Portico™ PRT-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 05415067012487), received between Oct 25, 2021 and Apr 25, 2025 — classified as 8 deaths, 44 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Device Stenosis; Device Stenosis

  N/A.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 21910822 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_1024 - PORTICO INDIA, PATIENT SITE ID: (B)(6), (B)(4).IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM PORTICO VALVE WAS IMPLANTED WITH A SMALL FLEXNAV DELIVERY SYSTEM. DURING PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) PROCEDURE WAS PERFORMED WITH AN 18MM NON-COMPLIANT NON-ABBOTT BALLOON. RAPID PACING AT 180BPM WAS REQUIRED DURING PROCEDURE. A POST-BAV WAS PERFORMED WITH A 20MM NON-COMPLAINT NON-ABBOTT BALLOON. THE FINAL IMPLANT DEPTH WAS 3-4MM BELOW THE NATIVE AORTIC ANNULUS AND POST-IMPLANT EVALUATION REVEALED EXCELLENT COAXIAL IMPLANT WITH NO RESIDUAL GRADIENT AND TRIVIAL AORTIC REGURGITATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS THEN REPORTED ON (B)(6) 2023, POST-PROCEDURE BUT PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION WITH FAST VENTRICULAR RATE. A DECISION WAS MADE TO ADMINISTER AMIODARONE INFUSION WITH NOVEL ORAL ANTICOAGULATION THERAPY. THE PATIENT'S RHYTHM REVERTED TO SINUS RHYTHM AND WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Atrial Fibrillation

  MAUDE report 21284878 ↗
• InjuryApr 16, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS ANNULUS DIAM 21.5MM, AREA 357MM2, PERIMETER 67.7MM. DURING DEPLOYMENT OF THE VALVE, THE STARTING IMPLANT DEPTH WAS 4MM-5MM, THE DEVICE WAS DEPLOYED WITH A FINAL IMPLANT DEPTH WAS 0MM, AND PERIVALVULAR LEAK PRESENCE. POST DEPLOYMENT THE DEVICE EMBOLIZED. A NEW 25MM PORTICO VALVES WAS SELECTED AS ARE PLACEMENT AND SUCCESSFULLY IMPLANTED WITH NO WITH PERIVALVULAR LEAK PRESENCE. THE PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116915 ↗
• InjuryJan 8, 2024Perivalvular Leak; Perivalvular Leak

  THE ARTICLE, "EMERGENT CONVERSION TO OPEN HEART SURGERY DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: THE PRESENCE OF A RESCUE TEAM IMPROVES OUTCOMES", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 85-YEAR-OLD MALE WITH DIABETES, ARTERIAL HYPERTENSION, AND MILD RENAL FAILURE. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 25MM NAVITOR VALVE WAS CHOSEN FOR IMPLANT. DURING PROCEDURE, THERE WAS A PERFORATION CAUSED BY POSITIONING OF A STIFF UNKNOWN GUIDEWIRE AND THE PATIENT EXPERIENCED CARDIOGENIC SHOCK AND CARDIAC ARREST. AFTER THE PATIENT WAS STABILIZED, A CARDIOPULMONARY BYPASS WAS REQUIRED TO SUPPORT THE TRANSCATHETER AORTIC VALVE IMPLANT PROCEDURE. AFTER IMPLANT, IT WAS NOTED THERE WAS MILD PARAVALVULAR LEAK AND THE PATIENT WAS ADMINISTERED THREE UNITS OF BLOOD TRANSFUSION. THE PATIENT STATUS WAS REPORTED STABLE AND DISCHARGED HOME AFTER 18 DAYS. THE ARTICLE CONCLUDED THAT SURGICAL TREATMENT IS RARE DURING TAVI. THE PRESENCE OF AN EXPERT COMPLETE RESCUE TEAM AS SUPPORT MEANS AN INCREASE IN SURVIVAL. SURGERY MUST BE USED ONLY TO RESTORE CIRCULATORY AND TO TREAT COMPLICATION WHILE PERCUTANEOUS APPROACHES SHOULD COMPLETE THE PROCEDURE. [THE PRIMARY AND CORRESPONDING AUTHOR WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470288 ↗
• MalfunctionAug 28, 2023Perivalvular Leak; Malposition of Device; Perivalvular Leak; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM PORTICO VALVE WAS IMPLANTED USING A SMALL FLEXNAV DELIVERY SYSTEM (LOT: 8583656) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. BALLOON AORTIC VALVULOPLASTY (BAV) PRE-DILATATION WAS PERFORMED. THE PORTICO WAS IMPLANTED AT 7MM ON EACH SIDE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. AT THE 30 DAY FOLLOW-UP APPOINTMENT, ECHOCARDIOGRAM IMAGING SHOWED A MODERATE PERIVALVULAR LEAK. THE PATIENT RETURNED ON (B)(6) 2023 FOR A BALLOON AORTIC VALVULOPLASTY (BAV) WITH A 23MM BALLOON WHICH RESOLVED THE LEAK. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633028 ↗
• InjuryAug 21, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON 27 JULY 2023, A 25MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS: ANNULUS DIAMETER 22.2MM AREA 381.6MM2, PERIMETER 69.9. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. A PRE-DILATATION BALLOON AORTIC VALVULOPLASTY (BAV) PERFORMED WITH A NON-ABBOTT DEVICE. DURING THE PROCEDURE, AFTER THE FULL DEPLOYMENT OF PORTICO, THE PHYSICIAN CONFIRMED 3 RETAINED TABS WAS FREE AND PULLED BACK FLEXNAV, HOWEVER PORTICO VALVE WAS MOVED TO THE ASCENDING AORTA WITH A FINAL IMPLANT DEPTH OF 4MM. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE VALVE MOVED OVER THE ANNULUS, THE PHYSICIAN SNARED OVER THE OSTIUMS IN ORDER TO AVOID CORONARY OCCLUSION. THE PHYSICIAN AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. IT WAS NECESSARY TO USE A SECOND 23MM PORTICO VALVE IN ORDER TO GUARANTEE THE SUCCESSES OF THE PROCEDURE. A POST-DILATATION PERFORMED DUE TO PARAVALVULAR LEAK (PVL) POST IMPLANT OF THE SECOND VALVE DUE TO TWO POINTS OF CALCIUM OVER THE ANNULUS. AFTER 2 DAYS, THE LEAK WAS TRACE ON ECHOCARDIOGRAM. THE PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591176 ↗
• DeathJul 27, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM PORTICO VALVE (SERIAL (B)(6)) WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (LOT 8359430) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THERE WAS SUFFICIENT CALCIUM TO ALLOW SEALING. THE AORTIC ANNULUS PERIMETER WAS 71.8MM, THE AREA WAS 389.9MM^2, AND THE AVERAGE DIAMETER WAS 22.6MM. A PRE-DILATATION WAS PERFORMED WITH A 22MM BALLOON. THE VALVE WAS IMPLANTED AT A DEPTH OF 2-3MM. THERE WAS NO DIFFICULTY DEPLOYING THE VALVE, AND THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. ALL THREE VALVE RETAINER TABS WERE CONFIRMED VIA IMAGING TO BE RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. AN ECHOCARDIOGRAM WAS PERFORMED, AND THE VALVE HAD MIGRATED TO THE SINUS OF VALSALVA AND A TRANSVALVULAR LEAK WAS PRESENT. THE CAUSE OF THE MIGRATION WAS BELIEVED TO BE DUE TO CALCIUM. THE VALVE DID NOT BLOCK A CORONARY ARTERY. ANOTHER 25MM PORTICO VALVE (SERIAL (B)(6)) WAS IMPLANTED VIA VALVE-IN-VALVE PROCEDURE USING ANOTHER FLEXNAV DELIVERY SYSTEM (LOT 8282305) AND WAS SLIGHTLY LOWER AT A DEPTH OF 4MM. A POST-DILATATION WAS PERFORMED WITH A 22MM BALLOON DUE TO VALVE UNDE

  Patient problems: Cardiac Arrest

  MAUDE report 17402620 ↗
• InjuryJul 26, 2023Migration or Expulsion of Device; Intravalvular regurgitation; Migration or Expulsion of Device; Intravalvular regurgitation

  IT WAS REPORTED THAT ON 30 JUNE 2023, A 25MM PORTICO VALVE (SERIAL (B)(6)) WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM (LOT 8359430) DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THERE WAS SUFFICIENT CALCIUM TO ALLOW SEALING. THE AORTIC ANNULUS PERIMETER WAS 71.8MM, THE AREA WAS 389.9MM^2, AND THE AVERAGE DIAMETER WAS 22.6MM. A PRE-DILATATION WAS PERFORMED WITH A 22MM BALLOON. THE VALVE WAS IMPLANTED AT A DEPTH OF 2-3MM. THERE WAS NO DIFFICULTY DEPLOYING THE VALVE, AND THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. ALL THREE VALVE RETAINER TABS WERE CONFIRMED VIA IMAGING TO BE RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. AN ECHOCARDIOGRAM WAS PERFORMED, AND THE VALVE HAD MIGRATED TO THE SINUS OF VALSALVA AND A TRANSVALVULAR LEAK WAS PRESENT. THE CAUSE OF THE MIGRATION WAS BELIEVED TO BE DUE TO CALCIUM. THE VALVE DID NOT BLOCK A CORONARY ARTERY. ANOTHER 25MM PORTICO VALVE (SERIAL (B)(6)) WAS IMPLANTED VIA VALVE-IN-VALVE PROCEDURE USING ANOTHER FLEXNAV DELIVERY SYSTEM (LOT 8282305) AND WAS SLIGHTLY LOWER AT A DEPTH OF 4MM. A POST-DILATATION WAS PERFORMED WITH A 22MM BALLOON DUE TO VALVE UND

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17398417 ↗
• InjuryJun 26, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM PORTICO VALVE ((B)(6)) WAS CHOSEN FOR IMPLANT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION USING FLEXNAV DELIVERY SYSTEM. THE ANNULUS DIAMETER WAS MEASURED AS 68.2MM. A 20MM NON-COMPLIANT BALLOON WAS USED DURING THE PRE-DILATATION. THE VALVE WAS DEPLOYED WITHOUT ISSUE. THE STARTING IMPLANT DEPTH AT DEPLOYMENT WAS 5MM, AND THE FINAL IMPLANT DEPTH AT RELEASE WAS 5MM. THERE WAS MILD CALCIUM PRESENT. THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. AFTER THE VALVE WAS FULLY RELEASED, THE VALVE DISLODGED FROM THE ANNULUS INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). AT THE TIME THE VALVE MIGRATED, THE PIGTAIL CATHETER WAS IN THE ASCENDING AORTA, AND THE DELIVERY SYSTEM WAS IN THE ANNULUS LEVEL OF DEPLOYMENT. HALF OF THE VALVE WAS IN THE AORTIC ANNULUS, AND HALF OF THE VALVE WAS IN THE LVOT. THE VALVE WAS SNARED INTO THE ANNULUS, BUT THEN THE VALVE EMBOLIZED INTO THE AORTA. THE VALVE POSITION WAS STABILIZED IN THE AORTA. THE VALVE DID NOT CAUSE AN OBSTRUCTION OF THE LVOT AND DID NOT BLOCK A CORONARY ARTERY OR ARTERIES. ANOTHER 25MM PORTICO VALVE ((B)(6)) WAS IMPLANTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203945 ↗
• InjuryJun 26, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM PORTICO VALVE (19399264) WAS CHOSEN FOR IMPLANT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION USING FLEXNAV DELIVERY SYSTEM. THE ANNULUS DIAMETER WAS MEASURED AS 68.2MM. A 20MM NON-COMPLIANT BALLOON WAS USED DURING THE PRE-DILATATION. THE VALVE WAS DEPLOYED WITHOUT ISSUE. THE STARTING IMPLANT DEPTH AT DEPLOYMENT WAS 5MM, AND THE FINAL IMPLANT DEPTH AT RELEASE WAS 5MM. THERE WAS MILD CALCIUM PRESENT. THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. AFTER THE VALVE WAS FULLY RELEASED, THE VALVE DISLODGED FROM THE ANNULUS INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). AT THE TIME THE VALVE MIGRATED, THE PIGTAIL CATHETER WAS IN THE ASCENDING AORTA, AND THE DELIVERY SYSTEM WAS IN THE ANNULUS LEVEL OF DEPLOYMENT. HALF OF THE VALVE WAS IN THE AORTIC ANNULUS, AND HALF OF THE VALVE WAS IN THE LVOT. THE VALVE WAS SNARED INTO THE ANNULUS, BUT THEN THE VALVE EMBOLIZED INTO THE AORTA. THE VALVE POSITION WAS STABILIZED IN THE AORTA. THE VALVE DID NOT CAUSE AN OBSTRUCTION OF THE LVOT AND DID NOT BLOCK A CORONARY ARTERY OR ARTERIES. ANOTHER 25MM PORTICO VALVE (19399258) WAS IMPL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17203929 ↗
• DeathJun 26, 2023Intravalvular regurgitation; Intravalvular regurgitation

  THE ARTICLE, "AORTIC SINUS CONTRAST RETENTION DURING TAVR", WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 73-YEAR-OLD WOMAN WITH SEVERE AORTIC STENOSIS THAT WAS REFERRED FOR AORTIC VALVE REPLACEMENT WITH A 25MM PORTICO VALVE. SHE HAD A HISTORY OF SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PREVIOUS ISCHEMIC STROKE, AMYLOID ANGIOPATHY-RELATED CEREBELLAR HEMORRHAGE, PERMANENT ATRIAL FIBRILLATION (AF) WITH PERCUTANEOUS LEFT ATRIAL APPENDAGE OCCLUSION, AND END-STAGE RENAL DISEASE. PREPROCEDURAL CT SHOWED MODERATE AORTIC VALVE CALCIFICATION, WITH AN AORTIC ANNULUS PERIMETER OF 69 MM AND AN AREA OF 361 MM2 AND A CALCIFIED SINOTUBULAR JUNCTION (STJ). FINAL ANGIOGRAPHY SHOWED MILD RESIDUAL AORTIC REGURGITATION, WITH DENSE CONTRAST AGENT STAGNATION AT THE NONCORONARY SINUS. FOUR HOURS LATER, THE PATIENT EXPERIENCED RIGHT HEMIPARESIS (4/5) AND APHASIA. EMERGENCY HEAD COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY (M2 SEGMENT), AND THE PATIENT UNDERWENT EMERGENCY THROMBECTOMY WITH TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) GRADE 2B PARTIAL RECANALIZATION. THE PATIENT DEVELOPED HEMORRHAGIC TRANSFORMATION AND DIED 3 WEEKS AFTER THE PROC

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Stroke/CVA

  MAUDE report 17200190 ↗
• DeathMay 16, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT A CORONARY ANGIOGRAM HAD REVEALED SEVERE CALCIFICATION AND STENOSIS OF THE OSTIAL LEFT MAIN CORONARY ARTERY. IT WAS ALSO NOTED THAT THERE WAS DIFFUSE DISEASE IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE ROTABLATION OF THE OSTIAL LEFT MAIN CORONARY ARTERY AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY HAD BEEN PERFORMED USING A NON-ABBOTT DEVICE. A 3.5 X 44MM NON-ABBOTT STENT WAS DEPLOYED. THE WAS NOTED THAT FOLLOWING THE STENTING THE PATIENT BECAME HYPOTENSIVE. THEREAFTER, A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. THE DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS. AFTER, THE PRE-IMPLANT DILATION WAS PERFORMED USING A 18 X 4CM NON-ABBOTT BALLOON, THE PORTICO VALVE WAS IMPLANTED AND ARTERIOTOMY WAS CLOSED OFF. THE PATIENT WAS THEN CONVERTED TO CARDIOVASCULAR AND THORACIC SURGERY FOR CORONARY BYPASS. A STERNOTOMY AND PERICARDIOTOMY WAS PERFORMED. IT WAS NOTED DURING THE STERNOTOMY/PERICARDIOTOMY THAT A PERFORATION OF THE RIGHT VENTRICLE WAS APPARENT. SUTURING WAS PERFORMED BESIDES THE LEFT ANTERIOR DESCENDING ARTERY. THE CAUSE OF

  Patient problems: Cardiac Perforation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940029 ↗
• InjuryMar 22, 2023Migration or Expulsion of Device; Perivalvular Leak; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED THAT ON 27 FEBRUARY 2023, A 25MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. PRE-PROCEDURAL IMAGING WAS PERFORMED AND SHOWED A SEVERELY CALCIFIED AORTIC VALVE ANNULUS. A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED USING A 22MM BALLOON CATHETER. THE VALVE WAS THEN POSITIONED AT 8MM BELOW THE NON-CORONARY CUSP AND 9MM BELOW THE LEFT CORONARY CUSP. AFTER THE VALVE WAS FIRST ATTEMPTED TO DEPLOY, THE VALVE WAS FUNCTIONING NORMALLY. AFTER THE FINAL DEPLOYMENT, THE VALVE TILTED CLOCKWISE, CAUSING THE LEFT CORONARY CUSP SIDE OF THE VALVE TO MOVE FURTHER DOWN TO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AT 12 TO 14MM BELOW THE LEFT CORONARY CUSP. THE AORTOGRAM INDICATED MODERATE TO SEVERE AORTIC REGURGITATION. A POST BALLOON VALVULOPLASTY WAS PERFORMED WITH A 22MM BALLOON BUT FAILED TO MITIGATE THE LEAK. A SECOND 25MM PORTICO VALVE WAS IMPLANTED SUCCESSFULLY IN A VALVE IN VALVE PROCEDURE. THE FINAL EVALUATION SHOWED GOOD HEMODYNAMIC RESULTS WITH NO TRANS-AORTIC VALVE GRADIENT OR TRACE REGURGITATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16594597 ↗
• InjuryMar 8, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  CRD_1025 - PORTICO VALVE-IN-VALVE RETROSPECTIVE REGISTRY, (B)(4). IT WAS REPORTED THAT ON (B)(6) 2015, A 25MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT HAD PNEUMONIA POTENTIALLY CAUSED BY ASPIRATION. PATIENT WAS ALSO HOSPITALIZED FOR OBSERVATION OF ENDOCARDITIS/UNSPECIFIED TAVI PROBLEMS. PATIENT WAS SEEN BY CARDIOLOGIST. NO SUSPECTED CARDIAC DISORDER ON CHEST X-RAY. PATIENT WAS TREATED WITH PREDNISOLONE INTRAVENOUSLY FOR PNEUMONIA. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Endocarditis

  MAUDE report 16506860 ↗
• InjuryFeb 6, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM PORTICO VALVE WAS IMPLANTED USING A SMALL FLEXNAV DELIVERY SYSTEM. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE MIGRATED UP OUT OF THE AORTIC ANNULUS. THE DEVICE WAS THEN SNARED AND MOVED INTO THE ASCENDING AORTA. A REPLACEMENT 23MM NON-ABBOTT VALVE WAS THEN IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308456 ↗
• InjuryJan 12, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE FEMORAL ROUTE WAS INACCESSIBLE; THEREFORE THE DELIVERY POINT WAS THE LEFT SUBCLAVIAN ARTERY. THE VALVE WAS "DIFFICULT TO BE POSITIONED WITH GOOD ANNULAR ALIGNMENT TO THE NATIVE AORTIC VALVE DUE TO THE STEEP AORTIC ANGULATION (HORIZONTAL AORTA)". AT THE 3RD DEPLOYMENT, THE VALVE LANDED AT AN ACCEPTABLE DEPTH (4MM BELOW THE NON-CORONARY CUSP (NCC) AND 9MM BELOW THE LEFT CORONARY CUSP (LCC). THE VALVE SELF-CENTERED AND TILTED CLOCKWISE AFTER COMPLETE DEPLOYMENT, CAUSING THE LCC SIDE TO DIVE FURTHER DOWN TO THE LVOT (12MM BELOW LCC). NO TRANSVALVULAR GRADIENT WAS OBSERVED, HOWEVER LOW AORTIC REGURGITATION (AR) INDEX SUGGESTED MODERATE TO SEVERE AORTIC REGURGITATION. IN ADDITION, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND AORTOGRAM ALSO SUGGESTED SEVERE LEAKAGE OVER THE LCC BORDER OF THE VALVE. BALLOON VALVULOPLASTY WAS ATTEMPTED WITH A 22MM BALLOON AND THEN A 23MM BALLOON WITH NO IMPROVEMENT. THE PHYSICIAN ELECTED TO IMPLANT A SECOND VALVE. A NEW 25MM PORTICO VALVE WAS PREPARED AND SUCCESSFULLY IMPLANTED WITH NO COMPLICATIONS. THE SECOND VALVE WAS RELEASED AT 1MM

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16153584 ↗
• InjuryJan 9, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A ON (B)(6) 2022 A 25MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PATIENT HAD A HORIZONTAL ANATOMY WITH A PERIMETER 72.5MM. THE VALVE WAS POSITIONED AT 4MM BELOW NON-CORONARY CUSP (NCC). DURING FINAL DEPLOYMENT, THE VALVE MIGRATED AND WAS SNARED ABOVE THE SINOTUBULAR JUNCTION (STJ) AND AWAY FROM THE CORONARIES. THE PHYSICIAN AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. THERE WAS NO FORWARD OR BACK TENSION NOTED ON THE DELIVERY SYSTEM DURING DEPLOYMENT. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH A SECOND 25MMPROTICO VALVE THAT WAS SUCCESSFULLY IMPLANTED. PATIENT DOING WELL ON POST DAY ONE ECHO AND DISCHARGED OVER THE WEEKEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125306 ↗
• InjuryDec 15, 2022Migration or Expulsion of Device; Perivalvular Leak; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVE (19238809) WAS CHOSEN FOR A TRANSCATHETER AORTIC VALVE IMPLANTATION USING A SMALL FLEXNAV DELIVERY SYSTEM (8421857). THE PATIENT HAD A PREVIOUSLY IMPLANTED UNKNOWN SIZE NON-ABBOTT VALVE IN PLACE, AND THE PATIENT REQUIRED A VALVE-IN-VALVE PROCEDURE DUE TO PURE AORTIC REGURGITATION (AR). THERE WAS NO OBSERVED CALCIUM ON THE EXISTING IMPLANTED NON-ABBOTT VALVE. THE PORTICO VALVE WAS DEPLOYED AT 3MM. UPON THE FINAL RELEASE OF THE PORTICO VALVE, IT MIGRATED DOWN MORE THAN 10MM AND ENDED UP SLIGHTLY TOO DEEP. DUE TO THE LEAKAGE AROUND THE VALVE, THEY DECIDED TO DEPLOY A SECOND 25MM PORTICO VALVE (19188508) USING A SMALL FLEXNAV DELIVERY SYSTEM (8418404). THE SECOND VALVE WAS IMPLANTED AND POSITIONED WELL. THERE WAS NO GRADIENT OR LEAK DETECTED POST IMPLANT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988975 ↗
• DeathDec 14, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVE WAS SELECTED FOR IMPLANTATION DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION USING A FLEXNAV DELIVERY SYSTEM. THE PATIENT HAD A HISTORY OF SEVERE AORTIC STENOSIS, AND PRIOR TO THE PROCEDURE THE PATIENTS CONDITION WAS CRITICAL. PRIOR TO THE PROCEDURE THE PATIENT HAD VENTRICULAR FIBRILLATION WAND WENT INTO CARDIAC ARREST. DURING PROCEDURE, A CORONARY ANGIOGRAPHY WAS PERFORMED. THE PATIENT HAD LOW BLOOD PRESSURE AT 60MMHG/30MMHG. THE PATIENT HAD CONTINUALLY LOWERING BLOOD PRESSURE AND FELL INTO CARDIAC ARREST. RESUSCITATION MANEUVERS WERE PERFORMED, AND BLOOD PRESSURE WAS RESTORED TO AN AVERAGE OF 50MMHG. A BALLOON VALVULOPLASTY WAS PERFORMED USING A NON-ABBOTT BALLOON TO REMOVE AORTIC STENOSIS. THE 25MM PORTICO VALVE WAS RELEASED WHILE THE PATIENT HAD LOW CARDIAC OUTPUT, LOW BLOOD PRESSURE, AND LOW CONTRACTION OF THE HEART. A POST-DILATATION BALLOON VALVULOPLASTY WAS PERFORMED DUE TO SEEING A SMALL WAIST OF THE VALVE. AN ECHOCARDIOGRAM WAS PERFORMED, AND THERE WAS NO PARAVALVULAR LEAK OF THE VALVE. THE AORTIC MEAN GRADIENT WAS 4MMHG. THE PATIENT WENT INTO CARDIAC ARREST AND WAS RESUSCITATED. THE PATIENT'S BLOOD PRESSURE WAS

  Patient problems: Cardiac Arrest

  MAUDE report 15977507 ↗
• InjuryDec 12, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVE WAS CHOSEN FOR IMPLANT. THE STARTING IMPLANT DEPTH WAS 2MM BELOW NATIVE ANNULUS, AND THE FINAL DEPLOYMENT DEPTH WAS ALMOST 1MM. DUE TO SEVERE CALCIFICATION OF NATIVE ANNULUS, THE VALVE WAS DISPLACED AND MIGRATED TOWARDS THE ASCENDING AORTA, 30MM BEYOND NATIVE ANNULUS. BECAUSE OF THIS, A SECOND 25MM PORTICO VALVE WAS IMPLANTED IN A VALVE IN VALVE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15961180 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THE PATIENT HAS A PAST MEDICAL HISTORY OF ATRIAL FIBRILLATION. THE IMPLANT DEPTH OF THE PORTICO VALVE WAS NON-CORONARY CUSP (NCC) 5MM AND LEFT CORONARY CUSP (LCC) 7MM DEPTH. THE PATIENT DEVELOPED ASYSTOLE AFTER THE PORTICO WAS DELIVERED. A PACEMAKER WAS IMPLANTED DUE TO HEART BLOCK. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Asystole

  MAUDE report 15874433 ↗
• InjuryOct 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT (B)(6) ON2022, A 25MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE IMPLANT DEPTH WAS 3-5MM AND THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THE SIZING OF THE ANNULAR DIMENSIONS WAS PERIMETER 71MM. THERE WAS NOT SUFFICIENT CALCIUM FOR THE VALVE TO ANCHO. DURING THE PROCEDURE, THE VALVE WAS LOADED INTO A SMALL FLEXNAV DELIVERY SYSTEM. PREDILATION WAS DONE USING A 18MM NON-ABBOTT BALLOON. THE DEPTH OF VALVE WAS CHECKED PRIOR TO FINAL DEPLOYMENT (80%). UPON CHECKING THAT DEPTH IS OPTIMAL, DEPLOYMENT BUTTON WAS DEPRESSED AND VALVE WAS RELEASED. THE USER BELIEVES THERE WAS TENSION EXERTED ON THE PRE-SHAPED WIRE. HOWEVER, AT THE FINAL RELEASE THE VALVE MIGRATED. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION AND THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY OR ARTERIES. THE VALVE WAS SNARED TOWARDS THE ASCENDING AORTA. THE PHYSICIAN IS AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. DECISION WAS THEN MADE TO DEPLOY A 2ND 25MM PORTICO VALVE IN A VALVE IN VALVE PROCEDURE. THE VALVE WAS LOADED AND DEPLOYED SUCCESSFULLY WITH NO COMPLICATION AND THE PATIENT REMAINS S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15669879 ↗
• InjuryOct 21, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE THE PATIENT'S ACTIVATED CLOTTING TIME WAS 350 SECONDS. HEPARIN WAS ADMINISTRATED. DURING DEPLOYMENT THE 25MM PORTICO VALVE MIGRATED INTO THE ASCENDING AORTA. THE IMPLANT DEPTH AT DEPLOYMENT WAS 3MM AND AT RELEASE WAS 3MM. THERE WAS MILD CALCIFICATION TO ALLOW ANCHORING. THE DEVICE WAS SNARE TOWARDS THE HIGHEST PART OF THE ASCENDING AORTA WITH A NON-ABBOTT DEVICE. AN ANGIOGRAPHY PERFORMED OF THE AORTIC ROOT THAT SHOWED A LEAK AND PERICARDIAL EFFUSION. GRADIENT WAS MEASURED AT 11MMHG WITH EVIDENCE OF PROSTHETIC REGURGITATION. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH A NEW 27MM PORTICO VALVES THAT HAD A FINAL DEPTH OF 3MM AND A MEAN GRADIENT OF 5MMHG. POST DEPLOYMENT, TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED A TRACE PARAVALVULAR LEAK WITHOUT CHANGES TO THE PERICARDIAL EFFUSION AND AN EJECTION FRACTION OF 30%, WITH IMPROVEMENT IN CONTRACTILITY. A PERICARDIOCENTESIS WAS PERFORMED DRAINING 700CC. THERE WAS SIGNIFICANT DECREASE IN THE EFFUSION. ABOUT 45 MINUTES AFTER THE END OF THE PROCEDURE WITH NO INCREASE IN EFFUSION. THE PATIENT WAS TRANSFER INTO THE CORONARY UNIT WITH MECHANI

  Patient problems: Pericardial Effusion

  MAUDE report 15652519 ↗
• InjurySep 30, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25 MM PORTICO VALVE WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, IT WAS FOUND THAT THE VALVE HAD MIGRATED INTO THE SINUS OF VALSALVA. THE VALVE WAS SNARED AND MOVED TO THE AORTIC ARCH, AND A 25 MM PORTICO VALVE WAS IMPLANTED SUCCESSFULLY INTO THE ANNULUS. THE PATIENT WAS NOT HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. THERE WAS A CLINICALLY SIGNIFICANT DELAY THAT HAD THE POTENTIAL TO CAUSE HEMODYNAMIC COMPROMISE. IT IS BELIEVED THAT FIBROTIC TISSUE AND HIGH PLACEMENT CAUSED THE MIGRATION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510498 ↗
• InjurySep 9, 2022Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Perivalvular Leak; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  THIS REPORT IS FOR THE 1ST PORTICO VALVE, PRT-25, (B)(4) DUE TO VALVE MIGRATION. IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM PORTICO VALVE ((B)(4)) WAS CHOSEN FOR IMPLANT FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT USING A FLEXNAV DELIVERY SYSTEM (8404696). THE PATIENT HAD A RAPHE TYPE 1 BICUSPID VALVE, AND THE RAPHE BETWEEN THE RIGHT CORONARY CUSP AND THE NON-CORONARY CUSP WAS EXTREMELY CALCIFIED. THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) WAS ALSO SMALLER THAN THE ANNULUS. THE PATIENT HAD A VERY ENLARGED SINUS, SINOTUBULAR JUNCTION (STJ), AND ASCENDING AORTA. THE AORTIC ANNULUS HAD A PERIMETER OF 72MM. WHEN THE VALVE WAS DEPLOYED, THE STARTING IMPLANT DEPTH WAS 3MM ON EACH SIDE. THE VALVE WAS RE-SHEATHED MORE THAN TWO TIMES, AND THE PHYSICIAN IS AWARE OF THE INSTRUCTIONS FOR USE (IFU) WARNING AGAINST THIS. WHEN THE VALVE WAS RELEASED, THE FINAL IMPLANT DEPTH WAS 3MM ON EACH SIDE. THE VALVE DID NOT EXPAND DUE TO THE PATIENT'S UNUSUAL ANATOMY, AND THERE WAS A PERIVALVULAR LEAK. THE VALVE WAS VERY CONSTRAINED, AND THE NOSE CONE OF THE DELIVERY SYSTEM WAS LEANING TOWARDS THE OUTER CURVATURE OF THE VALVE. WHEN TRYING TO REMOVE THE DELIVERY SYSTEM, THE NOSE CONE GOT CAUGHT ON THE VALVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391272 ↗

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