Comaneci 17 ANPP7199Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290015107150), received between Aug 12, 2021 and Mar 27, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. A 58-YEAR-OLD FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, HYPONATREMIA, TOBACCO ABUSE DISORDER, AND PREVIOUS ANEURYSMS, WAS TREATED WITH THE COMANECI 17 (L-MCA ANEURYSM). SUBJECT TOLERATED THE PROCEDURE BUT SHORTLY AFTER DEVELOPED RIGHT SIDED WEAKNESS, NEGLECT, INCOMPREHENSIBLE SPEECH (NIHSS 20). CT HEAD W/O CONTRAST NEGATIVE FOR ACUTE INTRACRANIAL ABNORMALITIES. SUBJECT WAS TAKEN BACK TO THE IR SUITE FOR A CEREBRAL ANGIOGRAM WHICH DEMONSTRATED DISTAL OCCLUSIONS, AGRRASTAT WAS INJECTED. S/P INJECTION PATIENT ABLE TO MOVE RIGHT SIDE, ALERT AND ORIENTED TO PERSON, ABLE TO SPEAK AND ANSWER QUESTIONS WITH SOME APHASIA AND DYSARTHRIA NOTED, SHE HAS FACIAL DROOP (NIHSS 8).

  Patient problems: Aneurysm

  MAUDE report 16618081 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. THE PATIENT WAS TREATED FOR RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM COIL EMBOLIZATION WITH THE COMANECI 17 AS COIL EMBOLIZATION ASSIST DEVICE. WHILE PLACING THE EMBOLIZATION COIL INSIDE THE ANEURYSM, THE PHYSICIAN NOTICED A THROMBUS FORMING WITHIN THE COMANECI STENT. THE PHYSICIAN STOPPED THE COILING AND REMOVED THE COMANECI AND THE MICROCATHETERS FROM THE PATIENT'S ANATOMY. A FOLLOW UP CONTRAST RUN STILL SHOWED SOME SLOW FILLING OF THE DISTAL RIGHT M3/M4 BRANCHES. THEREFORE, A MEDICATION WAS ADMINISTRATED, AND A FOLLOW-UP CONTRAST RUN SHOWED NORMAL DISTAL PERFUSION WITHOUT EVIDENCE OF DISTAL THROMBOEMBOLISM. A NEUROLOGICAL EXAM WAS PERFORMED 19 DAYS POST PROCEDURE, THE PATIENT WAS CLINICALLY ASYMPTOMATIC AND HAD NO CLINICAL SEQUELAE, MRS SCORE WAS 0.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16085542 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENT WAS REPORTED THROUGHOUT THE SUCCESS POST MARKET SURVEILLANCE STUDY. THE PATIENT WAS TREATED FOR RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM COIL EMBOLIZATION WITH THE COMANECI 17 AS COIL EMBOLIZATION ASSIST DEVICE. WHILE PLACING THE EMBOLIZATION COIL INSIDE THE ANEURYSM THE PHYSICIAN NOTICED A THROMBUS FORMING WITHIN THE COMANECI STENT. THE PHYSICIAN STOPPED THE COILING AND REMOVED THE COMANECI AND THE MICROCATHETERS FROM THE PATIENT'S ANATOMY. A FOLLOW UP CONTRAST RUN STILL SHOWED SOME SLOW FILLING OF THE DISTAL RIGHT M3/M4 BRANCHES, THEREFORE, A MEDICATION WAS ADMINISTRATED, AND A FOLLOW UP CONTRAST RUN SHOWED NORMAL DISTAL PERFUSION WITHOUT EVIDENCE OF DISTAL THROMBOEMBOLISM. A NEUROLOGICAL EXAM WAS PERFORMED 19 DAYS POST PROCEDURE, THE PATIENT WAS CLINICALLY ASYMPTOMATIC AND HAD NO CLINICAL SEQUELAE, MRS SCORE WAS 0.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16085192 ↗
• InjuryNov 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING SUBMISSION OF THE SUCCESS POST MARKET SURVEILLANCE STUDY SEMI-ANNUAL PROGRESS REPORT, THE COMPANY BECAME AWARE THAT A CASE WHERE A 56 YEAR OLD FEMALE THAT WAS TREATED WITH COMANECI 17 WAS CHARACTERIZED BY THE STUDY INDEPENDENT DATA SAFETY MONITORING BOARD (DSMB) AS A DEVICE-RELATED EVENT. THE PATIENT WAS DIAGNOSED WITH INCIDENTAL RICA TERMINUS ANEURYSM AND PRESENTED FOR ELECTIVE COIL EMBOLIZATION ON (B)(6) 2022. THE ANGIOGRAPHIC STUDY DEMONSTRATES A BI-LOBED RIGHT ICA TERMINUS ANEURYSM THAT MEASURED 6.1 X 7.1 X 6.0 MM WITH A 4.0 MM NECK. DURING THE EMBOLIZATION, THE COMANECI DEVICE WAS OPENED AND CLOSED AS NEEDED TO ASSURE PROPER COIL PLACEMENT. INTERMITTENT DSA WAS PERFORMED DEMONSTRATING PROGRESSIVE OCCLUSION OF THE ANEURYSM. AFTER PLACEMENT OF THE LAST COIL, THE MICROWIRE WAS RE-INSERTED AND THE MICROCATHETER WAS REMOVED FROM THE ANEURYSM WITHOUT COMPLICATION. WHEN THE COMANECI DEVICE WAS DEFLATED FOR THE FINAL TIME A COIL LOOP PROTRUDED FROM THE ANEURYSM AND THEN BECAME ATTACHED TO THE DEVICE. THE PHYSICIAN ATTEMPTED TO INSERT A TRANSFORM BALLOON IN ORDER TO OCCLUDE THE ANEURYSM NECK WHILE THE LAST COIL WAS BEING PULLED OUT OF THE ANEURYSM TO PROTECT THE FIRST 2 COILS

  Patient problems: Aneurysm

  MAUDE report 15741167 ↗
• InjuryNov 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING SUBMISSION OF THE SUCCESS POST MARKET SURVEILLANCE STUDY SEMI-ANNUAL PROGRESS REPORT, THE COMPANY BECAME AWARE THAT A CASE OF A 56 YEAR OLD FEMALE THAT WAS TREATED WITH COMANECI 17 WAS CHARACTERIZED BY THE STUDY INDEPENDENT DATA SAFETY MONITORING BOARD (DSMB) AS A DEVICE-RELATED EVENT. THE PATIENT WAS DIAGNOSED WITH INCIDENTAL R ICA TERMINUS ANEURYSM AND PRESENTED FOR ELECTIVE COIL EMBOLIZATION ON 4 AUGUST 2022. THE ANGIOGRAPHIC STUDY DEMONSTRATES A BILOBED RIGHT ICA TERMINUS ANEURYSM THAT MEASURES 6.1 X 7.1 X 6.0 MM WITH A 4.0 MM NECK. DURING THE EMBOLIZATION, THE COMANECI DEVICE WAS OPENED AND CLOSED AS NEEDED TO ASSURE PROPER COIL PLACEMENT. INTERMITTENT DSA WAS PERFORMED DEMONSTRATING PROGRESSIVE OCCLUSION OF THE ANEURYSM. AFTER PLACEMENT OF THE LAST COIL, THE MICROWIRE WAS RE-INSERTED AND THE MICROCATHETER WAS REMOVED FROM THE ANEURYSM WITHOUT COMPLICATION. WHEN THE COMANECI DEVICE WAS DEFLATED FOR THE FINAL TIME A COIL LOOP PROTRUDED FROM THE ANEURYSM AND THEN BECAME ATTACHED TO THE DEVICE. THE PHYSICIAN ATTEMPTED TO INSERT A TRANSFORM BALLOON IN ORDER TO OCCLUDE THE ANEURYSM NECK WHILE THE LAST COIL WAS BEING PULLED OUT OF THE ANEURYSM TO PROTECT THE FIRST 2 COILS

  Patient problems: Aneurysm

  MAUDE report 15741161 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A WIDE-NECKED BASILAR TIP ANEURYSM, THE COMANECI 17 WAS PROTRUDED INTO THE ANEURYSM COIL MASS AS IT WAS BEING WITHDRAWN. AFTER MULTIPLE MANIPULATIONS THE PHYSICIAN WITHDREW THE DEVICE AND COMPLETED THE ANEURYSM COILING PROCEDURE, HOWEVER ONE COIL REMAINED HERNIATED INTO THE PARENT ARTERY. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL CONSEQUENCE. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12337259 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A WIDE-NECKED BASILAR TIP ANEURYSM, THE COMANECI 17 WAS PROTRUDED INTO THE ANEURYSM COIL MASS AS IT WAS BEING WITHDRAWN. AFTER MULTIPLE MANIPULATIONS THE PHYSICIAN WITHDREW THE DEVICE AND COMPLETED THE ANEURYSM COILING PROCEDURE, HOWEVER ONE COIL REMAINED HERNIATED INTO THE PARENT ARTERY. THERE WAS NO REPORTED PATIENT INJURY OR CLINICAL CONSEQUENCE. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12312394 ↗