PorticoRecalls & reported problems across all models

We found 4 models of Portico by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2021 and Apr 25, 2025 — classified as 26 deaths, 157 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (79 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Portico problems

Portico models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Portico™ PRT-27

  Aortic valve, prosthesis, percutaneously delivered
  8 deaths57 reports
• Portico™ PRT-25

  Aortic valve, prosthesis, percutaneously delivered
  8 deaths53 reports
• Portico™ PRT-29

  Aortic valve, prosthesis, percutaneously delivered
  5 deaths49 reports
• Portico™ PRT-23

  Aortic valve, prosthesis, percutaneously delivered
  5 deaths31 reports

Recent Portico adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 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 ↗
• 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 ↗

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