMPTED WAS MADE TO RE-ACCESS THE ANEURYSM FROM THE RIGHT A2 SEGMENT, BUT THE MICROWIRE PUNCTURED THE ANEURYSMAL DOME LEADING TO EXCELLENT POSITION. ACT WAS NORMALIZED WITH PROTAMINE. BLOOD PRESSURE WAS CONTROLLED TO LESS THAN 140. AFTER REPEATED ATTEMPTS, ACCESS WAS MADE TO THE ANEURYSM FROM THE RIGHT A2, A COIL WAS DEPLOYED. ACCESS WAS DIFFICULT THROUGH STENT TYNES SO THE ACCESS WAS CHANGED TO THE LEFT INTERNAL CAROTID ARTERY. THE ANTERIOR LOBE OF THE ANEURYSM WAS COILED. FOLLOW-UP VIEWS REVEALED NO ACTIVE EXTRAVASATION, BUT TH

  Patient problems: Aneurysm; Death

  MAUDE report 5756905 ↗
• InjuryApr 13, 2016Positioning Problem; Unintended Movement; Positioning Problem; Unintended Movement

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN ACOMM ANEURYSM, MICROCATHETERS WERE POSITIONED TO ACCESS THE ANEURYSM FOR COIL DEPLOYMENT. AN LVIS JR. WAS PLACED TO DEPLOY FROM THE LEFT A2 ACROSS THE ACOMM AND SHOULDER IT TO PROTECT THE RIGHT A2 DURING COILING. DURING THE DEPLOYMENT, THE STENT OPENED WELL DISTALLY, BUT THE CATHETER STRAIGHTENED OUT THE VESSEL. DUE TO THE STRAIGHTENING, IT WAS NOT POSSIBLE TO SHOULDER THE LVIS JR. WELL ENOUGH TO PROTECT THE RIGHT A2. ATTEMPTS WERE MADE TO POSITION THE STENT AND CATHETER IN THE DESIRED LOCATION UNSUCCESSFULLY. AT THIS POINT AN ATTEMPT WAS MADE TO PULL THE LVIS JR. INTO THE ENVOY CATHETER. DURING THIS ATTEMPT THE LVIS JR. DEPLOYED IN THE CAVERNOUS SEGMENT OF THE RICA. THE RIGHT A1 WAS FILLING SLOWER AT THIS POINT. AN ATTEMPT WAS MADE TO RETRIEVE THE LVIS JR. USING A SOLITAIRE STENT UNSUCCESSFULLY. A 3MM GOOSENECK SNARE WAS UTILIZED TO RETRIEVE THE STENT SUCCESSFULLY ON THE FIRST ATTEMPT. A FOLLOW UP RUN SHOWED SPASM IN THE RIGHT MCA ARTERY ALONG WITH SOME CLOT IN THE PROXIMAL SECTION OF THE M1. AFTER A COUPLE MINUTES OF MINUTES ANOTHER ANGIO RUN WAS PERFORMED WHICH SHOWED THE CLOT CLEARED UP. THE A1 SEGMENT WAS FILLING MUCH BETTER AT

  Patient problems: Aneurysm

  MAUDE report 5574974 ↗
• InjuryApr 12, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN ANEURYSM, A "Y" STENTING OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION WAS PERFORMED. THE FIRST STENT (LVIS JR.) WAS SUCCESSFULLY PLACED IN THE INFERIOR BRANCH. MULTIPLE ATTEMPTS WERE MADE TO ACCESS THE SUPERIOR BRANCH WITH THE MICROCATHETER AND GUIDE WIRE. HOWEVER, DURING THIS ATTEMPT, THE STENT MIGRATED INTO THE MCA. THE STENT WAS REPORTED TO HELP BRIDGE THE NECK. A SECOND STENT WAS PLACED INSIDE THE FIRST STENT DEPLOYED AND COILS WERE PLACED IN THE ANEURYSM SUCCESSFULLY. NO PATIENT HARM OR INJURY WAS REPORTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Aneurysm

  MAUDE report 5571990 ↗