Neuroform Atlas M003SZAS30210Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613252656159), received between Jun 28, 2018 and Jun 3, 2021 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2021Fracture; Premature Activation; Fracture; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN TRIED TO RESHEATH THE STENT (SUBJECT DEVICE), A PIECE OF THE DISTAL STENT (SUBJECT DEVICE) BROKE OFF AND WAS DEPLOYED, THE OTHER PART OF THE STENT (SUBJECT DEVICE) WAS REMOVED FROM THE PATIENT IN THE MICROCATHETER. THE OTHER DISTAL PART OF THE STENT TINES (SUBJECT DEVICE) WERE LEFT IN THE PATIENT AND COVERED WITH THE SECOND STENT. BASED ON PHYSICIAN¿S OPINION, RESHEATHING WAS CAUSED THE STENT (SUBJECT DEVICE) TO BE FRACTURED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11935743 ↗
• MalfunctionMay 13, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE STENT WAS NOT VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605737 ↗
• MalfunctionApr 30, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE STENT (SUBJECT DEVICE) THROUGH A MICROCATHETER, THE STENT PREMATURELY DISCONNECTED FROM THE DELIVERY WIRE WITHIN THE MICROCATHETER. THE STENT AND MICROCATHETER WERE REMOVED AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8567575 ↗
• MalfunctionDec 4, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE STENT DELIVERY WIRE (SDW) WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131754 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS SUCCESSFULLY TREATED BY STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM LOCATED AT THE BASILAR APEX. MORE THAN 8 MONTH-POST-PROCEDURE, THE PATIENT SUFFERED RIGHT-SIDED WEAKNESS. THE ISSUE IS ONGOING. MEDICATION WAS REQUIRED. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE RIGHT-SIDED WEAKNESS WAS RELATED TO THE PROCEDURE AND TO THE ATLAS STENTS (SUBJECT DEVICE). ACCORDING TO THE SITE, THE RIGHT-SIDED WEAKNESS WAS RELATED TO PRE-EXISTING CONDITION/CO-MORBIDITY WITH A LARGE BASILAR ANEURYSM SWELLING, CAUSING PRESSURE ON BRAINSTEM PER SITE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7704660 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS SUCCESSFULLY TREATED BY STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM LOCATED AT THE BASILAR APEX. MORE THAN 8 MONTH-POST-PROCEDURE, THE PATIENT SUFFERED RIGHT-SIDED WEAKNESS. THE ISSUE IS ONGOING. MEDICATION WAS REQUIRED. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE RIGHT-SIDED WEAKNESS WAS RELATED TO THE PROCEDURE AND TO THE ATLAS STENTS (SUBJECT DEVICE). ACCORDING TO THE SITE, THE RIGHT-SIDED WEAKNESS WAS RELATED TO PRE-EXISTING CONDITION/CO-MORBIDITY WITH A LARGE BASILAR ANEURYSM SWELLING, CAUSING PRESSURE ON BRAINSTEM PER SITE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7704657 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED (Y-STENTING) COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM LOCATED ON THE BASILAR APEX. APPROXIMATELY 8 MONTH-POST-PROCEDURE, RE- INTERVENTION TO TARGET ANEURYSM WAS UNDERTAKEN. THE EVENT WAS RESOLVED WITH NO RESIDUAL EFFECTS. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE RE-TREATMENT WAS RELATED TO THE PROCEDURE, RELATED TO THE ATLAS STENTS (SUBJECT DEVICES), AND NOT RELATED TO THE COIL MASS. PER SITE, THE REASON FOR THE RE-INTERVENTION WAS A LARGE, EXPANDING BASILAR ANEURYSM WITH COMPRESSION ON THE BRAINSTEM CAUSING SYMPTOMS. ANEURYSM CONTINUED TO EXPAND DESPITE ATLAS STENTING AND COILING.

  Patient problems: Neurological Deficit/Dysfunction; No Known Impact Or Consequence To Patient

  MAUDE report 7676264 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED (Y-STENTING) COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM LOCATED ON THE BASILAR APEX. APPROXIMATELY 8 MONTH-POST-PROCEDURE, RE- INTERVENTION TO TARGET ANEURYSM WAS UNDERTAKEN. THE EVENT WAS RESOLVED WITH NO RESIDUAL EFFECTS. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE RE-TREATMENT WAS RELATED TO THE PROCEDURE, RELATED TO THE ATLAS STENTS (SUBJECT DEVICES), AND NOT RELATED TO THE COIL MASS. PER SITE, THE REASON FOR THE RE-INTERVENTION WAS A LARGE, EXPANDING BASILAR ANEURYSM WITH COMPRESSION ON THE BRAINSTEM CAUSING SYMPTOMS. ANEURYSM CONTINUED TO EXPAND DESPITE ATLAS STENTING AND COILING.

  Patient problems: Neurological Deficit/Dysfunction; No Known Impact Or Consequence To Patient

  MAUDE report 7676263 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION FOR AN UNRUPTURED ANEURYSM LOCATED ON THE BASILAR APEX ARTERY WITH 2 STENTS (SUBJECT DEVICE). POST-PROCEDURE THE PATIENT WAS ASSESSED HAVING A MRS AND NIHSS OF 0. AT THE 2 AND 6-MONTH FOLLOW-UP, THE PATIENT WAS ASSESSED HAVING A MRS AND NIHSS OF 0. IT WAS REPORTED THAT 7-MONTH POST-PROCEDURE, THE PATIENT EXPERIENCED 3 EPISODES OF OPHTHALMIC MIGRAINE OVER A PERIOD OF APPROXIMATELY 2 MONTHS. THE PATIENT WAS TREATED WITH MEDICATION AND THE MIGRAINE EPISODES WERE RESOLVED NO RESIDUAL EFFECTS. ACCORDING TO THE PHYSICIAN, THE ADVERSE EVENT OF MIGRAINE WAS POSSIBLY RELATED TO THE PROCEDURE, THE 2 STENTS, AND THE IMPLANTED COIL MASS. THIS REPORTS CONCERNS THE FIRST STENT.

  Patient problems: Headache

  MAUDE report 7648156 ↗