AxiumTM APB-1-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847536021112), received between Oct 22, 2018 and Jan 22, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PUSHWIRE PROXIMAL SEGMENT WAS KINKED/ BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 2 MM AND A 1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PHYSICIAN MANUALLY BROKE THE COIL (I.E. DID NOT USE THE INSTANT DETACHER). THEY BENT THE IMPLANT DELIVERY PUSHER JUST DISTAL TO THE HYPOTUBE BREAK INDICATOR. HE CONTINUED BENDING AND STRAIGHTENING THE PUSHER UNTIL THE PUSHER TUBING OPENED, BUT THE RELEASE ELEMENT WAS NOT VISIBLE. THE IMPLANT DELIVERY PUSHER WAS NOT THERE TO PULL. HE LOOKED CLOSER, AND THERE WAS ABOUT 1MM TO GRAB. HE PULLED BACK ON THE IMPLANT PUSHER, WHILE MAKING SURE THE COIL DIDN'T MOVE AND WAS ABLE TO REMOVE THE PUSHER COMPLETELY, WITH THE COIL IMPLANTED AND INTACT. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146070 ↗
• MalfunctionDec 2, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A TOTAL OF FOUR AXIUM PRIME COILS WERE USED, AND DETACHMENT FAILURE OCCURRED WITH THE FOURTH COIL. MANUAL ("FORCED") DETACHMENT WAS INEFFECTIVE, SO THE COIL WAS RETRIEVED AND THE EMBOLIZATION WAS CONCLUDED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR TREATMENT OF PERIPHERAL VESSELS DURING CERVICAL INTRA-ARTERIAL AND ARTERIAL CHEMOTHERAPY. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL (NO ABNORMALITIES). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THERE WAS POOR DETACHMENT ("DISLODGEMENT"). THERE WERE 3 ATTEMPTS TO DETACH USING THE INSTANT DETACHER AND 1 ATTEMPT TO DETACH MANUALLY VIA THE HYPOTUBE. IT WAS ALSO NOTED THAT THERE WERE NO DEFECTS WITH THE INSTANT DETACHER. ANCILLARY DEVICES INCLUDED LAMDA 17 MICROCATHETER AND CHIKAI NEXUS GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696602 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A COIL ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE CATHETER AND ANOTHER COIL HAD PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE LEFT ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT DURING THE FILLING PROCESS, APB-3-8-HX WAS USED AND GREATER RESISTANCE WAS FOUND DURING THE DELIVERY PROCESS. THE CATHETER WAS NOT DAMAGED AND IT WAS UNKNOWN IF THE COIL WAS DAMAGED. AFTER REPLACING WITH THE SAME MODEL, THE SPRING COIL SUCCESSFULLY DELIVERED THE EMBOLIZATION, AND THE LAST COIL WAS SELECTED APB-1-2-3D. AFTER SEVERAL ADJUSTMENTS, THE SURGEON DISCOVERED THAT THE SPRING COIL WIREDRAWN. APB-1-2-3D WAS REMOVED FROM THE PATIENT BY RETRACTING THE PUSHER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN REPOSITIONED THE COIL 3 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604200 ↗
• MalfunctionJan 24, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573497 ↗
• MalfunctionJul 19, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, THE COIL HAD NO MARK POINT AND COULDN'T BE DETACHED IN THE BODY. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 2 TIMES WITH THE INSTANT DETACHER AND 1 TIME WITH ANOTHER INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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 ANEURYSM OF THE MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 3.2MM AND A 4.0MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.  ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350930 ↗
• MalfunctionJul 18, 2023Therapy Delivered to Incorrect Body Area; Separation Failure; Therapy Delivered to Incorrect Body Area; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE¿DAMAGE OBS ERVED AFTER REMOVAL FROM THE PATIENT. ASPIRIN AND CLOPIDOGREL ROUTINE DOUBLE ANTIBODY IN PERIOPERATIVE PERIOD WAS NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17339940 ↗
• MalfunctionMar 20, 2023Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE STENT COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED POSTERIOR COMMUNICATING SEGMENT OF RIGHT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.4MM AND A 3.9MM NECK DIAMETER. THE LANDING ZONE WAS 3.2MM AT THE DISTAL END AND 3.6MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE PARENT VESSEL WAS THE POSTERIOR COMMUNICATINGSEGMENT OF THE INTERNAL CAROTID ARTERY WITH 3.6MM DIAMETER. THE BRANCH VESSEL WAS THE POSTERIOR COMMUNICATING ARTERY WITH 2.1MM DIAMETER. THERE WAS NO BIFURCATION SPAN. STROKE ONSET TO REPERFUSION TIME WAS 1. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT ANGIOGRAPHY SHOWED THAT THE ANEURYSM WAS A POSTERIOR COMMUNICATING SEGMENT ANEURYSM AND THERE WERE SUB-TUMORS. THE SURGICAL PLAN WAS STENT-ASSISTED EMBOLIZATION. THE MICRO-GUIDE WIRE WITH THE MICRO-CATHETER REBAR 18, AND THE MICRO-CATHETER REACHED THE PREDETERMINED POSITION. THE MICRO GUIDE WIRE WITH ECHELON-10 IN PLACE FOR THE ANEURYSM. THE FIRST COIL WAS EMBOLIZED WITH APB-4-8-3D-ES. PART OF THE CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571922 ↗
• InjuryFeb 7, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT REGARDING TWO AXIUM COILS BEING STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3.6 MM AND A 1.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT AS PER OPERATOR THE COIL WAS STRETCHED AND WAS DISTURBING THE COIL MASS. HENCE IT WAS REMOVED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE/STRETCHED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN REPOSITIONED THE COIL DURING THE PROCEDURE TWO TIMES WITH THE FIRST COIL (LOT# B056574) AND ONE TIME WITH THE SECOND COIL (LOT# B008426). 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 NEURON MAX SHEATH, NEURON GUIDE CATHETER, HEADWAY 17  MICROCATHETER, TRAXCESS GUIDEWIRE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED WITH NO ABUNDANT AND WAS PLANNED THE NEXT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313694 ↗
• MalfunctionJan 4, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ANEURYSM EMBOLIZATION WAS PERFORMED AND AFTER THE MICROCATHETER WAS IN PLACE, IT WAS FOUND THAT THE SPRING COIL COULD NOT BE PUSHED OUT. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE SPRING COIL WAS SELECTED FOR FILLING, AND THE TAIL END OF THE SPRING COIL WAS STRETCHED. LATER, IT WAS REPLACED WITH THE SPRING COIL OF ANOTHER MODEL, THE FILLING WENT SMOOTHLY AND THE SURGERY WAS COMPLETED. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES 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 A SACCULAR, UNRUPTURED LEFT SIDE OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. THE ACCESS ARTERY WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8 MM. ANCILLARY DEVICES INCLUDE A SHEATH AND ECHELON MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WERE NO ISSUES NOTED THAT RESULTED IN THE COIL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095509 ↗
• MalfunctionNov 4, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS NOT DETACHED. THE INSTANT DETACHER WAS USED 3 TIMES AND THE MANUAL DETACHMENT WAS ATTEMPTED ONCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE MCA 3MM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS NOT DETACHED. THE INSTANT DETACHER WAS USED 3 TIMES AND THE MANUAL DETACHMENT WAS ATTEMPTED ONCE. THE PHYSICIAN DID NOT USE ANOTHER INSTANT DETACHER. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A MICROCATHETER SL 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752284 ↗
• MalfunctionJun 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THE INSTANT DETACHER WAS USED ON THE COIL. ONE OF THE COILS WAS PREMATURELY RELEASED INTO THE MICROCATHETER, AND IT WAS NECESSARY TO REMOVE IT AND PUSH THE COIL WITH A MICROGUIDE. THE OTHER COIL WAS DETACHED INSIDE THE ANEURYSM, BUT WHEN IT WAS REMOVED OR PUSHED FROM IT, IT CAME WITH IT. WHEN AN ATTEMPT WAS MADE TO REPOSITION THE COIL, IT DETACHED IT EARLY. THERE WAS NO TWIST OR SIGN OF DAMAGE ON THE PUSHWIRE, AND THE COIL WAS IMPLANTED IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040155 ↗
• MalfunctionApr 12, 2021Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654171 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE ¿ILT.C-PC.¿ THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT EARLY DETACHMENT OCCURRED DURING INSERTION INTO THE MICROCATHETER THROUGH THE SHEATH IN THE THIRD PRIME WITH AN COIL. THE MICROCATHETER AND DETACHED COIL WERE REMOVED FROM THE PATIENT. THE DELIVERY PUSHER WAS DEFORMED/DAMAGED, WHICH WAS NOT DONE INTENTIONALLY. THE COIL HAD BEEN RELOCATED ONCE, AND NO DETACHMENT ATTEMPTS WERE MADE. THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT¿S BODY, AND A CONTINUOUS FLUSH WAS USED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, COMPLICATIONS, OR ADDITIONAL MEDICAL/SURGICAL PROCEDURES. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448826 ↗
• MalfunctionMay 27, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID-POSTERIOR CEREBRAL ARTERY. THE ANEURYSM MAX DIAMETER WAS 5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICE WAS PREPARED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED BUT FAILED TO DETACHER AFTER TWO ATTEMPTS WITH THE INSTANT DETACHER. MANUAL DETACHMENT WAS ATTEMPTED ONCE BUT ALSO FAILED. THE COIL WAS REMOVED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10091732 ↗
• MalfunctionNov 26, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH WITH THE INSTANT DETACHER OR MANUAL DETACHMENT METHOD. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION OR ARTERIOVENOUS FISTULA IN THE ELOQUENT AREA OF THE BRAIN. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE TRANSARTERIAL EMBOLIZATION (TAE) WAS PERFORMED FOR D-ARTERIOVENOUS FISTULA (AVF). COIL EMBOLIZATION WAS PERFORMED VIA HEADWAYDUO FROM DISTAL FEEDER OF OCCIPITAL ARTERY (OA). THE REPORTED PRODUCT WAS INSERTED AS THE 6TH ONE. THE DETACHMENT WAS ATTEMPTED WITH ID-1 TWICE, BUT IT FAILED. THE BREAK INDICATOR WAS BENT TO TRY TO PERFORM THE DETACHMENT, BUT, IT FAILED. AN ATTEMPT WAS MADE TO RETRIEVE THE DEVICE WITHOUT ANY ACTION, BUT IT WAS DETACHED HALFWAY IN THE MICROCATHETER. THE DEVICE WAS RETRIEVED TOGETHER WITH MICROCATHETER. THERE IS NO PATIENT INJURY. THE PROCEDURE WAS CONTINUED WITHOUT ANY ACTION, AND IT WAS COMPLETED SAFELY. ANCILLARY DEVICES INCLUDE A HEADWAY DUO MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9379063 ↗
• MalfunctionOct 14, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME DETACHABLE COIL SYSTEM FAILED TO DETACH AT THE TARGET SITE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF SACCULAR, UNRUPTURED, A-COM ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PRODUCT WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), INSERTED INTO THE TARGET SITE OF THE CEREBRAL ANEURYSM, AND ATTEMPTED TO BE IMPLANTED. HOWEVER, IT FAILED IN DETACHMENT EVEN THOUGH THE ATTEMPT WAS MADE TWICE WITH THE INSTANT DETACHER. THE MANUAL DETACHMENT METHOD WAS ATTEMPTED ONCE, BUT IT STILL FAILED DETACHMENT. THE DEVICE WAS RETRIEVED. WHEN THE HEALTHCARE PROVIDER (HCP) VISUALLY CONFIRMED THE COIL PART, THE COIL CAME OFF. THERE WAS NO PATIENT INJURY REPORTED WITH THE EVENT. ANCILLARY DEVICES INCLUDE AN ECHELON10 STRAIGHT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9189294 ↗
• MalfunctionOct 22, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN TRYING TO RETRIEVE THE WIRE, THE COIL CAME ALONG WITH IT. THE PHYSICIAN DETACHED THE COIL WITH THE DETACHER AND TRIED TO RETRIEVE THE WIRE AGAIN, BUT THE COIL CAME ALONG WITH THE WIRE. AS A RESULT THE PHYSICIAN USED THE MANUAL DETACHMENT METHOD, BREAKING ALONG THE INDICATOR, AND PULLED THE RELEASE WIRE INSIDE FOR ABOUT 3CM IN AN ATTEMPT TO RETRIEVE THE WIRE, BUT IT STILL CAME ALONG. THE PHYSICIAN THEN SLIGHTLY PUSHED THE WIRE OVER THE SECOND MARK A LITTLE AND REPEATED THIS ABOUT 7 TIMES, WITH THE WIRE EVENTUALLY RETRIEVED WITHOUT PROBLEM AND THE COIL PLACED IN THE ANEURYSM. AFTERWARDS ANOTHER NON-MDT COIL WAS USED AND THE PROCEDURE COMPLETED WITHOUT ISSUE., THE PATIENT WAS UNDERGOING SURGERY TO TREAT A 2.1MM CEREBRAL ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MEDIUM WITH A SLIGHTLY SMALL VESSEL DIAMETER. TWO XL COILD AND NANO HAD ALREADY BEEN PLACED SMOOTHLY AND DETACHED WITH A DETACHER PRIOR TO THE ISSUE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991415 ↗