MICRUSFRAME MFR140914Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704079361), received between Apr 1, 2020 and Dec 27, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR OLD FEMALE PATIENT WITH A HISTORY OF CONGESTIVE HEART FAILURE (CHF), DIABETES, CONTROLLED HYPERTENSION, HYPOTHYROIDISM, GASTROESOPHAGEAL REFLUX DISEASE (GERD), SLEEP APNEA, LIVER CIRRHOSIS, ESOPHAGEAL VARICES, OSTEOPOROSIS, IDIOPATHIC PULMONARY FIBROSIS (IPF), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND CLASS 1 OBESITY (BMI 30 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2021 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. MEDICATION WAS ADMINISTERED AS TREATMENT. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 2, UNCHANGED FROM BASELINE. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE ACOM BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 9.7MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 6.6MM, NECK SIZE 3.6MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 10M

  Patient problems: Thromboembolism

  MAUDE report 13090771 ↗
• InjuryApr 1, 2020Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CARDIAC ARRHYTHMIA, DIABETES, CONTROLLED HYPERLIPIDEMIA, AND CONTROLLED HYPERTENSION, UNDERWENT COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2018 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2019 REQUIRING RETREATMENT ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2018 REVEALED AN ANTERIOR CIRCULATION ANEURYSM ON RIGHT SIDEWALL OF THE POSTERIOR COMMUNICATING ARTERY. THE RUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.3MM, DOME 11.3MM, MAXIMUM ANEURYSM DIAMETER 11.9MM, NECK SIZE 4.4MM, AND DOME-TO-NECK RATIO 2.6MM. PARENT VESSEL DIAMETER WAS 3.9MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 9MM X 14CM MICRUSFRAME C (S11389), ONE 10MM X 30CM GALAXY G3 (L10166), ONE 9MM X 25CM GALAXY G3 (L10165), TWO 5MM X 15CM GALAXY G3 (L12691), TWO 4MM X 10CM GALAXY G3 (L12837), AND ONE 2MM X 6CM GALAXY G3 MINI (L12517) VIA A SL-10 (STRYKER) MICROCATHETER. TWO COILS FAILED TO UNSHEATHE PROPERLY (ONE 2MM X 6CM GALAXY G3 MINI - L12517 AND ONE 10MM X 16CM MICRUSFRAME14 ¿ S11391) AND WERE THEREFORE NOT IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9911113 ↗