ONYX 18 105-7100-060 (UDI 00847536006171)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00847536006171), received between Jun 2, 2017 and Dec 10, 2025 — classified as 1 death, 28 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (5 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, 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Material Deformation; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE, MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS LEFT M4 OCCLUSION. IT WAS REPORTED THAT WHEN DRAWING UP DMSO INTO THE SYRINGE PROVIDED IN THE ONYX KIT, THE LUER-LOCKED SYRINGE WAS ATTACHED TO THE DUO 167 MICROCATHETER, INFUSED DMSO AS USUAL. UPON REMOVING THE DMSO SYRINGE, THE INNER TIP OF THE SYRINGE BROKE OFF AND REMAINED IN THE MICROCATHETER HUB. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. MEDWATCH REPORT (MW5178827) PROVIDED CLARIFICATION OF EVENT DETAILS. IT WAS REPORTED THAT THE ONYX 18 KIT DSMO SYRINGE WAS ATTACHED TO A NON-MEDTRONIC MICROCATHETER, DSMO WAS INJECTED, AND THE DSMO SYRINGE WAS REMOVED. THE ONYX SYRINGE WAS ATTACHED TO THE MICROCATHETER AND RESISTANCE WAS MET DURING AN ATTEMPT TO INJECT ONYX 18 LIQUID EMBOLIC. THE DSMO SYRINGE WAS INSPECTED AND FOUND THAT THE TIP OF THE SYRINGE WAS MISSING AND HAD REMA

  Patient problems: Ischemia; Ischemia Stroke; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 23770541 ↗
• MalfunctionJun 11, 2025Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT THE MARATHON CATHETER ENCOUNTERED RESISTANCE AT THE DISTAL SECTION AND BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR A SPINAL ANGIO AND EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODE RATE. THE ACCESS VESSEL WAS IN THE RIGHT GROIN WITH A 6MM DIAMETER. IT WAS REPORTED THAT THE PHYSICIAN INJECTED ONYX, AND WHEN THEY ATTEMPTED TO REMOVE THE CATHETER, THEY FELT RESISTANCE AND THE CATHETER BROKE OFF AT THE DISTAL END. A SNARE WAS USED TO RETRIEVE THE DISTAL SEGMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE CATHETER BREAK/DIFFICULT REMOVAL WAS UNKNOWN. IT WAS HARD TO DETERMINE IF THE CATHETER WAS TRAPPED IN THE ONYX OR THE VESSEL. THERE IS AN ONYX CAST IN THE VESSEL. THE CATHETER BROKE OFF. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE ORIGINAL INTENDED PROCEDURE WAS DIAGNOSTIC SPINAL ANGIOGRAM, RIGHT T11 SPINAL ARTERIOVENOUS FISTULA ONYX 18 EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187342 ↗
• MalfunctionApr 4, 2025Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT A PROCEDURE WENT AS PLANNED. HOWEVER, WHEN THE MICROCATHETER WAS REMOVED AT THE END OF THE PROCEDURE, THE DISTAL END SNAPPED AND ABOUT 5CM WAS LEFT BEHIND IN THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER WITH A SNARE, BUT IT WAS UNSUCCESSFUL. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE BROKEN SEGMENTS REMAIN IN THE PATIENT IN THE IMAX. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR ONYX EMBOLIZATION OF MMA. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE EXTERNAL CAROTID ARTERY (ECA) - INTERNAL MAXILLARY ARTERY (IMAX) - MIDDLE MENINGEAL ARTERY (MMA) WITH A 2.5MM DIAMETER. ANCILLARY DEVICES INCLUDE AN ONYX 18 LIQUID EMBOLIC. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE

  Patient problems: Foreign Body In Patient

  MAUDE report 21778677 ↗
• InjuryMar 19, 2025Entrapment of Device; Migration or Expulsion of Device; Chemical Problem; Unintended Movement; Entrapment of Device; Migration or Expulsion of Device; Chemical Problem; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP AND WHAT WOULD SEEM TO BE THE LINER WAS DETACHED. THE INNER LINER IS NOT REFERRING TO THE DETACHABLE TIP. 2-4CM OF REFLUX WAS NOTED.

  Patient problems: Decreased Level of Consciousness; Foreign Body In Patient; Movement Disorder; Paresis; Perforation of Vessels; Rupture

  MAUDE report 21649267 ↗
• MalfunctionMar 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED USING ONYX AND N-BCA. THREE BOXES OF ONYX WERE USED DURING THE PROCEDURE, ALL OF THE SAME LOT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN PAUSED FOR 1 MINUTE BETWEEN INJECTIONS. THERE WAS NO ONYX REFLUX. THE DEAD SPACE OF THE DELIVERY CATHETER HAD BEEN FILLED WITH DMSO. THE AVM WAS LOCATED IN THE BRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576545 ↗
• MalfunctionSep 9, 2024Display or Visual Feedback Problem; Chemical Problem; Display or Visual Feedback Problem; Chemical Problem

  MEDTRONIC RECEIVED A REPORT THAT A ONYX HAD POOR VISUALIZATION AND WAS NOT COMING OUT OF THE MICROCATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A GRADE FOUR ARTERIOVENOUS MALFORMATION (AVM) IN AN ELOQUENT REGION. THE PATIENT¿S VESSEL TORTUOSITY WAS SEVERE. PHYSICIAN WAS TREATING A RUPTURED AVM WHICH WAS SUPPLIED FROM RIGHT DISTAL PCA. DUE TO TORTUOSITY AND A SMALL DIAMETER OF THE RIGHT DISTAL PCA, THEY DECIDED TO USE BALT'S SONIC 1.2F 2.5CM DETACHABLE TIP MICROCATHETER. AFTER POSITIONING THE MICROCATHETER AT THE OPTIMUM POSITION INSIDE THE NIDUS AND PRIMING IT WITH DMSO, THE PHYSICIAN STARTED TO INJECT ONYX-18. AFTER INJECTING APPX. 0.3 ML OF ONYX-18, THEY REALIZED THAT ONYX WAS NOT COMING OUT FROM MICROCATHETER AND WAS NOT VISIBLE. THE PHYSICIAN TOOK OUT THE ONYX SYRINGE AND HAD TO TAKE OUT A NEW ONYX-18 VIAL IMMEDIATELY. THE ONYX CAME OUT OF THE SONIC MICROCATHETER. THE SPEED SETTING ON THE SHAKER: 8. THE ONYX WAS MIXED FOR MORE THAN 30 MINUTES. THE ONYX VIALS DID NOT SIT MORE THAN 5 MINUTES PRIOR TO INJECTION. THE PHYSICIAN INJECTED THE ONYX IMMEDIATELY AFTER MIXING (ONYX DID NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170984 ↗
• InjuryJul 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED AN ELEVATED WHITE BLOOD CELL COUNT CONCERNING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19807886 ↗
• InjuryJul 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED AN ELEVATED WHITE BLOOD CELL COUNT CONCERNING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19807879 ↗
• MalfunctionJul 22, 2024Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error; Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LAB STATED, THEY MIXED UP THE VIALS. THEY TOOK MULTIPLE VIALS OUT OF THE BOX AND DID NOT PUT THEM BACK IN THE CORRECT BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19797797 ↗
• MalfunctionJul 22, 2024Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error; Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS AN ISSUE WITH THE EXPIRATION DATES IN AN ONYX KIT. THE ACCOUNT REPORTED THAT THE ONYX KIT CONTAINED A VIAL OF DMSO LOT B687507 AND ONYX 18 LOT B035828. THE ONYX LOT B035828 HAD AN EXPIRATION DATE OF 2023-06-05, WHILE THE DMSO AND TOP LEVEL ASSEMBLY HAD GOOD DATING (2027-01-31 AND 2026-11-01 RESPECTIVELY). IT WAS NOTED THE TOP LEVEL ASSEMBLY SHOULD HAVE A SHORTER DATE THAN THE ONYX 18 AND DMSO, AND THE ACCOUNT WAS WONDERING IF THE DEVICE WAS PACKAGED THIS WRONG. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795513 ↗
• MalfunctionFeb 13, 2024Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT DURING EMBOLIZATION OF SECOND SITTING OF AN ARTERIOVENOUS MALFORMATION (AVM) PROCEDURE, THERE WAS SOME RESIDUAL AVM LEFT WHICH WAS FED FROM RIGHT DISTAL P2 POSTERIOR CEREBRAL ARTERY (PCA). THE PHYSICIAN TOOK THIS APOLLO 1.5CM MICROCATHETER AND AFTER FILLING IT'S DEAD SPACE WITH DMSO, STARTED INJECTING THE ONYX-18 LES. AFTER INJECTING SOME OF THIS ONYX, HE FELT SOME RESISTANCE AND THE ONYX WAS NOT COMING OUT FROM APOLLO. THE PHYSICIAN TOOK OUT THIS APOLLO AND TOOK OUT A NEW APOLLO 3CM TO FINISH OF THE PROCEDURE. THE CATHETER WAS ENTRAPPED BY ONYX. THERE WAS NO ONYX REFLUX. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE WAS NO VASOSPASM. NO PORTION OF THE CATHETER REMAINS IN THE PATIENT. THERE WAS CATHETER OCCLUSION DURING ONYX INJECTION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AVM. THE AVM WAS NOT IN AN ELOQUENT REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS RIGHT DISTAL P2 PCA W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699570 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER INJECTING THE DMSO, THE PATIENT WENT INTO CARDIAC ARREST. AFTER ACLS, THE PATIENT DID NOT EXPIRE. THE ONYX AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Cardiac Arrest

  MAUDE report 17862180 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT ONYX EMBOLIZATION FOR A DURAL AV FISTULA AND BECAME A PARAPLEGIC.

  Patient problems: Paraplegia

  MAUDE report 17484606 ↗
• MalfunctionAug 8, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  MEDTRONIC RECEIVED A REPORT THAT WHILE INJECTING ONYX 18 AS PER IFU, THE APOLLO BURST AND THE ONYX 18 COULDN'T BE DELIVERED TO THE INTENDED LOCATION. THE ONYX CATHETER WAS RUPTURED (INTACT). THE INJECTION RATE WAS APPROXIMATELY 16ML PER MINUTE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR GRADE 2 ARTERIOVENOUS MALFORMATION (AVM). THE ACCESS VESSEL WAS THE ANTERIOR COMMUNICATING AR TERY WITH A DIAMETER OF 1.8MM.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481573 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY SPECIFIC SYMPTOMS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16993125 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AS THE MICROCATHETER WAS ADVANCED THROUGH THE SOFIA DISTAL ACCESS CATHETER INTO THE MIDDLE MENINGEAL ARTERY (MMA) AND THE PARIETAL AND TEMPORAL BRANCH OF THE MMA, VESSEL SPASM OCCURRED. THE CATHETER COULD NOT BE ADVANCED BEYOND THE BIFURCATION OF THE BRANCHES. THE MICROWIRE WAS WITHDRAWN. VERAPAMIL 5MG WAS INFUSED AND THEN THE PROCEDURE WAS CONTINUED TO COMPLETION. THE EVENT DID NOT RESULT IN HOSPITALIZATION. NO DIAGNOSTIC TESTS OR PROCEDURES WERE PERFORMED. THE EVENT WAS NOT ASSOCIATED WITH A SEIZURE AND THERE WAS NO DECLINE IN MRS. THE EVENT DID NOT RESULT FROM A DEVICE DEFICIENCY. THE EVENT WAS RECOVERED/RESOLVED ON (B)(6) 2023. THE RELATED ASSESSMENT TO THE STUDY PROCEDURE WAS PROBABLE AND NOT RELATED TO THE STUDY DEVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT DID NOT CAUSE A DECLINE IN MRS OR PROLONGED HOSPITALIZATION. THERE WERE NO SPECIFIC NEUROLOGICAL SYMPTOMS REPORTED BEYOND THE DIFFICULTY OF ADVANCING THE CATHETER. THE SITE WAS UNABLE TO PROVIDE MODEL AND LOT NUMBER OF THE MICROCATHETER UTILIZED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SITE USED A HEADWAY DUO MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVEN

  Patient problems: Vasoconstriction

  MAUDE report 16798329 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED/RESOLVED ON (B)(6) 2023.

  Patient problems: Cognitive Changes; Dysphasia; Muscle Weakness/Atrophy; Stroke/CVA; Unspecified Nervous System Problem

  MAUDE report 16648589 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AN ONYX PATIENT EXPERIENCED IATROGENIC DISSECTION OF THE RIGHT MIDDLE MENINGEAL ARTERY (MMA) DURING THE PROCEDURE WHICH LIMITED FLOW. THE DISSECTION RECOVERED/RESOLVED THE SAME DAY WITHOUT FURTHER TREATMENT. THE SITE ASSESSED THE DISSECTION AS NOT RELATED TO THE DEVICE AND CAUSED BY THE PROCEDURE. THE PATIENT EXPERIENCED A GENERALIZED DECLINE IN THEIR MRS SCORE FOLLOWING THE PROCEDURE. THEIR MRS SCORE WAS ASSESSED AS 3 AT 24 HOURS POST PROCEDURE, AND AT THEIR 14 DAY FOLLOW-UP THEY HAD INCREASED UNSTEADINESS WHICH REQUIRED ADDITIONAL ASSISTANCE. THE EVENT WAS NOT ASSOCIATED WITH A SEIZURE OR THE RESULT OF A DEVICE DEFICIENCY, AND NO FURTHER TREATMENT OR HOSPITALIZATION WAS GIVEN. THE EVENT WAS NOTED AS RECOVERING/RESOLVING. THE SITE ASSESSED THE MRS DECLINE AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Unspecified Nervous System Problem; Vascular Dissection

  MAUDE report 15053765 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AN ONYX PATIENT WAS READMITTED TO THE HOSPITAL AFTER THEIR INDEX PROCEDURE DUE TO A SEIZURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT SEIZURES ABATED, THE PATIENT NEEDED SURGERY FOR AN INFECTION AND WAS WORKING TOWARDS REHAB. THE PATIENT HAS AN EEG ((B)(6)), ANTIEPILEPTICS ((B)(6) ON), MRI ((B)(6)), SURGICAL EVACUATION OF PHLEGMON/WASHOUT FOR INFECTION ((B)(6)). IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS DUE TO AN INFECTION THAT WAS TREATED. NOT RELATED TO ONYX. MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO ONYX 18 EMBOLIZATION HAD COMPLICATIONS. THE PATIENT HAD LEFT SUBDURAL EMPYEMA/PHLEGMON. EVACUATION OF SUBDURAL EMPYEMA/PHLEGMON WITH DURAPLASTY DONE ON (B)(6) 2022 AS SEEN ON CT SCAN (B)(6) 2022. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO DEVICE. HOSPITALIZATION AND SURGICAL MEDICAL INTERVENTION WAS REQUIRED. THE EVENT IS RESOLVING.

  Patient problems: Convulsion/Seizure; Nausea; Unspecified Infection

  MAUDE report 15048740 ↗
• InjuryJul 1, 2022Improper Chemical Reaction; Material Deformation; Improper Chemical Reaction; Material Deformation

  MEDTRONIC RECEIVED A REPORT AFTER INJECTING THE DEAD SPACE OF THE DUO CATHETER AND THE SYRINGE OF THE ONYX18 WAS CONNECTED. WHEN THE INJECTION WAS STARTED, IT WAS NOTICED THE ONYX WAS LEAKING AND IT APPEARED THE HUB OR SYRINGE WAS MELTED. AS A RESULT THEY COULD NOT CONTINUE TO PUSH THE ONYX INTO THE VENOUS SIDE OF THE AVM. THE ISSUE WAS COMPOUNDED BY THE FACT THAT THEY ALREADY OCCLUDED THE VEIN AND THERE WAS NO WAY TO SHUT THE AVM DOWN BECAUSE THE CATHETER WAS NOT FUNCTIONAL. FURTHERMORE, THERE WAS NO WAY TO RECESS THE VEIN FOR EMBOLIZATION SO THE ONLY OPTION WAS TO COMPLETELY SHUT DOWN THE AVM VIA THE ARTERIAL ROUTE. THE HEALTHCARE PROVIDER FELT THIS LED TO THE PATIENT SUFFERING A STROKE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING ARTERIOVENOUS MALFORMATION (AVM). THE AVM WAS A GRADE 5 AND IN AN ELOQUENT REGION. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: Stroke/CVA

  MAUDE report 14885196 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO ONYX 18 EMBOLIZATION HAD COMPLICATIONS. THE PATIENT HAD LEFT SUBDURAL EMPYEMA/PHLEGMON. EVACUATION OF SUBDURAL EMPYEMA/PHLEGMON WITH DURAPLASTY DONE ON (B)(6) 2022 AS SEEN ON CT SCAN (B)(6) 2022. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO DEVICE. HOSPITALIZATION AND SURGICAL MEDICAL INTERVENTION WAS REQUIRED. THE EVENT IS RESOLVING.

  Patient problems: Abscess; Inflammation

  MAUDE report 14784393 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO ONYX 18 EMBOLIZATION HAD COMPLICATIONS. THE PATIENT HAD LEFT SUBDURAL EMPYEMA/PHLEGMON. EVACUATION OF SUBDURAL EMPYEMA/PHLEGMON WITH DURAPLASTY DONE ON (B)(6) 2022 AS SEEN ON CT SCAN (B)(6) 2022. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO DEVICE. HOSPITALIZATION AND SURGICAL MEDICAL INTERVENTION WAS REQUIRED. THE EVENT IS RESOLVING.

  Patient problems: Abscess; Inflammation

  MAUDE report 14784385 ↗
• MalfunctionMay 27, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED A REPORT THAT THE MARATHON MICROCATHETER WAS OCCLUDED DURING ONYX INJECTION. THE MARATHON WAS PLACED IN ONE OF THE FEEDER. DMSO WAS INJECTED, AND THEN ONYX WAS INJECTED. ONYX FLOW IN THE NIDUS WASN'T VISIBLE, SO THE MARATHON MICROCATHETER WAS IMMEDIATELY WITHDRAWN. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION (AVM). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT DISTAL MIDDLE CEREBRAL ARTERY, WHICH WAS 2.8MM IN DIAMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526875 ↗
• InjuryMay 10, 2022Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN ONYX HAD POOR VISUALIZATION. THE PATIENT WAS UNDERGOING EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA) FOR TREATMENT OF CHRONIC SUBDURAL HEMATOMA. CORE LAB HAS REVIEWED IMAGING FOR AN EMBOLISE SUBJECT FOR A RETREATMENT OF A SUBDURAL HEMATOMA THAT OCCURRED ON (B)(6) 2021. THE CORE STATES THAT "ONLY THE ANTERIOR BRANCH OF THE MMA HAS BEEN EMBOLIZED, BUT NOT WITH ONYX, AS NO ONYX CAST IS VISIBLE. IN ONE BRANCH OF THE STA THERE IS LOW-FLOW PRE EMBOLIZATION AND IN THE MAXILLAR ARTERY POST-EMBOLIZATION." IT'S MORE LIKELY POSSIBLE THAT THE SITE USED A DIFFERENT PRODUCT TO PERFORM MMA EMBOLIZATION, HOWEVER, AN ONYX LOT NUMBER WAS PROVIDED SO SUBMITTING A POTENTIAL COMPLAINT OUT OF AN ABUNDANCE OF CAUTION IN CASE THERE WAS ANY REASON WITH A DEPLOYED ONYX ISN'T SHOWING UP ON IMAGING.

  Patient problems: Hematoma; Insufficient Information

  MAUDE report 14350499 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AN ONYX PATIENT WAS READMITTED TO THE HOSPITAL AFTER THEIR INDEX PROCEDURE DUE TO A SEIZURE.

  Patient problems: Convulsion/Seizure; Nausea; Unspecified Infection

  MAUDE report 14220244 ↗