AxiumTM APB-4-12-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00847536008120), received between Aug 20, 2018 and Sep 2, 2025 — classified as 1 death, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Separation Failure; Detachment of Device or Device Component; Unintended Movement; Separation Failure; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH WITH THE INSTANT DETACHER. MANUAL DETACHMENT WAS ATTEMPTED BY BREAKING THE PUSH WIRE AND PULLING THE END, COIL DID NOT DETACH. WHILE RETRACTING THE MICROCATHETER THE COIL CAME BACK INTO THE MICROCATHETER. IT WAS PUSHED BACK INTO THE ANEURYSM WITH THE WIRE. AT THE END THERE WAS COIL PROTRUSION INTO THE PARENT VESSEL WHICH WAS TREATED WITH NEUROFORM ATLAS INTRACRANIAL STENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES. THE PHYSICIAN DID NOT TRY ANOTHER INSTANT DETACHER. THERE WAS ONE ATTEMPT AT DETACHMENT VIA HYPOTUBE. COIL DID NOT DETACH WITH THE DETACHER OR MANUAL DETACHMENT. IT WAS PUSHED INTO THE ANEURYSM WITH GUIDEWIRE AND THERE WAS PROTRUSION INTO THE PARENT VESSEL. THE PATIENT IS ALIVE WITH NO INJURY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A SL 10 EXCELSIOR MICROCATHETER, SYNCHRO SELECT SOFT STRAIGHT 0.014 GUIDEWIRE.

  Patient problems: Failure of Implant

  MAUDE report 22945847 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE COIL WAS IMPLANTED BUT NOT PROPERLY POSITIONED AND DR COMPLAINT IT¿S NOT SMOOTH DURING THE IMPLANT AND USE MORE PUSH. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, BUT GET STUCK WHEN DELIVERY TO THE DISTAL PART OF REBAR ALSO DURING THE IMPLANT. THERE WERE NO ISSUES THAT RESULTED IN THE COIL KINK/DAMAGE THAT WAS FOUND. THIS EVENT IS AN AUTO DETACH DURING THE HARD PUSH INSIDE THE CCF.

  Patient problems: Foreign Body In Patient

  MAUDE report 20799549 ↗
• MalfunctionNov 27, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798301 ↗
• MalfunctionMar 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT A PRE-DETACH WAS PERFORMED BEFORE THE COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED BY PUSHING IN THE WIRE. THE IMPLANT COIL REMAINS IN THE PATIENT. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A SOFIA 6F GUIDE CATHETER, HEADWAY 17 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004550 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE EVENT WAS THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE ALONG WITH 02 TIMES ATTEMPTS FOR DETACHMENT. CATHETER RESISTANCE OCCURRED IN THE DISTAL PORTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480670 ↗
• MalfunctionOct 4, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT AN AXIUM COIL FAILED TO DETACH INTRA-OPERATIVELY. IT WAS UNKNOWN IF THE DEVICE WAS PREPARED PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869044 ↗
• MalfunctionJul 31, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STUCK IN THE CATHETER. IT WAS REPORTED THAT DURING COIL DEPLOYMENT THE COIL GOT BENT AND WAS UNABLE TO NAVIGATE FURTHER. THE RESISTANCE WAS ENCOUNTERED IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY BUT WAS LATER NOTED TO BE DAMAGED. THE CATHETER WAS NOT MANUFACTURED BY MEDTRONIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430435 ↗
• MalfunctionMay 18, 2023Break; Stretched; Break; Stretched

  ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT THE REPORT OF THE COIL SEPARATION/BREAK/ PREMATURE DETACHMENT WAS ONLY REFERRING TO THE COIL STRETCH. IT WAS NOTED THAT PART OF THE COIL DID NOT FRACTURE AND SEPARATE FROM THE REST AND THE COIL DID NOT PREMATURELY SEPARATE FROM THE DELIVERY WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953640 ↗
• MalfunctionMar 6, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER RESISTANCE WAS IN THE DISTAL SEGMENT. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. DURING PREPARATION THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492813 ↗
• MalfunctionNov 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL'S PUSH WIRE WAS BROKEN WHILE INSERTING THE COIL INTO THE CATHETER. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS ON THE MIDDLE SEGMENT OF THE PUSHER. COIL SEPARATION/BREAK AND PREMATURE DETACHMENT OCCURRED. THE COIL WAS REMOVED FROM THE PATIENT BY PULLING OUT THE PUSH WIRE. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSH WIRE WAS BENT/BROKEN AND WAS NOT INTENTIONAL. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED 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 SACCULAR, UNRUPTURED LEFT PARACLINOID ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A SOFIA 5FR GUIDE CATHETER AND A SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779236 ↗
• MalfunctionJun 2, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE COIL TIP COULD BE SEEN UNDER FLUOROSCOPY, AS IT WAS CONNECTED INSIDE THE ANEURYSM. THE DEVICE MAY HAVE GOTTEN CAUGHT IN THE ELVIS WHEN IT WAS REMOVED AND BROKEN. THE MICROCATHETER WAS REMOVED AND THE TIP WAS CHECKED, BUT IT WAS NOT CONNECTED. THE COIL WAS SEPARATED/BROKEN. THE COIL WAS REMOVED WITH THE MICROCATHETER. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS NOT REPOSITIONED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE VA WITH A MAX DIAMETER OF 3.5MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE: XT-17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575692 ↗
• MalfunctionAug 25, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE REP CANNOT FIGURE OUT THE CAUSE BECAUSE THE PREVIOUS INVESTIGATION REPORT HAS NOT BEEN DONE YET. IN THE REP¿S PERSONAL OPINION, IT WAS A VERY SMALL PART, SO IT WAS THOUGHT THAT IT WAS A PRODUCT THAT REQUIRED ADVANCED MANUFACTURING TECHNOLOGY. THEREFORE, IT WAS THOUGHT THAT THE CAUSE MIGHT BE "UNEVENNESS IN ACCURACY" BY THE MANUFACTURER. PERHAPS THE RELOCATION OF THE FACTORY MIGHT ALSO BE RELATED WITH IT. ONLY AXIUM AND MYCLASS HAD DETACHMENT ERROR IN RECENT COILS. AXIUM'S DETACHMENT SYSTEM HAD A VERY SIMPLE AND EXCELLENT STRUCTURE, SO THE REASON WHY IT COULD NOT BE DETACHED WAS BECAUSE THE ACCURACY INSIDE THE DETACH LINK OR THE TIP PART OF THE PUSHER WIRE WAS LOW. THEREFORE, THE WIRE CAME OFF, BUT IT WAS SAID THAT THE DETACH LINK WAS STUCK FOR SOME REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366193 ↗
• MalfunctionOct 29, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD POOR POSITIONING AND DETACHED PREMATURELY DURING ATTEMPTS TO REPOSITION. THE PATIENT WAS BEING TREATED FOR A RUPTURED SACCULAR ANEURYSM OF A POSTERIOR CEREBRAL ARTERY P1 SEGMENT WITH RELATED SUBARACHNOID H EMORRHAGE. THE MAXIMUM DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE MICROCATHETER WAS DELIVERED TO THE ANEURYSM LOCATION. THE REPORTED COIL WAS BEING USED TO COIL THE FRAME BUT THE FRAMING WITH THE COIL WAS NOT STABLE SO THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL. HOWEVER, DURING THE ATTEMPT, WHEN HALF THE COIL WAS WITHIN THE ANEURYSM AND HALF THE COIL REMAINED WITHIN THE MICROCATHETER, THE COIL DID NOT MOVE. IT APPEARED THE COIL HAD DETACHED FROM THE PUSHWIRE. THE PUSHWIRE WAS RETRIEVED SUCCESSFULLY AND A 4MM SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED COIL. THE SAME MICROCATHETER WAS THEN USED WITH NON-MEDTRONIC COILS TO SUCCESSFULLY COMPLETE THE PROCEDURE. ALL DEVICES WERE PREPARED AND CONTINUOUS FLUSH OF THE CATHETER WAS PROVIDED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS DAMAGE OBSERVED TO THE PUSHWIRE. NO RESIS

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10755210 ↗
• MalfunctionOct 8, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SL-10 MICROCATHETER WAS PLACED, AND 4 COILS WERE IMPLANTED. THE REPORTED AXIUM COIL WAS DELIVERED, BUT WHEN TWO ATTEMPTS WERE MADE TO DETACH THE COIL, DETACHMENT FAILED. THE MANUAL DETACHMENT METHOD WAS PERFORMED, BUT DETACHMENT WAS STILL UNSUCCESSFUL. THE COIL WAS REMOVED AND RETRIEVAL WAS SMOOTH. WHEN THE IMPLANT WAS PULLED LIGHTLY OUTSIDE OF THE PATIENT'S BODY, IT DETACHED WITH THE FEELING THAT IT BROKE. AFTER, A REPLACEMENT COIL WAS IMPLANTED WITH NO PROBLEMS. 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 ANEURYSM OF THE VARIX OF LABBE ON THE PROXIMAL SIDE OF THE RIGHT T/S JUNCTION SITE. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A FUBUKI 6FR, SL-10 MICROCATHETER, CHIKAI GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10653850 ↗
• MalfunctionMay 23, 2019Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION THAT,DURING PROCEDURE, THE IMPLANT COIL WAS FOUND TO BE STRETCHED WHEN IT WAS WITHDRAWN FROM THE MICROCATHETER. THE IMPLANT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED ANEURYSM MEASURING 4MM X 2MM LOCATED IN THE C4 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE PATIENT¿S VASCULATURE WAS NORMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. IT WAS NOTED THAT THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY WITH A SIZE OF 4MM. THERE WAS NO FRICTION DURING TESTING OR DELIVERY, THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU, AND THE COIL WAS HYDRATED AS INDICATED PER THE IFU. THE PHYSICIAN DID NOT ATTEMPT TO REPOSITION THE COIL. THERE ARE NO IMAGES FOR REVIEW. ANCILLARY DEVICES: SYNCHRO GUIDEWIRE, ECHELON MICROCATHETER, 6F LONG SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637022 ↗
• MalfunctionApr 11, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PHYSICIAN WAS ATTEMPTING TO PUSH THE COIL THROUGH THE MICROCATHETER HUB IT GOT STUCK. AS A RESULT THEY TRIED TO RESHEATH BY PULLING THE COIL, BUT IT BECAME DETACHED IN THE HUB ITSELF. THERE WAS NO CATHETER DAMAGE SEEN, THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE WAS NO FRICTION DURING DELIVERY. IT WAS CONFIRMED THAT THE COIL PUSHED SMOOTHLY FROM THE INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL ONCE, BUT THEY DID NOT ATTEMPT TO DETACH THE COIL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR ANEURYSM IN THE LEFT DISTAL ACA WITH A MAX DIAMETER OF 4.4MM AND A NECK DIAMETER OF 1.6MM. THE PATIENT HAD A MINIMAL VESSEL TORTUOSITY AND NORMAL BLOOD FLOW. A CONTINUOUS FLUSH WAS USED, THE DEVICES WERE PREPARED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506673 ↗
• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483759 ↗
• MalfunctionFeb 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE 8TH AXIUM COIL FAILED TO DETACH. IT WAS CONSIDERED THAT PUSHWIRE DID NOT ENTER INSIDE DETACHER, THEREFORE, THE DETACHMENT WAS PERFORMED AGAIN BUT FAILED. MANUAL DETACHMENT METHOD WAS PERFORMED, BUT THE COIL CAME OUT TOGETHER AND WAS UNABLE TO BE DETACHED AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY OCCURRED. THE ANATOMY WAS MODERATE IN TORTUOSITY. THE IC-PARA ANEURYSM WAS 12 MM. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. ANCILLARY DEVICE. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377731 ↗
• MalfunctionNov 21, 2018Difficult or Delayed Positioning; Stretched; Physical Resistance/Sticking; Difficult or Delayed Positioning; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF RUPTURED MULTI LOBED SACCULAR ANEURYSM LOCATED IN LEFT ANTERIOR COMMUNICATING ARTERY, MEASURING 7.2MMX2.4MM, THE COIL FELT LOT OF RESISTANCE DURING PLACEMENT INSIDE ANEURYSM AND STRETCHED. IT WAS REPORTED THAT THIS WAS SECOND COIL IN THE PROCEDURE. THE PHYSICIAN STARTED TO DEPLOY THIS COIL BUT FELT LOT OF RESISTANCE AFTER 2ND LOOP DEPLOYED INTO ANEURYSM. PULLED THIS COIL <(>&<)> TRIED TO DEPLOY IT TWICE, BUT EVERY TIME HE FELT RESISTANCE. THEN HE DECIDED TO RE-SHEATH THIS COIL IN THE SLEEVE, WHILE TAKING THIS COIL OUT IN MICROCATHETER HE FELT A LOT OF RESISTANCE. THIS COIL WAS STRETCHED, SO PHYSICIAN HAD TO TAKE THE MICROCATHETER OUT FROM PATIENT BODY TO TAKE THIS COIL OUT. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE VESSEL WAS MODERATELY TORTUOUS. THE PATIENT¿S BLOOD FLOW WAS NORMAL. ACCESS VESSEL RIGHT FEMORAL ARTERY AND 6.5MM IN DIAMETER. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. YES, THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL TWO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096947 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT OF AXIUM PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT OF A RUPTURED, SACCULAR ANEURYSM AT THE BASAL ARTERY TIP. VESSEL TORTUOSITY WAS DESCRIBED AS NORMAL. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AXIUM COIL ACCIDENTALLY RELEASED DURING ADVANCEMENT THROUGH THE CATHETER. NO ATTEMPTS HAD BEEN MADE TO DETACH THE COIL. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT TOGETHER. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085657 ↗
• MalfunctionAug 24, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ATTEMPTED TO DETACH THE AXIUM COILS WITH AN INSTANT DETACHER BUT THEY WOULD NOT DETACH. AS A RESULT A NEW AXIUM WAS OPENED AND THE COIL DETACHED BY THE SAME DETACHER WITH NO ISSUE. THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE TO TREAT A 5MM CEREBRAL ANEURYSM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS UNKNOWN. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812988 ↗
• MalfunctionAug 20, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT DETACH. IT WAS NOTED THAT THERE WERE 3 ATTEMPTS MADE WITH THE INSTANT DETACHER AND 2 ATTEMPTS MADE WITH MANUAL DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN ANEURYSM AT THE MCA WITH A MAX DIAMETER OF 4MM AND A NECK DIAMETER OF 3MM. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICES INCLUDE AN ENVOY DA GUIDE CATHETER, SL10 MICROCATHETER, AND A SYNCHRO14 GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7798277 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab