Comaneci ANPP7177Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290015107136), received between Jan 28, 2020 and Jul 1, 2024 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS REPORTED IN THE SUCCESS POST-MARKET SURVEILLANCE STUDY INVOLVING A 65-YEAR-OLD MALE WITH A HISTORY OF HYPERTENSION AND MIGRAINES. HE WAS TREATED WITH THE COMANECI AND ATLAS STENT FOR A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED LEFT UPPER EXTREMITY WEAKNESS AND DYSMETRIA, LEADING TO HOSPITAL ADMISSION. AN MRI REVEALED MULTIPLE ACUTE CEREBROVASCULAR ACCIDENT (CVA) AREAS, PREDOMINANTLY IN THE RIGHT BILATERAL WATERSHED DISTRIBUTION. THE PATIENT CONTINUED DUAL ANTIPLATELET THERAPY AND STATIN TREATMENT. NEUROLOGY SUGGESTED A LOOP RECORDER IMPLANT AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR FURTHER EMBOLIC SOURCE EVALUATION. THE PATIENT UNDERWENT LINQ PLACEMENT AND TEE, WHICH SHOWED NO PATHOLOGY TO EXPLAIN THE CVA. CARDIOLOGY RECOMMENDED FOLLOW-UP IN ONE WEEK. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, WITH FOLLOW-UPS SCHEDULED WITH HIS PRIMARY CARE PHYSICIAN AND CARDIOLOGY. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON JUNE 19, 2023.

  Patient problems: Stroke/CVA

  MAUDE report 19641883 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS REPORTED IN THE SUCCESS POST-MARKET SURVEILLANCE STUDY INVOLVING A 65-YEAR-OLD MALE WITH A HISTORY OF HYPERTENSION AND MIGRAINES. HE WAS TREATED WITH THE COMANECI AND ATLAS STENT FOR A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED LEFT UPPER EXTREMITY WEAKNESS AND DYSMETRIA, LEADING TO HOSPITAL ADMISSION. AN MRI REVEALED MULTIPLE ACUTE CEREBROVASCULAR ACCIDENT (CVA) AREAS, PREDOMINANTLY IN THE RIGHT BILATERAL WATERSHED DISTRIBUTION. THE PATIENT CONTINUED DUAL ANTIPLATELET THERAPY AND STATIN TREATMENT. NEUROLOGY SUGGESTED A LOOP RECORDER IMPLANT AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FOR FURTHER EMBOLIC SOURCE EVALUATION. THE PATIENT UNDERWENT LINQ PLACEMENT AND TEE, WHICH SHOWED NO PATHOLOGY TO EXPLAIN THE CVA. CARDIOLOGY RECOMMENDED FOLLOW-UP IN ONE WEEK. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, WITH FOLLOW-UPS SCHEDULED WITH HIS PRIMARY CARE PHYSICIAN AND CARDIOLOGY. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON JUNE 19, 2023.

  Patient problems: Stroke/CVA

  MAUDE report 19641837 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RAPID MEDICAL RECEIVED REPORT THAT COILS GOT TANGLED IN THE COMANECI EMBOLIZATION ASSIST DEVICE. THIS EVENT OCCURRED DURING A COMANECI ASSISTED COILING OF A RIGHT OPHTHALMIC ANEURYSM. THE COMANECI PERFORMED AS INTENDED, HOWEVER, COILS GOT TANGLED IN THE DEVICE. THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO RELEASE THE TANGLED COILS BY OPENING AND CLOSING DEVICE MESH WITHOUT SUCCESS. THEREFORE, LVIS STENT WAS DEPLOYED DISTAL TO THE COMANECI, ONCE THE LVIS STENT WAS PLACED, THE PHYSICIAN CLOSED THE COMANECI MESH AND THE HERNIATED COILS END WERE PRESSED AGAINST THE VESSEL WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE PHYSICIAN RECOGNIZED IT WAS A TECHNICAL ERROR. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Aneurysm

  MAUDE report 9636460 ↗