LVIS Jr. 172014-LVISJ-C-HDERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812636020136), received between Jun 8, 2017 and Aug 16, 2017 — classified as 2 deaths, 1 injury.

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.

• DeathAug 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STENT-ASSISTED COILING TREATMENT WAS PERFORMED ON AN UNRUPTURED BUT GROWING RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM VIA THE RIGHT INTERNAL CAROTID ARTERY. THERE WERE NO TECHNICAL PROBLEMS DURING THE CASE; HOWEVER, THE PATIENT DIED FOUR (4) DAYS AFTER THE PROCEDURE. THE POST MORTEM EXAM SHOWED THE STENT, COILS, AND ANEURYSM WERE INTACT. THE PATHOLOGIST STATED THAT THE PATTERN OF THE MARKED SUBARACHNOID HEMORRHAGE WAS A HYPERTENSIVE-TYPE OF DEEP BASAL GANGLIA HEMORRHAGE, WHICH WAS LOCATED IN THE SAME HEMISPHERE AS THE TREATED SEGMENT, BUT DID NOT APPEAR TO BE RELATED TO THE DEVICES. THE REPORT STATED THE EXAM WAS NEGATIVE FOR GROSS DISRUPTION OF THE MIDDLE CEREBRAL ARTERY IN THE AREA OF PRIOR COILING.

  Patient problems: Death; Hemorrhage, Cerebral; Hemorrhage, Subarachnoid

  MAUDE report 6799193 ↗
• DeathJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STENT-ASSISTED COILING TREATMENT WAS PERFORMED ON AN ANTERIOR COMMUNICATION ARTERY (A-COMM) ANEURYSM VIA THE RIGHT INTERNAL CAROTID ARTERY, ON A PATIENT WITH 4-5 ANEURYSMS IN THE INTRACRANIAL VASCULATURE. THE MICROCATHETER WAS PLACED ACROSS THE A1 TO THE CONTRALATERAL A2, AND THE STENT WAS ADVANCED THROUGH THE MICROCATHETER THEN DEPLOYED. THE STENT LOOKED WELL APPOSED. THE MICROCATHETER WAS RE-CROSSED THROUGH THE DEPLOYED STENT TO ATTEMPT AN EXCHANGE FOR A SMALLER MICROCATHETER IN ORDER TO ACCESS ONE OF THE CELLS. A FEW MINUTES LATER, A SEVERE BLEED WAS DISCOVERED WITH ROADMAP IMAGING; HOWEVER, THE SOURCE OF THE BLEED COULD NOT BE DETERMINED. PROTAMINE WAS ADMINISTERED TO THE PATIENT AND A TEMPORARY COIL WAS PLACED IN THE RIGHT A1 TO STOP THE BLEEDING. ONCE THE BLEEDING STOPPED, THE PREVIOUS ANGIOGRAMS WERE REVIEWED. THE IMAGES REVEALED THE BLEEDING WAS PRESENT PRIOR TO THE STENT IMPLANTATION AND THE TORTUOUS A2 TO THE A-COMM TO THE CONTRALATERAL A2 VESSEL SEGMENT WAS STRAIGHTENED OUT BY THE MICROCATHETER. SURGICAL INTERVENTION WAS PERFORMED TO RELIEVE INTRACRANIAL PRESSURE AND EVACUATE CLOT. IT WAS THE CONSENSUS OF TWO PHYSICIANS THAT THERE WAS A SPONTANEOUS

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 6665726 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A RECURRENT LEFT A2/A3 PERICALLOSAL/CALLOSOMARGINAL ANEURYSM THAT HAD BEEN PREVIOUSLY COILED. THE PATIENT HAD BEEN PRE-OPERATIVELY TREATED WITH BRILINTA, AS HE WAS A NON-RESPONDER TO PLAVIX. THE LVIS JR. WAS IMPLANTED AT THE NECK OF THE ANEURYSM AND THEN THE ANEURYSM WAS SUBSEQUENTLY COILED, WITHOUT ISSUES. THE PATIENT WAS DISCHARGED ON POST-OP DAY 1 ON ASPIRIN AND BRILINTA. ON POST-OP DAY 3, THE PATIENT RETURNED WITH RIGHT LEG WEAKNESS WITH ASSOCIATED NUMBNESS. THE PATIENT HAD NOT TAKEN HIS ASPIRIN OR BRILINTA THE DAY BEFORE. MRI SHOWED EMBOLIC STROKES IN THE LEFT ACA TERRITORY. ANGIOGRAPHY DEMONSTRATED A SMALL AMOUNT OF THROMBUS IN THE DISTAL ASPECT OF THE STENT. ANTIPLATELET THERAPY WAS RESUMED AND THE PATIENT WAS ALSO PLACED ON A HEPARIN DRIP FOR 3 DAYS WHILE UNDER OBSERVATION IN THE HOSPITAL. REPEAT ANGIOGRAPHY DEMONSTRATED RESOLUTION OF THE THROMBUS, AND THE PATIENT WAS DISCHARGED. ONE MONTH LATER, THE PATIENT WAS SEEN IN CLINIC AND NOTED TO BE DOING BETTER WITH A MINOR AMOUNT OF RESIDUAL RIGHT LEG WEAKNESS. MRI PERFORMED 6 MONTHS AFTER THE PROCEDURE SHOWED NO RECURRENT ANEURYSM AND NO SIGN OF IN-STENT STENOSIS OR OCCLUSION. THE

  Patient problems: Neurological Deficit/Dysfunction; Thrombus; Weakness

  MAUDE report 6626900 ↗