Neuroform Atlas M003SZAS40210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252656197), received between Nov 19, 2018 and Nov 29, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A CLINICAL TRIAL THE PATIENT SUFFERED A CEREBRAL ANEURYSM RUPTURE 10 MONTHS POST PROCEDURE WITH RELATION TO THE SUBJECT STENT PER CLINICAL ENDPOINT COMMITTEES (CEC). THE PATIENT WAS HOSPITALIZED AND GIVEN MEDICATION FOR TREATMENT. THE EVENT RESOLVED WITH NO EFFECTS TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 12886713 ↗
• MalfunctionJul 30, 2021Fracture; Fracture

  THE SUBJECT STENT WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE STENT DELIVERY WIRE WAS BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250833 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 YEARS 5 MONTHS POST IMPLANTATION OF THE STENT (SUBJECT DEVICE) THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) AT THE POSTERIOR BASILAR APEX ARTERY ON (B)(6) 2020. THE TIA WAS RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2020. THE PHYSICIAN STATED THAT THE TIA HAD A POSSIBLE RELATION TO THE IMPLANTED SUBJECT DEVICE AND CONFIRMED THAT THE PATIENT WAS NONCOMPLIANT WITH ASA MEDICATION REGIMEN. THE PATIENT RESTARTED ASA MEDICATION REGIMEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Transient Ischemic Attack

  MAUDE report 11208036 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 12 MONTH-FOLLOW-UP A SUCCESSFUL STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT LEFT OCCLUDED "CULPRIT" ARTERY (OCA) WAS NONDOMINANT AND APPEARS OCCLUDED INTRASTENT (100%). LARGE PATENT LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) SUPPLIES LEFT POSTERIOR CEREBRAL ARTERY (PCA) TERRITORY BASILAR ARTERY AND RIGHT PCA STENTS (SUBJECT DEVICE) ARE PATENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Stenosis

  MAUDE report 8147939 ↗
• MalfunctionNov 19, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED; HOWEVER, THE MICROCATHETER SLIPPED BACK TO A POSITION NOT SUITABLE FOR IMPLANTING. THE PHYSICIAN WAS ABLE TO PULL BACK THE MICROCATHETER AND PARTIALLY DEPLOYED STENT INTO THE INTERMEDIATE SUPPORT MICROCATHETER AND BOTH PRODUCTS WERE REMOVED FROM THE PATIENT¿S BODY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087150 ↗