EnVeo™ R ENVEOR-N-US (UDI 00643169800939)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169800939), received between Dec 28, 2017 and Jul 1, 2025 — classified as 8 deaths, 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 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 A 29 PRO TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DCS), DURING OVERDRIVE THE DEPLOYMENT KNOB, ON THE DCS HANDLE SEPARATED. NO UNUSUAL RESISTANCE WAS FELT DURING THE LOADING OF THE VALVE. THE DCS WAS REPLACED AND THE VALVE WAS LOADED SUCCESSFULLY. NO PATIENT INVOLVEMENT WAS REPORTED WITH THE DCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372075 ↗
• DeathOct 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DCS), A NON-MEDTRONIC SURGICAL VALVE WAS IMPLANTED INTO A NATIVE BICUSPID VALVE WITH SEVERE AORTIC INSUFFICIENCY. ONE DAY FOLLOWING IMPLANT OF THE SURGICAL VALVE, SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED. IT WAS DECIDED TO TREAT WITH A VALVE-IN-VALVE USING A TRANSCATHETER BIOPROSTHETIC VALVE. TWO DAYS FOLLOWING THE IMPLANT OF THE SURGICAL VALVE, A TRANSCATHETER BIOPROSTHETIC VALVE WAS ATTEMPTED TO BE IMPLANTED. WHILE POSITIONING THIS DELIVERY CATHETER SYSTEM (DCS), THE SURGICAL VALVE WAS DISLODGED AND PUSHED INTO THE VENTRICLE. SUBSEQUENTLY, THE TRANSCATHETER AND SURGICAL VALVES WERE REMOVED AND A SURGICAL AORTIC VALVE REPLACEMENT (AVR) USING A NON-MEDTRONIC PRODUCT WAS PERFORMED. TWO DAYS AFTER ATTEMPTED IMPLANT OF THE TRANSCATHETER VALVE, THE PATIENT DIED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS SEVERE AORTIC INSUFFICIENCY OF THE PREVIOUSLY PLACED SURGICAL VALVE. PER THE PHYSICIAN, THE DCS DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

  Patient problems: Death

  MAUDE report 7978409 ↗
• InjuryAug 15, 2018Difficult to Advance; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SLOW BLOOD FLOW WAS NOTED IN THE ILIOFEMORAL ARTERY AND A RIGHT FEMORAL ARTERY DISSECTION WAS NOTED. THE INLINE SHEATH WAS USED AND THE MINIMUM ACCESS VESSEL DIAMETER WAS 4.7 MM. THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED WITHOUT ISSUE, HOWEVER THERE WAS DIFFICULTY ADVANCING AND A "POP" WAS F ELT AS THE DCS ADVANCED. SUBSEQUENTLY, A STENT WAS PLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 7784096 ↗
• InjuryJul 30, 2018Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO BE ADVANCED THROUGH THE NON-MEDTRONIC SHEATH AND PAST THE AORTIC ARCH DUE TO CALCIFICATION AND TORTUOSITY. AS THE DELIVERY CATHETER WAS WITHDRAWN, HYPOTENSION OCCURRED, AND A DISSECTION OF THE ABDOMINAL AORTA WAS FOUND. AN ENDOVASCULAR AORTIC REPAIR WAS PERFORMED AND THE VALVE WAS NOT IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Aortic Dissection; Calcium Deposits/Calcification; Low Blood Pressure/ Hypotension

  MAUDE report 7733360 ↗
• InjuryJul 30, 2018Device Dislodged or Dislocated; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT CENTERED AND DISLODGED THE VALVE OUT OF THE ANNULUS WHILE THE DCS WAS WITHDRAWN. THE VALVE WAS SNARED INTO THE ASCENDING AORTA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED FOR THIS DEVICE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7733240 ↗
• DeathJul 17, 2018Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VIA RIGHT FEMORAL ACCESS WITH PREVIOUS BILATERAL FEMORAL STENTS, THE PATIENT DIED DURING THE PROCEDURE DUE TO AN AORTIC DISSECTION. A CLOSURE DEVICE WAS USED PRIOR TO NOTING THE INJURY. NO AUTOPSY WAS REPORTED. THE PHYSICIAN DID NOT ATTRIBUTE THE DISSECTION TO THE DELIVERY CATHETER SYSTEM (DCS).

  Patient problems: Aortic Dissection; Death; Low Blood Pressure/ Hypotension

  MAUDE report 7695570 ↗
• DeathJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER THE LOADING WAS PERFORMED BY MEDTRONIC PERSONNEL AND CONFIRMED BY FLUOROSCOPIC INSPECTION, RIGHT ILIOFEMORAL ACCESS WAS USED WITH THE INLINE SHEATH OVER A NON-MEDTRONIC GUIDEWIRE. THE DELIVERY CATHETER SYSTEM (DCS) ADVANCED WITH NO RESISTANCE NOTED. THE NON-CORONARY CUSP (NCC) PIGTAIL WAS PULLED BACK INTO THE THORACIC AORTA FOR REPOSITIONING. WHEN THE PIGTAIL CATHETER WAS ADVANCED, IT WOULD NOT PASS OVER THE AORTIC ARCH. THE PATIENT¿S BLOOD PRESSURE BEGAN TO DECREASE. THE DCS WAS PULLED BACK FROM THE AORTIC ROOT, THE WIRE WAS REPOSITIONED, AND THE PRESSURE IMPROVED. THE WIRE WAS PASSED THROUGH THE PIGTAIL AND IT CROSSED THE ARCH INTO POSITION IN THE NCC. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED NO PERICARDIAL EFFUSION. THE DEVICE WAS INSERTED BACK ACROSS THE NATIVE VALVE AND SUCCESSFULLY IMPLANTED. AFTER THE DCS WAS REMOVED FROM THE PATIENT, TTE SHOWED NO PARAVALVULAR LEAK (PVL) AND A GRADIENT OF LESS THAN 5MMHG. ALL CATHETERS WERE REMOVED FROM THE PATIENT, BUT BEFORE MOVING TO THE RECOVERY ROOM, TTE REVEALED A SMALL PERICARDIAL EFFUSION. WHILE IN THE RECOVERY ROOM, THE PATIENT¿

  Patient problems: Aortic Dissection; Blood Loss; Death; Low Blood Pressure/ Hypotension

  MAUDE report 7665361 ↗
• InjuryJun 12, 2018Difficult to Insert; Difficult to Remove; Difficult to Advance; Difficult to Insert; Difficult to Remove; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, USING THE INLINE SHEATH, THERE WAS DIFFICULTY NEAR THE LEFT ILIAC ARTERY DURING INSERTION AND THE GUIDEWIRE WAS EXCHANGED. RESISTANCE WAS NOTED WHILE ADVANCING THE DELIVERY CATHETER SYSTEM (DCS) THROUGH BOTH THE EXTERNAL AND COMMON ILIAC ARTERIES. AFTER THE VALVE WAS IMPLANTED, AS THE DCS WAS BEING REMOVED FROM THE PATIENT, THE NOSE CONE BECAME STUCK AT THE ACCESS SITE. THE SURGEON USED A BLADE TO MAKE SPACE FOR THE NOSE CONE TO BE REMOVED. AN INTIMAL TEAR WAS NOTED IN THE LEFT FEMORAL ARTERY AND WAS REPAIRED WITH A GRAFT. THE PHYSICIAN REPORTED THE TEAR WAS LIKELY CAUSED DURING INSERTION BUT WAS NOT IDENTIFIED UNTIL REMOVAL OF THE DCS AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT A NON-MEDTRONIC CLOSURE DEVICE WAS USED PRIOR TO NOTING THE INJURY. THE MINIMUM FEMORAL ACCESS VESSEL DIAMETER WAS 5.2 X 7.3MM AND THE LEFT FEMORAL ARTERY WAS CALCIFIED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 7594100 ↗
• MalfunctionJun 1, 2018Difficult To Position; Material Separation; Detachment of Device or Device Component; Positioning Problem; Difficult To Position; Material Separation; Detachment of Device or Device Component; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING DEPLOYMENT, TENSION WAS FELT IN THE DELIVERY CATHETER SYSTEM (DCS) AND IT WAS DIFFICULT TO MANIPULATE. AN END CAP SEPARATION WAS NOTED SHORTLY AFTER DEPLOYMENT WAS INITIATED. THE VALVE AND DCS WERE REMOVED FROM THE PATIENT. WHEN THE DCS WAS INSPECTED, A SEPARATION OF THE TOP OF THE CAPSULE WAS NOTED AND THE VALVE WAS LODGED INSIDE OF THE DCS. SUBSEQUENTLY, ANOTHER VALVE AND DCS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7560479 ↗
• MalfunctionMay 11, 2018Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, TENSION BUILT UP IN THE DELIVERY CATHETER SYSTEM (DCS) DUE TO SEVERE TORTUOUSLY OF THE AORTA. IT WAS NOTED THAT THE DCS CAPSULE WAS BUCKLING AND THE SYSTEM WAS IMMEDIATELY REMOVED FROM THE PATIENT. WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE VALVE FROM THE DAMAGED DCS, THE CAPSULE BROKE. SUBSEQUENTLY , THE DCS WAS NOT USED FOR THE IMPLANT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DCS. IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A PREVIOUS ROSS PROCEDURE AND HAD MILDLY CALCIFIED ANATOMY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7507702 ↗
• MalfunctionMay 8, 2018Kinked; Difficult To Position; Kinked; Difficult To Position

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED. FLUOROSCOPY SHOWED A KINK IN THE DELIVERY CATHETER SYSTEM (DCS) PROXIMAL TO THE PADDLE POCKETS DURING ATTEMPTED DEPLOYMENT. THERE WAS NO SEPARATION OF THE CAPSULE NOTED. SUBSEQUENTLY, THE VALVE WAS RECAPTURED, AND THE SYSTEM WAS WITHDRAWN FROM THE PATIENT. A SECOND VALVE WAS LOADED ONTO A NEW DCS AND SUCCESSFULLY IMPLANTED. THE PATIENT ANATOMY WAS REPORTED TO HAVE AN ANGLE OF 58 DEGREES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7493708 ↗
• DeathMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC AORTIC VALVE WAS IMPLANTED. AS THE DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED, THE NOSE CONE CAUGHT THE OUTFLOW PORTION OF THE VALVES NEAR THE TABS AND CAUSED A DISLODGEMENT. IT WAS REPORTED THE NOSECONE CAUGHT THE VALVES DUE TO THE TORTUOUS AORTIC ARCH. AN ATTEMPT TO SNARE THE VALVES WAS MADE, HOWEVER HYPOTENSION OCCURRED DUE TO SEVERE CENTRAL AORTIC INSUFFICIENCY. A THIRD TRANSCATHETER BIOPROSTHETIC VALVE WAS POSITIONED, BUT AT 80% DEPLOYMENT CAUSED A CORONARY OCCLUSION, AS THE THREE VALVES TOGETHER CREATED A ¿TUBE GRAFT¿. THE THIRD VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. AORTIC INSUFFICIENCY AND HYPOTENSION PERSISTED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE VALVES. PER THE FAMILY¿S REQUEST FURTHER MEASURES WERE NOT TAKEN AND THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS RELATED TO CORONARY ISCHEMIA, CORONARY OCCLUSION, AND VALVE EMBOLIZATION.

  Patient problems: Aortic Regurgitation; Death; Low Blood Pressure/ Hypotension; Occlusion

  MAUDE report 7487321 ↗
• InjuryApr 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHEN PULLING THE DELIVERY CATHETER SYSTEM (DCS) OUT FROM THE VALVE AFTER DEPLOYMENT, THE NOSE CONE BECAME CAUGHT ON THE VALVE PADDLE AND DISLODGED THE VALVE. THE VALVE WAS SNARED INTO THE ASCENDING AORTA AND A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED. THE PATIENT DEVELOPED A MEDIASTINAL HEMATOMA THAT THE PHYSICIAN REPORTED WAS LIKELY CAUSED BY SNARING AND PULLING THE INITIAL VALVE TO ANCHOR IT IN THE ASCENDING AORTA. NO TREATMENT WAS PRESCRIBED FOR THE HEMATOMA. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 7473873 ↗
• DeathApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED. DURING THE IM PLANT OF AS SECOND TRANSCATHETER VALVE, AS THE DEVICE PASSED THROUGH THE AORTIC ARCH, HYPOTENSION AND AN ASCENDING AORTIC RUPTURE WERE NOTED. THE RUPTURE WAS NOT ABLE TO BE REPAIRED. SUBSEQUENTLY, THE PATIENT DIED. PER THE PHYSICIAN, IT WAS SUSPECTED THAT THE RUPTURE OCCURRED AS THE FIRST VALVE CROSSED THE ARCH AND WAS DUE TO POOR TISSUE CONDITION AND THE NARROW ANNULUS. DUE TO THE NARROW ANNULUS, A "LITTLE PUSH" WAS REQUIRED TO CROSS. IT WAS REPORTED THAT THE ILIAC ARTERIES WERE A SLIGHTLY TORTUOUS, BUT THAT NO RESISTANCE WAS MET WHEN ADVANCING OR INSERTING THE DELIVERY CATHETER SYSTEM.

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

  MAUDE report 7452187 ↗
• InjuryApr 10, 2018Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DCS), THE VALVE WAS DEPLOYED AND RECAPTURED FOUR TIMES SUCCESSFULLY. DURING THE FIFTH DEPLOYMENT ATTEMPT, THE CAPSULE WAS NOT RETRACTING, AND A CAPSULE SEPARATION OCCURRED. THE SYSTEM WAS REMOVED CAREFULLY THROUGH ARTERIOTOMY CAUSING NO INJURY TO THE VESSEL. A NEW VALVE AND DCS WAS PREPPED AND SUCCESSFULLY DEPLOYED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7410780 ↗
• MalfunctionApr 9, 2018Positioning Failure; Kinked; Detachment of Device or Device Component; Positioning Failure; Kinked; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE A MISLOAD WAS SUSPECTED. THE CAPSULE WAS PULLED BACK TO RELEASE THE VALVE. THE VALVE WAS RELOADED AND THE CAPSULE KINKED AND TORE AND THE VALVE COULD NOT BE RELEASED. NO RESISTANCE WAS FELT DURING THE LOADING. A SECOND VALVE WAS LOADED TO A SECOND DELIVERY CATHETER SYSTEM (DCS) AND USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7408200 ↗
• DeathMar 29, 2018Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITH THIS DELIVERY CATHETER SYSTEM (DCS), MULTIPLE ATTEMPTS TO CROSS THE ANNULUS WERE UNSUCCESSFUL. THE NATIVE AORTIC VALVE WAS NEVER SUCCESSFULLY CROSSED WITH THE DCS AND THE VALVE WAS NEVER DEPLOYED, RESHEATHED OR RECAPTURED. WHEN HYPOTENSION WAS NOTED, THE ATTEMPTS TO CROSS THE NATIVE VALVE WERE ABORTED, THE DCS WAS REMOVED, AND RESUSCITATIVE MEASURES WERE ADMINISTERED. ONGOING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED DURING THE ENTIRE PROCEDURE AND THE IMPLANTING TEAM SUSPECTED A MAJOR VASCULAR COMPLICATION AFTER THE PATIENT¿S ABDOMEN WAS NOTED TO BE ¿ENLARGED AND HARD,¿ DUE TO SEVERE INTERNAL BLEEDING. THE PATIENT DIED THE SAME DAY.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 7383044 ↗
• InjuryMar 21, 2018Difficult to Advance; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, INTO CALCIFIED ANATOMY, RESISTANCE WA S MET AND THE DELIVERY CATHETER SYSTEM WAS UNABLE TO ADVANCE PAST THE COMMON ILIAC ARTERY. THE SYSTEM WAS REMOVED AND A SYSTEM WITH A SMALLER DIAMETER WAS USED FOR A SUCCESSFUL IMPLANT. AFTER DEPLOYMENT, TWO PERFORATIONS WERE NOTED. IT WAS UNABLE TO BE DETERMINED IF THE INJURY OCCURRED DURING THE FIRST OR SECOND ATTEMPT AT IMPLANT. PER THE PHYSICIAN, THE INJURY WAS LIKELY CAUSED AS THE IN-LINE SHEATH AND THE DELIVERY CATHETER SYSTEM (DCS) WERE INTRODUCED. SUBSEQUENTLY TWO STENTS WERE PLACED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 7356589 ↗
• InjuryMar 8, 2018Failure to Advance; Failure to Advance

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE LEFT FEMORAL ARTERY (LFA) WAS PRE-DILATED WITH A 16 FRENCH DILATOR. THIS DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED USING THE INLINE SHEATH. THE DCS WAS ATTEMPTED TO BE ADVANCED THROUGH THE LFA THROUGH DISEASED AND TORTUOUS ANATOMY. DURING THE FIRST ATTEMPT THE CATHETER WAS UNABLE TO ADVANCE P AST THE LEFT COMMON ILIAC ARTERY. THE DCS WAS REMOVED, ROTATED 90 DEGREES, AND REINSERTED. THE SECOND ADVANCEMENT ATTEMPT WAS UNSUCCESSFUL. THE BLOOD PRESSURE BEGAN TO DROP AND AN ANGIOGRAM REVEALED A DISSECTION OF THE LFA. THE VALVE PROCEDURE WAS ABORTED AND FEMO RAL-TO-FEMORAL SURGICAL BYPASS WAS REQUIRED TO REPAIR THE DISSECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 7324813 ↗
• InjuryMar 8, 2018Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THERE WAS DIFFICULTY INSERTING THIS DELIVERY CATHETER SYSTEM (DCS) INTO THE 20 FRENCH INTRODUCER SHEATH. THE SYSTEM DID NOT ADVANCE SMOOTHLY AROUND THE AORTIC ARCH. THE DCS AND VALVE WERE WITHDRAWN AND SUBSEQUENTLY AN AORTIC DISSECTION OCCURRED WHICH REQUIRED RESCUE STEERING VIA A COVERED TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) STENTED GRAFT. A NEW DELIVERY CATHETER SYSTEM (DCS) WAS USED AND SUCCESSFULLY IMPLANTED THE SECOND VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Dissection

  MAUDE report 7324253 ↗
• InjuryFeb 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED WITHOUT ISSUE. WHILE TRYING TO CENTER THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS) BY PULLING BACK ON THE GUIDE WIRE, THE WIRE WAS STRAIGHTENING OUT IN THE VENTRICLE NEAR THE MITRAL VALVE. IT WAS REPORTED THERE WAS MITRAL ANNULAR CALCIFICATION AND THE GUIDE WIRE GOT CAUGHT ON THE CALCIFICATION. WHEN THE GUIDE WIRE RELEASED, THE DCS WAS IMMEDIATELY PULLED BACK TO THE ASCENDING AORTA. THE VALVE DISLODGED FROM THE ANNULUS AND IT WAS REPORTED THAT THE NOSE CONE CAUGHT THE INFLOW PORTION OF THE VALVE. THE VALVE WAS SNARED INTO THE ASCENDING AORTA AND A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7298855 ↗
• DeathFeb 22, 2018Difficult to Insert; Difficult to Insert

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THERE WAS RESISTANCE WHILE INSERTING THE INLINE SHEATH OF THE DELIVERY CATHETER SYSTEM (DCS), A PERFORATION OF THE ARTERY OCCURRED. SUDDEN HYPOTENSION WAS REPORTED THAT INDICATED BLOOD LOSS. A COVERED STENT WAS DEPLOYED OVER THE COURSE OF 20 TO 30 MINUTES. THE VALVE WAS NOT IMPLANTED, AND THE PATIENT LEFT THE OPERATING ROOM, BUT EXPIRED THAT NIGHT. NO AUTOPSY WAS PERFORMED.

  Patient problems: Blood Loss; Death; Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 7288930 ↗
• MalfunctionFeb 21, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED. DURING RECA PTURE, RESISTANCE WAS MET WHILE TURNING THE DELIVERY CATHETER SYSTEM (DCS). THE DCS WAS WITHDRAWN FROM THE BODY AND A CAPSULE SEPARATION WAS OBSERVED. A SECOND VALVE WAS LOADED TO A SECOND DCS AND USED FOR IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7286133 ↗
• DeathFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE GUIDEWIRE WAS INSERTED THROUGH A PRE-EXISTING ABDOMINAL AORTIC ANEURYSM (AAA). THE PHYSICIAN FAILED TO SEE THE GUIDEWIRE LOOPED IN THE ANEURYSM SAC. WHEN THE DELIVERY CATHETER SYSTEM (DCS) WAS ADVANCED, A DISSECTION OCCURRED AND RUPTURED THE AAA. THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Rupture

  MAUDE report 7284195 ↗
• InjuryFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED TWO TIMES DUE TO DISLODGEMENT. FOLLOWING THE RELEASE OF THE VALVE, AN AORTIC DISSECTION WAS REPORTED DUE TO THE DELIVERY CATHETER SYSTEM (DCS) AND WAS SURGICALLY REPAIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Dissection

  MAUDE report 7273167 ↗

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-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-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-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-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