Portico™ PRT-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05415067012500), received between Sep 29, 2021 and Jan 16, 2024 — classified as 5 deaths, 44 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (20 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2024Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Separation Problem; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Separation Problem

  IT WAS REPORTED THAT ON 20 DECEMBER 2023, A 29MM PORTICO VALVE WAS SELECTED FOR IMPLANT IN A PATIENT WITH A FORCED EXPIRATORY VOLUME LESS THAN 20%, USING A LARGE FLEXNAV DELIVERY SYSTEM. IT WAS NOTED AFTER PERFORMING A PRE-IMPLANT DILATATION WITH AN UNKNOWN DEVICE, THAT THE PATIENT WENT INTO CARDIAC ARREST. IT WAS ALSO NOTED DURING PROCEDURE VIA FLUOROSCOPY, THAT THE VALVE HAD EMBOLIZED DUE TO THE LARGE FLEXNAV DELIVERY SYSTEM INTERACTING WITH THE VALVE WHEN ATTEMPTING TO REMOVE THE DELIVERY SYSTEM. IT HAD NOT BEEN CONFIRMED THAT ALL THREE RETAINER TABS HAD RELEASED. THE 29MM PORTICO VALVE HAD BEEN SIZED USING COMPUTED TOMOGRAPHY SCAN MEASUREMENTS. THE DECISION WAS MADE TO IMPLANT A SECOND 29MM PORTICO VALVE IN A VALVE-IN-VALVE PROCEDURE. IT WAS NOTED THAT THE THE FIRST 29MM PORTICO VALVE WAS MOVED IN AN UNKNOWN FASHION ABOVE THE SINOTUBULAR JUNCTION, AND IMPLANT THE SECOND 29MM PORTICO VALVE WAS OVER THE AORTIC ANNULUS. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICES OR PROCEDURE. THE PATIENT WAS STABLE AT THE TIME OF REPORT. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT THAT A 22MM NON-ABBOTT DEVICE WAS USED FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518003 ↗
• InjuryOct 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A FLEXNAV DELIVERY SYSTEM FOR A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE NATIVE AORTIC ANNULUS HAD PERIMETER OF 80.3MM AND AREA OF 501.6MM^2. THE PATIENT HAD A HORIZONTAL AORTA AT 86 DEGREES. THE VALVE WAS DEPLOYED AND RE-SHEATHED ONCE. THERE WERE NO DIFFICULTIES IN DEPLOYING OR RETRACTING THE VALVE. THE STARTING IMPLANT DEPTH AT DEPLOYMENT WAS 2MM, AND THE FINAL IMPLANT DEPTH AT RELEASE WAS 1MM. DURING FINAL DEPLOYMENT OF THE VALVE, THE VALVE MIGRATED TO THE ASCENDING AORTA AND WAS NO LONGER WITHIN THE AORTIC ANNULUS. THERE WAS NO TENSION AT THE TIME OF FINAL DEPLOYMENT. THERE WAS NO SEPARATION ISSUE BETWEEN THE VALVE AND THE DELIVERY SYSTEM. ALL THREE RETAINER TABS WERE CONFIRMED VIA IMAGING TO BE RELEASED PRIOR TO REMOVAL OF THE DELIVERY SYSTEM. IT WAS REPORTED THAT THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. THE VALVE DID NOT BLOCK A CORONARY ARTERY. THE VALVE WAS NOT SNARED. A SECOND 29MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED USING A SECOND FLEXNAV DELIVERY SYSTEM. FOLLOWING THE SECOND VALVE IMPLANT, THE GRADIENT WAS 4MMHG. THE PATIENT DID NOT HAVE ANY CLINICAL SIGN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038934 ↗
• InjuryOct 16, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THE PATIENT ANGULATION WAS 54 DEGREES AND THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 27MM DIAMETER, AREA 559.5MM2, PERIMETER 84.9MM. DURING THE PROCEDURE, AFTER THE FULL DEPLOYMENT OF VALVE, THE PHYSICIAN CONFIRMED 3 RETAINED TABS WAS FREE AND PULLED BACK FLEXNAV, HOWEVER THE DEVICE WAS MOVED TO THE ASCENDING AORTA DUE TO UNDER EXPANSION. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE DEVICE WAS SNARED OVER THE CORONARIES OSTIUM AND THE PHYSICIAN IS AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. IT WAS NECESSARY TO USE A SECOND VALVE IN ORDER TO GUARANTEE THE SUCCESSFUL OF THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17943658 ↗
• InjuryJul 14, 2023Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  THE ARTICLE, ¿VALVE EMBOLIZATION DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: INCIDENCE, RISK FACTORS AND FOLLOW-UP BY COMPUTED TOMOGRAPHY¿, WAS REVIEWED. THIS RESEARCH ARTICLE AIMED OF THIS STUDY WAS TO ANALYZE THE INCIDENCE OF TRANSCATHETER VALVE EMBOLIZATION AND MIGRATION (TVEM) IN A LARGE COHORT OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND TO EXAMINE EMBOLIZED VALVES BY COMPUTED TOMOGRAPHY (CT) LATE AFTER TAVI. THIS RESEARCH ARTICLE REPORTED A CASE STUDY 77-YEAR-OLD FEMALE PATIENT THAT HAD A 29MM PORTICO VALVE IMPLANTED. THE VALVE WAS PULLED INTO THE ASCENDING AORTA DUE TO INCOMPLETE RELEASE FROM THE DELIVERY CATHETER. THE FINAL TRANSCATHETER HEART VALVE POSITION WAS NOTED TO BE IN THE ASCENDING AORTA. A VALVE-IN-VALVE WAS PERFORMED USING A 26MM SAPIEN 3. AT 43 MONTHS FOLLOW UP COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED UPPER CROWN PROTRUDING INTO THE AORTIC WALL. THE ARTICLE CONCLUDED TVEM REPRESENTS A RARE COMPLICATION OF TAVI. FOLLOW UP-CT DETECTED NO PATHOLOGICAL FINDINGS REQ SPONTANEOUS EMBOLIZATION INTO AORTA, MIGRATION INTO LEFT VENTRICLE, INCOMPLETE RELEASE FROM DELIVERY CATHETER, EMBOLIZATION DURING POST DILATATION, LOSS OF CAPTURE DURIN

  Patient problems: Insufficient Information

  MAUDE report 17326684 ↗
• InjuryJun 27, 2023Perivalvular Leak; Perivalvular Leak

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2023-02609. IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVE (B)(6) WAS CHOSEN FOR IMPLANT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION USING FLEXNAV DELIVERY SYSTEM. THE NATIVE VALVE PERIMETER WAS MEASURED AS 81.7MM. A PRE-DILATATION BALLOON VALVULOPLASTY WAS PERFORMED WITH A 22MM NON-COMPLIANT BALLOON. THERE WAS SEVERE CALCIUM PRESENT WITH EXTENSION OF CALCIFICATION TO INTERVENTRICULAR SEPTUM, BELOW THE ANNULUS. THE STARTING IMPLANT DEPTH OF THE VALVE WAS 4MM. FOR THE FINAL IMPLANT DEPTH AT RELEASE, THE VALVE HEIGHT WAS 2MM INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. AFTER FULL RELEASE OF THE VALVE, THE VALVE DISLODGED FROM THE AORTIC ANNULUS INTO THE SINUS TOWARDS THE ASCENDING AORTA. DURING THE VALVE MIGRATION, THE PIGTAIL WAS AT THE NON-CORONARY CUSP, AND THE DELIVERY SYSTEM WAS IN THE ASCENDING AORTA, AND THERE WERE NO SUDDEN CHANGES IN HEMODYNAMICS AT THE TIME OF MIGRATION. THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY OR ARTERIES, AND THE VALVE WAS NOT SNARED OR REPOSITIONED. ANOTHER 29MM

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17210656 ↗
• InjuryJun 16, 2023Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Malposition of Device; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS: AORTIC ANNULUS: MIN. 21.9MM, MAX 29.2MM, AVERAGE: 33.8MM, PERIMETER: 81.7MM. THE IMPLANT DEPTH AT DEPLOYMENT WAS 3MM AND THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT HAD HORIZONTAL AORTA OF 62º. DURING THE PROCEDURE, THE VALVE MIGRATED LEAVING THE PROPER ANCHORAGE ZONE WITH A RELEASED DEPTH OF -1MM, AND WORSENING THE AORTIC INSUFFICIENCY. THE PATIENT HAD NO HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE USER ATTEMPTED TO SNARE AND REPOSITION THE VALVE AND IS AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH A NEW 29MM PORTICO VALVE THAT COMPLETED THE PROCEDURE. AFTER THE SECOND IMPLANT THE GRADIENT WAS 8MMHG. THE PHYSICIAN BELIEVES THAT THERE HAS BEEN A SIGNIFICANT IMPACT TO THE PATIENT DUE TO THE DELAY IN THE PROCEDURE DURING THE SECOND VALVE IMPLANTATION. THE PATIENT IS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17145075 ↗
• InjuryJun 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 01 JUNE 2023, A 29MM PORTICO VALVE (19304666) WAS CHOSEN FOR IMPLANT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION USING FLEXNAV DELIVERY SYSTEM. THE NATIVE VALVE PERIMETER WAS MEASURED AS 81.7MM. A PRE-DILATATION BALLOON VALVULOPLASTY WAS PERFORMED WITH A 22MM NON-COMPLIANT BALLOON. THERE WAS SEVERE CALCIUM PRESENT WITH EXTENSION OF CALCIFICATION TO INTERVENTRICULAR SEPTUM, BELOW THE ANNULUS. THE STARTING IMPLANT DEPTH OF THE VALVE WAS 4MM. FOR THE FINAL IMPLANT DEPTH AT RELEASE, THE VALVE HEIGHT WAS 2MM INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. AFTER FULL RELEASE OF THE VALVE, THE VALVE DISLODGED FROM THE AORTIC ANNULUS INTO THE SINUS TOWARDS THE ASCENDING AORTA. DURING THE VALVE MIGRATION, THE PIGTAIL WAS AT THE NON-CORONARY CUSP, AND THE DELIVERY SYSTEM WAS IN THE ASCENDING AORTA, AND THERE WERE NO SUDDEN CHANGES IN HEMODYNAMICS AT THE TIME OF MIGRATION. THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY OR ARTERIES, AND THE VALVE WAS NOT SNARED OR REPOSITIONED. ANOTHER 29MM PORTICO VALVE (19331519) WAS IMPLANTED IMMEDIATELY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139880 ↗
• InjuryApr 7, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023 A 29MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE IMPLANT DEPTH AT DEPLOYMENT WAS 4MM AND THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT DID NOT HAVE PATIENT HAVE A HORIZONTAL AORTA. THE PERIMETER: 84,1 MM PERIMETER DERIVED Ø: 26,8 MM AREA: 540,4 MM². DURING THE FINAL LAUNCHING OF THE OF THE VALVE, IT SUDDENLY MIGRATED TO A POSITION THAT WAS TOO AORTIC. THE FINAL IMPLANT DEPTH AT RELEASED WAS 1MM. THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT, NO HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. IT WAS NECESSARY TO USE A SECOND 29MM PORTICO VALVE VALVE FOR A VALVE IN VALVE PROCEDURE. PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702694 ↗
• InjuryMar 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THE ANNULAR DIMENSION OF THE NATIVE VALVE WAS AORTIC ANNULUS PERIMETER: 80.6 MM. THE IMPLANT DEPTH AT DEPLOYMENT WAS NOTED AS 2MM. THE IMPLANTED DEPTH AT RELEASE WAS 1MM. THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING FINAL RELEASED OF THE VALVE, THE VALVE MIGRATED DUE TO FORWARD TENSION APPLIED ON THE FLEXNAV DELIVERY SYSTEM DURING FINAL DEPLOYMENT. THE VALVE WAS NOT SNARED. THE PATIENT DID NOT HAVE A HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY. THERE WAS NO INTERACTION BETWEEN THE DELIVERY SYSTEM AND THE VALVE. THERE WAS NO DIFFICULTY WITH DEPLOYING OR RETRACTING THE VALVE DURING THE PROCEDURE. THE PATIENT'S GRADIENT WAS NOTED AS 15 MMHG FOLLOWING THE IMPLANT. A 2ND 29MM PORTICO VALVE WAS SELECTED IN A VALVE-IN-VALVE PROCEDURE. THE PATIENT'S STATUS WAS NOTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657282 ↗
• InjuryMar 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  N/A.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16526343 ↗
• InjuryMar 6, 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 29MM PORTICO WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THERE WAS MILD TO MODERATE CALCIFICATION TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER AND THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. THE SIZING OF THE ANNULAR DIMENSIONS WAS AORTIC ANNULUS PERIMETER 79,4 MM. DURING THE PROCEDURE, THE VALVE WAS SUCCESSFULLY IMPLANTED IN OPTIMAL POSITION 3 MM BELOW THE ANNULUS. THE FLEXNAV DS WAS SUCCESSFULLY DETACHED AND THE PIGTAIL GUIDE WAS REMOVED FROM THE BOTTOM OF THE NON-CORONARY CUSP VIA WIRE. CONTROL ANGIOGRAPHY WAS PERFORMED AND EVALUATED AS GOOD. THEREFORE, THE SUPER STIFF WIRE WAS REMOVED FROM THE LEFT VENTRICLE VIA PIGTAIL. AFTER 1-2 MINUTES POST DEPLOYMENT, THE DEVICE MIGRATED UP FROM AORTIC ANNULUS TO ASCENDING AORTA. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE PHYSICIAN SNARED THE VALVE IN POSITION AND THE PHYSICIAN WAS AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. A SECOND 29MM PORTICO VALVE WAS IMPLANTED IN THE AORTIC ANNULUS IN CORRECT POSITION. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND NO PATIENT CONSEQUENCES WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492322 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM PORTICO VALVE WAS IMPLANTED USING A FLEXNAV DELIVERY SYSTEM DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION. THE PATIENT HAD A HISTORY OF HEART FAILURE AND A PRE-EXISTING RIGHT BUNDLE BRANCH BLOCK (RBBB). IT WAS REPORTED THAT THERE WAS CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM, AND THE FINAL IMPLANT DEPTH OF THE VALVE WAS 5MM. ON (B)(6) 2023, THE PATIENT WENT INTO COMPLETE HEART BLOCK AND RECEIVED A DUAL CHAMBER PERMANENT PACEMAKER IMPLANT (DC-PPM). ON (B)(6) 2023, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER AN EXTENDED STAY FOLLOWING THE PACEMAKER IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Block

  MAUDE report 16383231 ↗
• DeathJan 6, 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) 2022, A 29MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THE IMPLANTERS STATED THE LEAFLETS AND ANNULUS WAS HEAVILY CALCIFIED, UNSURE OF THE CALCIUM SCORE. THE ANNULAR PERIMETER DERIVED = 26.1MM AND THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING DEPLOYMENT, THE VALVE MIGRATION TO THE POINT OF THE SINOTUBULAR JUNCTION (STJ). ON INITIAL PLACEMENT IT WAS SLIGHTLY HIGH (0MM ON THE NON-CORONARY CUSP (NCC) AND 2MM ON THE LEFT-CORONARY CUSP (LCC)) AND AFTER A FEW CARDIAC CYCLES, THE VALVE MIGRATED. THE VALVE WAS SNARED TO THE ASCENDING AORTA AND A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH A NON-ABBOTT DEVICE WHICH WAS EXPANDABLE AND CONSEQUENTLY RUPTURED THE AORTIC ROOT ON DEPLOYMENT. AFTER 1 HOUR OF CARDIOPULMONARY RESUSCITATION (CPR). THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS ANNULAR RUPTURE DUE TO BAIL OUT BALLOON EXPANDABLE VALVE PLACED PORT EMBOLIZATION OF PORTICO VALVE. THE IMPLANTER STATED THAT HE HAD NO ISSUE WITH THE PORTICO VALVE USED BUT AS IT HAD MIGRATED, HE FELT MORE COMFORTABLE AND QUICKER AT USING THE NON-ABBOTT BALLOON EXPANDABLE VALVE AS A BAIL OUT OPTION- THIS WAS TOO BIG FOR THE ANNULUS/ LVOT AND RUPTURED THE AORTIC ROOT, SUBS

  Patient problems: Cardiac Arrest

  MAUDE report 16114197 ↗
• InjuryDec 11, 2022Intravalvular regurgitation; Intravalvular regurgitation

  CRD_669 ¿ PORTICO I, PATIENT SITE ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2016, A 29MM PORTICO VALVE WAS IMPLANTED. THERE WAS GOOD RESULTS POST-IMPLANT WITH SMALL PARA AND TRANSVALVULAR INSUFFICIENCY. ON (B)(6) 2021, ECHOCARDIOGRAM WAS PERFORMED AND REVEALED EXTRASYSTOLES AND ONLY MILD REGURGITATION. THE PATIENT WAS ADMINISTERED BETABLOCKER THERAPY. THE PATIENT IS REPORTED TO BE STABLE. IT IS BELIEVED THAT THE EXTRASYSTOLES ARE DUE TO PATIENT CONDITION AND NOT DEVICE PERFORMANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 15956395 ↗
• InjuryDec 7, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE IMPLANT DEPTH AT DEPLOYMENT WAS 2MM. THE IMPLANT DEPTH AT RELEASE WAS 3MM ABOVE THE NATIVE ANNULUS. THE VALVE WAS IMPLANTED IN AN INCORRECT POSITION, ABOVE THE NATIVE ANNULUS. THE GRADIENT WAS 15 MMHG POST IMPLANT. A SECOND 29MM PORTICO VALVE (19312740) WAS THEN IMPLANTED SUCCESSFULLY 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 15936722 ↗
• DeathNov 24, 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 29MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE DEATH WAS RELATED TO THE PROCEDURE AND PATIENT COMORBIDITIES (MITRAL VALVE INSUFFICIENCY/ REGURGITATION, LOW EJECTION FRACTION, RIGHT SIDED HEART ISSUES, RESPIRATORY ISSUES). THE CAUSE OF THE DEATH WAS NOTED AS MULTIORGAN FAILURE AND METABOLIC ACIDOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Respiratory Insufficiency

  MAUDE report 15859790 ↗
• InjuryNov 22, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM PORTICO VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S PERIMETER WAS DETERMINED TO BE 79.1MM VIA COMPUTED TOMOGRAPHY (CT) SCAN AND THE VALVE WAS SIZED ACCORDING TO THE IFU. IT WAS NOTED DURING PROCEDURE THAT THE VALVE WAS TOO PROXIMAL DURING AN INITIAL DEPLOYMENT ATTEMPT. AN ATTEMPT WAS MADE TO RES-SHEATH THE VALVE. HOWEVER, IT WAS NOTED THAT THE PORTICO VALVE WAS UNABLE TO BE RECAPTURED. THERE WERE MULTIPLE ATTEMPTS MADE TO TRY FULLY RECAPTURE THE PORTICO VALVE BACK INTO THE DELIVERY SYSTEM, BUT THE VALVE FOR REMAINED 40% DEPLOYED. IT WAS OBSERVED VIA ANGIOGRAPHY THAT THE DELIVERY SYSTEM WAS KINKED. THE DECISION WAS MADE TO IMPLANT THE 29MM PORTICO VALVE IN THE DESCENDING AORTA BECAUSE IT WAS THE SAFEST PLACE TO RELEASE WITHOUT CAUSING ANY DAMAGE. THE DELIVERY SYSTEM WAS REMOVED, AND IT WAS DISCOVERED THAT THE VALVE CAPSULE OF THE LARGE FLEXNAV DELIVERY SYSTEM WAS DAMAGED. A SECOND 29MM PORTICO VALVE (18832400) WAS IMPLANTED IN A VALVE IN VALVE PROCEDURE WITH A REPLACEMENT LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS IN RECOVERY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849666 ↗
• InjuryNov 22, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE IMPLANT DEPTH WAS 5MM, AND THERE WAS A LOT OF CALCIUM IN THE LEFT CORONARY LEAFLET AND PRESENCE OF CALCIUM IN THE VALVE ANNULUS. (1536MM3 BY 3MENSIO). THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING DEPLOYMENT THE DEVICE WAS RELEASED TOO QUICKLY AFTER THE FINAL RELEASE LATCH BUTTON WAS PRESSED. THERE WAS ALSO A LITTLE MORE TENSION ON THE DELIVERY SYSTEM THAN NECESSARY, PUSHING THE DEVICE FURTHER INTO THE VENTRICULAR POSITION. THE PHYSICIAN DID NOT SNARE THE DEVICE INTO TO POSITION. A NEW 29MM PORTICO VALVE WAS SELECTED AND SUCCESSFULLY IMPLANTED FOR A VALVE IN VALVE PROCEDURE. POST IMPLANT, THERE WAS A SMALL LEAK, NOTED BETWEEN THE TWO VALVES, AND MILD MITRAL REGURGITATION DUE TO POOR ANTERIOR LEAFLET MOBILITY, WITHOUT MITRAL STENOSIS ON ELECTROCARDIOGRAM. THE MEAN GRADIENT 3MMHG AND PEAK GRADIENT 7MMHG. NO TREATMENT WAS PROVIDED FOR THE LEAK AND NO ADVERSE PATIENT EFFECTS. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15846737 ↗
• InjuryNov 22, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE IMPLANT DEPTH WAS 5MM, AND THERE WAS A LOT OF CALCIUM IN THE LEFT CORONARY LEAFLET AND PRESENCE OF CALCIUM IN THE VALVE ANNULUS. (1536MM3 BY 3MENSIO). THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING DEPLOYMENT THE DEVICE WAS RELEASED TOO QUICKLY AFTER THE FINAL RELEASE LATCH BUTTON WAS PRESSED. THERE WAS ALSO A LITTLE MORE TENSION ON THE DELIVERY SYSTEM THAN NECESSARY, PUSHING THE DEVICE FURTHER INTO THE VENTRICULAR POSITION. THE PHYSICIAN DID NOT SNARE THE DEVICE INTO TO POSITION. A NEW 29MM PORTICO VALVE WAS SELECTED AND SUCCESSFULLY IMPLANTED FOR A VALVE IN VALVE PROCEDURE. POST IMPLANT, THERE WAS A SMALL LEAK, NOTED BETWEEN THE TWO VALVES, AND MILD MITRAL REGURGITATION DUE TO POOR ANTERIOR LEAFLET MOBILITY, WITHOUT MITRAL STENOSIS ON ELECTROCARDIOGRAM. THE MEAN GRADIENT 3MMHG AND PEAK GRADIENT 7MMHG. NO TREATMENT WAS PROVIDED FOR THE LEAK AND NO ADVERSE PATIENT EFFECTS. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846044 ↗
• InjuryNov 2, 2022Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2021, A 29MM PORTICO VALVE WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, THE PATIENT HAD ENDOCARDITIS ON THE MITRAL VALVE AND A LARGE VEGETATION ON THE LEFT VENTRICULAR OUTFLOW TRACT. AN ECHOCARDIOGRAM PERFORMED REVEALED MODERATE TO SEVERE PARAVALVULAR LEAK OF THE PORTICO VALVE, HOWEVER THIS WAS MOST LIKELY DUE TO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIUM AND THE VEGETATION AROUND THE AREA. THE SURGEON SAID NOTHING WAS WRONG WITH THE PORTICO VALVE, BUT THAT IT HAD TO BE REMOVED TO ACCESS AND REPLACE THE MITRAL VALVE, REMOVE ALL THE VEGETATION, REPLACE THE AORTIC VALVE, AND PERFORM A ROOT REPLACEMENT DUE TO THE DAMAGE OCCURRED DO TO REMOVING THE VEGETATION AND THE TAVI VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714790 ↗
• InjuryOct 28, 2022Migration or Expulsion of Device; Perivalvular Leak; Intravalvular regurgitation; Migration or Expulsion of Device; Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM NON-ABBOTT PRODUCT WAS IMPLANTED THAT WAS UNSUCCESSFUL WITH AORTIC REGURGITATION NOTED. A ROOT ENLARGEMENT WAS DONE WHEN THE 29MM NON-ABBOTT DEVICE WAS IMPLANTED. IT WAS DECIDED TO PROCEED WITH A VALVE IN VALVE PROCEDURE. A 29MM PORTICO VALVE WAS THEN IMPLANTED IN A VALVE IN VALVE PROCEDURE. IT WAS NOTED DURING THE PROCEDURE THAT THE DEVICE WAS NOT ANCHORED VERY WELL DUE TO NO CALCIUM IN THE IMPLANT LOCATION. DURING THE POST OPERATIVE ECHOCARDIOGRAM, A TRIVIAL LEAK WAS NOTED. ON (B)(6) 2022, DURING A FOLLOW UP ECHOCARDIOGRAM, IT WAS DISCOVERED THAT THERE WAS MODERATE AORTIC REGURGITATION AND PARAVALVULAR LEAK. THE VALVE HAD MIGRATED AND WAS NOW TOO DEEP. AN ADDITIONAL VALVE WILL NEED TO BE IMPLANTED, BUT IS NOT SCHEDULED YET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15693386 ↗
• InjuryOct 4, 2022Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2022,A 29MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED WITH MILD-MODERATE PARAVALVULAR LEAK AND IT WAS THOUGHT THAT IT WOULD RESOLVE OVER TIME AS THE VALVE SETTLED INTO THE ANATOMY. ON (B)(6) 2022, THE PATIENT PRESENTED WITH DYSPNEA. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED MODERATE CENTRAL AORTIC REGURGITATION. A COMPUTED TOMOGRAPHY (CT) DONE SHOWED THAT THAT THE VALVE FRAME LOOKED CONSTRAINED, WHICH WAS NOT SEEN ON POST-IMPLANT ECHOCARDIOGRAM AND ANGIOGRAM. THE PATIENT WAS SCHEDULED FOR REINTERVENTION, HOWEVER IT HAS NOT BEEN PERFORMED YET. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15540225 ↗
• InjurySep 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29 MM PORTICO VALVE WAS SELECTED FOR IMPLANT WITH A FLEXNAV DELIVERY SYSTEM. AFTER DEPLOYMENT OF THE VALVE IN THE AORTIC ANNULUS AND BEFORE THE DELIVERY CATHETER WAS REMOVED FROM THE ANNULUS, THE VALVE MIGRATED UP TOWARDS THE AORTA. THE PATIENT WAS SENT TO SURGERY TO EXPLANT THE VALVE. A 25 MM NON-ABBOTT VALVE WAS THEN IMPLANTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Embolism/Embolus; Insufficient Information; Low Blood Pressure/ Hypotension

  MAUDE report 15420502 ↗
• InjurySep 6, 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 TAVI CASE WAS BEING PERFORMED. DURING THE PROCEDURE THE PATIENT WENT INTO COMPLETE HEART BLOCK. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH A PERMANENT PACEMAKER TO RESOLVE THE EVENT.

  Patient problems: Heart Block

  MAUDE report 15366986 ↗
• InjurySep 6, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 29MM PORTICO VALVE (19258269) WAS CHOSEN FOR IMPLANT FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT. THE AORTIC VALVE CALCIFICATION WAS SEVERE. THE PATIENT'S AORTIC ANNULUS PERIMETER WAS 80.2MM, AND PERIMETER DERIVED WAS 25.5MM. THE AORTIC ANNULUS AREA WAS 497.3MM^2, AND THE AREA DERIVED WAS 25.2MM. DURING PROCEDURE, THE VALVE WAS SUCCESSFULLY DEPLOYED IN THE DESIRED POSITION IN THE AORTIC ANNULUS. APPROXIMATELY 30 TO 35 SECONDS AFTER THE VALVE WAS IMPLANTED, THE VALVE MIGRATED OUT OF THE ANNULUS. A SECOND 29MM PORTICO VALVE (19359176) WAS IMPLANTED WITHIN THE FIRST VALVE, VIA VALVE-IN-VALVE PROCEDURE. PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363868 ↗

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-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-0492-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-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