ApolloTM 105-5095-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00847536006010), received between Dec 3, 2018 and Dec 9, 2024 — classified as 19 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Difficult to Remove; Stretched; Difficult to Remove; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STABLE, NO BETTER OR WORSE. THE PATIENT EXPERIENCED ISCHEMIA IN A FEW LOCATIONS. THE VESSEL OCCLUSION WAS TREATED LIKE A STROKE. ASPIRATION AND SFR WAS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke; Rupture

  MAUDE report 20882909 ↗
• MalfunctionOct 18, 2024Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT CATHETER TIP OF THE APOLLO DROPPED OFF PREMATURELY. THERE WAS CATHETER SEPARATION/BREAK IN THE DISTAL SECTION DURING USE. THERE WAS FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE BROKEN SEGMENTS, DISTAL 1.5 CM OF APOLLO, REMAINS IN THE PATIENT IN THE MIDDLE MENINGEAL ARTERY (MMA). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR MMA TREATMENT. THE MMA WAS THE ACCESS VESSEL WITH A DIAMETER OF 2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20486810 ↗
• InjuryAug 12, 2024Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED AFTER THE PROCEDURE THE PATIENT IS DOING GREAT AND IS BACK TO BASELINE. ONYX WAS NOT USED WITH THE CATHETER. THE CAUSE OF THE DETACHMENT WAS RESISTANCE IN THE WIRE AND VESSEL FROM SPASM. APOLLO TIP CAME OFF BEFORE THEY TRIED TO RETRIEVE IT. THEY WERE STILL NAVIGATING TO THE ARTERIOVENOUS MALFORMATION (AVM). THE HEALTH CARE PROVIDER (HCP) PLANS TO BRING THE PATIENT BACK AND TREAT THEY AVM FOR SURGERY AND RETRIEVE THE CATHETER TIP. THE LOCATION OF THE TIP IS THE EXTERNAL CAROTID BRANCH. THERE WAS NO VESSEL CALCIFICATION. THE WAS NO DAMAGE NOTICED TO THE DEVICES.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 19961739 ↗
• MalfunctionDec 12, 2023Compatibility Problem; Physical Resistance/Sticking; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHILE DOING THE EMBOLIZATION OF A COMPLEX RUPTURED ARTERIOVENOUS MALFORMATION (AVM)  WITH ONYX-18 LES, THE PHYSICIAN PLACED THE APOLLO MICROCATHETER AT THE OPTIMUM POSITION INSIDE THE NIDUS. THEN AFTER INJECTING APPROXIMATELY 0.25ML. OF THE ONYX-18, THE PHYSICIAN REALIZED THAT IT WAS NOT COMING OUT FROM APOLLO <(>&<)> RESISTANCE WAS INCREASING. SO THE PHYSICIAN HAD TO TAKE OUT THIS APOLLO MICROCATHETER <(>&<)> ONYX-18 SYRINGE <(>&<)> USED NEW MICROCATHETER TO COMPLETE THE EMBOLIZATION PROCEDURE. WHILE TAKING OUT THE ATTACHED ONYX SYRINGE, SOME ONYX WAS DROPPED ON THE OPERATING TABLE.  THE ONYX AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE APOLLO 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 AN AVM. THE AVM IS AN ELOQUENT REGION. THE ACCESS VESSEL WAS THE RIGHT POSTERIOR INTERNAL CAROTID ARTERY WITH A DIAMETER OF 1.2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEAD SPACE OF 0.23ML. WAS FILLED WITH DMSO. DURING FLUSHING THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311251 ↗
• MalfunctionNov 3, 2023Break; Leak/Splash; Break; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PHYSICIAN SELECTED THE TARGET VESSEL, A CONTRAST RUN WAS DONE AND IT WAS NOTICED THAT CONTRAST WAS SEEPING OUT OF THE SIDE OF THE APOLLO CATHETER. NOTHING WAS COMING OUT OF THE DISTAL END BECAUSE THERE WAS A HOLE/TEAR IN THE DISTAL THIRD OF THE APOLLO. THE APOLLO AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE APOLLO 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 A PRE-SURGICAL ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY (MCA) AVM. THE ACCESS VESSEL WAS THE LEFT MCA WITH A DIAMETER OF 2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064335 ↗
• MalfunctionOct 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO BROKE AT THE DETACHMENT ZONE AS THE DOCTOR WENT UP TO THE M3 SEGMENT DURING A PRE-OP EMBO OF AN OCCIPITAL ARTERIOVENOUS MALFORMATION (AVM). HE NOTICED THE CATHETER HAD DETACHED AFTER DOING HIS MICRO RUN THROUGH THE CATHETER. THE APOLLO CATHETER BROKE OFF BEFORE TIP. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE DISTAL PORTION WAS BROKEN. MULTIPLE PEDICLES WERE EMBOLIZED AFTER THIS EVENT. PATIENT WAS SCHEDULED FOR RESECTION THE NEXT DAY AND NO SUBSEQUENT ISSUES WERE REPORTED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR PRE-OP EMBO FOR BRAIN AVM. THE ACCESS VESSEL WAS THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ANCILLARY DEVICES INCLUDE A 6FR FUBUKI XF SHEATH (FBKX-8S80DY) LOT # 220709C421 SHEATH, NAVIEN 058 115CM RFX058-115-08 LOT

  Patient problems: Foreign Body In Patient

  MAUDE report 17870872 ↗
• MalfunctionSep 20, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO BROKE IN THE MIDDLE WHILE DOING THE PROCEDURE. THE BROKEN PIECES ARE BEING RETURNED. THE APOLLO AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE APOLLO 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 A MIDDLE MENINGEAL ARTERY (MMA) ANEURYSM. THE ACCESS VESSEL WAS THE MMA WITH A DIAMETER OF 1-2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785380 ↗
• MalfunctionApr 17, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING AN APOLLO CATHETER THAT HAD A LEAK DURING ONYX INJECTION. THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE VIA THE RIGHT FEMORAL ARTERY TO TREAT A BRAIN ARTERIOVENOUS MALFORMATION (AVM). THE ACCESS VESSEL DIAMETER WAS 7MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). AFTER THE APOLLO MICROCATHETER WAS IN PLACE, IT WAS OBSERVED THAT ONYX FLOWED OUT FROM THE MIDDLE OF THE CATHETER AS WELL AS THE TIP. THE SURGEON SUSPECTED THE APOLLO CATHETER HAD RUPTURED. IT WAS NOTED THAT THE CATHETER WAS INSPECTED AND TESTED PRIOR TO USE. THE CATHETER WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753372 ↗
• InjuryFeb 15, 2023Break; Difficult to Remove; Separation Failure; Break; Difficult to Remove; Separation Failure

  NEW INFORMATION WAS RECEIVED THAT THE PATIENT WAS PLACED ON COMFORT CARES AND IS NOT DOING WELL POST PROCEDURE. PER THE PHYSICIAN THE PATIENT WAS NOT DOING WELL PRIOR TO THE PROCEDURE AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16379713 ↗
• InjuryOct 20, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT DURING VESSEL SELECTION, THE APOLLO CATHETER DISTAL END DETACHED PRIOR TO EMBOLIZATION. THE MARKER BAND WAS DISLODGED/DAMAGED. THE CATHETER TIP WAS NOT SHAPED. THE MARKER BAND REMAINS IN THE PATIENT IN THE RIGHT INTERNAL MAXILLARY ARTERY. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING MIDDLE MENINGEAL ARTERIAL EMBOLIZATION. IT WAS NOTED THE PATIENT'S AND VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE MIDDLE MENINGEAL ARTERY WITH AN APPROXIMATE DIAMETER OF 1.3MM.   ANCILLARY DEVICES INCLUDE A TERUMO 6/7 SLENDER SHEATH, 7F RIST GUIDE CATHETER, APOLLO MICROCATHETER, AND A SYNCHRO 10 GUIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15639973 ↗
• InjuryAug 26, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER TUBE TRANSITION SECTION LEAKED ONYX AND BLOCKED ONE SIDE OF A1. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION (AVM).  THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT ONYX WAS APPLIED TO THE PARALLEL BODY AND FRONTAL LOBE, AND AN APOLLO WAS USED IN FRONT OF IT. THE INJECTION OF ONYX WENT SMOOTHLY. WHEN OPENING THE SECOND ONE, DURING THE  APPLICATION IT WAS FOUND THAT ONYX LEAKED FROM THE PROXIMAL END. AFTER STOPPING, THE CATHETER WAS REPLACED AND TREATMENT WAS CONTINUED. THE DISTAL PART OF THE CATHETER HAD RUPTURED BUT WAS INTACT. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. ASIDE FROM THE RUPTURE THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE ON-SITE ANGIOGRAPHY SHOWED THAT THE CONTRALATERAL BLOOD VESSEL WAS BETTER, AND THE EVALUATION COMPENSATION SHOULD BE GOOD. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 15303476 ↗
• MalfunctionApr 18, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MICROCATHETER WAS IN PLACE AND THE GLUE WAS BEING APPLIED, IT WAS FOUND THAT THERE WAS NO GLUE SPILLAGE AT THE DISTAL END. DURING ANGIOGRAPHY, IT WAS FOUND THAT AT THE PETROUS SEGMENT VESSEL OF THE CAROTID ARTERY, THERE WAS AN ONYX OVERFLOW AND HAD BLOCKED A BLOOD VESSEL. THE SURGEON REMOVED THE MICROCATHETER, AND IT WAS FOUND THAT THE PROXIMAL END OF THE SOFT SEGMENT OF THE CATHETER WAS RUPTURED. THE SURGERY WAS STOPPED AFTER ANGIOGRAPHY. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CATHETER WAS RUPTURED AT THE DISTAL END. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY AND THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE INJECTION RATE WAS 0.15/MIN. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE LEFT ANGIOGRAPHY COULD ONLY DEVELOP TO THE C2 SEGMENT. THE DISTAL WAS BLOCKED AND UNABLE TO DEVELOP. THE PATIENT UNDERWENT TREATMENT FOR AN ARTERIOVENOUS MALFORMATION IN THE ANTERIOR CEREBRAL ARTERY. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139272 ↗
• InjuryApr 5, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION THAT AN APOLLO CATHETER RUPTURED WITH ONYX AND THE PATIENT HAD A STROKE. THE PATIENT WAS UNDERGOING ONYX TREATMENT FOR ARTERIOVENOUS MALFORMATION (AVM). THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DSMO WAS INJECTED. 23ML. SMOOTH INJECTION. PUSHED ABOUT .2ML OF ONYX AND WAS SEEN COMING OUT OF PROXIMAL CATHETER. EVERYTHING PULLED OUT. PATIENT THEN STROKED. THE CATHETER RUPTURED INTACT IN THE PROXIMAL SECTION. THE PATIENT IS ALIVE WITH INJURY. ANCILLARY DEVICES: UNKNOWN GUIDE CATHETER, CHIKAI GUIDEWIRE.

  Patient problems: Foreign Body In Patient; Intracranial Hemorrhage; Stenosis; Stroke/CVA

  MAUDE report 14018012 ↗
• MalfunctionJan 25, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE REP COVERED A CASE ON (B)(6) 2022 FOR BI-LATERAL MMA ONYX EMBOLIZATION. THE FIRST SIDE (BELIEVE LEFT SIDE) WENT FINE BY USING A SCEPTOR BALLOON. ON THE SECOND SIDE, THE DOCTOR USED AN APOLLO CATHETER. THE DOCTOR WAS INJECTING SLOWLY, .2-.3ML/MIN AND HE WAS SEEING ONYX SLOWLY COME OUT OF THE CATHETER. NO REFLUX WAS NOTICED. HE CONTINUED TO INJECT AT A SLOW RATE BUT HE WASN¿T HAPPY WITH HOW LITTLE HE WAS SEEING SO HE PANNED HIS VIEW DOWN AND NOTICED WHAT LOOKED LIKE A LARGE AMOUNT OF ONYX IN THE EXTERNAL CAROTID ARTERY. THE DOCTOR ENDED UP TAKING THE APOLLO OUT OF THE PATIENT AND STENTING THE INTERNAL CAROTID ARTERY WITH A CAROTID STENT. THE EXTERNAL CAROTID ARTERY REMAINED SHUT DOWN WITH ONYX. AFTER THE CASE WAS CONCLUDED, IT LOOKS LIKE THERE MAY BE A LEAK THAT COULD HAVE CAUSED THE ONYX TO SPILL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343605 ↗
• InjuryOct 25, 2021Break; Burst Container or Vessel; Break; Burst Container or Vessel

  THE PATIENT'S WEIGHT WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12689495 ↗
• InjuryOct 25, 2021Material Puncture/Hole; Compatibility Problem; Positioning Problem

  PATIENT UNDERWENT A CEREBRAL ANGIOGRAM AND ETHYLENE-VINYL ALCOHOL COPOLYMER (EVOH) EMBOLIZATION. WHILE INJECTING THE EMBOLIC AGENT DURING THE PROCEDURE, THE AGENT WAS OBSERVED TO BE COMING OUT OF THE CATHETER AT A POINT PROXIMAL TO THE TIP, WHICH LED TO A STROKE. PATIENT IS CURRENTLY REPORTED TO BE STABLE BUT GUARDED. POST PROCEDURE, THE CATHETER WAS EXAMINED UNDER A MICROSCOPE AND A SMALL HOLE WAS FOUND ABOUT 6CM FROM THE TIP.

  Patient problems: Stroke/CVA

  MAUDE report 12688356 ↗
• InjuryAug 4, 2021Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER WAS USED TO ACCESS THE ARTERIOVENOUS MALFORMATION (AVM). ONYX INJECTION WAS GIVEN, AND REFLUX WAS NOTICED JUST PAST THE CATHETER PROXIMAL MARKER. THE PHYSICIAN HAD PAUSED DURING INJECTION FOR LESS THAN 2 MIN TO LET THE CAST SET. AFTER 40 MIN INJECTION, THE CATHETER WAS WITHDRAWN, AND IT WAS NOTICED THE DISTAL SEGMENT OF THE CATHETER WAS LEFT IN THE PATIENT'S ECA. AFTER EMBOLIZATION, A SNARE WAS USED TO RETRIEVE A PORTION OF THE CATHETER, BUT IT WAS SEEN THAT A PART STILL REMAINED IN THE PATIENT. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AVM, AND THE PATIENT'S  VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE ONYX (LOT # A954941).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12274929 ↗
• MalfunctionJun 16, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE APOLLO CATHETER DISTAL SEPARATION OCCURRED DURING RETRIEVAL OF THE CATHETER. THERE WAS A SLIGHT RESISTANCE DURING RETRIEVAL OF THE APOLLO CATHETER. THERE WAS NO VESSEL CALCIFICATION NOTED. THE PHYSICIAN DID NOT OBSERVE ANY OTHER EVIDENCE OF DEVICE KINK OR DAMAGE. ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PROCEDURE WAS COMPLETED PRIOR TO THE CATHETER DISTAL SEPARATION BEING OBSERVED. THERE WAS NO PATIENT ADVERSE EVENT OR INJURY DURING OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012386 ↗
• MalfunctionMar 4, 2021Difficult to Remove; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult to Remove; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413176 ↗
• InjuryFeb 2, 2021Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFORMATION REGARDING AN APOLLO CATHETER THAT RUPTURED DURING AN ONYX PROCEDURE. THE PATIENT WAS UNDERGOING AN ONYX EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) OF THE RIGHT M3 ARTERY SEGMENT. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AND THE CATHETER FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THOUGH IT WAS ALSO NOTED THAT THE CATHETER WAS NOT INSPECTED OR TESTED PRIOR TO USE. DURING THE PROCEDURE, THE APOLLO CATHETER RUPTURED ABOUT 5CM FROM THE DISTAL TIP DURING ONYX INJECTION, LEADING TO SOME ONYX BEING IMPLANTED IN AN UNINTENDED LOCATION. THE ONYX INJECTION RATE WAS 0.01ML. THOUGH THE CATHETER RUPTURED, IT REMAINED INTACT AND NO OTHER DAMAGE TO THE CATHETER WAS OBSERVED. NO FRICTION OR OTHER DIFFICULTY OCCURRED DURING DELIVERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267438 ↗
• InjuryNov 24, 2020Break; Stretched; Separation Failure; Break; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE CATHETER FAILED TO DETACH AS INTENDED WHEN READY TO RELEASE. THE PHYSICIAN WAS ABLE TO GET THE DEVICE TO DETACH, BUT IT ENDED UP IN A SUBOPTIMAL POSITION, WHICH DID NOT RESULT IN HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10893093 ↗
• MalfunctionNov 16, 2020Burst Container or Vessel; Compatibility Problem; Burst Container or Vessel; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED MULTIPLE LOTS OF ONYX WERE USED IN THE PROCEDURE, AND SINCE THE VIAL REPORTED ON WAS DISCARDED, IT WAS UNKNOWN WHICH LOT NUMBER HAD THE ISSUE. THE DMSO HAD BEEN DELIVERED TO THE DEAD SPACE, ONYX WAS DELIVERED THROUGH THE CATHETER AFTERWARD. OCCLUSION OCCURRED AFTER MULTIPLE, CONTINUOUS INJECTIONS THROUGH THE CATHETER. THERE WAS NO PAUSE GREATER THAN TWO MINUTES BETWEEN INJECTIONS. NO KINK OR ADDITIONAL DAMAGE WAS OBSERVED TO THE CATHETER, NO REFLUX OCCURRED, AND NO ONYX LEAKED INTO THE PATIENT'S VESSEL. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL TREATMENT OR INTERVENTION AND WAS DOING WELL SINCE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10849379 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS CURRENTLY RECOVERING. THERE HAD BEEN NO LONG PAUSES OF OVER 2 MINUTES DURING THE INJECTION. THERE WAS NO RESISTANCE NOTED DURING THE DMSO INJECTION.

  Patient problems: Hemorrhage, Subarachnoid; Hemorrhage, Subdural; Perforation of Vessels

  MAUDE report 10727945 ↗
• InjurySep 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT NO KINK OR DAMAGE WAS NOTED TO ANY OF THE DEVICE USED IN THE PROCEDURE; ONLY THE APOLLO TIP SEPARATED PREMATURELY AT THE DETACHMENT ZONE. THERE WAS NO PATIENT VESSEL CALCIFICATION NOTED. THERE WAS NO REPORTED PATIENT ADVERSE EVENT AND THE PATIENT WAS RECOVERING WELL. AFTER THE CATHETER TIP DETACHED, THE PHYSICIAN EMBOLIZED THE VESSEL TO SECURE. THERE WAS NO PLAN TO RETRIEVE THE DETACHED CATHETER TIP. NO IMAGES WERE AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10580777 ↗
• InjuryAug 26, 2020Break; Difficult to Remove; Break; Difficult to Remove

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER BECAME ENTRAPPED IN ONYX DURING REMOVAL AND BROKE OFF IN THE PATIENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE APOLLO CATHETER WAS USED DURING THE DELIVERY OF ONYX. ON THE SECOND INJECTION, THERE WAS FRICTION/DIFFICULTY AND 4CM OF ONYX REFLUX, AND THE CATHETER WAS REMOVED. DURING THE REMOVAL, FORCE HAD TO BE APPLIED AND THE DISTAL PORTION OF THE CATHETER WAS ENTRAPPED AND BROKE OFF. THE BROKEN SEGMENT WAS RETRIEVED BY A SOLITAIRE DEVICE, AND THE REMAINING DISTAL PORTION WAS STENTED IN PLACE WITH AN ATLAS STENT. THERE WAS NO VASOSPASM, AND THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A COOK 6F SHUTTLE, PHENOM PLUS 120CM, MIRAGE .008, ATLAS STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10457936 ↗