MICRUSFRAMERecalls & reported problems across all models

We found 47 models of MICRUSFRAME by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 298 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2017 and Mar 24, 2026 — classified as 60 injuries, 238 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (60 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MICRUSFRAME problems

MICRUSFRAME models

47 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MICRUSFRAME MFR180830

  Device, Vascular, for Promoting Embolization
  23 reports
• MICRUSFRAME MFR100626

  DEVICE, NEUROVASCULAR EMBOLIZATION
  22 reports
• MICRUSFRAME MFR181240

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• MICRUSFRAME MFR181034

  DEVICE, NEUROVASCULAR EMBOLIZATION
  15 reports
• MICRUSFRAME MFR100517

  Device, Vascular, for Promoting Embolization
  12 reports
• MICRUSFRAME MFR140306

  Device, Vascular, for Promoting Embolization
  12 reports
• MICRUSFRAME MFR100412

  DEVICE, NEUROVASCULAR EMBOLIZATION
  11 reports
• MICRUSFRAME MFR100509

  DEVICE, NEUROVASCULAR EMBOLIZATION
  11 reports
• MICRUSFRAME MFR100730

  DEVICE, NEUROVASCULAR EMBOLIZATION
  10 reports
• MICRUSFRAME MFR140512

  DEVICE, NEUROVASCULAR EMBOLIZATION
  10 reports
• MICRUSFRAME MFR181137

  Device, Vascular, for Promoting Embolization
  10 reports
• MICRUSFRAME MFR181447

  Device, Vascular, for Promoting Embolization
  10 reports
• MICRUSFRAME MFR100407

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• MICRUSFRAME MFR100356

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• MICRUSFRAME MFR100305

  Device, Vascular, for Promoting Embolization
  7 reports
• MICRUSFRAME MFR100611

  Device, Vascular, for Promoting Embolization
  7 reports
• MICRUSFRAME MFR140408

  Device, Vascular, for Promoting Embolization
  7 reports
• MICRUSFRAME MFR100253

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• MICRUSFRAME MFR100829

  Device, Vascular, for Promoting Embolization
  6 reports
• MICRUSFRAME MFR181647

  Device, Vascular, for Promoting Embolization
  6 reports
• MICRUSFRAME MFR182050

  Device, Vascular, for Promoting Embolization
  6 reports
• MICRUSFRAME MFR180933

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• MICRUSFRAME MFR100713

  Device, Vascular, for Promoting Embolization
  5 reports
• MICRUSFRAME MFR140615

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• MICRUSFRAME MFR140820

  Device, Vascular, for Promoting Embolization
  5 reports
• MICRUSFRAME MFR181846

  Device, Vascular, for Promoting Embolization
  5 reports
• MICRUSFRAME MFR180612

  Device, Vascular, for Promoting Embolization
  5 reports
• MICRUSFRAME MFR140717

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• MICRUSFRAME MFR100202

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSFRAME MFR141025

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSFRAME MFR140922

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• MICRUSFRAME MFR181950

  Device, Vascular, for Promoting Embolization
  3 reports
• MICRUSFRAME MFR140225

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR180813

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR181118

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR181220

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR181550

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR180915

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• MICRUSFRAME MFR140711

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR140914

  Device, Vascular, for Promoting Embolization
  2 reports
• MICRUSFRAME MFR100816

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSFRAME MFR141230

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MICRUSFRAME MFR140304

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSFRAME MFR140406

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• MICRUSFRAME MFR181343

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSFRAME MFR181750

  Device, Vascular, for Promoting Embolization
  1 report
• MICRUSFRAME MFR180714

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent MICRUSFRAME adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Separation Failure

  ON (B)(6) 2026, DURING A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) TARGETING THE GASTRIC VEIN, DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS). THE BRTO WAS CONDUCTED USING A SYSTEM CONSISTING OF A 4FR ANGIOGRAPHIC CATHETER AND THE LEONISMOVA MICROCATHETER. THE GASTRIC VEIN WAS LOOSELY PACKED USING MEDICOS HIRATA COILS DELIVERED WITH THE ¿LEONIS HF.¿ OLDAMIN (UNSPECIFIED DOSAGE) WAS INJECTED, AND ADDITIONAL LOOSE PACKING OF THE PROXIMAL PORTION WAS PLANNED WITH CERENOVUS COILS. THE FIRST COIL WAS A 20MM X 50CM MICRUSFRAME 18 (MFR182050 / 3072525S), AND IT WAS USED AS ANCHOR. PRE-DEPLOYMENT ELECTRICAL CONTINUITY WAS CHECKED, AND AN ATTEMPT WAS MADE TO DETACH THE COIL. IT WAS REPORTED THAT, ¿ALTHOUGH THE USUAL DETACHMENT SOUND WAS HEARD, THE COIL DID NOT DETACH. WHEN THE CABLE WAS RECONNECTED, THE INDICATOR LIGHT DID NOT TURN ON, AND THE DETACHMENT BUTTON COULD NOT BE PRESSED. SINCE THE ISSUE WAS SUSPECTED TO BE ON THE CABLE SIDE, THE [ENPOWER CONTROL CABLE (ECB00018200 / 31127206)] WAS REPLACED, AND DETACHMENT WAS ATTEMPTED AGAIN. AS WITH THE FIRST ATTEMPT, THE INDICATOR LIGHT TURNED ON, AND THE DETACHMENT SOUND WAS HEARD WHEN THE BUTTON WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678333 ↗
• MalfunctionMar 19, 2026Retraction Problem; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING TWO BRONCHIAL ARTERY ANEURYSM, THE DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). AN APPROACH WAS MADE TO THE BRONCHIAL ARTERY USING A 5 FR ANGIOGRAPHIC CATHETER AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC). AFTER THE SYSTEM REACHED THE TARGET LESION, THE OUTFLOW TRACT OF THE ANEURYSM WAS EMBOLIZED WITH PUSHABLE COILS, THE EMBOLIZATION OF THE ANEURYSM ITSELF WAS INITIATED. AFTER IMPLANTING TWO 7 MM GALAXY G3 COILS, THE 6MM X 20CM GALAXY G3 (GLY120620 / 1682522S) WAS USED. IT WAS REPORTED THAT WHILE INSERTING THE GALAXY G3 COIL INTO THE MICROCATHETER, THE ANGIOGRAPHIC CATHETER DISLODGED FROM THE BRONCHIAL ARTERY. DURING THE ATTEMPT TO RESHEATH THE GALAXY G3 COIL IN ORDER TO RE-ENGAGE THE ANGIOGRAPHIC CATHETER, THE SHEATH BECAME MISALIGNED AND THE GALAXY G3 COULD NO LONGER BE REUSED. THE GALAXY G3 WAS REPLACED WITH NEW COIL. TWO ADDITIONAL COILS WERE PLACED, COMPLETING THE EMBOLIZATION OF THE FIRST BRONCHIAL ARTERY ANEURYSM. THE PROCEDURE THEN PROCEEDED TO THE SECOND ANEURYSM. THE 8MM X 30CM MICRUSFRAME 18 (MFR180830 / 2612528S) WAS THE FIRST COIL USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646186 ↗
• MalfunctionMar 18, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY PERFORMED DURING STENT GRAFT IMPLANTATION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DEVICES WERE USED ACCORDING TO THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). EMBOLIZATION OF THE INTERNAL ILIAC ARTERY WAS CONDUCTED USING A SYSTEM CONSISTING OF A 4 FR ANGIOGRAPHIC CATHETER AND THE COIL SUPPORT (MEDICOS HIRATA). THE 10MM X 34CM MICRUSFRAME 18 (MFR181034 / 2232569S) WAS USED AS THE FIRST COIL, SERVED AS AN ANCHOR FOR THE SUPERIOR GLUTEAL ARTERY. AFTER COILING AT THE TARGET SITE, DETACHMENT OF THE 10MM X 34CM MICRUSFRAME 18 COIL WAS ATTEMPTED, BUT THE COIL COULD NOT BE DETACHED. THE COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SPECIFICATION. THE REPLACEMENT COIL WAS SUCCESSFULLY DETACHED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. NO INDICATOR LIGHTS ON THE CONTROLLER BOX ILLUMINATED TO INDICATE ANY ABNORMALITY. THE REPORTED ISSUE DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634810 ↗
• MalfunctionDec 22, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY IN TREATING AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE REPORTEDLY USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE EMBOLIZATION OF THE INTERNAL ILIAC ARTERY WAS PERFORMED USING A 4F ANGIOGRAPHIC CATHETER (MEDICOS HIRATA); AFTER APPROACHING THE INTERNAL ILIAC ARTERY, THE 8MM X 30CM MICRUSFRAME 18 (MFR180830 / 0972519S) WAS USED AS AN ANCHOR. THE FOLLOWING WAS REPORTED, ¿AFTER CONFIRMING THAT THE COIL HAD BEEN WOUND WITHOUT PROBLEMS, [AN ATTEMPT] TO DETACH [WAS MADE], BUT [IT COULD NOT].¿ SEVERAL ATTEMPTS WERE MADE, AND EVEN THOUGH THE POWER INDICATOR ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD, THE COIL DID NOT DETACH. THE COIL WAS REPLACED WITH ANOTHER 8MM X 30CM MICRUSFRAME 18 (MFR180830) AND THE REPLACEMENT COIL DETACHED WITHOUT NEEDING TO REPLACE THE CABLE OR THE BOX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865841 ↗
• MalfunctionNov 17, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE MICRUSFRAME10 7MM X 30CM (MFR100730/ 31188535) COILS COULD NOT BE INTRODUCED INTO MICROCATHETER. MICROCATHETER WAS SAVED AND IS AVAILABLE FOR RETURN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER CNV COILS. NO PATIENT HARM. ADDITIONAL EVENT INFORMATION STATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE WAS CHECKED BEFORE INTRODUCTION INTO PATIENT, COIL COULD NOT BE PUSHED OUT OF INTRODUCER SHEATH BECAUSE RESISTANCE WAS FELT. A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT, BUT COMPLAINT HAPPENED BEFORE INTRODUCTION INTO MICROCATHETER (MC). THEY COULD NOT BE PUSHED OUT OF INTRODUCER SHEATH TO BE INSPECTED BEFORE USE IN PATIENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570333 ↗
• MalfunctionAug 6, 2025Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), A MICRUSFRAME10 4MM X 11.5CM COIL (MFR100412, 0552501S) WAS RELEASED WITH DIFFICULTY FROM THE SHEATH, SEEMINGLY RUBBING. IT CANNOT BE FULLY DEPLOYED, AND IT WAS WITHDRAWN. NO HARM WAS CAUSED TO THE PATIENT. THE SURGERY WAS DELAYED BY TWO MINUTES. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 18-JUL-2025 INDICATING THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE COIL WAS NOT INSERTED INTO THE PATIENT WITH DIFFICULTY. IT WAS CONFIRMED THAT THE COIL ATTEMPTED TO BE DETACHED BUT FAILED. A PHENON 17 MICROCATHETER WAS USED. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THERE WAS NOTHING SPECIAL ABOUT THE PATIENT ANATOMY OR VESSEL CHARACTERISTICS. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. A CONTINUOUS FLUSH WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727766 ↗
• MalfunctionJul 16, 2025Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A SPLENIC ARTERY ANEURYSM, DEVICES WERE ALL USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). IT WAS REPORTED THAT AFTER THE APPROACH TO THE SPLENIC ARTERY ANEURYSM WAS MADE WITH THE PARENT PLUS 30® GUIDE SHEATH (MEDIKIT), 5F ANGIOGRAPHIC CATHETER (UNSPECIFIED BRAND), AND AN ECHELON® MICROCATHETER (MEDTRONIC), THE FIRST 16MM X 47CM MICRUSFRAME 18 (MFR181647 / 31168434) WAS INSERTED VIA THE ECHELON MICROCATHETER. DUE TO THE IRREGULAR SHAPE OF THE ANEURYSM, THE COILING WAS UNSUCCESSFUL, AND THE COIL WAS RETRIEVED AND RE-WINDED SEVERAL TIMES. THE PHYSICIAN FELT INCREASED RESISTANCE INSIDE THE MICROCATHETER EACH TIME THE COIL WAS INSERTED AND REMOVED. DURING THE INSERTION AND REMOVAL, THE SHEATH WAS DAMAGED, SO THE COIL WAS REPLACED WITH A SECOND 16MM X 47CM MICRUSFRAME 18 (MFR181647 / 31168434). SIMILAR TO THE FIRST 16MM X 47CM MICRUSFRAME 18 COIL, THE SECOND COIL ALSO GRADUALLY ENCOUNTERED INCREASED RESISTANCE INSIDE THE MICROCATHETER, AND ULTIMATELY, UPON RETRIEVAL OF THE COIL, AN UNRAVELING WAS CONFIRMED, LEADING TO THE DECISION TO ABANDON ITS USE. DUE TO A SHORTAGE OF STOCK IN 16MM X

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521781 ↗
• MalfunctionJul 8, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  THE HEALTHCARE PROFESSIONAL REPORTED AN ISSUE WITH TWO (2) COILS: A 4MM X 11.5CM MICRUSFRAME 10 (MFR100412 / 31073024) AND A 7MM X 30CM MICRUSFRAME 10 (MFR100730 / 30762308) THAT COULD NOT BE REMOVED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE. IT WAS REPORTED THAT ADDITIONAL INFORMATION RELATED TO THE COMPLAINT IS NOT AVAILABLE. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSES. THE PRODUCT INVESTIGATIONS WERE COMPLETED ON 08-JUL-2025. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THE PRODUCT INVESTIGATION RELATED TO THE 4MM X 11.5CM MICRUSFRAME 10 (MFR100412 / 31073024) MEETS REPORTABILITY CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22449360 ↗
• MalfunctionMar 19, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE TARGET LESION AS APPROACHED USING A PARENT PLUS® GUIDE SHEATH (MEDIKIT) AND DOUBLE CATHETERS LANTERN® DELIVERY MICROCATHETER (PENUMBRA) AND LIGHTHOUSE MICROCATHETER (PIOLAX MEDICAL DEVICES). THE TWO MICROCATHETERS WERE ADVANCED INSIDE THE ANEURYSM. WHEN THE 20MM X 50CM MICRUSFRAME 18 (MFR182050 / 31168439) WAS CHOSEN TO BE USED AS A FRAMING COIL VIA THE LIGHTHOUSE MICROCATHETER, RESISTANCE WAS FELT INSIDE THE MICROCATHETER, AND THE COIL COULD NOT BE ADVANCED. CONTINUOUS FLUSH WAS MAINTAINED. THE COIL WAS RETRIEVED AND OBSERVED TO HAVE UNRAVELED. IT WAS REPLACED WITH ANOTHER CERENOVUS COIL OF THE SAME SIZE, WHICH WAS USED WITHOUT ANY ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 11-MAR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE COIL WAS WITHDRAWN ONCE AND WAS NOT REPOSITIONED. PRIOR TO THIS COIL, NO OTHER COIL WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE REPORTED ISSUE OCCURRED DURING INSERTION THROUGH THE MICROCATHETER, BEFORE EXITING THE MICROCATHETER. PER THE INFORMATION, THE MICROCATHETER WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643814 ↗
• MalfunctionMar 4, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING A SPLENIC ARTERY ANEURYSM VIA DOUBLE CATHETER TECHNIQUE, ALL DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). TWO (2) MICROCATHETERS, A LEONIS MOVA¿ MICROCATHETER (SUMIMOTO BAKELITE) AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC) WERE ADVANCED TO THE TARGET LESION USING THE PARENT PLUS® GUIDE SHEATH (MEDIKIT) AND A 5FR ANGIOGRAPHY CATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT ¿DUE TO THE DEFORMED SHAPE OF THE ANEURYSM,¿ A 12MM X 40CM MICRUSFRAME 18 (MFR181240 / 31168427) WAS USED THROUGH THE LEONIS MOVA¿ MICROCATHETER AND THE MICRUSFRAME S THROUGH THE BREAKTHROUGH¿ MICROCATHETER. THE 12MM X 40CM MICRUSFRAME 18 COIL INSERTED THROUGH THE LEONIS MOVA DID NOT HAVE GOOD ENGAGEMENT, THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL INTO THE MICROCATHETER FOR REPOSITION. DURING THE RESHEATHING ATTEMPT, THERE WAS NO RESISTANCE, ¿BUT A SENSATION OF ¿SNAPPING¿ WAS FELT MIDWAY. AFTER REMOVAL WITH THE MICROCATHETER, IT WAS FOUND THAT THE COIL HAD SEPARATED AT THE DETACHMENT POINT, AND THE DETACHED COIL WAS RECOVERED FROM WITHIN THE MICROCATHETER. UNRAVEL WAS NOT OBSERVED ON THE RECOVERED C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521111 ↗
• InjuryFeb 3, 2025Stretched; Positioning Problem; Stretched; Positioning Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A MICRUSFRAME18 6MM X 12.2CM (MFR180612/ 30751838) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY. IT WAS DISCLOSED THAT ¿THE VESSEL LEADING UP TO THE ANEURYSM NECK WAS VERY DYSPLASTIC (ALMOST BALLOON LIKE).¿ DURING THE PROCEDURE, THE USER REPORTED DIFFICULTY POSITIONING THE COIL AND COIL -UNRAVELING/STRETCHED DURING PLACEMENT. THE PHYSICIAN THEN CUT THE PROXIMAL PORTION OF THE MICROCATHETER (EXCELSIOR SL-10 MICROCATHETER; STRYKER) AND REMOVED THE COIL AND THE SEPARATED PORTION OF THE MICROCATHETER BY DEPLOYING A MICRO-SNARE. THE PHYSICIAN THEN DEPLOYED A MICRUSFRAME 10 5MM X 9.7CM SUCCESSFULLY ALONG WITH SUBSEQUENT MICROVENTION COILS TO A SATISFACTORY RESULT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES OCCURRED. NO DEVICE FRAGMENTS WERE GENERATED FROM THE EVENT. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. IT WAS FURTHER NOTED, ¿AFTER THE CASE THE PHYSICIAN NOTED THAT HE DIDN'T FEEL THAT THE COIL WAS AT FAULT FOR THE STRETCHING, AND IT WAS DUE TO ¿OVER-MANIPULATION¿ BY HIM IN TRYING TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293820 ↗
• MalfunctionSep 12, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A MICRUSFRAME10 8MM X 29CM (MFR100829/ 30762310) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE COIL WAS IMPEDED IN THE MICROCATHETER WITH NO LOSS OF CEREBRAL TARGET POSITION. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿WHEN THE FIRST COIL WAS FORTIFIED, THE MC COULD NOT BE INSERTED.¿ ON 13-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL. SUMMARY: PER THE INFORMATION, THE EVENT DATE/PROCEDURE DATE WAS (B)(6) 2024. IT WAS CONFIRMED THE REPORTED EVENT REFERS TO A COIL THAT COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE MICROCATHETER USED WAS AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). REGARDING IF THE EVENT RESULTED IN ANY UNDUE PROCEDURAL DELAY OR CONSEQUENCE THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS STATED, ¿THE PATIENT UNDERWENT ANEURYSM EMBOLIZATION DUE TO A RUPTURED AND BLEEDING ANEURYSM. HOWEVER, CONTINUOUS COIL DEFECTS OCCURRED, CAUSING A DELAY OF APPROXIMATELY TEN MINUTES DURING THE REPLACEMENT PROCESS, WHICH MAY HAVE LED TO FURTHER BLEEDING.¿ REGARDING IF OTHER DEVICES WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER PRIOR TO OR AFTER THE ENCOUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202643 ↗
• MalfunctionAug 23, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER THE INTRODUCTION OF THE COIL, A 7MM X 11CM MICRUSFRAME 14 (MFR140711 / 31136249), IT COULD NOT BE RELEASED. IT WAS REPORTED THAT THE PHYSICIAN WANTED TO PULL THE COIL OUT OF THE ANEURYSM, BUT IT BECAME PREMATURELY DETACHED. THE PROCEDURE WAS DELAYED BY 20 MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053413 ↗
• InjuryAug 5, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, ¿MATERIAL FAILS TO PASS THROUGH THE MICROCATHETER.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. PER THE SOURCE FILE INCLUDED IN THE COMPLAINT ON 18-JUL-2024, THE PATIENT UNDERWENT THE PROCEDURE AT SAN JOSÉ CHILDREN'S HOSPITAL ON (B)(6) 2024, IN THE MORNING HOURS, FOR AN EMBOLIZATION OF AN ANEURYSM IN THE BASILAR ARTERY. THE PHYSICIANS ACCESSED THE TARGET ANEURYSM USING AN ENVOY DA GUIDE CATHETER (CATALOG / LOT# UNKNOWN) AND THE PROWLER SELECT LPES MICROCATHETER (606S155X / LOT# UNKNOWN) FOR THE DELIVERY OF THE COILS. FOR THIS PROCEDURE, APPROXIMATELY 6 ¿ 7 COILS WERE REQUIRED, OF WHICH, 2 WERE CERENOVUS COILS: ONE OF THE COILS, A 6MM X 26CM MICRUSFRAME 10 (MFR100626 / 31071519) COULD NOT PASS THROUGH THE MICROCATHETER. PER THE SOURCE FILE, DURING THE PROCEDURE, OTHER COMPETITOR COILS WERE INTRODUCED AND PASSED THROUGH THE MICROCATHETER WITHOUT ANY ISSUE. ON 22-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS AN 18-YEAR-OLD FEMALE WITH A HISTORY OF ANEURYSM. THE PROCEDURE WAS TARGETING A LARGE FUSIFORM ANEURYSM ON THE ¿VASCULAR ARTERY, LEAVING THE PICA B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908007 ↗
• MalfunctionJul 24, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A CEREBRAL ANEURYSM, THREE COILS WERE USED: A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30692213), A 3MM X 6CM GALAXY G3 (GLY120306 / 30618612), AND A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / 30396193). IT WAS REPORTED THAT THE TWO GALAXY G3 COILS ENCOUNTERED FRICTION AND COULD NOT BE RE-SHEATHED. THE MICRUSFRAME COIL ¿DID NOT SLIDE INTO THE CATHETER WITH TOO MUCH FRICTION AND DID NOT GO INTO THE MICROCATHETER.¿ IT WAS REPORTED THAT ¿ANOTHER COIL WAS USED PERFECTLY WITH NO FRICTION NOTICED.¿ THERE WAS NO NEGATIVE PATIENT IMPACT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSES COMPLETED ON 24-JUL-2024, THE MICRUSFRAME COIL WAS OBSERVED KINKED. THIS OBSERVED MALFUNCTION MEETS USFDA REPORTING CRITERIA AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822240 ↗

Other Cerenovus, Inc. products

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• DELTAFILL29 models · 294 reports
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• CEREBASE3 models · 143 reports · 1 recall
• DELTAXSFT13 models · 130 reports
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