FlexNav™ FNAV-DS-LGRecalls & reported problems

Summary

The FDA's MAUDE database contains 347 adverse event reports that list this exact device (DI 05415067031389), received between Nov 18, 2021 and Sep 21, 2026 — classified as 15 deaths, 115 injuries, 217 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (114 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 347 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Difficult to Remove; Retraction Problem; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847783 ↗
• MalfunctionSep 18, 2026Retraction Problem

  It was reported that on (b)(6) 2026, a 35mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). The patient's aortic valve was measured to be 53 degrees. During the procedure, two recaptures were performed since it was unable to achieve appropriate depth. The valve was not able to be recaptured completely, and the DS was retracted into the abdominal aorta then micro-adjustment wheel was attempted to close the gap, but the valve was still unable to be recaptured completely. A new 35mm, Navitor Vision valve was replaced using a new large FlexNav DS and able to be implanted successfully. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819444 ↗
• MalfunctionSep 18, 2026Off-Label Use; Retraction Problem

  It was reported that on (b)(6)2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient has a prior medical history of being implanted with a Bi-Ventricular pacemaker and 27mm non-Abbott surgical valve. During the procedure, on the initial attempt, the valve was in deeper position, and it was attempted for a partial recapture then the valve capsule migrated above the annulus requiring a full recapture of the valve. DS was retracted back into the descending aorta, and multiple rotations were made with the micro-adjustment wheel. However, it was unable to fully recapture the valve, and the DS was removed from the patient's anatomy. A new 35mm, Navitor Vision valve was replaced by using a new large FlexNav DS resulting in successful implantation. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818507 ↗
• MalfunctionAug 27, 2026Retraction Problem

  It was reported that on (b)(6). 2026, a 29mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). During the procedure, after two recapture attempts, the valve was unable to be recaptured completely. DS was pulled into the descending aorta, then micro-adjustment wheel was used, and the valve was able to be recaptured but the gap remained. A new 29mm Navitor Vision valve was replaced using a new large FlexNav DS resulting in successful implantation. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479039 ↗
• MalfunctionAug 13, 2026Retraction Problem; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243696 ↗
• MalfunctionAug 7, 2026Retraction Problem; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  It was reported that on (b)(6) 2026, a 29 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System. During device preparation, no issues were reported with retracting the valve into the delivery system, leading the retainer tabs into the retainer receptacle, increased drag on the deployment/resheath wheel, or requiring excess force to turn the resheath wheel. The valve was loaded by a clinical engineer. During loading, the resheath/deploy wheel reached end of travel, and the gap was completely closed. At 80% deployment, the implanter switched to the LAO view and confirmed, with stent parallax removed, that the implant depth was not at an acceptable level below the annulus. Repeated recaptures were performed due to the horizontal anatomy and concerns regarding ISO findings and inappropriate implantation depth. The physician was reported to be aware of the IFU warning against resheathing more than two times. The user believed the non-uniform valve expansion was caused by severe calcification, resulting in incomplete valve expansion. The implanter evaluated the non-uniform expansion and performed mitigation according to established steps. During the fourt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181889 ↗
• InjuryAug 7, 2026Retraction Problem; Material Twisted/Bent; Physical Resistance/Sticking

  It was reported that on (b)(6) 2026, a 35 mm Navitor Vision Valve was selected for implant using a Large FlexNav Delivery System (DS). The patient had a prior medical history of Coronary Artery Bypass Graft (CABG), heart failure, hypertension, diabetes, ischemic heart disease, Parkinson¿s disease, gastritis, and anemia. During device preparation, the valve was loaded by an Abbott employee. No issues were reported with retracting the valve into the delivery system or leading the retainer tabs into the retainer receptacle. The valve was observed to enter the capsule slowly during loading. It was reported that loading was harder than usual, but no excess force was required to turn the resheath wheel. The deploy/resheath wheel did not reach the end of travel, and an approximately 4-5 mm gap remained. The gap was subsequently closed using the micro-adjustment wheel. The procedure was performed under general anesthesia. The patient was reported to have calcified femoral vessels, and the heart team elected to obtain vascular access via surgical cutdown. A 14 Fr non-Abbott introducer sheath was used with a 26 mm non-Abbott balloon for pre-dilatation and was subsequently removed. The DS was

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180907 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: (b)(4) - Envision IDE Study, Patient Site (b)(6) - (R1012864301).It was reported that on (b)(6) 2026, a 29mm Navitor Vision Valve was chosen for implant using a Small FlexNav Delivery System. The valve got fully re-sheathed 1 time due to the implant being too low. The final implant depth at non-coronary cusp (NCC) was 4.3mm and left coronary cusp (LCC) was 6.4mm. The patient was discharged from the hospital the following day. On (b)(6) 2026, the patient removed the right groin dressing and noted bleeding at the access-site for 2 hours despite direct pressure. Anemia was not noted. The bleeding was resolved and the patient was discharged home.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50180764 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 35mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). During the procedure, the patient became hypotensive and vasoactive medications were administered with a brief episode of Cardiopulmonary resuscitation to recover from the event. The patient was stabilized and the procedure was concluded. In the physician's opinion, the cause of this event was related to recapture of the Navitor. The patient's condition is unknown.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50180059 ↗
• MalfunctionAug 7, 2026Retraction Problem

  It was reported that on (b)(6) 2026, a 29 Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). During the procedure. while attempting to recapture on the second attempt, the valve was unable to be recaptured into the DS. It was also reported that micro-adjustment wheel was used while the DS was in the descending aorta. A new 29mm, Navitor Vision valve was replaced using a new large FlexNav DS resulting in a successful implantation. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient was reportedly discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178691 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Clinical Information: CRD (b)(4)- Envision IDE Study, Patient Site (b)(6).It was reported that on (b)(6) 2026, a 35mm Navitor Vision Valve was chosen for implant using a Large FlexNav Delivery System. A pre-implant balloon valvuloplasty was done with a 26mm non-Abbott balloon. The final implant depth at non-coronary cusp (NCC) was 3mm and left coronary cusp (LCC) was 3mm. Post-procedure, a hematoma was noted at the right access site. Manual pressure was performed and the hematoma was resolved. The patient was discharged from the hospital the following day.

  Patient problems: Hematoma

  MAUDE report 50060972 ↗
• InjuryJul 27, 2026Difficult to Advance

  It was reported that on (b)(6) 2026, a 29mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). The patient has a tortuous anatomy. During the procedure, DS was not able to be advanced through the left iliac artery, so it was removed from the patient's anatomy. Non-Abbott wire was exchanged to a different non-Abbott wire. A new valve was selected for implant using a new DS and it was able to advance through left iliac artery with some exertion. The valve was able to be implanted at a depth of 2mm on the non-coronary cusp (NCC) and 3mm on the left-coronary cusp (LCC). Upon removal of the DS, bleeding was noted in the access site; the patient was transferred to the vascular operation room; vascular dissection was observed in the femoral then a left femoral artery repair was performed surgically. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Cardiology fellow believed the cause of bleeding to be due to the perclose device. The patient's condition is unknown. On follow-up, it was reported that the blood transfusion was administered and the patient had an extended hospita

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 50024277 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a FlexNav Delivery System (DS). Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 23mm, non-Abbott balloon. During the procedure, the valve was recaptured as it was positioned higher on the left-coronary cusp (LCC). On the second attempt, the patient became hypotensive and the valve was quickly deployed in a deeper position. On Echocardiogram (ECHO) showed pericardial effusion; the physician(s) conclude the presence of cardiac tamponade and obstructive shock. Pericardiocentesis was performed to resolve the event and there was no clinically significant delay reported. The patient became stable and the user suspects that the adverse event might be due to the manipulation of non-Abbot wire. The patient had an extended hospitalization and in a stable condition, scheduled (waiting) for discharge.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Shock

  MAUDE report 50024273 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 27mm Navitor Vision valve was selected for implant using a large FlexNav Delivery System (DS). Prior to the procedure, the patient was in a stable condition. Pre-implant Balloon Aortic Valvuloplasty (pre-BAV) was performed by using a 23mm, unspecified balloon. During the procedure, the valve was able to be implanted successfully after one recapture. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. Post-implant, Echocardiogram (ECG) showed sinus rhythm without pacing dependency; no pericardial effusion was observed. In the recovery room, shortly after extubating, the patient was developed with a sudden drop in blood pressure, requiring re-intubation and urgent Transesophageal Echocardiography (TEE) revealing a presence of cardiac tamponade. Localized pericardial effusion was observed in the apex; Pericardiocentesis was performed but it was unsuccessful; Cardiopulmonary resuscitation (CPR) was performed and transferred to the operating room. Sternotomy was performed revealing an apical hematoma due to perforation and a patch was placed to resolve the event. The patient i

  Patient problems: Cardiac Tamponade; Hematoma; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 50024272 ↗
• MalfunctionJul 27, 2026Difficult to Remove

  It was reported that on (b)(6) 2026, a Navitor valve was selected for implant using a large FlexNav Delivery System (DS). Pre-implant Balloon Valvuloplasty (Pre-BAV) was performed using an unspecified balloon. The same wire was reported to be used for pre-BAV, pacing, and the valve implant procedure. During the procedure, the valve was able to be implanted. Upon removal of the DS, it was difficult to remove, and it was removed together with a XS, Circulo guidewire. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported. The patient was reported to be discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012948 ↗
• MalfunctionJul 17, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25862025 ↗
• MalfunctionJul 1, 2026Retraction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). SUBCLAVIAN ROUTE WAS SELECTED AS THE ACCESS SITE. DURING THE PROCEDURE, THE VALVE WAS UNABLE TO BE RECAPTURED COMPLETELY INTO THE DS THEREFORE IT WAS REMOVED FROM THE PATIENT'S ANATOMY WITH THE PARTIALLY EXPOSED VALVE. A NEW 35MM, NAVITOR VISION VALVE WAS REPLACED WITH A NEW FLEXNAV DS RESULTING IN SUCCESSFUL IMPLANTATION. NO ADVERSE HEALTH CONSEQUENCES WERE REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681009 ↗
• MalfunctionJul 1, 2026Retraction Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, ON THE SECOND ATTEMPT, THE VALVE COULD NOT BE ABLE TO BE RECAPTURED COMPLETELY THEREFORE MICRO-ADJUSTMENT WHEEL WAS USED BY PULLING INTO THE DESCENDING AORTA AND ABLE TO BE RECAPTURED. ON THE THIRD ATTEMPT, THE VALVE WAS ONCE AGAIN NOT ABLE TO BE RECAPTURED COMPLETELY DESPITE WITH THE USE OF MICRO-ADJUSTMENT WHEEL. IT WAS ALSO OBSERVED THAT THERE WAS AN INTERFERENCE BETWEEN THE VALVE FRAME AND THE AORTIC VALVE LEAFLET. IT WAS ALSO REPORTED THAT THE DS WAS UNABLE TO BE ADVANCED THE AORTIC VALVE, SO BOTH WERE REPLACED WITH A NEW 35MM, NAVITOR VISION VALVE AND NEW LARGE FLEXNAV DS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680878 ↗
• MalfunctionJul 1, 2026Retraction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 35MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, ON 80 PERCENT OF THE DEPLOYMENT, AN INCOMPLETE STENT OPENING (ISO) WAS OBSERVED AND A RECAPTURE WAS ATTEMPTED TO REDEPLOY. HOWEVER, THE VALVE WAS UNABLE TO BE RECAPTURED COMPLETELY; MICRO-ADJUSTMENT WHEEL WAS USED WHEN THE DS WAS PULLED AT THE DESCENDING AORTA, BUT THE GAP REMAINED UNCHANGED. THE DS WITH THE HALF-CAPTURED VALVE WAS REMOVED FROM THE PATIENT'S ANATOMY THROUGH A 20FR UNSPECIFIED SHEATH. A NEW 35MM, NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A NEW LARGE FLEXNAV DS/ DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. THE USER BELIEVES THE VALVE EXPANDED NON-UNIFORMLY DUE TO THE EXCESS CALCIUM. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680810 ↗
• DeathJun 16, 2026Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2026, A 27MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. IT WAS NOTED THAT THE PATIENT HAD A COMPLEX VASCULAR ACCESS DUE TO THE SIGNIFICANT DEGREE OF ARTERIAL CALCIFICATION. A 14F SHEATH WAS INSERTED, FOLLOWED BY THE DELIVERY SYSTEM. HOWEVER, THE DELIVERY SYSTEM WAS UNABLE TO BE ADVANCED. A 18F SHEATH WAS ALSO USED WITHOUT SUCCESS. THEN A 20F SHEATH WAS USED AND ADVANCEMENT OF THE DELIVERY SYSTEM WAS SUCCESSFUL. DURING ADVANCEMENT, A PERIPHERAL BALLOON FOR DILATION WAS REQUIRED DUE TO THE SIGNIFICANT CALCIFICATION OF THE PATHWAY. THE VALVE THEN SUCCESSFULLY IMPLANTED. AFTER THE REMOVAL OF THE FLEXNAV DELIVERY SYSTEM, DURING THE WITHDRAWAL OF THE SHEATH, AN ILIAC ARTERY DISSECTION WAS OBSERVED. A BALLOON INFLATION WAS PERFORMED AT THE SITE, WHILE THE VASCULAR SURGERY TEAM ARRIVED. A COVERED STENT WAS THEN IMPLANTED. DURING THE SUBSEQUENT COURSE, THE PATIENT DEVELOPED CARDIAC ARREST SECONDARY TO HYPOVOLEMIC SHOCK. RESUSCITATION MANEUVERS WERE PERFORMED. HOWEVER, THEY WERE UNSUCCESSFUL AND THE PATIENT PASSED AWAY.

  Patient problems: Cardiac Arrest; Shock; Vascular Dissection

  MAUDE report 25524175 ↗
• MalfunctionJun 5, 2026Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). ACCESS SITE WAS SELECTED AS FEMORAL ARTERY. DURING THE PROCEDURE, THE DS WAS ATTEMPTED TO PASS THROUGH THE FEMORAL ARTERY AND AT THE END OF THE BIFURCATION OF SUPERIOR COMMON ILIAC ARTERY IT WAS UNABLE TO BE ADVANCED. FOLLOWING SEVERAL ATTEMPTS, THE DS WAS REMOVED FROM THE PATIENT'S ANATOMY, AND THE EXTERNAL SHEATH WAS RE-INSERTED. UPON INSPECTION, THE DS'S VALVE CAPSULE AROUND THE RADIOPAQUE MARKER BANK WAS OBSERVED TO BE DAMAGED AND THE TRANSITION BETWEEN THE MARKER BAND AND RADIOPAQUE TIP WAS ROUGH AND ALSO DAMAGED. A SECOND 29MM, NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DS. A NON-ABBOTT BALLOON WAS USED AS A DILATION. THE SYSTEM WAS INTRODUCED AND ATTEMPTED TO ADVANCE BUT RESULTED WITHOUT SUCCESS. THE CASE WAS DECIDED TO BE ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS IN A STABLE CONDITION AND SUBSEQUENTLY DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25413895 ↗
• DeathMay 20, 2026Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2026, A NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAD EXTREMELY SEVERE CALCIFIED AORTA & BI-LATERAL ILIAC ARTERIES. PRIOR TO THE IMPLANT, THE PATIENT WAS IN A STABLE CONDITION. THE PATIENT DID NOT HAVE A HISTORY OF RIGHT BRANCH BUNDLE BLOCK (RBBB), LEFT BUNDLE BRANCH BLOCK (LBBB) OR 1ST/2ND DEGREE ATRIOVENTRICULAR (AV) BLOCK. PRE-IMPLANT BALLOON VALVULOPLASTY (PRE-BAV) WAS PERFORMED USING AN UNSPECIFIED BALLOON. THE PATIENT WAS DEVELOPED WITH VENTRICULAR TACHYCARDIA (VT) AND REQUIRED DEFIBRILLATION TO BECOME STABLE. DURING THE PROCEDURE, THE DS COULDN'T PASS THROUGH BOTH THE SIDES OF ILIAC ARTERIES. IT WAS ALSO REPORTED THAT SEVERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTIES (PTA) WERE PERFORMED; HOWEVER, THE DIFFICULTY REMAINED PERSISTED. THE PATIENT BECAME HYPOTENSIVE THEN DEVELOPED WITH CARDIAC ARREST AND ILIAC ARTERY PERFORATION. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS SENT TO INTENSIVE CARE UNIT (ICU) FOR FURTHER MANAGEMENT, BUT THE PATIENT COULD NOT BE RECOVERED AND PRONOUNCED TO BE DECEASED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Perforation; Tachycardia

  MAUDE report 25236955 ↗
• MalfunctionMay 20, 2026Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, IT WAS NOT ABLE TO BE INSERTED INTO THE PATIENT'S ANATOMY, AND THE VALVE CAPSULE BECAME DAMAGED. A SECOND 29MM, NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A NEW LARGE FLEXNAV DS. WIRE WAS EXCHANGED FOR A STIFFER WIRE, AND THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PATIENT WAS REPORTED TO BE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236930 ↗
• MalfunctionMay 15, 2026Retraction Problem; Material Deformation

  CLINICAL INFORMATION: CRD_1059 - VISTA NOVA STUDY, PATIENT SITE ID: SITE ID: (B)(6) (AE-R995117901, DM-R995171201, DM-R995171001). IT WAS REPORTED THAT ON (B)(6) 2026, A 29MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE ACTIVATED CLOTTING LEVELS WERE 220,294S AND HEPARIN WAS GIVEN. THERE WAS NOT ENOUGH CALCIFICATION. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 23MM NON-ABBOTT BALLOON. AFTER 1ST DEPLOYMENT ATTEMPT THE PHYSICIAN DECIDED TO RE-SHEATH THE VALVE BECAUSE WAS TOO HIGH. DURING THE RE-SHEATH THE CAPSULE WAS DEFORMED AND WAS IMPOSSIBLE TO RE-SHEATH COMPLETELY THE VALVE. THE VALVE AND DELIVERY SYSTEM WERE REMOVED AND A NEW 29MM NAVITOR VISION VALVE AND LARGE FLEXNAV DELIVERY SYSTEM WERE CHOSEN AND SUCCESSFULLY IMPLANTED. THE FINAL IMPLANT DEPTH AT NON-CORONARY CUSP (NCC) WAS 6.08MM AND AT LEFT CORONARY CUSP (NCC) WAS 8.25MM. A POST-IMPLANT BALLOON VALVULOPLASTY WAS PERFORMED DUE TO HIGH MEAN GRADIENT. AFTER THE VALVE IMPLANT, THE PATIENT HAD A COMPLETE HEART BLOCK AND PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185548 ↗
• MalfunctionMay 14, 2026Difficult to Insert; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2026, A 29 MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM (DS). THE PATIENT HAS A PRIOR MEDICAL HISTORY OF CAROTID ARTERY STENOSIS, AND A VASCULAR GRAFT WAS PLACED IN THE AORTA FOR AN UNKNOWN REASON. THE PATIENT ALSO HAD A HORIZONTAL ANATOMY WITH AN ANGULATION OF 71 DEGREES. TRANSFEMORAL ACCESS WAS SELECTED AS THE ACCESS SITE. DURING THE PROCEDURE, THE DS WAS DIFFICULT TO BE INSERTED AND UNABLE TO BE ADVANCED, AND THE VALVE CAPSULE PART WAS REPORTED TO BE FLARED. A NEW 29 MM, NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DS. IT WAS UNABLE TO BE ADVANCED, AND A KINK WAS OBSERVED AND IT WAS REMOVED FROM THE PATIENT'S ANATOMY. A THIRD NEW 29 MM, NAVITOR VALVE WAS SELECTED FOR IMPLANT USING A THIRD LARGE FLEXNAV DS. IT WAS UNABLE TO BE RECAPTURED SO IT WAS PULLED INTO DESCENDING AORTA, AND A MICRO-ADJUSTMENT WHEEL WAS USED. THE VALVE WAS ABLE TO BE IMPLANTED SUCCESSFULLY AT A DEPTH OF 6 MM BOTH ON THE NON-CORONARY CUSP (NCC) AND LEFT-CORONARY CUSP (LCC). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. POST-PROCEDURE, N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167103 ↗

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