Neuroform Atlas M003SZAS45300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252656241), received between Jul 19, 2018 and Dec 6, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (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.

• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Material Too Soft/Flexible; Adverse Event Without Identified Device or Use Problem; Material Too Soft/Flexible

  IT WAS REPORTED THAT THAT THE PHYSICIAN WAS PERFORMING A STENT ASSISTED-COILING PROCEDURE OF A SMALL, UN-RUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC ANEURYSM IN A RELATIVELY DYSPLASTIC VESSEL. THE STENT (SUBJECT DEVICE) WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM NECK USING JAILED TECHNIQUE. THE PHYSICIAN ATTEMPTED TO DEPLOY A FIRST COIL, BUT THE COIL APPEARED TO BE TOO BIG AND LONG FOR THE ANEURYSM, AS THE COIL KEPT HERNIATING DOWNWARD INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1.5MM X 2CM COIL. UNFORTUNATELY, THE SAME ISSUE HAPPENED WITH THIS COIL AS IT CONTINUED TO HERNIATE DOWN INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1MM X 1CM COIL. THIS 1MM X 1CM COIL SUCCESSFULLY DEPLOYED INTO THE ANEURYSM DOME AND WAS DETACHED. UPON INSPECTING THE COIL MASS, AS THE PHYSICIAN NOTICED THAT THERE WAS STILL OPEN SPACE IN THE MIDDLE OF THE ANEURYSM, THE PHYSICIAN DECIDED TO DEPLOY OF A SECOND 1MM X 1CM COIL INTO THE ANEURYSM DOME. UNFORTUNATELY, THIS SECOND 1MM X 1CM COIL MECHANICALLY PUSHED TH

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 9421274 ↗
• MalfunctionOct 8, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PREMATURELY DEPLOYED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169990 ↗
• DeathJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 MONTH-POST SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM LOCATED ON THE BASILAR APEX, THE PATIENT MECHANICALLY FELL AND HAD SUBSEQUENT FALCINE SUBDURAL HEMATOMA. HOSPITALIZATION/PROLONGED HOSPITALIZATION WAS REQUIRED. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS 2 DAYS LATER. EIGHT DAYS POST FALL, THE PATIENT SUFFERED SEVERE ASPIRATION PNEUMONIA AND MULTI ORGAN SYSTEM FAILURE. THE PATIENT DIED 15 DAYS POST FALL. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE FALL AND SUBSEQUENT FALCINE SUBDURAL HEMATOMA WERE RELATED TO PARKINSON'S DISEASE, CONCOMITANT MEDICATION (PLAVIX/ASA), AND ATLAS STENTS (SUBJECT DEVICE) AND SEVERE ASPIRATION PNEUMONIA AND MULTI ORGAN SYSTEM FAILURE WERE RELATED TO PARKINSON'S DISEASE, MEDICAL COMPLICATIONS, AND ATLAS STENTS. HAD THE PATIENT NOT HAD AN INTRACRANIAL STENT, SHE WOULD NOT HAVE BEEN ON DUAL ANTIPLATELET THERAPY (DAPT) SO THIS EVENT IS DEVICE AND DRUG RELATED.

  Patient problems: Death; Hematoma; Multiple Organ Dysfunction Syndrome; Pneumonia

  MAUDE report 7704726 ↗