Axium PrimeTM APB-2-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536032194), received between Dec 29, 2020 and Feb 8, 2023 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2023Detachment 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 RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION. THE MAX DIAMETER WAS 5.33MM, AND THE NECK DIAMETER WAS 3.16MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS NO RESISTANCE FELT WHILE PUSHING OUT FROM THE COIL INTRODUCER. WHILE A FEW CENTIMETERS OF THE COIL WERE ALREADY PUSHED INSIDE THE ANEURYSM, THE DISTAL END OF THE PUSHER WIRE SUDDENLY SNAPPED AND DETACHED FROM THE COIL. THE COIL FAILED TO BE RETRIEVED USING A TREVO STENT AND REMAINED IN THE VESSEL. IT WAS NOT IMPLANTED IN THE INTENDED LOCATION, AND THE PATIENT REQUIRED DUAL ANTIPLATELET TREATMENT FOR 6 MONTHS. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, ATTEMPTS TO DETACH THE COIL, OR ROTATE THE DELIVERY PUSHER. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BOSTON SCIENTIFIC SOFT TIP

  Patient problems: Foreign Body In Patient

  MAUDE report 16321521 ↗
• InjurySep 2, 2021Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AWAKE FROM NORMAL ANESTHESIA AFTER THE SURGERY. THEY EXPERIENCED TO SYMPTOMS, AND WERE DISCHARGED NORMALLY WITH NO EXTENDED HOSPITALIZATION. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE COIL DETACHED, RADIOGRAPHY SHOWED THAT THERE WAS NO OBVIOUS ADVERSE EFFECT, AND THE COIL WAS FILLED IN THE FOLLOW-UP, AND THE SURGERY WAS COMPLETED NORMALLY. NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE COIL DETACHED ON ITS OWN. POSTOPERATIVE ANGIOGRAPHY SHOWED THAT THE COIL WAS STABLE, DID NOT MOVE, AND THE ARTERY WAS UNOBSTRUCTED WITH NO THROMBOSIS. THE SURGEON JUDGED THAT THERE WAS NO NEED FOR STENT ASSISTANCE OR OTHER ADDITIONAL INTERVENTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414038 ↗
• MalfunctionJun 1, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE DOCTOR TRIED DETACHMENT SEVERAL TIMES, THE COIL WAS CONTINUOUSLY COMING OUT WITH THE PUSHER. NO MANUAL DETACHMENTS WERE MADE WITH THE HYPOTUBE, AND ONLY A SINGLE INSTANT DETACHER WAS USED. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE DOCTOR REMOVED THE COIL WITH THE CATHETER AND WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A 6F ENVOY GUIDE CATHETER, SL-10 MICROCATHETER, AND SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914573 ↗
• DeathMay 17, 2021Stretched; Detachment of Device or Device Component; Material Deformation; Stretched; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT DIED ON THE EARLY MORNING OF (B)(6). THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION, AND IT IS UNKNOWN IF ANY SURGICAL OR MEDICAL INTERVENTION WAS TAKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY.

  Patient problems: Foreign Body In Patient; Loss of consciousness; Obstruction/Occlusion; Perforation of Vessels; Respiratory Failure; Stroke/CVA

  MAUDE report 11838740 ↗
• InjuryJan 15, 2021Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE FIRST TWO COILS (3*2, 2*8) WERE SUCCESSFULLY FILLED INTO THE ANEURYSM. DURING THE FILLING OF THE THIRD COLIL (2*6) THE COIL WAS STRETCHED, AND A STENT WAS USED TO ASSIST TO MAKE THE COIL GO AGAINST THE WALL. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION, THERE WAS NO MEDICAL OR SURGICAL INTERVENTION, AND THE PUSHWIRE WAS NOT DAMAGED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY NOTED, NO DETACHMENT ATTEMPTS WERE MADE, REPOSITIONING WAS PERFORMED THREE TIMES, ROTATION WAS PERFORMED, AND A CONTINUOUS FLUSH WAS ADMINISTERED. 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 AMORPHOUS, RUPTURED ANEURYSM OF THE MIDDLE CEREBRAL ARTERY (MCA) WITH A MAX D IAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A TERMAO SHEATH, JOHNSON & JOHNSON GUIDECATHETER, MEDTRONIC MICROCATHETER. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATED THAT THE COIL WAS STRETCHED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11178257 ↗
• MalfunctionDec 29, 2020Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088191 ↗