Axium PrimeTMRecalls & reported problems across all models

We found 66 models of Axium PrimeTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 237 adverse event reports in the FDA's MAUDE database, received between Sep 24, 2019 and Mar 29, 2024 — classified as 1 death, 14 injuries, 222 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (112 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 Axium PrimeTM problems

Axium PrimeTM models

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

• Axium PrimeTM APB-1.5-2-HX-ES

  Device, Vascular, for Promoting Embolization
  13 reports
• Axium PrimeTM APB-1-3-3D-ES

  Device, Vascular, for Promoting Embolization
  9 reports
• Axium PrimeTM APB-3-4-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• Axium PrimeTM APB-6-20-3D-SS

  Device, Vascular, for Promoting Embolization
  9 reports
• Axium PrimeTM APB-1-2-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Axium PrimeTM APB-2-4-3D-ES

  Device, Vascular, for Promoting Embolization
  8 reports
• Axium PrimeTM APB-3-6-3D-ES

  Device, Vascular, for Promoting Embolization
  8 reports
• Axium PrimeTM APB-1.5-4-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Axium PrimeTM APB-2-8-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Axium PrimeTM APB-1.5-2-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• Axium PrimeTM APB-2.5-6-3D-ES

  Device, Vascular, for Promoting Embolization
  7 reports
• Axium PrimeTM APB-5-15-3D-SS

  Device, Vascular, for Promoting Embolization
  7 reports
• Axium PrimeTM APB-1-2-HX-ES

  Device, Vascular, for Promoting Embolization
  7 reports
• Axium PrimeTM APB-1.5-3-HX-ES

  Device, Vascular, for Promoting Embolization
  7 reports
• Axium PrimeTM APB-2.5-4-3D-ES

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium PrimeTM APB-4-8-3D-SS

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium PrimeTM APB-2-6-HX-ES

  Device, Vascular, for Promoting Embolization
  1 death6 reports
• Axium PrimeTM APB-1-4-3D-ES

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium PrimeTM APB-2-2-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Axium PrimeTM APB-4-12-3D-SS

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium PrimeTM APB-2-4-HX-ES

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium PrimeTM APB-3-8-HX-ES

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium PrimeTM APB-3-8-3D-ES

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium PrimeTM APB-5-20-HX-SS

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium PrimeTM FC-3-8-3D

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium PrimeTM APB-2-3-3D-ES

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium PrimeTM APB-4-6-3D-SS

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium PrimeTM APB-4-10-3D-SS

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium PrimeTM APB-1-1-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium PrimeTM FC-4-8-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium PrimeTM FC-5-10-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium PrimeTM FC-7-20-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium PrimeTM APB-1.5-3-3D-ES

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM APB-5-10-3D-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM APB-1-3-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Axium PrimeTM APB-2-2-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Axium PrimeTM APB-3-6-HX-ES

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM APB-4-8-HX-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM APB-4-12-HX-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM FC-3-6-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM FC-3.5-8-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM FC-7-30-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM FC-9-30-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium PrimeTM FC-14-40-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Axium PrimeTM APB-3.5-6-3D-ES

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-6-15-3D-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-1.5-1-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM APB-2-1-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM APB-2-3-HX-ES

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-2.5-4-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM APB-2.5-6-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM APB-2.5-8-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM APB-3-4-HX-ES

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-3-10-HX-ES

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-4-10-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-5-15-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM APB-6-20-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM FC-3-10-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM FC-3.5-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM FC-4-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM FC-5-15-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM FC-5-20-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM FC-6-20-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM FC-8-30-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium PrimeTM FC-12-40-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium PrimeTM FC-25-50-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent Axium PrimeTM adverse event reports

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

• MalfunctionMar 29, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED A2/PERICALLOSAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COMPLEX STENT COIL, DISTAL ANATOMY THAT DID WAS NOT AMENABLE TO DUAL MICROCATHETER PLACEMENT. ATLAS STENT WAS DEPLOYED WITH NO COMPLICATION. DUE TO 1 MICROCATHETER BEING USED, THEY HAD TO RE-ACCESS THE ANEURYSM THROUGH THE STENT (NOT UNCOMMON). THEY ENCOUNTERED SOME RESISTANCE ON THE PROXIMAL TINES OF THE STENT WITH THE MICROCATHETER (017 MC, 014 WIRE). THE STENT DID SLIGHTLY MIGRATE PROXIMAL TO DISTAL BUT NOTHING THAT PREVENTED FROM CONTINUING. THEY CONTINUED TO HAVE DIFFICULTY GETTING THROUGH THE STENT TO THE ANEURYSM WITH MULTIPLE ATTEMPTS. ONCE THEY DID GET ACCESS, THE MICROCATHETER TIP WAS IN THE SMALLER OF THE 2 LOBES OF THE ANEURYSM. TRIED TO DEVIATE BUT THE MICROCATHETER HAD A WEIRD SHAPE. THE DECISION TO DELIVER THE FIRST COIL WAS MADE. THE FIRST COIL 3.5 X 6 FRAME WAS ABLE TO FORM PROPERLY AND FILL IN SPACES THAT THEY WANTED. THE DETACHER WAS USED PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004275 ↗
• MalfunctionMar 29, 2024Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THREE COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED A2/PERICALLOSAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT COMPLEX STENT COIL, DISTAL ANATOMY THAT DID WAS NOT AMENABLE TO DUAL MICROCATHETER PLACEMENT. ATLAS STENT WAS DEPLOYED WITH NO COMPLICATION. DUE TO 1 MICROCATHETER BEING USED, THEY HAD TO RE-ACCESS THE ANEURYSM THROUGH THE STENT (NOT UNCOMMON). THEY ENCOUNTERED SOME RESISTANCE ON THE PROXIMAL TINES OF THE STENT WITH THE MICROCATHETER (017 MC, 014 WIRE). THE STENT DID SLIGHTLY MIGRATE PROXIMAL TO DISTAL BUT NOTHING THAT PREVENTED FROM CONTINUING. THEY CONTINUED TO HAVE DIFFICULTY GETTING THROUGH THE STENT TO THE ANEURYSM WITH MULTIPLE ATTEMPTS. ONCE THEY DID GET ACCESS, THE MICROCATHETER TIP WAS IN THE SMALLER OF THE 2 LOBES OF THE ANEURYSM. TRIED TO DEVIATE BUT THE MICROCATHETER HAD A WEIRD SHAPE. THE DECISION TO DELIVER THE FIRST COIL WAS MADE. THE FIRST COIL 3.5 X 6 FRAME WAS ABLE TO FORM PROPERLY AND FILL IN SPACES THAT THEY WANTED. THE DETACHER WAS USED PER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004252 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. THE COIL HAS BEEN DETACHMENT IN ADVANCE. THE PROCEDURE IS COMPLETED BY PUSHING THE COIL WITH A WIRE. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICAIN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN DID NOT ROTATED GTHE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PERPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT PARACLINOID. THE MAX DIAMETER WAS 10MM AND THE NECK DIAMETER WAS 4MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTOUSITY WAS MODERATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996433 ↗
• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE OF THE COIL FAILED TO PASS THE MICROCATHETER'S HUB. THE SECOND COIL WAS STRETCHED IN THE MICROCATHETER. THE THIRD COIL'S WIRE WAS BROKEN WHEN THE DOCTOR TOOK IT OUT. 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. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO SYMPTOMS ASSOCIATED WITH THIS EVENT. THE MODEL NUMBER OF THE COIL THAT FAILED TO PASS THE MICROCATHETER HUB (LOT NUMBER A239068) B239068. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT; STRYKER SL-10.THE COIL¿S WIRE WAS BROKEN INSIDE THE BOX. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS PREPARATION COMPLETED BEFORE THE DAMAGE WAS NOTICED AND THAT THE DAMAGE WAS NOTICED IMMEDIATELY AFTER OPENING THE PACKAGE. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18900132 ↗
• MalfunctionFeb 19, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) BIFURCATION WITH A MAX DIAMETER OF 3.8 MM AND A 2.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE COILING PROCEDURE APB-2-4-3D-ES COULDN'T BE DETACHED. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. 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 18731300 ↗
• MalfunctionJan 16, 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 THERE WERE ANY NO DETACHMENT ATTEMPTS (INSTANT DETACH OR MANUAL METHOD) MADE. THERE WAS NO KI NK/DAMAGE OBSERVED ON THE PUSHWIRE. THERE WERE 2 COILS IMPLANTED BEFORE AND 2 COILS IMPLANTED AFTER THIS MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517575 ↗
• MalfunctionJan 5, 2024Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. DURING PROCEDURE COIL HAD PREMATURE DETACHMENT INTO MICROCATHETER'S DISTAL PORTION BEFORE COMPLETE THE WALL APPOSITION IN ANEURYSM, THEN PHYSICIAN CAREFULLY REMOVED FULL SYSTEM, GUIDE CATHETER, AND MICRO CATHETER WITH DAMAGE COIL. THEN HEALTHCARE PROVIDER (HCP) CAREFULLY REMOVED ALL SYSTEMS FROM THE PATIENT'S RIGHT MIDDLE CEREBRAL ARTERY (MCA) 1 SEGMENT WITHOUT MOVING FORWARD. THE COIL WAS REMOVED FROM THE PATIENT. THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICAN ATTEMPTED TO DETACH THE COIL 1 TIME WITH THE INSTANT DETACHED. THE PHYSICAN TRIED 2 INSTANT DETACHERS. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE RIGHT MCA. THE MAX DIAMETER WAS 6.7MM AND THE NECK DIAMETER WAS 4.3MM. PATIENT BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: REDIO FUCUS, 7 F, 10 CM SHEATH, ENVOY 6F, 100 CM GUIDE CATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450358 ↗
• MalfunctionDec 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL HAD RESISTANCE IN THE PHENOM 17 HUB. THE AXIUM COIL AND PHENOM 17 WERE NOT DAMAGED. THE AXIUM COIL AND ANY ACCESSORIES 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 ENVOY DA 6F GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279412 ↗
• MalfunctionDec 4, 2023Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO SYMPTOMS ASSOCIATED WITH THIS EVENT. THE MODEL NUMBER OF THE COIL THAT FAILED TO PASS THE MICROCATHETER HUB (LOT NUMBER A239068) B239068. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT; STRYKER SL-10.THE COIL¿S WIRE WAS BROKEN INSIDE THE BOX. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18260162 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE LOCATION IN THE CATHETER OF THE RESISTANCE WAS UNKNOWN. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED ON THE COIL AFTER REMOVAL. THERE WERE NO ISSUES THAT RESULTED FROM THE DAMAGE THAT WAS FOUND. THERE WERE NO DETACHMENT ATTEMPTS. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE PHYSICIAN OBSERVED THE PREMATURE DETACHMENT IN THE CATHETER. IT WAS UNKNOWN HOW MANY COILS WERE IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED DUE TO COIL IMPLANTATION IN AN UNTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257582 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT VESSEL TORTUOSITY WAS NORMAL. THE PATIENT DIDN'T EXPERIENCE ANY SYMPTOMS RELATED TO THE PREMATURE DETACHMENT. THE CAUSE OF THE PUSHER KINK WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. NO DETACHMENT ATTEMPTS WERE ATTEMPTED. IT WAS NOTED THAT THE DOCTOR USED 5 OR 6 COILS IN TOTAL. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257570 ↗
• MalfunctionSep 20, 2023Separation 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 17783011 ↗
• MalfunctionSep 12, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE 5TH AXIUM COIL WAS TAKEN TO FILL THE INFERIOR SPACE OF THE ANEURYSM WHICH WAS FILLING IN THE ANGIOGRAPHY, IT COULD NOT DETACH. THE AXIUM COIL WAS NOT DETACHED WITH THE INSTANT DETACHER AND MANUAL ALSO TRIED BUT THAT WAS UNSUCCESSFUL. THE PHYSICIAN TOOK OUT THE AXIUM COIL AND ANOTHER COIL WAS DEPLOYED. THE PHYSICIAN ATTEMPTED TO DETACH THE AXIUM USING THE INSTANT DETACHER 3 TIMES WITH ONLY 1 INSTANT DETACHER. THERE WAS A 1 MANUAL ATTEMPT BY USING THE HYPOTUBE BUT IT GOT BROKEN. THE AXIUM AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (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, RUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 16MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A NEURONMAX SHEATH, NEURON GUIDE CATHETER, ECHELON 10 MICROCATHETER, AND A TRAXCESS GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733772 ↗
• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE ECHELON 10 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4 MM. THE NECK DIAMETER WAS 3 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, AND IT WAS 7 MM IN DIAMETER. IT WAS REPORTED THAT THE SPRING COIL COULD NOT BE PUSHED OUT OF THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AXIUM COIL PUSH OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430056 ↗
• MalfunctionJul 31, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL BECAME STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.79 MM. THE NECK DIAMETER WAS 3.68 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT IN THE PROCESS OF DEPLOYING AND RECAPTURING THE FIRST COIL, THE COIL WAS STRETCHED AND PULLED OUT TOGETHER WITH THE CATHETER. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PHYSICIAN HAD REPOSITIONED THE COIL TWO TIMES. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL 10 S SHAPE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL STAYED IN THE MICROCATHETER, WITH THE CAUSE OF THE STRESS BEING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17429714 ↗

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