Portico™ PRT-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05415067010728), received between Dec 16, 2021 and Dec 21, 2023 — classified as 5 deaths, 25 injuries, 1 malfunction.

The most frequently reported specific device problem is “Perivalvular Leak” (11 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2023Migration or Expulsion of Device; Perivalvular Leak; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM PORTICO VALVE WAS CHOSEN FOR IMPLANT, USING SMALL FLEXNAV DELIVERY SYSTEM. THE PATIENT WAS PRESENTED WITH SEVERE AORTIC STENOSIS. THE ANNULAR DIMENSIONS OF THE NATIVE VALVE WERE MEASURED TO BE 63.1 MM ANNULUS PERIMETER, 20.1MM PERIMETER DERIVED DIAMETER, 312.3 MMSQ AREA. PRE-DILATATION OF THE NATIVE VALVE WAS DONE WITH A 18MM NON-ABBOTT BALLOON. AFTER TWO ATTEMPTS OF RECAPTURE AND DEPLOYMENT, THE PORTICO VALVE WAS DEPLOYED AT A STARTING IMPLANT DEPTH OF APPROXIMATELY 3MM AND A FINAL IMPLANT DEPTH OF ABOUT 1-2MM. IN THE PHYSICIAN¿S OPINION, THERE WAS A SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE. PATIENT HAD MODERATE PARAVALVULAR LEAK (PVL) AND MEAN PRESSURE GRADIENT OF 12MMHG, HENCE POST-DILATATION WAS PERFORMED WITH 20MM NON-ABBOTT BALLOON. DUE TO POST-DILATATION, THE VALVE MIGRATED TO ZERO DEPTH AT ANNULUS. THE GRADIENTS AND AORTIC REGURGITATION (AR) WERE REDUCED; HOWEVER, AFTER A FEW MINUTES, THE VALVE EMBOLIZED AND MOVED TO -1 ABOVE THE AORTIC ANNULUS. A SECOND 23MM PORTICO VALVE HAD TO BE DEPLOYED AS THE PATIENT EXPERIENCED SEVERE AR DUE TO VALVE EMBOLIZATION. THIS ISSUE REPORTEDLY CAUSED A CLINICALLY SIGNIFICANT DELAY. THE P

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

  MAUDE report 18378972 ↗
• InjuryOct 11, 2023Intravalvular regurgitation; Intravalvular regurgitation

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, A 23MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH MITRAL STENOSIS AND MITRAL REGURGITATION. IT WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAM PRIOR TO DISCHARGE ON (B)(6) 2018, THAT THE PATIENT HAD MILD AORTIC REGURGITATION. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT HAD BEGUN TO EXPERIENCE SIGNIFICANT BREATHLESSNESS, ORTHOPNEA, AND NOCTURNAL DYSPNEA. THE PATIENT ARRIVED AT THE EMERGENCY ROOM AND WAS FOUND TO BE CLINICALLY OVERLOADED WITH DECREASED BREATH SOUNDS/CRACKLES IN THE MID-SECTION, AND WHEEZING. THE DECISION WAS INITIALLY MADE TO ADMINISTER THE PATIENT INTRAVENOUS LASIX AND THEN CONVERTED TO ORAL LASIX. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED AND REVEALED PRESERVED LET VENTRICULAR SYSTOLIC FUNCTION, BUT ALSO MODERATE AORTIC REGURGITATION, MILD MITRAL STENOSIS, AND MILD TO MODERATE TRICUSPID REGURGITATION. THE PATIENT'S CONDITION WAS MONITORED AND NOTED TO HAVE IMPROVED OVER THE NEXT FEW DAYS. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE EVENTS ARE ATTRIBUTED TO THE PATIENT'S PAST MEDICAL HISTORY AND FLUID OV

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Dyspnea

  MAUDE report 17916651 ↗
• InjuryAug 21, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 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 17591280 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON 07 JUNE 2021, A 23MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE HAD BEEN NO DIFFICULTY EXPERIENCED IMPLANTING THE VALVE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS NOTED POST-OPERATION THAT THE PATIENT HAD A GROIN HEMATOMA AND AN INCREASED HEMOGLOBIN LEVELS DUE TO BLEEDING FROM THE CONTRALATERAL (NON-TAVI) PUNCTURE SIDE. THE DECISION WAS MADE TO TRANSFUSE THE PATIENT WITH 2 UNITS OF OF RED BLOOD CELLS CONTAINING SALINE, ADENINE, GLUCOSE AND MANNITOL (SAGM). ON (B)(6), 2023, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO LOW HEMOGLOBIN LEVELS AND LIGHT CHEST PAIN. THE PATIENT WAS AGAIN TRANSFUSED WITH RED BLOOD CELLS. THE CAUSE OF THE PATIENT'S LIGHT CHEST PAIN IS UNKNOWN, BUT A POSSIBLE PARTIAL CORONARY OBSTRUCTION CAN NOT BE EXCLUDED. THE CAUSE OF THE PATIENT'S LOW HEMOGLOBIN WAS DUE TO THE MINOR GROIN HEMATOMA. IT WAS NOTED THAT ON (B)(6), 2021, THE PATIENT PASSED AWAY UNDER SURGERY FOR A CORONARY ARTERY BYPASS GRAFT DUE TO 75% REVERSIBLE ISCHEMIA OF THE LEFT VENTRIC

  Patient problems: Angina

  MAUDE report 17356700 ↗
• InjuryMay 31, 2023Perivalvular Leak; Incomplete Coaptation; Intravalvular regurgitation; Perivalvular Leak; Incomplete Coaptation; Intravalvular regurgitation

  N/A

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Low Blood Pressure/ Hypotension

  MAUDE report 17033649 ↗
• InjuryMay 25, 2023Off-Label Use; Off-Label Use

  THE ARTICLE, " TAVI-IN-TAVI IN A PATIENT AFTER ALCOHOL SEPTAL ABLATION", WAS REVIEWED. THIS ARTICLE PRESENTED A CASE STUDY OF A 72-YEAR-OLD WOMAN PRESENTED TO AN OUTPATIENT CLINIC WITH SHORTNESS OF BREATH AS A MAIN MANIFESTATION, HEART FAILURE NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASS III AND NOCTURNAL DYSPNEA. ON THE PHYSICAL EXAMINATION, THE PATIENT HAD RALES HEARD OVER BOTH LUNG BASES, BLOOD PRESSURE WAS 130/70 MM HG, HEART RATE WAS 70 BEATS/MIN WITH ATRIOVENTRICULAR DUAL PACED RHYTHM. THE PATIENT HAS AN APPLE SHAPE BODY HABITUS AND SHORT STATURE. THE PATIENT HAS A HISTORY OF HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY (HOCM), HAD A PACEMAKER IMPLANTATION 30 YEARS EARLIER AND UNDERWENT ALCOHOL SEPTAL ABLATION (ASA) FOR LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION 8 YEARS AFTERWARDS. MOREOVER, SHE HAD SYMPTOMATIC SEVERE AORTIC STENOSIS 5 YEARS AGO. BASED ON THE PATIENT¿S PREFERENCE AND HIGH SURGICAL RISK TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WAS PERFORMED USING A LOTUS 23 MM (BOSTON SCIENTIFIC). THE PATIENT WAS PRESCRIBED DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND CLOPIDOGREL FOR 6 MONTHS FOLLOWED BY ASPIRIN ALONE. ON TOP OF THAT, PAROXYSMAL ATRIAL FIBRILLATION WAS DE

  Patient problems: Insufficient Information

  MAUDE report 17007653 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6) - PORTICO VALVE-IN-VALVE RETROSPECTIVE REGISTRY, PATIENT SITE ID: (B)(6). SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE MOST PATIENT SYMPTOMS RESOLVED WITHIN DAYS OR WEEKS OF ONSET, BUT APRAXIA OF FINGERS IS STILL PERSISTENT. IN JUNE 2023, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND VALVE HAD THROMBOSIS PRESENT. HYPOATTENUATED LEAFLET THICKENING (HALT) WAS ALSO OBSERVED, WHICH WAS ACCENTUATED ON NON-CORONARY CUSP (NCC) AND RIGHT CORONARY CUSP (RCC), ALONG WITH REDUCED LEAFLET MOTION OF NCC AND RCC, GRADE 2 INSUFFICIENCY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 16998732 ↗
• InjuryApr 24, 2023Malposition of Device; Intravalvular regurgitation; Malposition of Device; Intravalvular regurgitation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THERE WAS CALCIFICATION EXTENDING BENEATH THE AORTIC ANNULAR PLANE IN THE INTERVENTRICULAR SEPTUM. DURING THE PROCEDURE, THE VALVE WAS IMPLANTED 20MM LOWER TO LEFT VENTRICULAR OUTFLOW (LVOT) RESULTING INTO WORSENING AORTIC INSUFFICIENCY NEEDING FOR A SECOND UNKNOWN DEVICE TO BE IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16800965 ↗
• DeathApr 24, 2023Off-Label Use; Improper or Incorrect Procedure or Method; Expiration Date Error; Off-Label Use; Improper or Incorrect Procedure or Method; Expiration Date Error

  CLINICAL INFORMATION: CRD_1025 - PORTICO VALVE-IN-VALVE RETROSPECTIVE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2016, A 23MM PORTICO VALVE WAS IMPLANTED USING A FLEXNAV DELIVERY SYSTEM DURING A VALVE-IN-VALVE PROCEDURE. THE PORTICO VALVE WAS IMPLANTED INTO A PREVIOUSLY IMPLANTED 23MM NON-ABBOTT VALVE. THE ROUTE FOR THE TRANSCATHETER AORTIC VALVE REPLACEMENT WAS THE RIGHT TRANSFEMORAL ARTERY. FOLLOWING THE IMPLANT OF THE VALVE, THE TAVR ACCESS ROUTE WAS CLOSED USING AN ANGIO-SEAL CLOSURE DEVICE. THE NON-TAVR ACCESS SITE ON THE RIGHT SIDE WAS CLOSED WITH A PROSTAR CLOSURE DEVICE. 2 SUTURES WERE ALSO PLACED. ON (B)(6) 2016, THERE WAS BLEEDING AT THE ACCESS POINT FROM THE RIGHT GROIN AND CLOPIDOGREL TREATMENT WAS PAUSED. OVER THE NEXT TWO DAYS THERE WAS SWELLING AND A HEMATOMA IN THE LEFT GROIN, AND THE SCROTUM BECAME SWOLLEN. PAIN MEDICATION WAS INCREASED. THERE WAS NO SUSPICION OF BACTERIAL INFECTION. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED. ON (B)(6) 2016, THE PATIENT PASSED AWAY DUE TO HEART FAILURE. ON THE LABEL OF THE 23MM PORTICO VALVE, THE EXPIRATION DATE WAS LISTED AS 18 FEBRUARY 2017 INSTEAD OF 19 FEBRUARY 2016.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16796701 ↗
• InjuryMar 31, 2023Migration or Expulsion of Device; Perivalvular Leak; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED THE WEEK PRIOR. THE PATIENT'S NATIVE ANNULUS DIMENSIONS WERE AS FOLLOWS: MIN:16MM, MAX:24.4MM, AVERAGE:20.2MM, PEREMATER:62.7MM, AREA:288.9 MM2. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING THE PRE-PROCEDURE IMAGING, IT WAS OBSERVED THAT THE PATIENT HAD A SEVERELY CALCIFIED ST JUNCTION AND FEMORAL ROUTE. WHEN ATTEMPTING TO PLACE THE DEVICE AT THE IDEAL DEPTH, DIFFICULTY WAS ENCOUNTERED DUE TO TORTUOUS PATIENT ANATOMY AND THE CALCIFIED AORTA. WHEN THE DEVICE WAS 80% DEPLOYED, IT WAS LOCATED 5-6MM BELOW THE NON-CORONARY CUSP AND 7-8MM BELOW THE LEFT CORONARY CUSP. IMMEDIATELY AFTER THE DEVICE WAS DETACHED FROM THE DELIVERY SYSTEM, IT MIGRATED ABOUT 2MM; THERE WAS NO TENSION ON THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE AT THE TIME OF MIGRATION AND THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY. A MILD TO MODERATE PERIVALVULAR LEAK (PVL) AROUND THE LEFT CORONARY CUSP (LCC) WAS SEEN VIA ANGIOGRAM. A POST IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657710 ↗
• InjuryMar 31, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM PORTICO VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED THE WEEK PRIOR. THE PATIENT'S NATIVE ANNULUS DIMENSIONS WERE AS FOLLOWS: MIN:16MM, MAX:24.4MM, AVERAGE:20.2MM, PEREMATER:62.7MM, AREA:288.9 MM2. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA. DURING THE PRE-PROCEDURE IMAGING, IT WAS OBSERVED THAT THE PATIENT HAD A SEVERELY CALCIFIED ST JUNCTION AND FEMORAL ROUTE. WHEN ATTEMPTING TO PLACE THE DEVICE AT THE IDEAL DEPTH, DIFFICULTY WAS ENCOUNTERED DUE TO TORTUOUS PATIENT ANATOMY AND THE CALCIFIED AORTA. WHEN THE DEVICE WAS 80% DEPLOYED, IT WAS LOCATED 5-6MM BELOW THE NON-CORONARY CUSP AND 7-8MM BELOW THE LEFT CORONARY CUSP. IMMEDIATELY AFTER THE DEVICE WAS DETACHED FROM THE DELIVERY SYSTEM, IT MIGRATED ABOUT 2MM; THERE WAS NO TENSION ON THE DELIVERY SYSTEM AT THE TIME OF FINAL DEPLOYMENT. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE AT THE TIME OF MIGRATION AND THE MIGRATED VALVE DID NOT BLOCK A CORONARY ARTERY. A MILD TO MODERATE PERIVALVULAR LEAK (PVL) AROUND THE LEFT CORONARY CUSP (LCC) WAS SEEN VIA ANGIOGRAM. A POST IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS P

  Patient problems: Heart Block

  MAUDE report 16657670 ↗
• InjuryFeb 28, 2023Perivalvular Leak; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 23MM PORTICO VALVE WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE, BEFORE THE VALVE WAS PLACED, THE PATIENT WENT INTO ASYSTOLE AND WAS PACED AT 180 BEATS PER MINUTE. AFTER THE VALVE WAS SUCCESSFULLY IMPLANTED, A TEMPORARY PACEMAKER WAS PLACED. ON (B)(6) 2023, COMPLETE HEART BLOCK WAS SEEN VIA ELECTROCARDIOGRAM. ON THE SAME DAY, A DUAL CHAMBER PACEMAKER WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Bradycardia; Heart Block

  MAUDE report 16452937 ↗
• InjuryJan 20, 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 23MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS NOTED DURING PROCEDURE THAT THE 23MM PORTICO VALVE MIGRATED AFTER FULL DEPLOYMENT OF THE VALVE. THE DECISION WAS MADE TO PERFORM A VALVE-IN-VALVE PROCEDURE USING ANOTHER UNKNOWN SIZE PORTICO VALVE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16218647 ↗
• InjuryJan 12, 2023Migration or Expulsion of Device; Perivalvular Leak; Migration or Expulsion of Device; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. THE PATIENT DID NOT HAVE A HORIZONTAL AORTA AND THERE WAS SUFFICIENT CALCIUM TO ALLOW ANCHORING OF THE DEVICE IN THE OPINION OF THE USER. DURING THE PROCEDURE, THE FIRST PHYSICIAN, AT THE TIME OF RELEASE, APPLIED VENTRICULAR PRESSURE IN THE SYSTEM, WHICH MADE THE PORTICO VALVE TO DESCEND INTO THE VENTRICLE. THE PATIENT DID NOT HAVE A HYPERTENSIVE SPIKE OR PULMONARY HYPERTENSIVE EPISODE AT THE TIME OF MIGRATION. THE MIGRATED DEVICE CAUSED A SEVERE PERIVALVULAR LEAK REQUIRING A SECOND VALVE IN VALVE PROCEDURE WITH A 23MM PORTICO VALVE. THE LEAK STOPPED AFTER SUCCESSFULLY IMPLANTATION OF THE SECOND 23MM PORTICO VALVE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH. PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153426 ↗
• InjuryJan 5, 2023Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  CRD_1025 - PORTICO VALVE-IN-VALVE RETROSPECTIVE REGISTRY, PATIENT SITE ID: EU0119 - 75, R727408201, R727412001, R727410501. IT WAS REPORTED THAT ON (B)(6) 2021, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANTATION USING A SMALL FLEXNAV DELIVERY SYSTEM INTO A PATIENT WITH A PAST MEDICAL HISTORY OF ANEMIA AND 2ND DEGREE HEART BLOCK. DURING THE PROCEDURE, AFTER THE VALVE WAS IMPLANTED, A GRADE 3 PARAVALVULAR LEAK WAS FOUND BY ECHOCARDIOGRAM. BALLOON VALVULOPLASTY WAS ATTEMPTED TWICE WITHOUT SUCCESS. A SECOND 23MM NAVITOR VALVE WAS THEN IMPLANTED AND THE LEAK WAS RESOLVED. ON (B)(6) 2021, THE PATIENT WAS TRANSFUSED PACKED RED BLOOD CELLS. NO OVERT BLEEDING DURING PROCEDURE WAS NOTED. ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH THIRD DEGREE COMPLETE HEART BLOCK AND HAD A PERMANENT PACEMAKER IMPLANTED. THE PATIENT HAD A PROLONGED STAY AT THE HOSPITAL FOR MONITORING OF THE RHYTHM. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Heart Block; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108211 ↗
• InjuryDec 22, 2022Perivalvular Leak; Perivalvular Leak

  CRD_1025 - PORTICO VALVE-IN-VALVE RETROSPECTIVE REGISTRY, (B)(4). IT WAS REPORTED THAT ON (B)(6) 2021, A 23MM NAVITOR VALVE WAS SELECTED FOR IMPLANTATION USING A SMALL FLEXNAV DELIVERY SYSTEM INTO A PATIENT WITH A PAST MEDICAL HISTORY OF ANEMIA AND 2ND DEGREE HEART BLOCK. DURING THE PROCEDURE, AFTER THE VALVE WAS IMPLANTED, A GRADE 3 PARAVALVULAR LEAK WAS FOUND BY ECHOCARDIOGRAM. BALLOON VALVULOPLASTY WAS ATTEMPTED TWICE WITHOUT SUCCESS. A SECOND 23MM NAVITOR VALVE WAS THEN IMPLANTED AND THE LEAK WAS RESOLVED. ON (B)(6) 2021, THE PATIENT WAS TRANSFUSED PACKED RED BLOOD CELLS. NO OVERT BLEEDING DURING PROCEDURE WAS NOTED. ON (B)(6) 2021 THE PATIENT WAS DIAGNOSED WITH THIRD DEGREE COMPLETE HEART BLOCK AND HAD A PERMANENT PACEMAKER IMPLANTED. THE PATIENT HAD A PROLONGED STAY AT THE HOSPITAL FOR MONITORING OF THE RHYTHM. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Heart Block; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16037293 ↗
• InjuryDec 13, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  CLINICAL STUDY PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM PORTICO VALVE WAS SELECTED FOR AN IMPLANT. THE VALVE WAS IMPLANTED, HOWEVER, DURING REMOVAL OF DELIVERY SYSTEM, THE VALVE MIGRATED TO THE AORTA IN SUPRA ANNULAR POSITION. THE PHYSICIAN DECIDED TO IMPLANT A STENT. THE FIRST STENT WAS DAMAGED AND REMOVED. THEN, A SECOND STENT WAS IMPLANTED WITH GOOD RESULT. ON (B)(6) 2022, THE PATIENT HAD DROP IN HEMOGLOBIN. COMPUTERIZED TOMOGRAPHY (CT) OF ABDOMEN FOUND AN ANEURYSM SPRURIUM. TWO UNITS OF ERYTHROCYTE CONCENTRATES WAS TRANSFUSED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974465 ↗
• DeathDec 12, 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 23MM PORTICO VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. IT WAS NOTED THAT A PRE-IMPLANT DILATATION WAS PERFORMED USING AN UNKNOWN 20MM BALLOON CATHETER. IT WAS ALSO NOTED THAT DURING PROCEDURE THE VALVE HAD TO BE RE-SHEATHED DUE TO BE DEPLOYED TOO DEEP. IT WAS NOTED DURING A SECOND DEPLOYMENT ATTEMPT, THAT THE PATIENT'S BLOOD PRESSURE DROPPED WHEN THE 23MM PORTICO VALVE WAS 80% DEPLOYED. THE DECISION WAS MADE TO FULLY DEPLOYED/RELEASE THE VALVE, BUT THE PATIENT'S BLOOD PRESSURE REMAINED LOW. THE PATIENT WAS ADMINISTERED UNKNOWN DRUGS AND GIVEN A CARDIAC MASSAGE IN AN ATTEMPT TO MITIGATE THEIR LOW BLOOD PRESSURE, BUT WAS DEEMED INEFFECTIVE. AN ANGIOGRAM WAS PERFORMED AND DISCOVERED A PERICARDIAL EFFUSION. THE DECISION WAS MADE TO PERFORM A PERICARDIOCENTESIS. A FEW MINUTES AFTER THE PERICARDIOCENTESIS THE PATIENT PASSED AWAY. THE CAUSE OF THE PATIENT'S DROP IN BLOOD PRESSURE, PERICARDIAL EFFUSION AND DEATH ARE UNKNOWN.

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

  MAUDE report 15965197 ↗
• InjuryNov 20, 2022Adverse Event Without Identified Device or Use Problem; 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) 2020, A 23MM PORTICO VALVES WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2020, POST PROCEDURE THE PATIENT DEVELOPED AURIC ACUTE KIDNEY INJURY ON A BACKGROUND OF CHRONIC KIDNEY DISEASE. COMMENCED ON CONTINUOUS VENO-VENOUS HEMOFILTRATION WAS DONE ON (B)(6) 2020. BASELINE CREATINE 130 UMOL/L. IT WAS NOTED THAT THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Renal Failure

  MAUDE report 15831442 ↗
• MalfunctionOct 24, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM PORTICO VALVE WAS SELECTED FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT WHEN DEPLOYING THE 23MM PORTICO VALVE AT A DEPTH OF 5MM ON THE LEFT CORONARY CUSP AND 6MM ON THE NON CORONARY CUSP. A 3 CUSP AND CUSP OVERLAP RADIOGRAPHIC VIEW WAS ASCERTAINED TO ASSESS TRUE DEPTH. THE PORTICO VALVE WAS DEPLOYED AND LOOKED SUB-ANNULAR ON FULL DEPLOYMENT. AN UNKNOWN GUIDEWIRE WAS PULLED BACK TO CENTRALIZE THE RADIOPAQUE TIP OF THE DELIVERY SYSTEM. HOWEVER, IT WAS NOTED THAT WHILE THE RADIOPAQUE TIP WAS BEING REMOVED AS THE DELIVERY SYSTEM INTERACTED WITH THE PORTICO VALVE AND CAUSED IT TO MIGRATE ABOVE THE ANNULAR PLAIN. THE DECISION WAS MADE TO IMPLANT A SECOND 23MM PORTICO VALVE USING A NEW SMALL FLEXNAV DELIVERY SYSTEM TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THE SECOND PORTICO VALVE WAS IMPLANTED AT AN OPTIMAL DEPTH AND THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED WITHOUT ISSUE. THE PATIENT REMAINED HEMODYNAMICALLY THROUGHOUT THE PROCEDURE AND NO VALVE GRADIENT OR LEAK WAS NOTED ON FINAL AORTOGRAM. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AND RECOVERING AT THE TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663175 ↗
• DeathSep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS BEING CONSERVATIVELY REPORTED AS THE CAUSE OF THE PATIENT¿S DEATH WAS DUE TO PERFORATION CAUSED BY NON-ABBOTT DEVICES (PTFE GUIDEWIRE AND AL-1 CATHETER). IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PROCEDURE A NON-ABBOTT CATHETER (AL-1 CATHETER) WAS INITIALLY FOUND TO BE IN A BAD POSITION. A PIGTAIL CATHETER WAS USED TO REPOSITION THE GUIDEWIRE. DELIVERY OF THE 23MM PORTICO VALVE WAS ATTEMPTED 3 TIMES AND THE VALVE WAS FULLY RECAPTURED TO REPOSITION FOR OPTIMAL DEPTH. THERE WAS SOME DIFFICULTY WITH MAINTAINING OPTIMAL POSITION OF THE PORTICO VALVE DUE TO MILD CALCIFICATION AND ARRHYTHMIA, THE PATIENT WAS PLACED ON A TEMPORARY PACEMAKER AT 120 BEATS PER MINUTE, WHICH HELPED SUCCESSFULLY IMPLANT THE VALVE. AORTOGRAPHY WAS PERFORMED AND THERE WAS MINIMAL AORTIC INSUFFICIENCY THAT DECREASED AFTER A FEW MINUTES. AT THE TIME OF RELEASE THE PATIENT FELL INTO CARDIAC ARREST AND RESUSCITATION MANEUVERS WERE PERFORMED. THE PATIENT HAD BECOME HYPOTENSIVE DESPITE MEDICATION AND RESUSCITATION MEASURES. THE PATIENT WAS STABILIZED AND THE CAUSE WAS REPORTED TO BE PERICARDIAL EFFUSION WITH TAMPONADE DUE TO POSTERIOR PERFORATION AS SEEN BY TRANSTHORACIC ECHOCARDIOGRAM. ATTEMPT TO

  Patient problems: Arrhythmia; Cardiac Arrest

  MAUDE report 15473923 ↗
• InjuryAug 15, 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 23MM PORTICO VALVE WAS SUCCESSFULLY IMPLANTED USING A SMALL FLEXNAV DELIVERY SYSTEM, IN A PATIENT WITH A HISTORY OF A LEFT BUNDLE BRANCH BLOCK. IT WAS CONFIRMED VIA ELECTROCARDIOGRAM THAT POST-IMPLANT THE PATIENT WAS EXPERIENCING A COMPLETE HEART BLOCK. THE PATIENT HAD A NOTED NORMAL SINUS RHYTHM WITH LEFT BUNDLE BRANCH BLOCK PRIOR TO IMPLANT. THERE WERE NO RECAPTURES OF THE 23MM PORTICO VALVE AND NO NOTED COMPLICATIONS DURING THE IMPLANT PROCEDURE. THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE IMPLANT PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER TO TREAT THE COMPLETE HEART BLOCK. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Heart Block

  MAUDE report 15226658 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM PORTICO VALVE WAS IMPLANTED. POST-IMPLANT, ATRIOVENTRICULAR BLOCK III WAS OBSERVED AND PACEMAKER IMPLANTATION WAS NECESSARY. IN ADDITION, NORMOCHROMIC ANEMIA WAS OBSERVED, HOWEVER NO BLEEDING WAS OBSERVED, THEREFORE NO INTERVENTION WAS REQUIRED. POSTOPERATIVE VISUAL DISTURBANCES, HOMONYMOUS HEMIANOPSIA LEFT SIDE WAS OBSERVED. ON (B)(6) 2022, THE PATIENT WAS TRANSFERRED TO THE STROKE UNIT. ON (B)(6) 2022, THE PATIENT REQUESTED DISCHARGE OF THEIR OWN RESPONSIBILITY WITH EXISTING SYSTEMS WITHOUT FURTHER TREATMENT.

  Patient problems: Anemia; Heart Block

  MAUDE report 15214896 ↗
• InjuryAug 9, 2022Calcified; Patient-Device Incompatibility; Calcified; Patient-Device Incompatibility

  IT WAS REPORTED THAT IN 2013, A 78 YEAR OLD PATIENT WITH HISTORY OF SEVERE AORTIC STENOSIS HAD A 23MM PORTICO VALVE SUCCESSFULLY IMPLANTED. THE PATIENTS ANNULUS HAD A CORONARY HEIGHT OF 7-8MM AND A VERY SLIM SINOTUBULAR JUNCTION. ON (B)(6) 2022, THE PATIENT RETURNED AND THE DECISION WAS MADE TO EXPLANT THE PORTICO VALVE BECAUSE OF AORTIC STENOSIS. A VALVE-IN-VALVE PROCEDURE WAS NOT FEASIBLE DUE TO ANATOMICAL RISKS AND EXTREME RISK OF CORONARY OBSTRUCTION. THE PORTICO VALVE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH A 19MM NON-ABBOTT DEVICE. THE PATIENT WAS DOING WELL AT THE TIME OF REPORT.

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

  MAUDE report 15196137 ↗
• InjuryJun 27, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM PORTICO VALVE AND A SMALL FLEXNAV DELIVERY SYSTEM WERE SELECTED FOR PROCEDURE. THE PATIENT ORIGINALLY HAD A NORMAL SINUS RHYTHM. PRIOR TO IMPLANT, A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED, AND THE PATIENT EXPERIENCED A HEART BLOCK. THE VALVE WAS SUCCESSFULLY IMPLANTED, BUT THE HEART BLOCK CONTINUED TO PERSIST. A PACEMAKER WAS REQUIRED TO BE IMPLANTED TO TREAT THE HEART BLOCK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THE PATIENT WAS STABLE AND DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Heart Block

  MAUDE report 14838241 ↗

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