EnVeo™ R ENVEOR-N-US (UDI 00643169956193)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169956193), received between Aug 7, 2017 and Jul 10, 2025 — classified as 4 deaths, 15 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 reports).

4 other recalls cover devices cleared under the same FDA submission (P130021); 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE APPEARED CONSTRAINED AND UNDER-EXPANDED. THE VALVE WAS RECAPTURED AND DURING THE SECOND DEPLOYMENT OF THE VALVE, IT WAS NOTED THAT THE VALVE APPEARED CONSTRAINED. IT WAS DECIDED TO RECAPTURE THE VALVE AND TO PERFORM A BALLOON AORTIC VALVULOPLASTY (BAV). HOWEVER, UPON RECAPTURING THE VALVE AT ABOUT 60%, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) BROKE INTO TWO PARTS. THE HANDLE WAS MANUALLY PUT BACK TOGETHER AND THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS REPORTED THAT NO TENSION WAS FELT IN THE SYSTEM. A NEW VALVE AND DCS WERE USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473138 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) CAPSULE WAS INTENTIONALLY OVER-DRIVEN IN ORDER TO NAVIGATE THE UNFAVORABLE ANGLE OF THE PATIENT ANATOMY. THE DCS WAS HUGGING THE LESSER CURVE AND DID NOT LINE UP CORRECTLY WITH THE ANNULAR PLANE. AFTER THREE RECAPTURES AND AFTER THE DCS HAD BEEN OVER-DRIVEN TWICE, THE ACTUATOR HANDLE SEPARATED DURING ATTEMPTED DEPLOYMENT. THE VALVE WAS RECAPTURED AND THE SYSTEM WAS REMOVED. A NEW DCS WAS USED FOR SUCCESSFUL IMPLANT. THERE WAS NOT A LOOSE TAB PRESENT IN THE PACKAGING AND BOTH KNOBS WERE INTACT. IT WAS NOTED THAT THE LOADER WAS EXPERIENCED. NO ADDITIONAL DAMAGE WAS NOTED ON THE DEPLOYMENT KNOB. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385331 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS CROSSED AND DEPLOYMENT HAD BEGUN WITH NORMAL TURNING OF THE DELIVERY CATHETER SYSTEM (DCS) DEPLOYMENT KNOB. WHILE TURNING THE KNOB, THE DEPLOYMENT KNOB BROKE. THE DCS WAS ABLE TO BE PULLED OUT OF THE PATIENT. A NEW DCS WAS USED FOR IMPLANT. IT WAS REPORTED THAT THE VALVE WAS LOADED ONCE PRIOR TO FLUORO CHECK AND THE DEPLOYMENT HANDLE ROTATED FINE DURING LOADING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371429 ↗
• MalfunctionJun 30, 2025Difficult or Delayed Positioning; Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Positioning; Difficult or Delayed Activation; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A 29MM TRANSCATHETER BIOPROSTHETIC VALVE, WAS LOADED ON THE DELIVERY CATHETER SYSTEM¿S (DCS). A FLUOROSCOPY CHECK CONFIRMED A GOOD LOAD. THE VALVE WAS THEN DEPLOYED TOO DEEP AND WAS RECAPTURED. DURING REDEPLOYMENT OF THE VALVE, THE BLUE DEPLOYMENT KNOB SEPARATED INTO TWO PIECES AND FELL APART FROM THE DCS. THE OPERATOR HAD TO MANUALLY ASSEMBLE THE DEPLOYMENT KNOB AND MOUNT IT BACK ON THE DCS. THE DEPLOYMENT WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359678 ↗
• MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE INITIAL INSPECTION OF THE DELIVERY CATHETER SYSTEM (DCS), PRIOR TO LOADING THE VALVE, IDENTIFIED THAT THE DCS¿S DEPLOYMENT KNOB ON THE HANDLE WAS SLIGHTLY SEPARATED. THE SLIGHT SEPARATION WAS OBSERVED BETWEEN THE SEAM OF THE DEPLOYMENT KNOB, LOCATED IN THE TAB AREA. THE KNOB WAS SLIGHTLY SQUEEZED, WITHOUT EXCESSIVE FORCE AND AN AUDIBLE ¿CLICK¿ WAS HEARD, CONFIRMING A SECURE ATTACHMENT OF THE HANDLE. AT ONE THIRD OF THE INITIAL LOAD, THE KNOB SEPARATED WITHIN THE FIRST ROTATION, WHILE ATTEMPTING TO CAPTURING THE VALVE. THE CAPSULE DID NOT REACH THE PADDLE ATTACHMENT BEFORE THE SEPARATION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT WITH THE DCS AND ANOTHER DCS WAS USED FOR THE IMPLANT PROCEDURE. NOTE: THE DEPLOYMENT KNOW TRIGGER WAS UTILIZED WHEN THE CAPSULE WAS OPENED FOR FLUSHING. NO UNUSUAL TENSION WAS FELT IN THE SYSTEM DURING THE LOADING PROCEDURE AND NO ADDITIONAL DAMAGE OR MARKS WERE NOTED ON THE DEPLOYMENT KNOB. THE LOADER HAD PREVIOUSLY LOADED APPROXIMATELY 10 VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345327 ↗
• MalfunctionJun 27, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE AND THE CLEAR TUBE WAS REMOVED, IT WAS REPORTED THAT THE VALVE WAS MISLOADED. IT WAS NOTED THAT THE PADDLE WAS OUT OF POCKET. ON THE SECOND LOAD TURN, THE HANDLE FELL OFF. THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT USED AND THE VALVE WAS LOADED ONTO A DIFFERENT DCS FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345207 ↗
• MalfunctionJun 26, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON RECAPTURING THE VALVE DUE TO A DEEP IMPLANT, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED HALF WAY THROUGH THE RECAPTURE. THE PHYSICIAN WAS ABLE TO CLICK THE HANDLE BACK TOGETHER AND COMPLETE THE VALVE RECAPTURE. THE VALVE WAS SUCCESSFULLY DEPLOYED ON THE SECOND ATTEMPT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. OF NOTE, THE PATIENT HAS A MEDICAL HISTORY OF AORTIC STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341239 ↗
• MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, WHILE LOADING THE VALVE ONTO THE DELIVERY CATHETER SYSTEM (DCS), THE BLUE HANDLE SPLIT AT THE SEAM AND SEPARATED. SUBSEQUENTLY, THE DCS WAS NOT USED FOR THE IMPLANT AND WILL BE RETURNED FOR ANALYSIS. ANOTHER DCS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE LOADING WAS PERFORMED BY EXPERIENCED MEDTRONIC PERSONNEL AND NO EXCESS RESISTANCE WAS FELT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340867 ↗
• MalfunctionJun 26, 2025Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult to Open or Close; Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult to Open or Close

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING THE SECOND RECAPTURE OF THE VALVE, THE DELIVERY HANDLE SEPARATED AND COULD NOT BE RECAPTURED ANY FURTHER. THE VALVE WAS PULLED TO THE ASCENDING AORTA AND THE HANDLE STILL WAS NOT ABLE TO RECAPTURE THE VALVE. THE HANDLE WAS PUSHED TOGETHER AND THE VALVE WAS ABLE TO BE RECAPTURED AND REMOVED FROM THE PATIENT. THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WILL BE RETURNED TO MEDTRONIC AND A NEW VALVE WAS LOADED ONTO A NEW DCS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340618 ↗
• MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, AS THE VALVE WAS BEING LOADED ONTO THE DELIVERY CATHETER SYSTEM (DCS) BY AN EXPERIENCED LOADER, THE BLUE HANDLE SEPARATED INTO TWO PIECES WHEN APPROXIMATELY 50% OF THE VALVE WAS INSIDE THE CAPSULE. AT THAT TIME, THE DISTAL PORTION OF THE DCS AND THE VALVE CAPSULE APPEARED TO HAVE A BANANA SHAPE TO IT. THE BLUE HANDLE EASILY SNAPPED BACK INTO PLACE AND THE VALVE WAS ABLE TO BE REMOVED FROM THE DCS. THERE WERE NO IMAGESTAKEN OF THIS INCIDENT. IT WAS REPORTED THAT THERE MAY HAVE BEEN A MISLOAD THAT CAUSED THE INITIAL PROBLEM. UPON INSPECTION OF THE DCS, THE BLUE HANDLE APPEARED TO HAVE WOBBLE BUT CONTINUED TO MOVE UP AND DOWN THE HANDLE. THE DCS WAS NOT USED FOR THE IMPLANT. ANOTHER DCS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340502 ↗
• MalfunctionJun 26, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE LOADING OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE ADVANCING THE CAPSULE FORWARD OVER THE VALVE, THE BLUE HANDLE OF THE DELIVERY CATHETER SYSTEM (DCS) SEPARATED AND EXPOSED INTERNAL THREADS. THE DCS WAS NOT USED. THE VALVE WAS LOADED ONTO A NEW DCS SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22339015 ↗
• InjuryFeb 28, 2019Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, USING A NON-MEDTRONIC EXTRA STIFF GUIDEWIRE, UPON DEPLOYMENT AS THE DELIVERY CATHETER SYSTEM (DCS) WAS WITHDRAWN, THE NOSE CONE CAUGHT THE INFLOW PORTION OF THE VALVE AND THE VALVE DISLODGED INTO THE ASCENDING AORTA. A SNARE WAS USED TO POSITION THE VALVE TO THE AORTIC ARCH, PROXIMAL TO THE INNOMINATE ARTERY. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED IN A GOOD POSITION WITH MODERATE PARAVALVULAR LEAK (PVL) NOTED. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 23MM NON-MEDTRONIC BALLOON. THE PVL REDUCED TO MILD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8380545 ↗
• InjuryMay 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26 MM TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED INTO THE ASCENDING AORTA AS THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS) WAS PULLED BACK THROUGH THE DEVICE. SUBSEQUENTLY, A SECOND 26 MM TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED SUCCESSFULLY. IT WAS REPORTED THE DIFFICULTY ADVANCING OCCURRED DUE TO AN THAT AORTA WAS VERY TORTUOUS WITH A TIGHT BEND IN THE ARCH BETWEEN THE VESSELS AND THE DESCENDING AORTA, AND THE AORTIC ROOT WAS VERY HORIZONTAL. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7529364 ↗
• DeathMay 9, 2018Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT BECAME ISCHEMIC IN MID DEPLOYMENT. THE VALVE WAS RECAPTURED TWO TIMES BECAUSE THE VALVE WAS TOO HIGH IN THE ANNULAR POSITION. THE VALVE WAS THEN REMOVED WHILE EFFORTS WERE MADE TO STABILIZE THE PATIENT AND INCREASE THEIR PRESSURE. THE PATIENT WAS PLACED ON A BYPASS PUMP AND THE PROCEDURE WAS ABORTED. IT WAS UNKNOWN WHETHER THE RECAPTURES OR THE MEDTRONIC PRODUCT CAUSED OR CONTRIBUTED TO THE ISCHEMIA. THE PATIENT SUBSEQUENTLY DIED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death; Ischemia; Low Blood Pressure/ Hypotension

  MAUDE report 7500544 ↗
• InjuryMay 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED SUCCESSFULLY BUT WHILE REMOVING THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE CAUGHT THE INFLOW POTION OF THE VALVE, AND DISLODGE IT INTO THE ASCENDING AORTA. A BALLOON WAS USED TO STABILIZE THE VALVE WHILE, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482471 ↗
• MalfunctionApr 27, 2018Material Separation; Positioning Problem; Material Separation; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, INTO A TORTUOUS ANATOMY AND A TORTUOU S ASCENDING AORTA, IT WAS REPORTED THE CAPSULE WAS BENT ON THE SECOND VALVE RECAPTURE. ON THE FOURTH RECAPTURE, THE CAPSULE SHOWED DAMAGE ON FLUOROSCOPY. THE DELIVERY CATHETER SYSTEM (DCS) AND VALVE WERE REMOVED FROM THE PATIENT. A NEW VALVE WAS LOADED ONTO A NEW DELIVERY CATHETER SYSTEM AND WAS DEPLOYED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469864 ↗
• MalfunctionFeb 20, 2018Fracture; Positioning Problem; Fracture; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THREE ATTEMPTS WERE MADE TO PROPERLY POSITION THE VALVE. THE VALVE WAS RECAPTURED EACH TIME AND THE DEVICE WAS WITHDRAWN FROM THE BODY. UPON ATTEMPTING TO DEPLOY THE VALVE ON THE BACK TABLE, THE CAPSULE FRACTURED. A DIFFERENT VALVE WAS LOADED INTO ANOTHER DCS AND WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7283368 ↗
• MalfunctionFeb 14, 2018Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, AND AUDIBLE ¿POP¿ OCCURRED DURING DEPLOYMENT OF THE VALVE. IT WAS NOTED THAT AT THAT POINT THE END CAP TO THE DELIVERY CATHETER SYSTEM (DCS) DID NOT SEPARATE. THE VALVE WAS ATTEMPTED TO BE DEPLOYED BY TURNING THE DEPLOYMENT HANDLE, BUT THE DCS WOULD NOT DEPLOY THE VALVE. THE SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND THE CAPSULE SEPARATED FROM THE CATHETER. IT WAS REPORTED THAT CALCIFICATION WAS ENCOUNTERED IN THE COMMON LILACS AND THE AORTA. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7271175 ↗
• InjuryFeb 12, 2018Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DC S), THE ACCESS VESSELS WERE PRETREATED WITH DILATORS. DURING THE INITIAL INSERTION OF THE DCS USING THE INLINE SHEATH, RESISTANCE WAS FELT IN THE LEFT FEMORAL ARTERY. A SECOND ATTEMPT WAS MADE TO INSERT THE DCS THAT ALSO ENCOUNTERED RESISTANCE. A 20 FR INTRODUCER SHEATH WAS THEN INSERTED AND THE DCS ENTERED THE VESSEL WITHOUT ISSUE AND THE VALVE WAS IMPLANTED. THE PATIENT TOLERATED THE IMPLANT PROCEDURE AND THE SHEATH WAS REMOVED. AFTER REMOVAL OF THE SHEATH AN ANGIOGRAM OF THE LEFT ILIOFEMORAL ARTERY SHOWED A DISSECTION. A SURGICAL CUT DOWN WAS PERFORMED AND TWO STENTS WERE IMPLANTED. THE CAUSE OF THE DISSECTION WAS REPORTEDLY DUE TO THE SERIAL DILATIONS OR THE INLINE SHEATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 7262825 ↗
• InjuryJan 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, UPON DEPLOYMENT THE VALVE MOVED AORTIC AND OUT OF THE ANNULUS. THE VALVE WAS RECAPTURED AND REPOSITIONED. THE BLOOD PRESSURE DAMPENED AND REMAINED LOW THROUGHOUT THE SECOND DEPLOYMENT ATTEMPT. THE VALVE WAS IMPLANTED WITH GOOD RESULT. THE BLOOD PRESSURE REMAINED LOW AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. AN IMPELLA DEVICE WAS INSERTED AND UTILIZED FOR LEFT VENTRICLE SUPPORT. AN ECHOCARDIOGRAM CONFIRMED THE PRE-EXISTING LEFT VENTRICLE EFFUSION HAD WORSENED AND A PERICARDIOCENTESIS WAS PERFORMED. THE EFFUSION IMPROVED AND THE PATIENT WAS STABLE. EXPLORATORY SURGERY WAS PERFORMED AND THREE PERFORATIONS WERE REPAIRED: ONE IN THE RIGHT VENTRICLE AND 2 IN THE LEFT VENTRICLE. THE PHYSICIAN STATED THE PATIENT HAD FRIABLE PERICARDIAL TISSUE WHICH MOST LIKELY RESULTED IN A WIRE PERFORATION DURING THE VALVE PROCEDURE. IT COULD NOT BE DETERMINED WHEN A WIRE PERFORATION OCCURRED, BUT THERE WAS A REPORTED POSSIBILITY THE PERFORATION OCCURRED DURING POSITIONING OR DEPLOYMENT OF THE VALVE. THE PATIENT WAS STABLE ON A VENTILATOR. THE IMPELLA DEVICE WAS REMOVED AND THE VALVE WAS FUNCTION

  Patient problems: Cardiac Perforation; Left Ventricular Failure; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 7225074 ↗
• MalfunctionDec 22, 2017Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, FOLLOWING THE THIRD VALVE RECAPTURE, THE VALVE CAPSULE SEPARATED ABOUT 4 MM NEAR THE PROXIMAL END. THE HANDLE MADE SEVERAL AUDIBLE CLICKING NOISES WHEN THE FOURTH DELIVERY OF THE VALVE WAS ATTEMPTED. THERE WAS NO DISTAL CAPSULE MOVEMENT, HOWEVER, THE PROXIMAL END THAT SEPARATED WAS ABLE TO MOVE. THE VALVE WAS FULLY RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS REPORTED THAT IT WAS POSSIBLE THAT THE TIP OF THE CATHETER WAS AT A SLIGHT ANGLE WHEN IT WAS RECAPTURED AND CAUSED IT TO BECOME STUCK WITHIN THE VALVE CAPSULE. THE VALVE AND CAPSULE BECAME STUCK AT THE END OF THE CATHETER AND CAUSED THE CAPSULE TO TEAR NEAR THE PROXIMAL END AND EXPOSED THE SPINES. THE REST OF THE CAPSULE REMAINED INTACT. NO HARM WAS DONE TO THE PATIENT. A NEW VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE USED FOR FINAL IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142239 ↗
• InjuryDec 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS PULLED BACK DURING DEPLOYMENT, PRIOR TO THE TABS FULLY RELEASING THE VALVE. SUBSEQUENTLY, THE VALVE DISLODGED INTO THE SINUS OF VALSALVA (SOV). A SNARE WAS USED TO REPOSITION THE VALVE IN THE ABDOMINAL AORTA. A SECOND VALVE WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119310 ↗
• DeathDec 11, 2017Bent; Fracture; Material Separation; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Bent; Fracture; Material Separation; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34 MM TRANSCATHETER BIOPROSTHETIC VALVE, AT APPROXIMATELY 50% DEPLOYMENT, THE VALVE DISLODGED TOWARD THE AORTA. THE DELIVERY CATHETER SYSTEM (DCS) HANDLE WAS TURNED IN THE OPPOSITE DIRECTION TO RECAPTURE. IT WAS NOTED ON FLUOROSCOPY THAT THE CAPSULE WAS SLIGHTLY BENT IN THE PROXIMAL PORTION APPROXIMATELY 1 CM BELOW THE PADDLES. A SECOND DEPLOYMENT ATTEMPT WAS STARTED WITHOUT ISSUE BUT AGAIN AT 50% DEPLOYMENT, THE VALVE DISLODGED INTO ASCENDING AORTA. RECAPTURE WAS AGAIN STARTED, BUT IT WAS NOTED THAT THE HANDLE WAS REQUIRING MORE FORCE TO RECAPTURE. ON FLUOROSCOPY, THERE APPEARED TO BE A BULGE IN THE UPPER THIRD OF THE CAPSULE AREA AT THE PROXIMAL END NEAR THE PADDLES. A DECISION WAS MADE TO REMOVE AND EXAMINE THE SYSTEM. THE VALVE AND DCS WERE SUCCESSFULLY REMOVED FROM THE PATIENT BUT WITH SOME TIGHTNESS NOTED THROUGH THE 20 FRENCH NON-MEDTRONIC SHEATH. THE DEVICE WAS EXAMINED ON THE BACK TABLE AND THE CAPSULE WAS SLIGHTLY OVER-CAPTURED AT THE NOSECONE WITH A SLIGHT BEND. A DEFORMED AREA OF PROXIMAL END OF CAPSULE WAS NOTED BUT THE CAPSULE APPEARED INTACT. THE HANDLE WAS TURNED TO DETERMINE WHETHER THE CAPSULE WOULD RE

  Patient problems: Aortic Dissection; Calcium Deposits/Calcification; Cardiac Tamponade; Death; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 7106833 ↗
• InjuryNov 14, 2017Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED THREE TIMES AND WAS RECAPTURED. UPON THE FOURTH DEPLOYMENT ATTEMPT, THE CAPSULE SEPARATED AND THE VALVE WAS UNABLE TO BE DELIVERED OR FULLY RETRIEVED. IT WAS REPORTED THAT TENSION HAD BEEN FELT IN THE SYSTEM DURING DEPLOYMENT DUE TO A TORTUOUS AORTA. DUE TO TORTUOSITY AND OBESITY, A DECISION WAS MADE TO PERFORM AN ARTERIAL CUTDOWN ON THE LEFT FEMORAL ARTERY TO REMOVE THE DELIVERY CATHETER SYSTEM (DCS) WITH THE PARTIALLY DEPLOYED VALVE TO AVOID RISK OF VESSEL INJURY. THE PHYSICIAN BELIEVED THAT THE CUTDOWN WOULD PROVIDE A CONTROLLED AND SAFER METHOD FOR REMOVAL. AFTER TWO HOURS, DUE TO THE PATIENT'S SIZE AND TORTUOUS ANATOMY, THE VALVE AND DCS WERE REMOVED FROM THE PATIENT. PATCH REPAIR WAS PERFORMED AT THE LEFT GROIN. IT WAS DECIDED NOT TO PROCEED WITH THE IMPLANT PROCEDURE AT THAT TIME. IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED AND PATCH REPAIR COMPLETED DUE TO SIGNIFICANT DAMAGE TO THE LEFT FEMORAL ARTERY, AFTER THE CUTDOWN WAS PERFORMED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 7031930 ↗
• DeathOct 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, A POST-IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IDENTIFIED AN EFFUSION, WITH NO KNOWN CAUSE. THE PATIENT EXPIRED ON THE DAY OF THE VALVE IMPLANT. THE CAUSE OF DEATH WAS ATTRIBUTED TO THE EFFUSION. THE PHYSICIAN NOTED THAT THE DEATH WAS NOT RELATED TO THE VALVE OR ITS FUNCTION. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE DELIVERY CATHETER SYSTEM (DCS) CAUSED OR CONTRIBUTED TO THE EFFUSION AND RESULTING DEATH, AS NO AUTOPSY WAS TO BE PERFORMED.

  Patient problems: Death; Pericardial Effusion

  MAUDE report 6988059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130021. One submission often covers many models, so check the product and lot details in each record.

• Z-0561-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as
• Z-0560-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 B
• Z-0559-2021 · Oct 23, 2020 · Terminated
  Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE
• Z-2264-2015 · Jul 15, 2015 · Terminated
  EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evol