ConcertoTM PV-20-50-HELIX (UDI 00847536033689)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536033689), received between Sep 13, 2019 and Apr 4, 2024 — classified as 1 death, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT INITIALLY, THE COIL WAS ADVANCED APPROPRIATELY, HOWEVER DURING THE PROCEDURE THE COIL WAS RELEASED SPONTANEOUSLY, WITHOUT HAVING FRACTURED THE GUIDE WIRE. THE COIL WAS REMOVED. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE PATIENT TOGETHER WITH THE COVER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING 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 PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT UNDERWENT SURGERY FOR PELVIC VARICOSE VEIN EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042143 ↗
• MalfunctionFeb 6, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS ENCOUNTERED RESISTANCE IN THE MICROCATHETER AND ONE COIL WAS FOUND STRETCHED. THE PATIENT WAS UNDERGOING A RENAL EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT PHYSICIAN FLUSHED MICROCATHETER, BUT COILS STRUGGLED TO GET THROUGH THE MICROCATHETER. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE MIDDLE OF THE CATHETER. THERE WAS NO CATHETER DAMAGE. THE PUSHWIRE DISTAL SEGMENT WAS DAMAGED. IT WAS REPORTED THE CONCERTO COIL (LOT # B406926) WAS STRETCHED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DAMAGE/STRETCHED LOCATION WAS FOUND ON THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. 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 TERUMO PROGREAT 2.4 F MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE COIL SEEMED TO COME OUT OF THE INTRODUCER SHEATH SMOOTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652399 ↗
• MalfunctionOct 26, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS NOT DETACHED SUCCESSFULLY DURING AN EMBOLIZATION PROCEDURE. THE VESSEL TREATED WAS T HE LEFT GONADAL VEIN. IT IS UNKNOWN IF THERE WERE ANY IMPACTS TO THE PATIENT OR IF ANY ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. NO FOLLOW UP HAS OCCURRED SINCE THE INDEX PROCEDURE. NO ADVERSE EVENTS (AE) OR DEVICE DEFICIENCIES (DD) HAVE BEEN REPORTED BY THE SITE. SAFETY QUERIED THE SITE TO COMPLETE EITHER AN AE OR DD FOR THE DEVICE NOT DETACHING SUCCESSFULLY. THERE WAS NO ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR, SPONSOR, OR CEC. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014589 ↗
• MalfunctionOct 23, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE INSTANT DETACHER WAS NOT USED. THERE WERE 3 ATTEMPTS MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO DAMAGE WAS OBSERVED TO THE PUSHWIRE AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986605 ↗
• MalfunctionDec 5, 2022Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING CONCERTO COIL PREMATURE DETACHMENT, STUCK IN THE MICROCATHETER, AND PUSHWIRE DAMAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE SPLENIC ARTERY WITH A MAX DIAMETER OF 2.5 CM AND A 9 MM PROXIMAL AND 6 MM DISTAL NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE SPLENIC ARTERY VESSEL WAS SEVERELY TORTUROUS, THE DOCTOR AFTER ENGAGING THE MOUTH OF THE 2.5CM SPLENIC ARTERY ANEURYSM CONCERTO COIL 20*50 WAS TAKEN THROUGH THE PROGREAT MICROCATHETER 0.027 WITH DISTAL ID , 0.025 INCH. THE COIL WENT THROUGH THE MICRO CATHETER MICRO HUB, THE INTRODUCER SHEATH OF THE COIL HAD BEEN WITHDRAWN AND THE DOCTOR ADVANCED THE DELIVER PUSHER, AFTER GOING FOR 10 CM DISTANCE INSIDE THE MICROCATHETER COIL PUSHER WAS NOT MOVING FURTHER. THE DOCTOR CONFIRMED ON FLUOROSCOPY AND THE DOCTOR WAS FEELING RESISTANCE WHILE PUSHING THE DELIVERY PUSHER. THE CONTINUOUS FLUSH WAS ADMINISTERED AT THE GUIDE CATHETER C2 HUB AND MICROCATHETER HUB. FINALLY THE DOCTOR DECIDED TO WITHDRAW THE COIL, BUT THE COIL WAS NOT MOVING BACK IN THE MICROCATHETER. FINALLY, WHEN CONFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914762 ↗
• MalfunctionOct 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS DETACHED WHEN THE SCRUB TECH PULLED THE COIL OUT OF HOOP. COIL SEPARATION/BREAK AND PREMATURE DETACHMENT OCCURRED. THE COIL WAS NEVER PLACED IN THE PATIENT AS THE ISSUE WAS NOTICED DURING PREPARATION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OF DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED DURING THE PROCEDURE AND CONTINUOUS FLUSH WAS NOT ADMINISTERED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM OF THE ABDOMINAL AORTIC AND LEFT COMMON ILIAC ARTERY WITH A MAX DIAMETER OF 62 MM AND A 23 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A REBAR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611455 ↗
• MalfunctionJun 20, 2022Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR EMBOLIZATION OR PELVIC VARICOSE VEINS. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PREMATURE DETACHMENT WAS VIEWED ON FLUOROSCOPY. THE COIL DID NOT CONTINUE ADVANCING AND IT WAS NOT REPOSITIONED. THE PUSHWIRE WAS NOTED TO BE BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, AND THE PHYSICIAN DID NOT REPOSITION THE COIL. IT WAS NOTED THAT ONE DETACHMENT ATTEMPT HAD BEEN MADE WITH THE INSTANT DETACHER, AND ONE DETACHMENT ATTEMPT HAD BEEN MADE MANUALLY. THE PHYSICIAN DID NOT ROTATE THE PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, ADDITIONAL MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743408 ↗
• MalfunctionApr 24, 2022Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS INTRODUCED AND WHEN ENTERING THE VESSEL, THE COIL DID NOT UNFOLD AND ADVANCE WITHIN IT. THIS WAS ATTEMPTED A SECOND TIME, BUT THE COIL DID NOT DEPLOY. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS INSPECTED AND THERE WERE NO ISSUES IDENTIFIED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE LESION SITE WAS THE VENA GONADAL, THE RIGHT DISTAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191433 ↗
• InjuryMar 20, 2022Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS MIGRATION AFTER DEPLOYMENT. THE PATIENT WAS TAKEN TO AN INTRA-ABDOMINAL VEIN OCCLUSION PROCEDURE. THE COILS WERE PLACED IN THE RIGHT HYPOGASTRIC VEIN AND THE COIL MIGRATED AND WAS LOCATED IN THE RIGHT PULMONARY ARTERY SUPERIOR LOBAL BRANCH. THE PATIENT WAS REPROGRAMMED FOR REMOVAL OF THE FOREIGN BODY COILS AND THEY WERE SUCCESSFULLY REMOVED. THE CAUSE OF THE MIGRATION WAS NOT DETERMINED. THE COIL ENDED UP BEING PLACED IN THE CORRECT LOCATION. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. NO SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. THIS EVENT DID LEAD TO SURGICAL INTERVENTION AND A HOSPITALIZATION FOR REINTERVENTION. THE PATIENT HAD NORMAL BLOOD FLOW AND MINIMAL VESSEL TORTUOSITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13834931 ↗
• InjuryMar 20, 2022Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS MIGRATION AFTER DEPLOYMENT. THE PATIENT WAS TAKEN TO AN INTRA-ABDOMINAL VEIN OCCLUSION PROCEDURE. THE COILS WERE PLACED IN THE RIGHT HYPOGASTRIC VEIN AND THE COIL MIGRATED AND WAS LOCATED IN THE RIGHT PULMONARY ARTERY SUPERIOR LOBAL BRANCH. THE PATIENT WAS REPROGRAMMED FOR REMOVAL OF THE FOREIGN BODY COILS AND THEY WERE SUCCESSFULLY REMOVED. THE CAUSE OF THE MIGRATION WAS NOT DETERMINED. THE COIL ENDED UP BEING PLACED IN THE CORRECT LOCATION. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. NO SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. THIS EVENT DID LEAD TO SURGICAL INTERVENTION AND A HOSPITALIZATION FOR REINTERVENTION. THE PATIENT HAD NORMAL BLOOD FLOW AND MINIMAL VESSEL TORTUOSITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13834919 ↗
• DeathMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT INTRA-ABDOMINAL VEIN OCCLUSION PROCEDURE WAS PERFORMED ON THE PATIENT, THE COIL THAT IS PLACED IN THE RIGHT HYPOGASTRIC VEIN, MIGRATES AND IS LOCATED IN THE LEFT PULMONARY ARTERY. THE MIGRATING COIL, LOCATED IN THE LEFT PULMONARY ARTERY AND INFERIOR LOBAL BRANCH, REMOVES ONE COIL BUT ANOTHER ONE REMAINS THAT CANNOT BE REMOVED. MIGRATION AFTER DEPLOYMENT. CAUSE UNKNOWN, THE COILS MIGRATE IN THE POSTOPERATIVE PERIOD. PATIENT IS SCHEDULED FOR FOREIGN BODY REMOVAL, DURING THE PROCEDURE, THE PATIENT PRESENTS COMPLICATIONS AND DIES. AFTER MULTIPLE ATTEMPTS, ITS EXTRACTION IS NOT FEASIBLE AND DURING THESE ATTEMPTS IT PRESENTS MASSIVE BLEEDING DUE TO TOT, SO IT IS DECIDED TO PERFORM INTRATHORACIC ARTERY OCCLUSION, LEFT PULMONARY TRUNK, THUS OCCLUDING THE BLEEDING AND REPAIRING THE ARTERIOBRONCHIAL FISSURE, THE PATIENT GOES INTO UNEMPLOYMENT MULTIPLE MANEUVERS OF RESUSCITATION WITHOUT BEING SATISFACTORY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: Cardiac Arrest; Device Embedded In Tissue or Plaque; Hemorrhage/Blood Loss/Bleeding; Perforation; Shock

  MAUDE report 13832829 ↗
• MalfunctionMar 20, 2022Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT INTRA-ABDOMINAL VEIN OCCLUSION PROCEDURE WAS PERFORMED ON THE PATIENT, THE COIL THAT IS PLACED IN THE RIGHT HYPOGASTRIC VEIN, MIGRATES AND IS LOCATED IN THE LEFT PULMONARY ARTERY. THE MIGRATING COIL, LOCATED IN THE LEFT PULMONARY ARTERY AND INFERIOR LOBAL BRANCH, REMOVES ONE COIL BUT ANOTHER ONE REMAINS THAT CANNOT BE REMOVED. MIGRATION AFTER DEPLOYMENT. CAUSE UNKNOWN, THE COILS MIGRATE IN THE POSTOPERATIVE PERIOD. PATIENT IS SCHEDULED FOR FOREIGN BODY REMOVAL, DURING THE PROCEDURE, THE PATIENT PRESENTS COMPLICATIONS AND DIES. AFTER MULTIPLE ATTEMPTS, ITS EXTRACTION IS NOT FEASIBLE AND DURING THESE ATTEMPTS IT PRESENTS MASSIVE BLEEDING DUE TO TOT, SO IT IS DECIDED TO PERFORM INTRATHORACIC ARTERY OCCLUSION, LEFT PULMONARY TRUNK, THUS OCCLUDING THE BLEEDING AND REPAIRING THE ARTERIOBRONCHIAL FISSURE, THE PATIENT GOES INTO UNEMPLOYMENT MULTIPLE MANEUVERS OF RESUSCITATION WITHOUT BEING SATISFACTORY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13832828 ↗
• MalfunctionOct 13, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE COIL WAS NEVER DETACHED BY THE PHYSICIAN. IT MIGRATED WHEN IT WAS ADVANCED THROUGH THE CATHETER. THERE WAS NO DAMAGE TO THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT. THE CATHETER WAS A BOSTON CATHETER (DIREXION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624221 ↗
• MalfunctionAug 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL STUCK IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN ANEURYSM WITH A MAX DIAMETER OF 20 MM. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THE TWO COMPLAINT COIL FOR THIS EVENT DID PUSH OUT SMOOTHLY FROM THE INTRODUCER SHEATHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351779 ↗
• MalfunctionAug 3, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE TWO COILS HAD DETACHMENT ISSUES AND THE PUSHER WIRE GOT STUCK IN THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR SPLENIC ANEURYSM. THE MAX DIAMETER WAS 35MM, AND THE NECK DIAMETER WAS 10MM. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT A COIL WAS DEPLOYED AND HAD ISSUES DETACHING. THE DOCTOR USED THE INSTANT DETACHER, AND THEN MANUALLY DETACHED. TWO INSTANT DETACHERS WERE USED, WITH EACH BEING ATTEMPTED ONCE. EVEN AFTER MANUAL DETACHMENT THE COIL WAS COMING OUT WHEN THEY REMOVED THE PUSHER WIRE. THE COIL WAS BROKEN MORE DISTAL TO THE BREAK INDICATOR MARKER AND THEY PULLED THE FILAMENT WIRE WHICH SEEMED TO WORK. THE COIL STAYED IN PLACE AND THE PUSHER WIRE WAS REMOVED. ANOTHER COIL THAT WAS DEPLOYED NEXT AND AGAIN WOULD NOT DETACH DESPITE DOING WHAT WAS EXPLAINED ABOVE. THE PUSHER WIRE GOT CAUGHT IN THE INSTANT DETACHER AS WELL, AND HAD TO BE BROKEN OFF. THEY ENDED UP HAVING TO TAKE THE COIL OUT OF THE PATIENT. THE DOCTOR STOPPED USING THE INSTANT DETACHER AND JUST MANUALLY DETACHED NEW COILS, WHICH DETACHED PERFECTLY WITH MANUAL DETACHMENT. THERE WAS NO NOTICE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271613 ↗
• MalfunctionApr 5, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT CATHETER USED WAS A PROGREAT 2.4. THREE ATTEMPTS HAD BEEN MADE TO DETACH THE COIL WITH THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE MANUALLY. THE MANUAL BREAK POINT WAS BROKEN APART COMPLETELY SO THAT THERE WERE TWO SEPARATE PIECES OF THE PUSHER WIRE. NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT, AND NO PUSHER WIRE DAMAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615872 ↗
• MalfunctionMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED. IT WAS REPORTED THAT THE DEVICE WAS ADVANCED TO THE LESION AS PER THE INSTRUCTIONS FOR USE (IFU), BUT THE COIL DETACHED ITSELF ON ITS OWN. THE PHYSICIAN DECIDED THE PRODUCT COULD NOT BE USED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396639 ↗
• MalfunctionSep 13, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT BE DETACHED WHEN PLACED IN THE PATIENT'S VESSEL. AS A RESULT IT WAS REMOVED AND REPLACED SUCCESSFULLY. IT IS UNKNOWN IF THE DEVICES WERE PREPARED PER THE IFU, INFORMATION REGARDING DETACHMENT ATTEMPTS, PATIENT ANATOMY ARE UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ANCILLARY DEVICES INCLUDE A RENEGADE STC 2.4F MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9039451 ↗