Neuroform Atlas M003SZAS40240Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613252656203), received between Jul 19, 2018 and Sep 23, 2019 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE STENT HAD DEPLOYED PREMATURELY DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106323 ↗
• MalfunctionMay 10, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE STENT(SUBJECT DEVICE) RADIOPAQUE MARKERS WERE MISALIGNED. THE PHYSICIAN CONTINUED THE PROCEDURE AND DETACHED THE COIL SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600483 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DURING IMPLANTATION OF THE STENT (SUBJECT DEVICE) INTO THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA), THE PATIENT SUFFERED A STROKE OF THE DISTAL BASILAR ARTERY. THE PHYSICIAN PERFORMED A THROMBECTOMY AND BLOOD CIRCULATION WAS RESTORED. THE PHYSICIAN SUSPECTS THAT THE STROKE OCCURRED DUE TO THROMBUS FORMATION IN THE STENT LUMEN AT THE TOP OF THE BASILAR ARTERY. THE PATIENT IS CURRENTLY HOSPITALIZED WITH A MID-BRAIN STROKE OF SCORE 18 ON NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NHISS). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Stroke/CVA; Thrombus

  MAUDE report 8510339 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THROMBOSIS WAS NOTICED WITHIN THE STENT. THEREFORE, INTRAARTERIAL AGGRASTAT WAS PROVIDED TO THE PATIENT.

  Patient problems: Thrombosis

  MAUDE report 8351475 ↗
• MalfunctionSep 10, 2018Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS DEPLOYED FROM THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) TO THE BASILAR ARTERY (BA). THE STENT OPENED PROXIMALLY IN THE BASILAR ARTERY; HOWEVER, THE DISTAL OF THE STENT DID NOT OPEN IN THE POSTERIOR CEREBRAL ARTERY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7860479 ↗
• MalfunctionAug 3, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE STENT DELIVERY WIRE BECAME STUCK INSIDE THE DEPLOYED STENT (SUBJECT DEVICE) ALONG WITH THE GUIDEWIRE AND MICROCATHETER. THE PHYSICIAN REMOVED ALL THREE DEVICES AND COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7748437 ↗
• 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 7704724 ↗