Concerto Detachable Coil System NV-5-20-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00847536044944), received between Jun 28, 2022 and Aug 13, 2026 — classified as 1 death, 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (12 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Deformation; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235267 ↗
• MalfunctionJul 9, 2026Inadequacy of Device Shape and/or Size; Compatibility Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT MODEL WAS INCOMPATIBLE, SO IT WAS REPLACED WITH A DIFFERENT MODEL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COLLATERAL EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765216 ↗
• MalfunctionJun 15, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT CONCERTO COIL PREMATURE DETACHMENT IN CATHETER WAS ENCOUNTERED WHEN ADVANCING. THE COIL WAS REMOVED FROM THE PATIENT BY PULLOUT TOGETHER WITH WIRE. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDED TOKAI 1.9 FR MICROCATHETER, BOSTON TRANSEND 0.014 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511234 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DETACHED PREMATURELY WITHIN MICROCATHETER AND THE SURGEON HAD TO SNARE IT OUT. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED; THE STATUS OF WHETHER THE PUSHWIRE WAS BENT OR BROKEN IS UNKNOWN, IT WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED, THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL, DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE, AND A CONTINUOUS FLUSH WAS NOT ADMINISTERED. 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 24730284 ↗
• MalfunctionMar 19, 2026Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO 20 MM CONCERTO COILS WOULD NOT DETACH DUE TO FILAMENT BREAK, AND ONE 15 MM CONCERTO COIL WOULD NOT DETACH WHEN IT BROKE AT ITS END. THE PATIENT WAS TREATMENT FOR A GASTROINTESTINAL BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE TWO 20MM CONCERTO COILS WOULD NOT DETACH BECAUSE THE FILAMENT IN THE DETACHMENT FILAMENT BROKE AT HYPO TUBE BREAK INDICATOR WHEN ATTEMPTING TO MANUALLY DETACH THE COILS. THERE WAS NOT ENOUGH FILAMENT EXPOSED TO MANUALLY PULL TO DETACH THE COILS. THE COILS WERE REMOVED WITHOUT COMPLICATION AND NO RESISTANCE OCCURRED IN THE NON-MEDTRONIC CATHETER DURING DELIVERY OR POSITIONING. THE CONCERTO COIL 15MM COIL WOULD NOT DETACH MANUALLY. THIS PHYSICIAN/ACCOUNT TYPICALLY DOES NOT USE THE INSTANT DETACHER. THEY PREFER TO MANUALLY DETACH COILS. AFTER THESE THREE COILS DID NOT DEPLOY SUCCESSFULLY, THEY WENT ON TO USE SEVERAL MORE CONCERTO COILS WITHOUT COMPLICATIONS. THE PHYSICIAN DID NOT ATTEMPT TO DETACH USING ANY INSTANT DETACHER. INSTEAD, THERE WAS A SINGLE MANUAL ATTEMPT AT DETACHMENT. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSH WIRE DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640298 ↗
• MalfunctionMar 19, 2026Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO 20 MM CONCERTO COILS WOULD NOT DETACH DUE TO FILAMENT BREAK, AND ONE 15 MM CONCERTO COIL WOULD NOT DETACH WHEN IT BROKE AT ITS END. THE PATIENT WAS TREATMENT FOR A GASTROINTESTINAL BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE TWO 20MM CONCERTO COILS WOULD NOT DETACH BECAUSE THE FILAMENT IN THE DETACHMENT FILAMENT BROKE AT HYPO TUBE BREAK INDICATOR WHEN ATTEMPTING TO MANUALLY DETACH THE COILS. THERE WAS NOT ENOUGH FILAMENT EXPOSED TO MANUALLY PULL TO DETACH THE COILS. THE COILS WERE REMOVED WITHOUT COMPLICATION AND NO RESISTANCE OCCURRED IN THE NON-MEDTRONIC CATHETER DURING DELIVERY OR POSITIONING. THE CONCERTO COIL 15MM COIL WOULD NOT DETACH MANUALLY. THIS PHYSICIAN/ACCOUNT TYPICALLY DOES NOT USE THE INSTANT DETACHER. THEY PREFER TO MANUALLY DETACH COILS. AFTER THESE THREE COILS DID NOT DEPLOY SUCCESSFULLY, THEY WENT ON TO USE SEVERAL MORE CONCERTO COILS WITHOUT COMPLICATIONS. THE PHYSICIAN DID NOT ATTEMPT TO DETACH USING ANY INSTANT DETACHER. INSTEAD, THERE WAS A SINGLE MANUAL ATTEMPT AT DETACHMENT. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSH WIRE DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640254 ↗
• MalfunctionMar 9, 2026Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PUSHWIRE PROXIMAL SEGMENT WAS KINKED. THE PATIENT WAS UNDERGOING RECTAL ARTERY EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COIL DETACHED. THE MANUFACTURER'S REPRESENTATIVE (REP) WAS UNAVAILABLE DURING THE IMPLANTATION OF THE PRODUCT. THE HEALTHCARE PROVIDER (HCP) DESCRIBED THAT THE PROXIMAL PORTION OF THE PUSHER WIRE (NEAR THE HYPER TUBE BREAK POINT) WAS KINKED. THIS DID NOT AFFECT THE HCP FROM USING AND DEPLOYING THE COIL. NO DAMAGE TO THE COIL WAS NOTED. THE REP ARRIVED AND OBSERVED 3 FURTHER CONCERTO COILS BEING PREPARED AND NOTICED THAT THE PLASTIC HOUSING MAY HAVE BENT THE PUSHER WIRE WHILE THE SCRUB NURSE WAS REMOVING IT FROM THE STERILE BAG. THIS INFORMATION WAS RELAYED TO THE NURSING TEAM AND HCP. CONTINUOUS FLUSH WAS NOT 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 COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A 2.4F PROGRETE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545883 ↗
• MalfunctionOct 29, 2025Use of Device Problem; Separation Failure; Use of Device Problem; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT FAILED TO DETACH. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A ANEURYSM COIL EMBOLIZATION PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED IN THE ANEURYSM. THE CLINICIAN BROKE THE DETACHMENT ZONE AND PULLED THE RELEASE WIRE, BUT THE COIL DID NOT DETACH. IT WAS NOTED THAT THE INTERNAL FILAMENT WAS NOT VISIBLE WHEN THE RELEASE WIRE WAS BROKEN. THE CLINICIAN MOVED UP THE WIRE SLIGHTLY TO TRY AGAIN, BUT STILL THE FILAMENT WAS NOT VISIBLE. THE CLINICIAN THEN REPORTED INTENTIONALLY CUTTING THE DELIVERY WIRE BUT THE COIL STILL DID NOT DETACH. IT WAS NOTED THAT NO INSTANT DETACHER WAS USED PER THE DOCTOR'S PREFERENCE. TWO UNSUCCESSFUL ATTEMPTS WERE MADE AT MANUAL DETACHMENTS. THE COIL WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: A 021 MICROCATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417873 ↗
• MalfunctionAug 22, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL FAILED TO DEPLOY. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878246 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO WAS BEING USED AS PER THE IFU BUT THE COIL DID NOT PASS THROUGH THE MICROCATHETER THAT WAS USED IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE 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. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS AT THE CATHETER HUB. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE OVERSERVED TO THE COIL OR CATHETER. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513033 ↗
• MalfunctionJul 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT PASS THROUGH THE MICROCATHETER THAT WAS USED IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE RESISTANCE COULD NOT BE REMEMBERED. CATHETER RESISTANCE OCCURRED AT THE HUB. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK/DAMAGE TO THE COIL AND CATHETER WAS OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475733 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE PREMATURE DEPLOYMENT WAS NOT DETERMINED. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. NO DAMAGE TO PACKAGING WAS NOTED ON DELIVERY. NO KINK ON THE PUSHWIRE NOTED ON DELIVERY OR OPENING PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464297 ↗
• MalfunctionJun 24, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO PUSHWIRE WAS BENT IN THE DISTAL SEGMENT. THERE HAD BEEN FRICTION/DIFFICULTY DURING TESTING OR DELIVERY. ADDITIONALLY, ANOTHER CONCERTO COIL COULD NOT BE DEPLOYED WITH THE INSTANT DETACHER AND THE CUSTOMER HAD REFUSED TO USE A BACKUP DEPLOYMENT METHOD. THE PHYSICIAN MADE 4 ATTEMPTS TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. A 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 COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF DUODENUM BLEEDING. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319298 ↗
• MalfunctionJun 9, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL HAD PREMATURE DETACHMENT FROM NON-DETACHMENT. THE PATIENT WAS UNDERGOING INTERNAL ILIAC ARTERY (IIA) EMBOLIZATION. IT WAS REPORTED THAT THE COIL WAS DEPLOYED BY BREAKING THE HYPOTUBE AND THE RELEASE ELEMENT WAS EXPOSED AND TRIED TO BE PULLED BACK, BUT THE COIL WAS NOT DEPLOYED. THE PHYSICIAN TRIED TO REMOVE THE WHOLE THING FROM THE PATIENT BODY (INCLUDING THE MICROCATHETER), BUT THE COIL SUDDENLY DEPLOYED. THE COIL REMAINED IN THE PATIENT AT THE INTENDED LOCATION AND THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS BENT OR BROKEN ON PURPOSE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL ONCE WITH THE INSTANT DETACHER AND ONCE WITH THE MANUAL METHOD. THE PHYSICIAN DID NOT ROTATE THE DELIVERY WIRE DURING THE PROCEDURE AND CONTINUOUS FLUSH WAS NOT ADMINISTERED. 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. ANCILLARY DEVICES INCLUDE A REBAR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169102 ↗
• MalfunctionFeb 20, 2025Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO DETACHMENT ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426375 ↗
• MalfunctionDec 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL ENCOUNTERED RESISTANCE IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A PULMONARY ARTERIOVENOUS MALFORMATION (AVM). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL COULDN'T BE DELIVERED OUT FROM THE MICROCATHETER. THE PHYSICIAN THEN REPLACED THE COIL WITH ANOTHER ONE AND SUCCESSFULLY COMPLETED 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. ANCILLARY DEVICES INCLUDE A REBAR-27 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. ONLY THE PROXIMAL PART OF COIL IS SMOOTH TO COME OUT OF THE INTRODUCER SHEATH, THE COIL CANNOT COME OUT AT THE MIDDLE PART OF COIL. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047168 ↗
• MalfunctionNov 14, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WOULD NOT DEPLOY (NON DETACHMENT). THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT¿S CONDITION BEING TREATED, BLOOD FLOW AND VESSEL TORTUOSITY WAS UNKNOWN. IT WAS UNKNOWN HOW MANY TIMES THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER. IT WAS UNKNOWN IF THERE A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS UNKNOWN IF THERE WERE ANY ISSUES WITH THE INSTANT DETACHER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683183 ↗
• MalfunctionJul 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE ADVANCED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19843250 ↗
• MalfunctionJul 17, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT DURING A PROCEDURE THE PHYSICIAN COULD NOT DEPLOY THE CONCERTO COIL CORRECTLY. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WAS NO KNOWN HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. THE PATIENT, WHO HAD A HISTORY OF DUODENAL ULCER WITH ACUTE GI BLEED AND HEMORRHAGIC SHOCK, WAS UNDERGOING A MESENTERIC ARTERIOGRAM WITH COIL EMBOLIZATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761278 ↗
• MalfunctionJul 9, 2024

  ELDERLY MALE WITH HISTORY OF DUODENAL ULCER WITH ACUTE GI BLEED AND HEMORRHAGIC SHOCK. PROCEDURE: MESENTERIC ARTERIOGRAM WITH EMBOLIZATION PERFORMED. PHYSICIAN UNABLE TO DEPLOY THE COIL CORRECTLY. NEW ONE USED WITHOUT FURTHER PROBLEMS. NO KNOWN HARM TO PATIENT FROM THIS EVENT. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, CONCERTO DETACHABLE COIL SYSTEM (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700602 ↗
• MalfunctionJun 26, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DOCTOR COULD NOT DEPLOY THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613300 ↗
• MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WAS UNKNOWN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559164 ↗
• 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 19128813 ↗
• MalfunctionJan 10, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL HAD NON-DETACHMENT. NO OTHER INFORMATION WAS AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485651 ↗
• MalfunctionDec 7, 2023Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL DID NOT DEPLOY FROM THE CATHETER. THE CONCERTO 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287489 ↗