Concerto Detachable Coil System NV-4-10-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00847536044920), received between Jun 24, 2022 and Sep 28, 2026 — classified as 2 deaths, 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (12 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919760 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875993 ↗
• MalfunctionJun 30, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO FINISH THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS NOTED THE VESSEL TORTUOSITY WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO CAUSES OR CONTRIBUTING FACTORS FOR THE KINK AND RESISTANCE WERE IDENTIFIED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. RESISTANCE LOCATION WITHIN THE CATHETER, WHETHER OR NOT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND IF THERE WAS ANY KINK/DAMAGE OBSERVED TO THE COIL OR CATHETER AFTER REMOVAL COULD NOT BE RECALLED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668059 ↗
• MalfunctionJun 9, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW MEDTRONIC DEVICE WAS USED TO FINISH THE PROCEDURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS NOTED THE VESSEL TORTUOSITY WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSES AND CONTRIBUTING FACTORS FOR THE KINK WERE NOT IDENTIFIED. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE; ALL INFORMATION WAS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448342 ↗
• MalfunctionMay 12, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH FROM THE DELIVERY SYSTEM. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING AN INSTANT DETACHER AND ALSO ATTEMPTED A MANUAL BREAK. NO SECOND INSTANT DETACHER WAS USED. A MANUAL DETACHMENT VIA THE HYPOTUBE WAS PERFORMED MULTIPLE TIMES, AND THE MANUAL BREAK WAS ATTEMPTED AT THE CORRECT BREAK MARK LOCATION (THE SECOND DISTAL HYPOTUBE BREAK INDICATOR). THE INSTANT DETACHER WILL NOT BE RETURNED FOR INVESTIGATION, AND NO ISSUE WITH THE INSTANT DETACHER WAS REPORTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED .NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149925 ↗
• MalfunctionMar 12, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO HELIX COIL ENCOUNTERED RESISTANCE, AND FAILED TO PASS AND BECAME STUCK AT THE HUB OF A N ON-MEDTRONIC MICROCATHETER. THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.  IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THEINSTRUCTIONS FOR USE (IFU). THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WAS NO DAMAGE TO THE CATHETER OR COIL. ANCILLARY DEVICES INCLUDED A PROGREAT MICROCATHETER. 2025-DEC-11 E1 (FOR, REP, HCP): ADDITIONAL INFORMATION WAS RECEIVED THAT THE LESION WAS LOCATED IN THE PULMONARY ARTERY, 2-3MM. IT WAS NOTED THAT CAUSE OF THE RESISTANCE WAS THOUGHT TO BE THAT IT CAUGHT INSIDE THE MICROCATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584412 ↗
• MalfunctionJan 16, 2026Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED AN INSTANT DETACHER WAS NOT USED IN THIS PROCEDURE. IT WAS UNKNOWN HOW MANY MANUAL DETACHMENTS WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095359 ↗
• MalfunctionDec 29, 2025Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH FROM DELIVERY WIRE WHEN WIRE WAS SNAPPED. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN DID NOT USE AN INSTANT DETACHER, THE WIRE WAS SNAPPED. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906388 ↗
• MalfunctionNov 26, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONCERTO COIL WAS KINKED AND GOT STUCK WITHIN THE MICROCATHETER. A NEW COIL WAS USED TO FINISH THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663060 ↗
• MalfunctionNov 5, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN DID NOT REPORT RESISTANCE FOR THE NV-4-10-HELIX COIL DESPITE REPORT THAT THE COIL BROKE AND APPEARED TO BE STUCK IN THE CATHETER. THE CAUSE OF THE ISSUES WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476827 ↗
• MalfunctionSep 5, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CONCERTO COIL DID NOT DETACH DURING A PROCEDURE. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL THREE TIMES WITH THE INSTANT DETACHER AND THREE TIMES MANUALLY VIA THE HYPOTUBE, BUT DETACHMENT WAS UNSUCCESSFUL. A SECOND INSTANT DETACHER HAD NOT BEEN USED, AND IT WAS SAID THERE WAS NO PROBLEM WITH THE INSTANT DETACHER. NO CONTINUOUS FLUSH WAS USED DURING DEVICE PREPARATION AS INDICATED IN THE INSTRUCTIONS FOR USE. THE PATIENT HAD NORMAL BLOOD FLOW. THE PRODUCT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A PROGREAT 2.4 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986908 ↗
• MalfunctionAug 19, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO PUSHWIRE KINKED IN THE DISTAL SEGMENT. THERE HAD BEEN FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH WAS ADMINISTERED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INVOLVED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETE WITH ANOTHER MANUFACTURERS COIL. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE SECURED WAS IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPEN ED. THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE. PREPARATION WAS PERFORMED PRIOR TO DAMAGE BEING SEEN. THERE WAS NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. DIDN'T INSERT THE MICROCATHETER. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOT HLY. THE KINK WAS OBSERVED AFTER REMOVAL. THERE WAS NO DAMAGE THE CATHETER. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844791 ↗
• MalfunctionJul 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONCERTO COIL DID NOT PASS THROUGH THE MICROCATHETER. THE PRODUCT WAS BEING USED AS PER THE INSTRUCTIONS FOR USE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE CATHETER HUB. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE COIL OR CATHETER. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22499241 ↗
• MalfunctionMar 19, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE COIL CONCERTO HELIX 4MM X 10CM AND COIL CONCERTO HELIX 3MM X 4CM, THERE WAS A NON-DETACHMENT ISSUE WITH BOTH COILS. THE DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE, SPECIFICALLY LACKING CONTINUOUS FLUSH. MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE WERE MADE TWICE FOR EACH COIL, BUT DETACHMENT FAILED. ONE INSTANT DETACHER WAS USED AND WAS DISCARDED, THUS NOT RETURNED FOR INVESTIGATION. TWO ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER FOR THE COIL CONCERTO HELIX 3MM X 4CM. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE PATIENT WAS ALIVE WITH NO INJURY REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649291 ↗
• MalfunctionMar 11, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY REMOVING THE COIL AND USING ANOTHER. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE¿DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THERE WERE NO ISSUES WITH THE REBAR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575204 ↗
• MalfunctionFeb 21, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COILS EXPERIENCE RESISTANCE IN THE MIDDLE OF THE ECHELON (ECHELON 10 .017 ID) CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: Foreign Body In Patient

  MAUDE report 21433133 ↗
• MalfunctionMay 6, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL PUSHER COULDN¿T BE INSERT INTO THE DETACHER AND IT CAUSED THE POSITIVE LOAD MARKER KINK (DISTAL END). THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A NEUROVASCULAR ABNORMALITIES (E.G. ARTERIOVENOUS MALFORMATIONS OR FISTULAE). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER DEPLOYED THE COIL BY BREAKING DOWN THE HYPOTUBE. THE CAUSE OF THE EVENT WAS NOTED THAT IT CANNOT BE INSERT INTO THE DETACHER, AND THE CUSTOMER SAID THERE IS NO ANY INDICATION FOR EASY INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250363 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD 6 CONCERTO COILS IMPLANTED TO TREAT A 13MM SACCULAR ANEURYSM WITH VESSEL OCCLUSION COIL EMBOLIZATION ON (B)(6) 2022. ALL THE INVOLVED COILS WERE DELIVERED AND DEPLOYED SUCCESSFULLY TO ACHIEVE SUCCESSFUL TREATMENT OF THE TARGET VESSEL. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED ISCHEMIC CHOLECYSTITIS. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT RESOLVED WITH THE MEDICAL TREATMENT AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THE SITE AND STUDY SPONSOR ASSESSMENTS OF THE EVENT BOTH CONCLUDED THE EVENT WAS POSSIBLY/PROBABLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE CONCERTO DEVICES.

  Patient problems: Inflammation; Ischemia

  MAUDE report 19128242 ↗
• MalfunctionMar 18, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CORRECTED THAT THERE WERE NO ATTEMPTS AT ALL TO RELEASE THE COIL. THEY COULD NOT START THE RELEASE PROCESS AS THE COIL WAS STUCK IN THE MICROCATHETER. THERE WAS NOT RESISTANCE WHEN THEY WERE MOVING THE COIL FORWARD WITH THE PUSHWIRE, AT WHICH TIME NO PUSHWIRE KINK WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924565 ↗
• MalfunctionFeb 14, 2024Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE OPENING OF THE SUPPLY IN THE HEMODYNAMICS ROOM REALIZED IT WAS ALREADY RELEASED. IT IS CLEAR THAT THIS DEVICE DID NOT REACH THE PATIENT. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. TH ERE WAS NO FRICTION 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. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704671 ↗
• MalfunctionJan 26, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE CONCERTO COIL WOULD NOT DETACH AND ANOTHER CONCERTO COIL ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF GROSS HEMATURIA. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE CONCERTO COIL (LOT # 226824988) AND IT TRACKED AS USUAL. WHEN TRYING TO DETACH WITH THE INSTANT DETACHER IT DID NOT DETACH. THEN, WHEN TRYING TO DETACH VIA THE MANUAL WIRE BREAK IT ALSO WOULD NOT DETACH. WE PULLED THE ENTIRE SYSTEM AND AT SOME POINT THE COIL DETACHED. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WERE THREE ATTEMPTS MADE AT MANUAL DETACHMENT VIA HYPOTUBE.  FOR CONCERTO COIL (LOT # 227053104) COIL WOULD NOT TRACK THROUGH THE MICROCATHETER, MAJOR RESISTANCE WAS DETECTED. AFTER PRIOR COIL OF THE SAME SIZE HAD DETACHMENT ISSUES, I ADVISE OPERATOR TO PULL COIL IMMEDIATELY. IT WAS REPORTED THE COIL WAS STUCK AT THE CATHETER HUB AND IN THE PROXIMAL SECTION. THE COIL DID PUSH OUT OF THE INTRODUCER SHEATH SMOOTHLY. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18590054 ↗
• MalfunctionJan 24, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576166 ↗
• MalfunctionAug 29, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH AFTER MULTIPLE ATTEMPTS. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644790 ↗
• DeathJun 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REGARDING 10 CONCERTO COILS THAT HAD COMPACTION DURING THE PROCEDURE. IN THE FOLLOWING WEEKS POST-OPERATIVE, THE PATIENT EXPERIENCED UNRELATED SUBDURAL HEMATOMA AND DIED. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A 1-2MM SACCULAR PSEUDOANEURYSM AND HEMORRHOIDS. IT WAS NOTED THAT THE 10 CONCERTO COILS WERE DELIVERED, DEPLOYED, AND DETACHED SUCCESSFULLY AS INTENDED. COIL COMPACTION WAS OBSERVED BUT NO REPORTED IMPACT TO THE PATIENT AT THE TIME OF THE PROCEDURE. ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL AND WAS NOTED TO HAVE AN ACUTE LEFT SUBDURAL HEMATOMA (SDH). THE PATIENT EXPERIENCED SEVERAL EPILEPTIC SEIZURES AND DIED, AS A RESULT, ON (B)(6) 2023. THE SITE ASSESSMENT OF THE EVENTS CONCLUDED THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR THE DEVICES. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLY RELATED TO THE PROCEDURE BUT NOT RELATED TO THE DEVICES. HOWEVER, THE INVESTIGATOR CONCLUSION AGREED WITH THE SITE ASSESSMENT THAT THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR DEVICES. ADDITIONAL INFORMATION RECEIVED REPORTED SINCE THIS ADVERSE EVENT OCCURRED 10

  Patient problems: Convulsion/Seizure; Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175193 ↗
• DeathJun 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE HOSPITAL STAY AN INTRACRANIAL BLEEDING WAS OBSERVED. ANEURYSM EMBOLIZATION TECHNIQUE-1: FRONT DOOR. TRAUMATIC BLEED EMBOLIZATION TECHNIQUE-1: TOTAL VESSEL OCCLUSION.

  Patient problems: Convulsion/Seizure; Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175180 ↗

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