Concerto Detachable Coil System NV-8-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00847536044975), received between Feb 14, 2022 and Sep 28, 2026 — classified as 2 deaths, 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923062 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922516 ↗
• MalfunctionJul 14, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25821265 ↗
• MalfunctionMar 16, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE PHYSICIAN WAS ABLE TO PULL HALF OF THE COIL OUT USING A TULIP SNARE AND THEN PUSH THE REMAINING PORTION INTO THE SPLENIC ARTERY AS A COILED MASS, WHICH WAS IMPLANTED AT THE INTENDED LOCATION. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. NO ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER, AS ONLY THE MANUAL METHOD WAS USED, AND ONE MANUAL DETACHMENT ATTEMPT WAS PERFORMED. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON DETACHMENT. AFTER REMOVAL FROM THE PATIENT, NO PUSHWIRE DAMAGE WAS OBSERVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24611707 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER DURING ADVANCEMENT. THE PHYSICIAN HAD TO REMOVE THE REBAR MICROCATHETER AND USE A NEW ONE. THE COIL WAS REMOVED FROM THE PATIENT BY REMOVING THE MICROCATHETER. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTIONS 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 THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING 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. ANCILLARY DEVICES INCLUDE A REBAR 18 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594236 ↗
• MalfunctionJan 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO CONCERTO COILS OF THE SAME MODEL/LOT THAT HAD RESISTANCE IN THE MICROCATHETER DURING DELIVERY. IT WAS REPORTED THAT THE CONCERTO COILS AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COILS GOT STUCK AT THE MIDDLE SEGMENT OF THE MICROCATHETER. THERE WAS NO DAMAGE OBSERVED TO THE COILS OR THE CATHETER. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT; INSTEAD, A BOSTON TRUSELECT 021 MICROCATHETER WAS UTILIZED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223436 ↗
• MalfunctionDec 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695595 ↗
• MalfunctionJul 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING 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 KINK/DAMAGE TO THE COIL OR CATHETER OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516188 ↗
• MalfunctionJun 24, 2025Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS (LOT: 229646653 AND 229927355) COULD NOT BE DETACHED BY DETACHER, AND PHYSICIAN REFUSED TO USE BACK UP DEPLOYMENT. THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. COIL (LOT: 228640128) COULD NOT BE DETACHED BY DETACHER, AND PHYSICIAN BROKE THE HYPOTUBE, THE COIL DID NOT SEPARATE INSTANTLY, WHILE RETRIEVING THE COIL FROM PATIENT, THE COIL SUDDENLY DEPOLYED, AND GOT STUCK IN MICROCATHETER (LOT: B615929). THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE PATIENT. 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 REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES AND 1 TIME USING THE MANUAL METHOD. TWO INSTANT DETACHERS WERE USED. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER TWICE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. COIL (LOT: B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322795 ↗
• MalfunctionJun 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CONCERTO COIL COULD NOT PASS THROUGH THE MICROCATHETER DURING 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. ANCILLARY DEVICE USED WAS A MICROCATHETER. 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 22294113 ↗
• MalfunctionJun 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT SINCE THE PHYSICIAN WAS USING THE COIL FOR THE FIRST TIME, THEY REQUESTED TO SEE IT DURING THE PROCEDURE. UNDER THE SUPERVISION OF THE MEDTRONIC REPRESENTATIVE, ONE COIL WAS TAKEN OUT AND HANDLED. THEY HAD BEEN ASKED TO PROCESS IT AS A SAMPLE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS UNKNOWN IF ANY ISSUE OCCURRED WITH THE CONCERTO COIL. PROCEDURE COMPLETION AND CAUSE OF EVENT WERE ALSO UNKNOWN. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THERE WAS NO DEVICE ISSUE WITH THE CONCERTO COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195662 ↗
• MalfunctionMay 31, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE COIL CONCERTO HELIX 8MM X 30CM AND COIL CONCERTO HELIX 2MM X 6CM, RESISTANCE WAS FELT WHEN ADVANCING THE COIL WITHIN THE MICROCATHETER, AND THE COIL COULD NOT BE DEPLOYED. THE COIL BECAME STUCK IN THE DISTAL LOCATION OF THE CATHETER. THE CATHETER AND COIL WERE NOT DAMAGED. THE DEVICES WERE NEVER IMPLANTED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER AND COILS WERE NOT DAMAGED. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, ILLNESSES, INFECTIONS, IRREGULARITIES, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120468 ↗
• MalfunctionMay 19, 2025Use of Device Problem; Separation Failure; Use of Device Problem; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT BE DEPLOYED (NON-DETACHMENT) BY BACK UP METHOD AND THE RELEASE ELEMENT WAS EXPOSED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 1 TIME. THEY DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WERE 2 MANUAL ATTEMPTS 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 COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045690 ↗
• MalfunctionFeb 20, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING NON-DETACHMENT OF TWO CONCERTO 8 X 30 HELIX COILS OF DIFFERENT LOTS. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO DETACH THE COILS WITH THE INSTANT DETACHER BUT WERE NOT SUCCESSFUL. THE COILS WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420120 ↗
• MalfunctionFeb 20, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING NON-DETACHMENT OF TWO CONCERTO 8 X 30 HELIX COILS OF DIFFERENT LOTS. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO DETACH THE COILS WITH THE INSTANT DETACHER BUT WERE NOT SUCCESSFUL. THE COILS WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420112 ↗
• MalfunctionJan 15, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO 8MM X 30CM COIL THAT THAT RELEASE PREMATURELY DURING AN EMBOLIZATION OF THE OVARIAN VEIN. IT WAS REPORTED THAT THE COIL WAS THE FIRST TO BE USED. THE COIL RELEASED "WITHOUT USING THE RELEASE HANDLE" AND BECAME STUCK IN THE COBRA TUBE. THE COIL HAD TO BE COMPLETELY REMOVED TO PREVENT ANY MIGRATION INTO THE VENA CAVA. NO PATIENT INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157814 ↗
• MalfunctionDec 2, 2024Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL HAD AN OUT OF BOX ISSUE. IT WAS OPENED AND HANDED TO SCRUB TECH. UPON INSPECTION, THE COIL PUSHWIRE DISTAL SEGMENT WAS BROKEN WHILE STILL IN THE HOOP. THE PUSHWIRE WAS BROKEN AND SEPARATED WHEN THE PACKAGE WAS OPENED, AND NO PREPARATION HAD BEEN DONE PRIOR TO THE DAMAGE BEING SEEN. THE BREAK LOCATION WAS JUST PROXIMAL TO THE HYPOTUBE BREAK INDICATOR. THE PROXIMAL END OF THE PUSHWIRE HAD BEEN SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. THE COIL TAKEN OFF STERILE FIELD AND A NEW COIL WAS USED. THE DEVICE WAS NEVER USED IN THE PATIENT. THERE HAD BEEN NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE PATIENT DID NOT EXPERIENCE ANY IMPACT OR INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT ISSUE. THE PATIENT WAS UNDERGOING TREATMENT FOR A A LESION IN THE DISTAL SOFT TISSUE OF THE GONADAL VEIN. THE VESSEL TORTUOSITY AND CALCIFICATION WERE MINIMAL WITH NO STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819073 ↗
• MalfunctionAug 7, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A PULMONARY AVM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE PROCEDURE THIS SPECIFIC CONCERTO COIL WAS DELIVERED TO THE NIDUS FULLY DEPLOYED, BUT DID NOT DETACH USING THE MANUAL DETACHMENT SYSTEM. WE SAW THE FILAMENT BUT THE COIL REMAINED CONNECTED TO THE DELIVERY PUSHER. NO DETACHER WAS USED. OTHER CONCERTO COILS WERE USED BEFORE AND AFTER, WITH THE SAME DELIVERY SYSTEM AND ALL DETACHED SUCCESSFULLY. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. A SECOND INSTANT DETACHER WAS NOT USED. THE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE WAS PERFORMED 2-3 TIMES. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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 DIREXION MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929171 ↗
• MalfunctionJun 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED AS PER THE INSTRUCTIONS FOR USE (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 PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER WAS NOT A MEDTRONIC DEVICE. NO OTHER INFORMATION WAS KNOWN OR AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519989 ↗
• MalfunctionApr 25, 2024Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Unintended Movement; Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT DIFFICULT PLACEMENT OCCURRED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COILS WOULD NOT FORM AND CONTINUED TO BE STRAIGHT. THERE WAS NO SHAPE TO THE COIL. IT CONTINUED MIGRATING INTO THE VESSEL. THE REPORTED DEVICES 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 GUIDE CATHETER AND MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19185570 ↗
• MalfunctionApr 4, 2024Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WOULD NOT DETACH. THE DEPLOYMENT DID NOT OCCUR AFTER THE COIL WAS PLACED IN SITU. THE BACK END UNTWISTED AND CRACKED. THE COIL WAS STILL ATTACHED. ATTEMPTS TO "RE CRACK" WERE MADE TO DEPLOY THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042114 ↗
• DeathSep 29, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT A GASTRIC VARICES PROCEDURE ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 FOR TIPS PLACEMENT AND BEGAN EXPERIENCING SEVERE DECLINE IN HEALTH DUE TO COMPLICATIONS FROM SEPSIS AND GI BLEED ON (B)(6) 2023. THE PATIENT'S DATE OF DEATH WAS (B)(6) 2023. THE DECISION WAS MADE BY THE PATIENT'S SON TO MOVE TOWARD PALLIATION AS OPPOSED TO ICU ADMISSION. THE EVENT DATE WAS ASSESSED AS CLOSE TO THE PROCEDURE DATE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE CLARIFYING THIS EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE EVENT HAD A FATAL OUTCOME. THE PATIENT BEGAN SUFFERING FROM SEPSIS IN THE CONTEXT OF GI BLEED ON (B)(6) 2023 WHILE ALREADY ADMITTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THE END DATE OF THE HOSPITALIZATION AND THE DATE OF THE FATAL OUTCOME WERE BOTH NOTED AS (B)(6) 2023, SO IT WOULD APPEAR THE SUBJECT WAS HOSPITALIZED AT THE TIME OF DEATH. THE FACILITY NAME AND LOCATION, AS WELL AS INFORMATION REGARDING AUTOPSY RECORDS ARE NOT COLLECTED IN THE ELECTRONIC CR

  Patient problems: Gastrointestinal Hemorrhage; Sepsis

  MAUDE report 17844469 ↗
• DeathSep 29, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT A GASTRIC VARICES PROCEDURE ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 FOR TIPS PLACEMENT AND BEGAN EXPERIENCING SEVERE DECLINE IN HEALTH DUE TO COMPLICATIONS FROM SEPSIS AND GI BLEED ON (B)(6) 2023. THE PATIENT'S DATE OF DEATH WAS (B)(6) 2023. THE DECISION WAS MADE BY THE PATIENT'S SON TO MOVE TOWARD PALLIATION AS OPPOSED TO ICU ADMISSION. THE EVENT DATE WAS ASSESSED AS CLOSE TO THE PROCEDURE DATE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE CLARIFYING THIS EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE EVENT HAD A FATAL OUTCOME. THE PATIENT BEGAN SUFFERING FROM SEPSIS IN THE CONTEXT OF GI BLEED ON (B)(6) 2023 WHILE ALREADY ADMITTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THE END DATE OF THE HOSPITALIZATION AND THE DATE OF THE FATAL OUTCOME WERE BOTH NOTED AS (B)(6) 2023, SO IT WOULD APPEAR THE SUBJECT WAS HOSPITALIZED AT THE TIME OF DEATH. THE FACILITY NAME AND LOCATION, AS WELL AS INFORMATION REGARDING AUTOPSY RECORDS ARE NOT COLLECTED IN THE ELECTRONIC CR

  Patient problems: Gastrointestinal Hemorrhage; Sepsis

  MAUDE report 17844438 ↗
• MalfunctionApr 27, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED AS PER THE INSTRUCTIONS FOR USE (IFU) BUT THE COIL COULD NOT BE DETACHED FROM THE WIRE - BOTH MANUAL AND THE DETACHER METHOD WERE TRIED. A MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE 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 16822872 ↗
• MalfunctionApr 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT WAS PREMATURELY DETACHED. IT WAS REPORTED THAT THE CONCERTO COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). UPON PREPPING THE COIL PRIOR TO INSERTION, IT WAS NOTED THAT THE COIL HAD ALREADY DETACHED WITHIN THE INTRODUCER SHEATH. IT WAS NOTED THAT THERE WAS NO FRICTION OR DIFFICULTY AND THE PHYSICIAN DID NOT REPOSITION THE COIL AND ROTATE THE DELIVERY PUSHER. THE PUSHER WAS NOT BENT OR BROKEN. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. AS THE ISSUE OCCURRED PRIOR TO USE IN THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT. THE COIL WAS REPLACED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795289 ↗