Navitor™ NVTR-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 05415067031570), received between Jun 17, 2022 and Jun 19, 2026 — classified as 11 deaths, 105 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (22 reports).

5 other recalls cover devices cleared under the same FDA submission (P190023); 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Fracture

  IT WAS REPORTED THAT ON 27 MAY 2026, A 23MM, NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE AND ARTERIOTOMIES IN THE ACCESS. RIGHT FEMORAL WAS SELECTED AS THE ACCESS SITE. CALCIFICATION WAS OBSERVED IN THE ACCESS SITE, UPON INSERTION OF THE FIRST PROGLIDE, SIGNIFICANT DIFFICULTY WAS FELT WHILE PUNCTURING. AFTER PLACEMENT OF THE FIRST PROGLIDE, THE FEMORAL ARTERY RUPTURED AND AN UNSPECIFIED PERIPHERAL BALLOON WAS USED TO CONTROL THE BLEEDING. AN ARTERIAL DISSECTION WAS REQUIRED TO ADVANCE THE DS. THE VALVE AND DS WERE PREPARED; DURING THE PROCEDURE, ON THE FIRST DEPLOYMENT ATTEMPT, IT APPEARED THAT THE NAVITOR VISION STENT HAD BROKEN; THE VALVE WAS RECAPTURED TWICE DUE TO POSITIONING ISSUE. AT THIS POINT, THE VALVE CAPSULE DID NOT FULLY RECAPTURED. ALL NECESSARY MANEUVERS WERE PERFORMED WITHOUT SUCCESS IN RECAPTURING THE VALVE, RESULTING IN DEPLOYING THE VALVE IN THE DESCENDING AORTA. A SECOND UNSPECIFIED VALVE WAS SELECTED FOR IMPLANT AND ADVANCED THROUGH THE DESCENDING AORTA. THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS. THE PATIENT REMAINED HEMODYNAMICALLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566373 ↗
• InjuryJan 2, 2026Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT'S AORTIC VALVE ANGLE WAS MEASURED TO BE 43 DEGREES. PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING A 20MM, NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED AT A DEPTH OF 3MM ON THE NON-CORONARY CUSP (NCC). POST-IMPLANT, IT WAS OBSERVED THAT THE VALVE CELLS IN THE NON-CORONARY SINUS DID NOT EXPAND AND THERE WAS NO CALCIUM TO HINDER THIS OPENING. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (POST-BAV) WAS PERFORMED USING AN 22MM, NON-ABBOTT BALLOON; HOWEVER, FULL EXPANSION OF THE CELL WAS NOT ACHIEVED SINCE SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED. SUBSEQUENTLY, THE VALVE POPPED UP ON THE NON-CORONARY SINUS (NCC). AT THIS POINT, ECHOCARDIOGRAM (ECHO) SHOWED SIGNIFICANT VALVE REGURGITATION AND HIGH GRADIENT. A NEW 23MM, NAVITOR VALVE WAS IMPLANTED USING A NEW FLEXNAV DS. GRADIENT WAS MEASURED AS 4 MMHG. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE IMPLANTER BELIEVES FAILURE IN VALVE EXPANSION AS THE CAUSE OF MIGRATIO

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23950773 ↗
• InjuryDec 30, 2025Difficult to Fold, Unfold or Collapse; Patient Device Interaction Problem; Difficult to Fold, Unfold or Collapse; Patient Device Interaction Problem

  CLINICAL INFORMATION: CRD_1003 - VANTAGE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE ACTIVATED CLOTTING LEVELS WERE 273S AND HEPARIN GIVEN. A PRE-IMPLANT BALLOON VALVULOPLASTY DONE WITH A 18MM NON-ABBOTT BALLOON. THE VALVE RE-SHEATHED 2 TIMES DUE TO IMPLANT DEPTH WAS HIGH AND NON-UNIFORM EXPANSION. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 4.43MM AND AT LEFT CORONARY CUSP (LCC) WAS 4.45MM. ON (B)(6) 2025, A COMPUTERIZED TOMOGRAPHY (CT) SCAN SHOWED CIRCUMFERENTIAL THROMBOSIS WITHIN THE PROSETHIC VALVE IN THE LEFT VENTRICULAR OUTFLOW TRACT WITH A THICKNESS OF APPROXIMATELY 2.9MM. ON (B)(6) 2024, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THE GRADIENTS WERE INCREASED. ON (B)(6) 2025, SHOWED DECREASED GRADIENTS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23924309 ↗
• InjuryNov 7, 2025Intravalvular regurgitation; Intravalvular regurgitation

  N/A.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23497990 ↗
• InjuryOct 15, 2025Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23 MM NAVITOR VALVE WAS CHOSEN FOR A VALVE IN VALVE PROCEDURE. A 21 MM NON-ABBOTT VALVE WAS IMPLANTED IN 2021. THE PATIENT'S AORTIC VALVE ANGLE (AV ANGLE FROM 3MENSIO) WAS 48. DUE TO AORTIC INSUFFICIENCY, THE PATIENT UNDERWENT A VALVE-IN-VALVE AORTIC VALVE REPLACEMENT WITH A 23 MM NAVITOR VALVE. A PRE-IMPLANT BALLOON VALVULOPLASTY DONE WITH A 20 MM NON-ABBOTT BALLOON AND WHICH WAS SUCCESSFUL. AFTER THE RELEASE THE VALVE MIGRATED INTO AORTA. AT 80%, THE IMPLANT DEPTH WAS 6 MM AND THE IMPLANT DEPTH AT RELEASE PRIOR TO MIGRATION WAS 6 MM. THE NAVITOR VALVE WAS IMPLANTED IN A GOOD POSITION. AFTER IMPLANTATION, THE PROSTHESIS BEGAN TO EMBOLIZE, GRADUALLY MIGRATING UPWARD. A POST DILATATION WAS PERFORMED WITH A 20 MM BALLOON TO BETTER ANCHOR THE PROSTHESIS, WHICH INITIALLY STABILIZED BUT THEN MIGRATED SLIGHTLY FURTHER. A NEW 23 MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT. BEFORE IMPLANTING THE SECOND VALVE, CRACKING WAS PERFORMED USING 20 MM NON-ABBOTT BALLOON, FOLLOWED BY SUCCESSFUL IMPLANTATION OF A SECOND NAVITOR 23. THERE WAS ZERO LEAK AND A GRADIENT OF 7 MMHG. THE PATIENT LEFT THE PROCEDURE ROOM IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285958 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1003 - VANTAGE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS NOT PERFORMED. THE LENGTH OF THE MEMBRANOUS SEPTUM WAS 4.0MM. WHILE IN CUSP OVERLAP VIEW AND PRIOR TO DEPLOYMENT, THE INFLOW EDGE OF THE CONSTRAINED VALVE FRAME WAS ALIGNED AT THE BASE OF THE NON-CORONARY CUSP. THE VALVE WAS RE-SHEATHED ONCE DURING PROCEDURE DUE TO BEING DEPLOYED TOO LOW. THE FINAL NON-CORONARY CUSP IMPLANT DEPTH WAS 5.59MM.POST-PROCEDURE, A PHYSICAL EXAM REVEALED THAT THE PATIENT HAD WORSENING HYPERTENSION OF 210/70. THE DECISION WAS MADE TO START THE PATIENT AN PERGANIT EV AND PRESCRIBE A REGIMEN OF AMLODIPINE, SPIRONOLACTONE, AND CARDURA. ON (B)(6) 2025, IT WAS NOTED VIA ELECTROCARDIOGRAM SHOWED A SINUS RHYTHM AND LEFT ANTERIOR FASCICULAR BLOCK. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Block; High Blood Pressure/ Hypertension

  MAUDE report 22892100 ↗
• InjuryJul 7, 2025Migration or Expulsion of Device; Perivalvular Leak; Off-Label Use; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Perivalvular Leak; Off-Label Use; Improper or Incorrect Procedure or Method

  CLINICAL INFORMATION: (B)(4) - VANTAGE, PATIENT SITE ID: (B)(6) ((B)(4)). IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT AS PART OF A VALVE-IN-VALVE PROCEDURE WITHIN A 23MM TRIFECTA VALVE USING A SMALL FLEXNAV DELIVERY SYSTEM. NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED. IT WAS NOTED DURING PROCEDURE THAT THE VALVE WAS RE-SHEATHED TWICE DUE TO DIVING INTO THE LEFT VENTRICULAR OUTFLOW TRACT. ON THE THIRD ATTEMPT A SATISFACTORY POSITION WAS OBTAINED, AT 80% DEPLOYMENT THE VALVE WAS AT 6-7MM, AND THE VALVE WAS FULLY DEPLOYED. PRIOR TO FINAL DEPLOYMENT, THE IMPLANTER ENSURED THE DELIVERY SYSTEM WAS IN A NEUTRAL POSITION/TO SLIGHT FORWARD PRESSURE AND THE GUIDEWIRE WAS PULLED TO A MIDVENTRICULAR POSITION TO DEFLECT THE NOSECONE. UPON FULL RELEASE WITH CONFIRMATION OF ALL 3 RETAINER TABS RELEASING IN 2 DIFFERENT VIEWS, IT WAS NOTED THAT THE VALVE SLIPPED/MIGRATED TOWARD THE (LVOT) WITH A FINAL IMPLANT DEPTH OF 10MM. THERE WAS NO ENTANGLEMENT WITH THE DELIVERY SYSTEM AND 23MM NAVITOR WHILE REMOVING THE DELIVERY SYSTEM AFTER FINAL DEPLOYMENT. AN ANGIOGRAM AND ECHOCARDIOGRAM WERE PERFORMED AND REVEALED A SEVERE PERIVALVULAR LE

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22413990 ↗
• InjuryMay 30, 2025Off-Label Use; Device Stenosis; Off-Label Use; Device Stenosis

  CLINICAL INFORMATION: (B)(4) VANTAGE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITHIN A 23MM NON-ABBOTT SURGICAL VALVE. WHILE IN CUSP OVERLAP VIEW AND PRIOR TO DEPLOYMENT, THE INFLOW EDGE OF THE CONSTRAINED VALVE FRAME WAS ALIGNED AT THE BASE OF THE NON-CORONARY CUSP. THE VALVE WAS RE-SHEATHED TWICE DURING PROCEDURE ONCE FOR BEING DEPLOYED TO LOW, AND ONCE TOO HIGH. THE FINAL NON-CORONARY CUSP IMPLANT DEPTH WAS 6.7MM. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 22MM NON-ABBOTT DEVICE, DUE TO A HIGH AORTIC VALVE GRADIENT OF 15MMHG NOTED BY INVASIVE PRESSURE MEASUREMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. ON (B)(6) 2025, IT WAS NOTED VIA ELECTROCARDIOGRAM THAT THE PATIENT DEVELOPED A COMPLETE HEART BLOCK. ON (B)(6) 2025, THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER. THE CAUSE OF THE PATIENT'S HIGH AORTIC VALVE GRADIENT IS ATTRIBUTED TO THE NON-PERFECT ADHERENCE OF 23MM NAVITOR VALVE INTO THE 23MM NON-ABBOTT SURGICAL VALVE. THE PATIENT WAS DIS

  Patient problems: Aortic Valve Stenosis; Heart Block

  MAUDE report 22114963 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: ON (B)(6)2025, DURING THE PROCEDURE, TO TREAT THE HEART BLOCK, A TEMPORARY PACEMAKER WAS PLACED.

  Patient problems: Heart Block

  MAUDE report 22020393 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. DURING DEPLOYMENT OF THE NAVITOR VALVE THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE VALVE WAS SUCCESSFULLY DEPLOYED AT A DEPTH OF 4 MM ON THE NON CORONARY CUSP (NCC) AND 4 MM ON THE LEFT CORONARY CUSP (LCC). A TEMPORARY PACEMAKER WAS LEFT IN PLACE FOR SEVERAL DAYS WHILE THE PATIENT WAS OBSERVED. THE HEART BLOCK DID NOT RESOLVE AND THE PATIENT RECEIVED A PERMANENT PACEMAKER ON (B)(6) 2025. THE PATIENT HAD A PROLONGED HOSPITAL STAY FOR MONITORING OF RHYTHM. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Heart Block

  MAUDE report 21979618 ↗
• DeathApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. SAME DAY POST PROCEDURE, DELAYED AWAKENING AND RIGHT UPPER LIMB PARALYSIS WERE OBSERVED. AN MRI WAS PERFORMED AND A NEW ACUTE CEREBRAL INFARCTION WAS DIAGNOSED. SINCE PATIENT HAD HISTORY OF HYPOTHYROIDISM, MYXEDEMA COMA WAS SUSPECTED, AND HYDROCORTISONE 100 MG WAS ADMINISTERED EVERY 8 HOURS, ALONG WITH THYROXINE 100 G VIA A GASTRIC TUBE. AT AN UNKNOWN POINT POST PROCEDURE, THE PATIENT WAS CARDIOVERTED FOR THE PRE-EXISTING ATRIAL FIBRILLATION.

  Patient problems: Low Blood Pressure/ Hypotension; Pulmonary Edema; Renal Failure; Respiratory Insufficiency; Stroke/CVA

  MAUDE report 21778551 ↗
• DeathMar 28, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23 MM NAVITOR VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT WAS NOTED TO HAVE PASSED AWAY DUE TO AORTIC INJURY.

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 21722530 ↗
• DeathMar 14, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE VALVE WAS IMPLANTED AS PART OF A VALVE-IN-VALVE INTO A 21MM TRIFECTA VALVE DUE TO VALVE DEGENERATION. THE PATIENT'S CONDITION PRIOR TO PROCEDURE WAS "GOOD BUT FRAGILE." THE PATIENT'S AORTIC VALVE ANGLE WAS NOTED AS NORMAL. PRE-DILATATION WAS NOT PERFORMED. THE IMPLANT DEPTH AT 80% WAS 5MM AND THE IMPLANT DEPTH AT RELEASE PRIOR TO MIGRATION WAS 5MM. THE DS WAS IN NEUTRAL POSITION AND THE GUIDEWIRE WAS IN MIDVENTRICULAR POSITION PRIOR TO FINAL DEPLOYMENT. POST-DILATATION WAS PERFORMED. AFTER POST-DILATATION, THE NAVITOR VALVE "WAS CARRIED INTO THE AORTIC ARCH WHEN THE GUIDE WAS REMOVED." THE NAVITOR VALVE WAS NOT SNARED INTO POSITION AND IT DID NOT BLOCK ANY ARTERIES. THERE WAS NO ENTANGLEMENT WITH THE DS. THERE ARE NO ALLEGATIONS OF MALFUNCTION WITH THE NAVITOR VALVE. ON (B)(6) 2025, THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES. THE USER SUSPECTS THAT THE PATIENT PASSING WAS RELATED TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609896 ↗
• DeathMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED AT A DEPTH OF 3MM USING A SMALL FLEXNAV DELIVERY SYSTEM (DS) WITHOUT ISSUE. THERE WAS NO CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. ON (B)(6) 2025, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION (AF), WHICH WAS REVERTED. ON (B)(6) 2025, THE PATIENT¿S HEART RATE WAS ABLE TO BE CONTROLLED. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE A FEVER, LETHARGY, AND ANOTHER OCCURRENCE OF AF. ANTIBIOTICS AND AMIODARONE WERE ADMINISTERED TO TREAT THE ISSUE. ON (B)(6) 2025, THE PATIENT WAS ABLE TO BE STABILIZED. ON (B)(6) 2025, AN ECG WAS REPEATED, SHOWING A WIDER QRS. IT WAS DECIDED TO CONTINUE TREATING THE PATIENT WITH ANTIBIOTICS, AND A PACEMAKER WAS ALSO IMPLANTED. AFTER THIS, THE PATIENT ENDED UP GOING INTO SHOCK AND AN X-RAY INDICATED POSSIBLE VENTRICULAR PERFORATION. THE PATIENT THEN BECAME UNSTABLE, AND A PERICARDIAL PUNCTURE AND DRAIN WAS ATTEMPTED. THE PATIENT¿S HEMODYNAMICS DIDN'T IMPROVE AND THEY PASSED AWAY (B)(6) 2025. THE PHYSICIAN BELIEVES THAT IT WAS LIKELY DUE TO A MULTI-RESISTANT PSEUDOMONAS INFECTION.

  Patient problems: Arrhythmia; Atrial Fibrillation; Fatigue; Fever; Perforation; Respiratory Tract Infection; Shock

  MAUDE report 21588182 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. POST-PROCEDURE, THE PATIENT EXPERIENCED A STROKE THAT REQUIRED ADDITIONAL HOSPITALIZATION TIME. NO PERMANENT INJURY OR DISABILITY HAS BEEN REPORTED. THE PATIENT IS STABLE.

  Patient problems: Stroke/CVA

  MAUDE report 21538464 ↗
• InjuryFeb 28, 2025Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  CLINICAL INFORMATION: (B)(6): IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS NOT PERFORMED DUE TO THE PATIENT HAVING A LOW MEAN AORTIC VALVE GRADIENT. WHILE IN CUSP OVERLAP VIEW AND PRIOR TO DEPLOYMENT, THE INFLOW EDGE OF THE CONSTRAINED VALVE FRAME WAS ALIGNED AT THE BASE OF THE NON-CORONARY CUSP. THE VALVE WAS RE-SHEATHED ONCE DUE TO BEING DEPLOYED TOO HIGH. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 20MM NON-ABBOTT DEVICE DUE TO VALVE UNDER EXPANSION. AT 80% DEPLOYMENT, THE IMPLANTER DID SWITCH TO LEFT ANTERIOR OBLIQUE (LAO) VIEW AND CONFIRMED WITH STENT PARALLAX REMOVED THAT THE IMPLANT DEPTH WAS AT AN ACCEPTABLE LEVEL BELOW ANNULUS IN THAT VIEW. THE FINAL NON-CORONARY CUSP IMPLANT DEPTH WAS 2.47MM. THERE WAS CALCIUM NOTED FROM THE LEFT CORONARY CUSP TO THE LEFT VENTRICULAR OUTFLOW TRACT. POST-PROCEDURE, IT WAS NOTED VIA ELECTROCARDIOGRAM THAT THE PATIENT DEVELOPED AN ONSET OF BRADYCARDIA. THE DECISION WAS MADE TO PLACE A TEMPORARY PACEMAKER. ON (B)(6) 2025, IT WAS NOTED VIA ELECTROCARDIOGRAM THAT THE PATIENT DEVELOPED A COMPLETE HEART BLOCK. ON (B)(6) 2025,

  Patient problems: Anemia; Bradycardia; Heart Block

  MAUDE report 21490927 ↗
• InjuryFeb 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, THE PATIENT HAD A STROKE AND A CYANOTIC FINGER SUGGESTING EMBOLIC CAUSES AND ARTERIAL OBSTRUCTION. THERE IS NO ALLEGATION THAT THE PATIENT EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PHYSICIAN ALLEGES THAT THE STROKE WAS CAUSED BY THE PROCEDURE AND NOTED THAT THE PATIENT HAD CALCIFIED ARTERIES.

  Patient problems: Embolism/Embolus; Stroke/CVA

  MAUDE report 21479447 ↗
• MalfunctionFeb 21, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 23MM NAVITOR VALVE WAS CHOSEN FOR IMPLANTATION UTILIZING A SMALL FLEXNAV DELIVERY SYSTEM. THE VALVE WAS SUCCESSFULLY IMPLANTED. AFTER REMOVING THE NOSE CONE FROM THE VALVE, THE SAFARI GUIDE WIRE IN THE LEFT VENTRICLE COULD NOT BE CONTROLLED DUE TO POSSIBLE INTERFERENCE WITH LEFT ATRIUM OR CHORDAE. IN AN ATTEMPT TO REGAIN CONTROL OF THE GUIDEWIRE, THE NOSE CONE WAS ADVANCED BACK INTO THE NAVITOR VALVE WHICH ALLOWED THE GUIDEWIRE TO BE REMOVED. LATER ON, (B)(6) 2025, A POST PROCEDURE CASE REVIEW OF THE IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE METAL PART OF THE FLEXNAV RETAINER RECEPTACLE INTERFERED WITH THE ASCENDING FRAME OF THE NAVITOR, CAUSING ONE STENT FRAME CELL TO DEFORM. THE DEFORMATION LEFT THE CELL BENT AND IN CONTACT WITH TISSUE. THERE WERE NO PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432443 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 23MM NAVITOR TRANSCATHETER AORTIC VALVE WAS SELECTED FOR IMPLANT ON (B)(6) 2025 USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PERIMETER OF THE ANNULUS WAS 63.8MM AND THE AREA WAS 306.9MM^2. A PRE-BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH AN 18MM NON-ABBOTT BALLOON, WHICH CAUSED THE PATIENT TO GO INTO COMPLETE HEART BLOCK. THE VALVE WAS IMPLANTED. THE FINAL IMPLANT DEPTH WAS 4MM FROM THE NON-CORONARY CUSP (NCC) AND 4MM FROM THE LEFT CORONARY CUSP (LCC). THE HEART BLOCK PERSISTED. THE PATIENT HAD A PROLONGED HOSPITALIZATION FOR MONITORING. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A PERMANENT PACEMAKER WAS PLANNED FOR IMPLANT AT A FUTURE DATE. THE PATIENT STATUS WAS STABLE.

  Patient problems: Heart Block

  MAUDE report 21265230 ↗
• DeathNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANT. THE PATIENT'S ANNULUS DIAMETER WAS 19.5MM. DURING THE PROCEDURE, A PRE-BAV WAS PERFORMED USING A 20MM BALLOON, AFTER THE PRE-BAV THE PATIENTS BLOOD PRESSURE (BP) WAS NOTED TO BE LOW. WHEN THE FLEXNAV DS WAS INTRODUCED, THE BP WAS 85/40. AFTER PASSING THE NATIVE ANNULUS, THE BP WAS 60/35. THE VALVE WAS QUICKLY DEPLOYED AND CPR WAS STARTED IMMEDIATELY AND LASTED FOR 30MIN. A PERICARDIAL EFFUSION WAS OBSERVED AND 600ML OF FLUID WAS ASPIRATED. THE PATIENT PASSED AWAY AFTER THERE WERE NO MORE OPTIONS FOR STABILIZING.

  Patient problems: Cardiac Arrest; Pericardial Effusion

  MAUDE report 20727190 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 21 OCTOBER 2024, A 23MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THERE WAS NO CALCIFICATION WAS CONFIRMED FROM THE ANNULUS TO THE SUB VALVULAR TO LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND THE LENGTH OF THE MEMBRANOUS SEPTUM WAS 0MM. THE VALVE WAS IMPLANTED AT A DEPTH OF 4MM AT NON-CORONARY CUSP (NCC) AND 4MM AT LEFT CORONARY CUSP (LCC). ON (B)(6) 2024, A COMPLETE ATRIOVENTRICULAR BLOCK OCCURRED. ON (B)(6) 2024. A MICRA (MDT) PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Heart Block

  MAUDE report 20726489 ↗
• MalfunctionNov 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM NAVITOR TRANSCATHETER AORTIC VALVE (SERIAL: (B)(6)) WAS CHOSEN FOR IMPLANTATION UTILIZING A SMALL FLEXNAV DELIVERY SYSTEM. PRE-BALLOON VALVUOPLASTY WAS PERFORMED WITH A 16MM ATLAS GOLD BALLOON. THE NAVITOR VALVE WAS THEN DELIVERY TO THE ANNULUS. WHEN CHECKING THE COMMISURAL ALIGNMENT WITH OVERLAPPING PROJECTION OF FLUOROSCOPY, THE AORTIC END OF THE VALVE STENT WAS DISTORTED. IT WAS SUSPECTED THE STENT STRUTS WERE TWISTED INSIDE THE VALVE CAPSULE. THERE WAS NO TORQUE APPLIED TO THE DELIVERY SYSTEM. THE NAVITOR WAS RECAPTURED AND REMOVED. A REPLACEMENT 23MM NAVITOR AND SMALL FLEXNAV DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH GOOD RESULT. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695114 ↗
• DeathNov 12, 2024Perivalvular Leak; Improper or Incorrect Procedure or Method; Perivalvular Leak; Improper or Incorrect Procedure or Method

  CLINICAL INFORMATION: CRD_1003 - VANTAGE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM NAVITOR VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT IN A VALVE-IN-VALVE PROCEDURE. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 18MM NON-ABBOTT DEVICE. WHILE IN CUSP OVERLAP VIEW AND PRIOR TO DEPLOYMENT, THE INFLOW EDGE OF THE CONSTRAINED VALVE FRAME WAS ALIGNED AT THE BASE OF THE NON-CORONARY CUSP. THE VALVE WAS RE-SHEATHED 3 TIMES DURING PROCEDURE DUE TO BEING DEPLOYED TOO HIGH AND TOO LOW. IT'S NOTED THAT THE VALVE WAS NOT ANCHORING CORRECTLY AND TENDED TO SHIFT TOWARD THE VENTRICLE. THE FINAL NON-CORONARY CUSP IMPLANT DEPTH WAS 7MM AND THE VALVE HAD UNIFORM EXPANSION. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 20MM NON-ABBOTT DEVICE DUE TO MODERATE PERIVALVULAR LEAK (PVL). AFTER THE POST-BAV THE PVL WAS MILD. ON (B)(6) 2024, IT WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAM, THAT THERE WAS MODERATE PVL. THE PATIENT DID NOT HAVE ANY OTHER CLINICAL SIGNS OR SYMPTOMS AND NO INTERVENTION WAS PERFORMED. THE CAUSE OF THE PATIENT'S PVL IS ATTRIBUTED TO THE PROCEDURE BEING A VALVE-IN-VALVE PROCEDURE THE PATIENT WAS IN STABLE CONDI

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

  MAUDE report 20664864 ↗
• InjuryOct 30, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM AND A SMALL NAVITOR LOADING SYSTEM. THE PATIENT'S AORTIC ANGLE WAS LESS THAN 45 DEGREES. THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE VALVE; THE CALCIUM SCORE IS UNAVAILABLE. PRE-DILATATION WAS PERFORMED WITH A 18MM UNKNOWN MANUFACTURER BALLOON; THE BALLOON DID NOT EXCEED THE MINIMUM DIAMETER. THE PATIENT'S ANNULUS DIMENSIONS WERE AS FOLLOWS: ANNULUS DIAM: 21MM, AREA 337.9MM2, PERIMETER 66MM, LVOT 21.3MM THE IMPLANT DEPTH AT 80% WAS 5MM. THE IMPLANT DEPTH PRIOR TO RELEASE WAS 3MM. THE FLEXNAV WAS IN NEUTRAL POSITION PRIOR TO RELEASE AND THE GUIDEWIRE WAS PULLED BACK PRIOR TO PULLING THE FLEXNAV. ALL 3 TABS WERE CONFIRMED TO HAVE BEEN RELEASED. THE VALVE WAS RECAPTURED ONCE. POST-RELEASE, VALVE MIGRATION OCCURRED AND THE VALVE MIGRATED TOWARDS THE AORTA; IT DID NOT BLOCK ANY ARTERIES. THERE WAS NO ENTANGLEMENT BETWEEN THE NAVITOR AND THE FLEXNAV WHILE REMOVING THE DELIVERY SYSTEM. THE PHYSICIAN ALLEGED THAT UNDER-EXPANSION WAS THE CAUSE OF MIGRATION. THE VALVE WAS SNARED TO POSITION AND A NEW 23MM NAVITOR VALVE WAS IMPLANTED VIA VALVE-IN-VALVE. POST-DILA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568181 ↗
• InjuryOct 17, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANT. THE PATIENT HAD MODERATE CALCIFICATION AND AN AORTIC ANNULUS SIZE OF: PERIMETER: 65.9 MM, PERIMETER DERIVED Ø: 21.0 MM, AREA: 341.9 MM², AREA DERIVED Ø: 20.9 MM, MIN Ø: 20.0 MM, MAX Ø: 22.2 MM, AVERAGE Ø: 21.1 MM, ECCENTRICITY: 0.10. THE AORTIC VALVE ANGLE WAS 50. A PRE-DILATION WAS PERFORMED WITH A 20MM X 4.5CM NON-ABBOTT BALLOON. DURING THE PROCEDURE, THE VALVE WAS POSITIONED AND DEPLOYED AT 3MM. THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. THE DEVICE ENDED UP MIGRATING INTO THE ASCENDING AORTA DUE TO THE DELIVERY SYSTEM INTERACTING WITH THE VALVE. THERE WAS NO OBSTRUCTION OF BLOOD FLOW FROM THE MIGRATION. A SECOND 23MM NAVITOR VALVE WAS TAKEN AND SUCCESSFULLY IMPLANTED BELOW THE VALVE WITHOUT COMPLICATIONS. THERE WAS NO PVL POST IMPLANT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471980 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P190023. One submission often covers many models, so check the product and lot details in each record.

• Z-0492-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
• Z-0494-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
• Z-0493-2025 · Oct 17, 2024 · Open, Classified
  Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
• Z-0491-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
• Z-0495-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile