Portico™ PRT-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 05415067012494), received between Oct 28, 2021 and Feb 3, 2025 — classified as 8 deaths, 44 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (25 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  (B)(4) - PORTICO INDIA, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS CHOSEN FOR IMPLANT. PRIOR TO PROCEDURE, THE PATIENT'S PLATELET COUNT WAS LOW, 58,000 - 60,000. DURING PROCEDURE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (PRE-BAV) PROCEDURE WAS PERFORMED WITH AN 22MM NON-COMPLIANT NON-ABBOTT BALLOON. RAPID PACING AT 180BPM WAS REQUIRED DURING PROCEDURE. POST-DEPLOYMENT, IT WAS NOTED THE PORTICO VALVE APPEARED A LITTLE CONSTRAINED AT THE MIDDLE PART. A DECISION WAS MADE TO PERFORM A POST-BAV WITH A 23MM NON-COMPLAINT NON-ABBOTT BALLOON. FINAL IMPLANT DEPTH WAS 6MM AND THERE WAS NO/TRACE AORTIC REGURGITATION AND NO PARAVALVULAR LEAK AT END OF PROCEDURE. POST-PROCEDURE ON (B)(6) 2023 THE PLATELET COUNT REDUCED TO 26,000 WITH NO OVERT BLEEDING MANIFESTATIONS AND ANTICOAGULATION WAS STOPPED. THE PATIENT'S PLATELET COUNT WAS CLOSELY MONITORED, HOWEVER, THERE WERE NO FURTHER DROPS IN PLATELET COUNTS AND GIANT PLATELETS WERE NOTED IN PERIPHERAL SMEAR. THE PATIENT WAS DISCHARGED IN STABLE CONDITION AND THEIR PLATELET COUNT HAD INCREASED TO 48,000. IT WAS REPORTED THE PATIENT HAD A HISTORY OF THROMBOCYTOPENIA WITH GIANT PLATELETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294493 ↗
• InjuryApr 11, 2024Migration 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

  CRD_1024 - PORTICO INDIA. IN4509 - 27 (R834632101,R83529850). IT WAS REPORTED THAT ON (B)(6) 2024, 27MM PORTICO VALVE WAS SELECTED FOR IMPLANT. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS: PERIMETER DERIVED DIAMETER 23.8, AREA 441.5 MMSQ, PERIMETER 74.8 MM. THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT PRESENTED WITH SEVERE ASYMPTOMATIC AORTIC STENOSIS WITH HEART FAILURE, NEW YORK HEART ASSOCIATION CLASS IV. HE WAS MANAGED INITIALLY WITH NON-INVASIVE VENTILATION AND INTRAVENOUS DIURETICS. THE DEVICE WAS IMPLANTED IN THE PATIENT WITH A FINAL DEPTH OF 0MM. A SUBTLE DISTAL MIGRATION TOWARDS AORTIC SIDE WAS NOTED POST DEPLOYMENT RESULTING IN MODERATE AORTIC REGURGITATION., IMPLANTER SNARED THE VALVE UP TO THE ASCENDING AORTA WITH THE SNARE ABOVE THE CORONARIES AND THE PHYSICIAN AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE. THERE WAS A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH A NEW 27MM PORTICO VALVE. POST DEPLOYMENT OF THE SECOND VALVE, THERE WAS NO LEAK OR ANY SIGNIFICANT GRADIENT ACROSS THE VALVE. ON THE SAME DAY, THE PATIENT POST PROCEDURE EKG SHOWED LEFT BUNDLE BRANCH BLOCK. A 3 DAYS HOLTER TEST WA

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Block; Vascular Dissection

  MAUDE report 19090364 ↗
• InjuryJan 18, 2024Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Malposition of Device; Difficult to Fold, Unfold or Collapse; Migration or Expulsion of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE ANNULAR DIAMETER OF THE NATIVE VALVE WAS 24MM, AREA WAS 434.4MM AND PERIMETER WAS 75.3MM. A PRE-DILATATION WAS PERFORMED WITH A 20MM BALLOON AND THE PATIENT WENT TO CARDIAC ARREST. IT WAS NECESSARY TO RELEASE THE UNDER EXPANDED VALVE. THE INITIAL IMPLANT DEPTH WAS 8-9MM. DURING FINAL DEPLOYMENT, THERE WAS TENSION IN THE DELIVERY SYSTEM AND IT WAS NEUTRAL. THE FINAL IMPLANT DEPTH OF THE VALVE WAS 8-9MM. AFTER THE IMPLANT, IT WAS NOTED THAT THE VALVE EMBOLIZED. THE PHYSICIAN BELIEVED THE CAUSE OF EMBOLIZATION WAS THE UNDER EXPANDED VALVE AND CARDIOPULMONARY RESUSCITATION (CPR) MANEUVERS. A NEW 27MM PORTICO VALVE WAS CHOSEN AND A PRE-DILATATION WAS PERFORMED BEFORE TO RELEASE THE SECOND VALVE. THE VALVE WAS IMPLANTED UNDER EXPANDED. A POST DILATATION WAS PERFORMED IN ORDER TO REDUCE UNDER EXPANSION OF THE SECOND VALVE. AFTER THE IMPLANT OF THE SECOND VALVE THE PATIENT CONTINUED IN CARDIAC ARREST. THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST. THE PHYSICIAN MENTIONED THE DEATH WAS RELATED TO HIGH RISK PROCEDURE AND PATIENT´S COMORBIDITIES.

  Patient problems: Cardiac Arrest

  MAUDE report 18536932 ↗
• DeathJan 18, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 29 DECEMBER 2023, A 27MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE ANNULAR DIAMETER OF THE NATIVE VALVE WAS 24MM, AREA WAS 434.4MM AND PERIMETER WAS 75.3MM. A PRE-DILATATION WAS PERFORMED WITH A 20MM BALLOON AND THE PATIENT WENT TO CARDIAC ARREST. IT WAS NECESSARY TO RELEASE THE UNDER EXPANDED VALVE. THE INITIAL IMPLANT DEPTH WAS 8-9MM. DURING FINAL DEPLOYMENT, THERE WAS TENSION IN THE DELIVERY SYSTEM AND IT WAS NEUTRAL. THE FINAL IMPLANT DEPTH OF THE VALVE WAS 8-9MM. AFTER THE IMPLANT, IT WAS NOTED THAT THE VALVE EMBOLIZED. THE PHYSICIAN BELIEVED THE CAUSE OF EMBOLIZATION WAS THE UNDER EXPANDED VALVE AND CARDIOPULMONARY RESUSCITATION (CPR) MANEUVERS. A NEW 27MM PORTICO VALVE WAS CHOSEN AND A PRE-DILATATION WAS PERFORMED BEFORE TO RELEASE THE SECOND VALVE. THE VALVE WAS IMPLANTED UNDER EXPANDED. A POST DILATATION WAS PERFORMED IN ORDER TO REDUCE UNDER EXPANSION OF THE SECOND VALVE. AFTER THE IMPLANT OF THE SECOND VALVE THE PATIENT CONTINUED IN CARDIAC ARREST. THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST. THE PHYSICIAN MENTIONED THE DEATH WAS RELATED TO HIGH RISK PROCEDURE AND PATIENT´S COMORBIDITIES.

  Patient problems: Cardiac Arrest

  MAUDE report 18536931 ↗
• InjuryNov 13, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVES WAS SELECTED FOR AN IMPLANT. THERE SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT HAD A 55 DEGREED HORIZONTAL AORTA. DURING THE PROCEDURE, THE DEVICE MIGRATED FURTHER INSIDE THE VENTRICLE. A CAPTURE LOOP SNARE (NON-ABBOTT DEVICE) WAS USED IN AN ATTEMPT TO REPOSITION THE DEVICE, BUT THE MANEUVER CAUSED THE VALVE TO POP UP. THE PHYSICIAN AWARE OF THE IFU WARNING AGAINST SNARING THE VALVE AND IT WAS NECESSARY TO IMPLANT A NEW VALVE IN THE CORRECT POSITION. THE PATIENT WAS DISCHARGED ON SATURDAY WITHOUT ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119414 ↗
• DeathOct 31, 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 27MM PORTICO VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. DURING THE PRE-DILATATION, AN AORTIC ROOT RUPTURED HAPPENED. THE CALCIUM OVER THE NON CORONARY SINUS WAS THOUGHT TO BE THE CAUSE OF THE AORTIC ROOT RUPTURED. A PERICARDIOCENTESIS PUNCTURE WAS DONE AS TREATMENT. THE LARGE FLEXNAV DELIVERY SYSTEM AND THE 27MM PORTICO VALVE WAS NOT IN THE PATIENT WHEN THE AORTIC RUPTURED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND IMPLANTED THE 27MM PORTICO VALVE IN OPTIMAL POSITION. IT WAS ALSO REPORTED THAT THE PATIENT PASSED AWAY THE SAME DAY DUE TO THE AORTIC ROOT RUPTURE.

  Patient problems: Insufficient Information

  MAUDE report 18043496 ↗
• InjuryOct 30, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE ARTICLE, "INTRACARDIAC ECHOCARDIOGRAM TO DIAGNOSE INFECTIVE ENDOCARDITIS AFTER TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 70-YEAR-OLD MALE PATIENT HISTORY OF HYPERCHOLESTEROLEMIA, OBESITY, ABDOMINAL AORTIC ANEURYSM, AND CARDIAC VALVE SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM PORTICO VALVE WAS CHOSEN FOR AN OFF-LABEL USE OF VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION (VIV-TAVI) PROCEDURE. IT WAS LATER REPORTED FOUR MONTHS POST-PROCEDURE, THE PATIENT PRESENTED WITH FEVER, DYSPNEA, AND GENERAL MALAISE. INFECTIVE ENDOCARDITIS (IE) WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE) UNDER LOCAL ANESTHESIA AND A MOBILE ECHOGENICITY WAS NOTED ATTACHED TO THE VALVE LEAFLET, CONSISTENT WITH VEGETATION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS WHICH SUCCESSFULLY TREATED THE ENDOCARDITIS. THE ARTICLE CONCLUDED THAT WITH INCREASING USE OF VIV-TAVI OR TAVI-IN-TAVI, CONVENTIONAL ECHOCARDIOGRAPHIC DIAGNOSIS FOR IE COULD BE MORE DIFFICULT, DUE TO ARTIFACTS GENERATED BY THE METALLIC MATERIALS. ICE CAN DIRECTLY VISUALIZE THE PROSTHETIC VALVE LEAFLETS INSIDE THE METALLIC STENT FRAMES FREE FROM ANY ARTIFACTS. CAR

  Patient problems: Endocarditis

  MAUDE report 18035656 ↗
• InjurySep 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT IN A PATIENT WITH SEVERE AORTIC STENOSIS. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS PERIMETER: 74.1MM, AREA: 411.8 MM SQ, DIAMETER 23.4 MM AND THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING THE PROCEDURE, CALCIUM DISTRIBUTION WAS SYMMETRICAL. PRE-DILATATION OF THE NATIVE AORTIC VALVE WAS DONE WITH 22 MM BALLOON (NON-ABBOTT), AFTER WHICH PHYSICIAN ATTEMPTED VALVE DEPLOYMENT. DESPITE 2 RESHEATHING AND DEPLOYING ATTEMPTS, THE 27 MM PORTICO VALVE HAD NON UNIFORM EXPANSION AND DID NOT OPEN UP COMPLETELY, HENCE THE VALVE WAS NOT FULLY DEPLOYED, IT WAS RESHEATHED AND REMOVED. A NEW 27 MM PORTICO WAS INSTEAD FULLY DEPLOYED AND IMPLANTED, WHICH OPENED UP WELL WITH AN IMPLANT DEPTH OF 4MM. ON (B)(6) 2023, IT WAS REPORTED THAT THE VALVE MIGRATED ON ECHOCARDIOGRAM. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH ANOTHER 27MM PORTICO VALVE. THE PATIENT REMAINS HEMODYNAMICALLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731591 ↗
• MalfunctionSep 11, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  CRD_1024 - PORTICO INDIA. IN5860 - 22 (R773902801, R774040801). IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT IN A PATIENT WITH SEVERE AORTIC STENOSIS. THE SIZING OF THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS PERIMETER: 74.1MM, AREA: 411.8 MM SQ, DIAMETER 23.4 MM AND THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING THE PROCEDURE, CALCIUM DISTRIBUTION WAS SYMMETRICAL. PRE-DILATATION OF THE NATIVE AORTIC VALVE WAS DONE WITH 22 MM BALLOON (NON-ABBOTT), AFTER WHICH PHYSICIAN ATTEMPTED VALVE DEPLOYMENT. DESPITE 2 RESHEATHING AND DEPLOYING ATTEMPTS, THE 27 MM PORTICO VALVE HAD NON UNIFORM EXPANSION AND DID NOT OPEN UP COMPLETELY, HENCE THE VALVE WAS NOT FULLY DEPLOYED, IT WAS RESHEATHED AND REMOVED. A NEW 27 MM PORTICO WAS INSTEAD FULLY DEPLOYED AND IMPLANTED, WHICH OPENED UP WELL WITH AN IMPLANT DEPTH OF 4MM. ON (B)(6) 2023, IT WAS REPORTED THAT THE VALVE MIGRATED ON ECHOCARDIOGRAM. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH ANOTHER 27MM PORTICO

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17723990 ↗
• InjuryAug 23, 2023Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT USING A A LARGE FLEX NAV DELIVERY SYSTEM. THERE WAS MODERATE CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WAS 27MM/403.1/74 PERIMETER. DURING THE PROCEDURE, THE VALVE WAS DEPLOYED AT VERY GOOD DEPTH (5MM) AT 80% STAGE, AT THE FINAL RELEASE ONE OF THE RETAINER TABS WAS STILL ATTACHED, AFTER TOO MANY MANIPULATION TO RELEASE BY ROTATING THE DELIVERY SYSTEM AND SLIGHTLY FORWARD, UNFORTUNATELY IT DISLODGE THE VALVE TO THE ANNULUS LEVEL AND DURING PULLING THE NOSE CONE IT HITS THE VALVE AND EMBOLIZED ABOVE THE SINUS OF VALSALVA (SOV). THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF EMBOLIZATION AND NO TENSION WAS APPLIED ON THE DELIVERY CABLE. THE PATIENT REMAINS STABLE WITHOUT ANY COMPLICATIONS AND THE HEART TEAM DECIDED NOT TO SNARE HIGHER RATHER THAN FIX IT WITH A SNARE AND IMPLANT A LOW PROFILE NON-ABBOTT VALVE. THE PATIENT REMAIN STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607229 ↗
• DeathJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A (B)(6) 2023, A 27MM PORTICO VALVE WAS CHOSEN FOR IMPLANT. THE PATIENT WAS CONSIDERED HIGH RISK FOR SURGERY. THE VALVE WAS SUCCESSFULLY IMPLANTED WITH THE PRE-RELEASE AND FINAL IMPLANT DEPTH AT 3MM ON THE NON-CORONARY CUSP AND 5MM ON THE LEFT CORONARY CUSP. A 22MMHG GRADIENT REMAINED PRESENT POST VALVE IMPLANT. A POST BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22MM AND A 24MM NON-ABBOTT BALLOON TO RESOLVE THE GRADIENT. AFTER THE POST-BAV, THE PATIENT'S BLOOD PRESSURE DROPPED, AND IT WAS SUSPECTED THAT THE PATIENT EXPERIENCED POSSIBLE CORONARY ARTERY OCCLUSION. THE PATIENT WENT INTO CARDIAC ARREST AND A CODE BLUE WAS CALLED. CODE BLUE MEDICATIONS WERE ADMINISTERED, AND CHEST COMPRESSIONS WERE PERFORMED. ON (B)(6) 2023, THE PATIENT PASSED AWAY IN THE OPERATING ROOM. IT WAS CONFIRMED THAT THE NATIVE LEAFLET WAS SUCKED INTO THE LEFT CORONARY ARTERY POST BAV, AND THE CONFIRMED CAUSE OF DEATH WAS CORONARY OCCLUSION.

  Patient problems: Aortic Valve Stenosis; Cardiac Arrest; Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 17339955 ↗
• DeathJul 18, 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 27MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE THE PATIENT HAD ANNULAR RUPTURE (SLOW LEAK). THE CAUSE OF THE ANNULAR RUPTURE (SLOW LEAK) AND TREATMENT IS UNKNOWN. THE PHYSICIAN ALLEGED THAT THE ANNULAR RAPTURE MAY HAD BEEN CAUSE BY BALLOON AORTIC VALVULOPLASTY (BAV). THE DEVICE WAS IMPLANTED SUCCESSFULLY. THE PATIENT LEFT THE CATH LAB STABLE. THE PATIENT WAS TRANSPORTED BACK TO THE UNIT AND WAS "HARD TO WAKE UP FROM ANESTHESIA. A CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE HEAD WAS PERFORMED AND THE PATIENT CRASHED. CODE BLUE WAS INITIATED AND THEN PATIENT PASSED ON (B)(6) 2023. THE CAUSE OF THE DEATH IS ANNULAR RUPTURE. THE IMPLANTER CLASSIFY THIS DEATH AS BEING RELATED TO THE PATIENT¿S COMORBIDITIES.

  Patient problems: Perforation of Vessels

  MAUDE report 17339942 ↗
• InjuryJul 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  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 84-YEAR-OLD FEMALE PATIENT THAT HAD A 27MM PORTICO VALVE IMPLANTED. POST IMPLANT THE VALVE MIGRATED AFTER VALVE WAS RELEASED. THE FINAL TRANSCATHETER HEART VALVE POSITION WAS NOTED TO BE IN THE ASCENDING AORTA. A VALVE-IN-VALVE WAS PERFORMED USING A 23MM SAPIEN 3. AT 9 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 REQUIRING INTERVENTION. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS ARTICLE HENRYK DREGER, MD, 1MEDIZINISCHE KLINIK MIT SCHWERPUNKT KARDIOLOGIE UND ANGIOLOGIE, CHARITÉ ¿ UNIVERSITÄTSMEDIZIN BERLIN, BERLIN, GERMANY]

  Patient problems: Insufficient Information

  MAUDE report 17326137 ↗
• InjuryJul 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  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 84-YEAR-OLD FEMALE PATIENT THAT HAD A 27MM PORTICO VALVE IMPLANTED. POST IMPLANT THE VALVE MIGRATED AFTER VALVE WAS RELEASED. THE FINAL TRANSCATHETER HEART VALVE POSITION WAS NOTED TO BE IN THE ASCENDING AORTA. A VALVE-IN-VALVE WAS PERFORMED USING A 23MM SAPIEN ULTRA 3. AT 2 MONTHS FOLLOW UP COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED HYPOATTENUATION. THERE WAS NO LEAFLET THICKENING AT EMBOLIZED VALVE. THE ARTICLE CONCLUDED TVEM REPRESENTS A RARE COMPLICATION OF TAVI. FOLLOW UP-CT DETECTED NO PATHOLOGICAL FINDINGS REQUIRING INTERVENTION. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS ARTICLE HENRYK DREGER, MD, 1MEDIZINISCHE KLINIK MIT SCHWERPUNKT KARDIOLOGIE UND ANGIOLOGIE, CHARITÉ ¿ UNIVERSITÄTSME

  Patient problems: Insufficient Information

  MAUDE report 17325959 ↗
• InjuryMay 10, 2023Perivalvular Leak; Perivalvular Leak

  THE ARTICLE, "COMPLEX CLINICAL CASE PRESENTATIONS: FIT INTERVENTIONAL AND STRUCTURAL 4", WAS REVIEWED. THE RESEARCH ARTICLE PRESENTED A CASE STUDY OF AN 85 YEAR OLD FEMALE WITH PRIOR CORONARY STENTING AND CRITICAL AORTIC STENOSIS. THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING A 27MM PORTICO VALVE. AFTER IMPLANT, THERE WAS COMPLICATIONS OF MODERATE PARAVALVULAR REGURGITATION REQUIRING BALLOON VALVULOPLASTY AND EVENTUALLY A VALVE IN VALVE (VIV) TAVR USING A 26MM SAPIEN-3 EDWARDS VALVE. AFTERWARDS, ROUTINE ONE MONTH FOLLOW UP ECHOCARDIOGRAM SHOWED THE AORTIC PROTHESIS WAS WELL SEATED WITHOUT SIGNIFICANT STENOSIS OR REGURGITATION BUT NOTED A NEW RESTRICTIVE MEMBRANOUS VSD (4MM) WITH LEFT TO RIGHT SHUNT. TEN MONTHS LATER, SYMPTOMS PROMPTED ADMISSION, WHERE TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED THAT THE MEMBRANOUS VSD HAD PROGRESSED IN SIZE FROM 4MM TO 9MM, WITH PEAK VELOCITY 3.2 M/S AND PEAK GRADIENT OF 40 MMHG. DUE TO HIGH SURGICAL RISK AND PROGRESSIVE SYMPTOMS, THE DECISION WAS MADE TO TREAT THE VSD WITH A 25MM AMPLATZER PFO OCCLUDER DEVICE, PLACED SUCCESSFULLY WITH NO RESIDUAL LEAK. THE PATIENT'S SYMPTOMS SUBSEQUENTLY IMPROVED. THE ARTICLE CONCLUDED TH

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 16900363 ↗
• InjuryApr 14, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6)2023, A 27MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE IMPLANT DEPTH AT DEPLOYMENT WAS 3MM AND THERE SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT HAD A 48° HORIZONTAL AORTA. DURING DEPLOYMENT OF THE VALVE, IN THE FINAL PHASE OF THE RELEASE, DEVICE MIGRATED IN THE AORTIC POSITION AND THE PHYSICIAN DID NOT ATTEMPT TO SNARE AND REPOSITION THE VALVE . THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY OR ARTERIES AND THE PATIENT DID NOT HAVE HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. SUBSEQUENTLY, THIS REQUIRED THE IMPLANTATION OF A 2ND 27MM PORTICO VALVE VIA VALVE IN VALVE PROCEDURE. ON (B)(6) 2023, IT WAS REPORTED THAT A POST-DILATATION WAS PERFORMED DUE TO MODERATE PVL AFTER THE SECOND VALVE WAS IMPLANTED. DURING THE ENTIRE PERIOD, THE PATIENT WAS HEMODYNAMICALLY STABLE AND DID NOT SUFFER ANY ADVERSE EFFECTS. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740643 ↗
• InjuryMar 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE IMPLANT DEPTH AT DEPLOYMENT WAS 3MM AND THERE SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. THE PATIENT HAD A 48° HORIZONTAL AORTA. DURING DEPLOYMENT OF THE VALVE, IN THE FINAL PHASE OF THE RELEASE, DEVICE MIGRATED IN THE AORTIC POSITION AND THE PHYSICIAN DID NOT ATTEMPT TO SNARE AND REPOSITION THE VALVE . THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY OR ARTERIES AND THE PATIENT DID NOT HAVE HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. SUBSEQUENTLY, THIS REQUIRED THE IMPLANTATION OF A 2ND 27MM PORTICO VALVE VIA VALVE IN VALVE PROCEDURE. ON (B)(6) 2023, IT WAS REPORTED THAT A POST-DILATATION WAS PERFORMED DUE TO MODERATE PVL AFTER THE SECOND VALVE WAS IMPLANTED. DURING THE ENTIRE PERIOD, THE PATIENT WAS HEMODYNAMICALLY STABLE AND DID NOT SUFFER ANY ADVERSE EFFECTS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632313 ↗
• InjuryMar 22, 2023Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE ANNULUS WAS MEASURED TO BE 73.2MM AT THE PERIMETER, AND THE AREA WAS MEASURED TO BE 418MM. IT WAS REPORTED THAT THE PATIENT HAD A HORIZONTAL AORTA. THE VALVE (19320141) WAS DEPLOYED AT 5MM. THERE WAS NO TENSION IN THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. AFTER THE VALVE WAS FULLY DEPLOYED, ONE OF THE RETAINER TABS REMAINED ATTACHED TO THE CAPSULE. THE OPERATOR SLIGHTLY ROTATED THE DELIVERY SYSTEM AND GENTLY PUSHED ON THE SYSTEM UNTIL THE VALVE SEPARATED FROM THE DELIVERY SYSTEM. AFTER THE VALVE WAS RELEASED AT 5-6MM, IT MIGRATED UP INTO THE SINUS OF VALSALVA (SOV) AT 3MM ABOVE THE NON-CORONARY CUSP. THE PATIENT PRESENTED WITH SEVERE AORTIC INSUFFICIENCY. A SECOND 27MM PORTICO VALVE (19324788) WAS PLACED IN AN EMERGENCY VALVE-IN-VALVE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO REPORTED RISK OF CORONARY OBSTRUCTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16594593 ↗
• MalfunctionMar 6, 2023Perivalvular Leak; Malposition of Device; Perivalvular Leak; Malposition of Device

  CLINICAL INFORMATION: CRD_699 - PORTICO IDE, PATIENT SITE ID:(B)(6).ALTHOUGH A DEATH OCCURRED, THIS REPORT IS FOR THE MODERATE PARAVALVULAR AORTIC REGURGITATION. IT WAS NOTED THAT THIS WAS ALSO PRESENT POST IMPLANT. THE CAUSE OF DEATH WAS UNKNOWN BUT THE PHYSICIAN DID NOT CLASSIFY THE CAUSE OF THE PATIENT'S DEATH AS BEING RELATED TO THE PERFORMANCE OF THE DEVICE.IT WAS REPORTED THAT ON (B)(6) 2019, A 27MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED IN PATIENT. THERE WAS NO POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) PERFORMED. THE PATIENT WAS STABLE PRIOR TO PROCEDURE. POST PROCEDURE DAY ONE ON (B)(6) 2019, IT WAS NOTED THAT THERE WAS MODERATE PARAVALVULAR LEAK ON THE ECHOCARDIOGRAM. THE FINAL IMPLANT DEPTH OF THE VALVE WAS 1MM. IT WAS NOTED THAT WITHIN THE LAST YEAR THE PATIENT WAS DOING WELL WITH NO ISSUE WITH PAIN, PALPITATIONS, OR BREATHLESSNESS. ON AN UNKNOWN DAY IN (B)(6) 2022, THE PATIENT WAS EVALUATED AND AN ECHOCARDIOGRAM REVEALED THAT THE PATIENT'S LEFT EJECTION FRACTION HAD IMPROVED FROM 35% TO 50%, WITH ONLY ABNORMAL WALL MOTIONS NOTED. IT WAS ALSO NOTED THAT THERE WAS MODERATE PARAVALVULAR AORTIC REGURGITATION PRESENT. IT WAS UNKNOWN IF THERE WERE ANY INTERVENTION PER

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492434 ↗
• InjuryJan 24, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM PORTICO VALVE WAS IMPLANTED. POST-IMPLANT WITH ADEQUATE HEIGHT, "THE VALVE SMOOTHLY MIGRATED TO THE AORTA." THERE WAS NO ISSUE WITH THE LARGE FLEXNAV DELIVERY SYSTEM. THE MIGRATION OF THE 27MM PORTICO VALVE HAD BEEN CONFIRMED USING ECHOCARDIOGRAPHY AND FLUOROSCOPY. THE VALVE WAS SIZED USING COMPUTED TOMOGRAPHY SCANS. THE FINAL IMPLANT DEPTH OF THE 27MM PORTICO VALVE WAS 3MM, AS RECOMMENDED PER THE INSTRUCTIONS FOR USE. IT WAS NOTED THAT THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. THE PATIENT DID NOT HAVE HORIZONTAL AORTA AND THERE HAD BEEN NO DIFFICULTY IMPLANTING THE VALVE. THE MIGRATED VALVE DID NOT BLOCK ANY CORONARY ARTERIES. NO DAMAGED WAS REPORTED TO THE PATIENT. A NEW 27MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED. IT WAS ALSO NOTED THAT A POST-IMPLANT DILATATION WAS PERFORMED AFTER THE IMPLANT OF THE SECOND 27MM PORTICO VALVE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE 27MM PORTICO VALVE, LARGE FLEXNAV DELIVERY SYSTEM OR PROCEDURE. THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233259 ↗
• InjuryJan 6, 2023Migration 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) 2022 , A 27MM PORTICO VALVE WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING A PRE-IMPLANT DILATATION THAT THE PATIENT DEVELOPED AN ARRHYTHMIA. IT WAS NOTED THAT THE ARRHYTHMIA PERSISTED EVEN AFTER IMPLANT OF THE 27MM PORTICO VALVE. THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER IN THE PATIENT TO TREAT THE ARRHYTHMIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 16118128 ↗
• MalfunctionJan 6, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM PORTICO VALVE WAS SELECTED FOR IMPLANT. DURING PROCEDURE, THE VALVE MIGRATED ABOVE THE ANNULUS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118070 ↗
• DeathJan 6, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A PORTICO VALVE WAS CHOSEN FOR IMPLANT USING LARGE FLEXNAV DELIVERY SYSTEM IN A PATIENT WITH AORTIC STENOSIS. DURING THE PROCEDURE, AFTER THE DELIVERY SYSTEM HAD BEEN INTRODUCED, THE PATIENT'S BLOOD PRESSURE DROPPED AND WAS UNABLE TO RETURN TO NORMAL. IT WAS DISCOVERED THAT THERE HAD BEEN AN ANNULUS DISSECTION, RESULTING IN THE PATIENT PASSING AWAY DURING THE PROCEDURE. IT'S UNKNOWN AS TO WHEN EXACTLY THE ANNULUS DISSECTION OCCURRED DURING THE PROCEDURE AS THE ANNULUS RUPTURE ITSELF WAS NOT ABLE TO BE OBSERVED ON IMAGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 16113641 ↗
• InjuryDec 16, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM PORTICO VALVE WAS SELECTED FOR IMPLANTATION USING A LARGE FLEXNAV DELIVERY SYSTEM. AT AN UNKNOWN POINT, THE VALVE WAS REPORTED TO HAVE EMBOLIZED. THE PATIENT REPORTED HEAVY CHEST PAIN, THEIR BLOOD PRESSURE DROPPED QUICKLY, AND THEY WENT INTO VENTRICULAR FIBRILLATION, AND CARDIAC ARREST, AS NOTED BY ELECTROCARDIOGRAM (EKG). THE VALVE WAS CAPTURED BY TWO SNARES AND DRAGGED UP TO THE AORTIC ARCH. THE PATIENT HAD CARDIAC PULMONARY RESUSCITATION PERFORMED FOR 45 MIN, WAS SHOCKED SEVERAL TIMES, AND WAS RESUSCITATED. NEAR SINUS RHYTHM WAS ESTABLISHED. IT WAS DISCOVERED THAT THE VALVE HAD BEEN CRUSHED DUE TO CARDIAC PULMONARY RESUSCITATION. THE VALVE WAS THEN MOVED TO THE DESCENDING AORTA. A NEW, 27MM PORTICO VALVE WAS IMPLANTED USING A LARGE FLEXNAV DELIVERY SYSTEM. THE FOLLOWING DAY, THE PATIENT WAS RESPONDING AND SHOWED NO BRAIN DAMAGE.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Pain; Ventricular Fibrillation

  MAUDE report 15999945 ↗
• InjuryDec 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS REPORT IS FOR THE INITIAL 27MM PORTICO VALVE THAT MIGRATED REQUIRING A VALVE-IN-VALVE. IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. DURING THE PROCEDURE, THE VALVE WAS IMPLANTED AT THE INTENDED DEPTH WITH ABOUT 4MM IN THE OUTFLOW TRACT. AFTER THE VALVE WAS FULLY RELEASED, IT EMBOLIZED THROUGH THE AORTA AND STOPPED AT THE AORTIC ARCH. IT WAS DETERMINED THE EMBOLIZED DEVICE HAD NOT CAUSED DAMAGE AND WOULD NOT CAUSE DAMAGE TO THE PATIENT'S HEALTH AND IT WAS DECIDED THAT IT WOULD REMAIN IMPLANTED. THEN, A SECOND 27MM PORTICO VALVE WAS THEN SUCCESSFULLY IMPLANTED. AFTERWARDS, THE PATIENT'S BLOOD PRESSURE DROPPED AND REMAINED LOW FOR 10 MINUTES. THE PATIENT THEN WENT INTO CARDIOGENIC SHOCK AND THEIR HEART STOPPED. A 180V SHOCK WAS DELIVERED AND THE PATIENT WAS STABILIZED. THE PATIENT THEN LEFT THE SURGICAL CENTER AND WENT UNDER OBSERVATION IN THE INTENSIVE CARE UNIT (ICU). FOUR HOURS POST-SURGERY, THE PATIENT WAS REPORTED AS STABLE AND REACTING WELL TO STIMULUS. THE FOLLOWING MORNING, ON (B)(6) 2022, THE PATIENT WENT INTO CARDIAC ARREST AND DIED. THERE WAS NO INTERACTION BETWEEN THE DELIVERY SYSTEM AND THE 1S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982536 ↗

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-0491-2025 · Oct 17, 2024 · Open, Classified
  Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, 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