PERCEVAL PVS21 (UDI 00896208000412)Recalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 00896208000412), received between Aug 10, 2016 and Jan 18, 2026 — classified as 15 deaths, 176 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Perivalvular Leak” (61 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 195 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2026Calcified

  MANUFACTURER WAS INFORMED THAT A PATIENT WHO HAD A PERCEVAL VALVE SIZE S IMPLANTED ON (B)(6) 2021, NOW HAS GENERATED SVD. ACCORDING TO THE ORIGINAL OPERATIVE RECORD, ANNULUS DIAMETER MEASURED INTRAOPERATIVELY WAS 22 MM; IMPLANTED AS USUAL, WITH A NOTE THAT THE RCC OF THE PROSTHETIC VALVE APPEARED SLIGHTLY FOLDED. POSTOPERATIVE TTE SHOWED NO PARAVALVULAR LEAKAGE AND TRIVIAL TRANSVALVULAR LEAKAGE. REPORTEDLY, PATIENT WAS HOSPITALIZED FOR HEART FAILURE; MARKED ASCITES DUE TO CONCOMITANT LIVER CIRRHOSIS, BUT SYMPTOMS IMPROVED AFTER PARACENTESIS AND WAS DISCHARGED. CT REVEALED CALCIFICATION OF ALL THREE CUSPS; DIAGNOSED AS SVD RATHER THAN PROSTHETIC VALVE THROMBOSIS. PATIENT'S MEDICATIONS ARE REPORTED AS: FUROSEMIDE 20 MG, BAYASPIRIN 100 MG, TAKECAB 10 MG, FEBUXOSTAT 10 MG, BISOPROLOL FUMARATE 2.5 MG, LOFLAZEPATE ETHYL 1 MG, URSODEOXYCHOLIC ACID 300 MG, AMITIZA CAPSULE 12 G, DAYVIGO 2.5 MG, TOLVAPTAN 11.25 MG, SPIRONOLACTONE 25 MG, LIONA TABLET 500 MG, LIXIANA 15 MG.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24106756 ↗
• DeathMay 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE PVS21 WAS IMPLANTED ON (B)(6) 2019. REPORTEDLY, PATIENT PASSED AWAY ON (B)(6) 2024 DUE TO UNKNOWN REASON. PER MEDICAL JUDGMENT RECEIVED, HEPATOCELLULAR CARCINOMA, CHRONIC DIC, AND POOR NUTRITIONAL STATUS COULD BE POSSIBLE REASONS, BUT THE EXACT CAUSE CANNOT BE DETERMINED. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21981427 ↗
• InjuryJan 21, 2025Perivalvular Leak; Perivalvular Leak

  MANUFACTURER WAS INFORMED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2024. REPORTEDLY, MODERATE PVL WAS NOTED AFTER THE SURGERY, BUT THE SURGERY WAS COMPLETED. AT THE FOLLOW UP EXAMINATION, IT WAS NOTED THAT PVL GOT WORSE, AND THE VALVE WAS ULTIMATELY EXPLANTED ON (B)(6) 2024 AND REPLACED WITH EPIC 19 VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21194612 ↗
• InjuryJan 9, 2025Degraded; Degraded

  MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE PVS21 WAS IMPLANTED ON (B)(6) 2022. REPORTEDLY, SINCE SVD WAS FOUND, THE VALVE WAS EXPLANTED AND REPLACED BY AVALUS 19MM ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21108818 ↗
• InjuryJan 2, 2025Perivalvular Leak; Deformation Due to Compressive Stress; Perivalvular Leak; Deformation Due to Compressive Stress

  THE MANUFACTURER WAS NOTIFIED OF A PERCEVAL S VALVE EXPLANT THAT OCCURRED ON THE FIRST POST-OPERATIVE DAY DUE TO A PARAVALVULAR LEAK (PVL) AND INCREASED GRADIENTS (40 MMHG). REPORTEDLY, THE PROSTHESIS WAS IMPLANTED DURING AN ISOLATED AVR SURGERY, WITH NO DIFFICULTIES ENCOUNTERED IN COLLAPSING AND POSITIONING THE DEVICE. ACCORDING TO THE INFORMATION RECEIVED, POST-DILATION OF THE INFLOW RING WAS PERFORMED AFTER THE COMPLETE DEPLOYMENT OF THE PROSTHESIS, AS PRESCRIBED BY THE IFU, AND NO COMPLICATIONS WERE EXPERIENCED DURING THE SURGERY. BASED ON THE INFORMATION RECEIVED, THE PATIENT'S NATIVE VALVE WAS TRICUSPID AND STENO-INSUFFICIENT, WITH PREDOMINANT AORTIC STENOSIS. ALTHOUGH THE ANNULUS GEOMETRY WAS NOT ABNORMAL, THERE WAS SOME DEGREE OF CALCIFICATION OF THE MITRAL ANNULUS. AS REPORTED, THE DAY AFTER SURGERY IT WAS DECIDED TO REINTERVENE ON THE PATIENT AND REPLACE THE PERCEVAL VALVE WITH A CONVENTIONAL BIOPROSTHESIS (CORCYM CROWN 21 MM) DUE TO THE PARAVALVULAR LEAK AND INCREASED PRESSURE GRADIENTS, WHICH LEFT THE PATIENT IN CRITICAL CONDITION. THE CORONARY ARTERIES WERE REPORTED TO BE PERMEABLE. ACCORDING TO THE MEDICAL JUDGEMENT RECEIVED, THE PVL WAS CAUSED BY A DEFORMATION OF THE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased

  MAUDE report 21054964 ↗
• InjuryOct 18, 2024Calcified; Difficult to Open or Close; Calcified; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A PERCEVAL S SUTURELESS AORTIC BIOPROSTHESIS DUE TO STENOTIC DEGENERATION. REPORTEDLY THE PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2021 IN A RE-DO SURGERY TO REPLACE A DEGENERATED SUTURED BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (ABBOTT, TRIFECTA SIZE 19) IMPLANTED 1 YEAR BEFORE. BASED ON THE INFORMATION RECEIVED, GRADIENT AT IMPLANT WAS 16 MMHG AND PREVALENCE OF PERIVALVULAR LEAK, FROM NONE/MINIMAL IN 2021 TO MODERATE/SEVERE IN 2024 WAS RECORDED. AT THE ECHO EXAMINATION PERFORMED ON (B)(6) 2024 HIGH GRADIENTS WERE ALSO RECORDED (MEAN GRADIENT 57 MMHG, SURFACE 0.51CM2). AS SUCH, THE PERCEVAL VALVE WAS EXPLANTED ON (B)(6) 2024 AND REPLACED WITH A MECHANICAL VALVE (CORCYM, SLIMLINE 21 MM). REPORTEDLY, THE PERCEVAL STENT WAS FOUND EMBEDDED IN THE AORTIC WALL FOR HALF OF ITS CIRCUMFERENCE AND IT WAS SEPARATED STEP BY STEP BY USING A VASCULAR SPATULA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH GOOD PATIENT¿S OUTCOME. ACCORDING TO FURTHER INFORMATION RECEIVED, THE PATIENT PRESENTED THE FOLLOWING RISK FACTORS: HYPERLIPIDEMIA, HYPERTENSION, DIABETES.

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

  MAUDE report 20479204 ↗
• InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH COMPETITOR'S PATIENT TRACKING. BASED ON THE INFORMATION RECEIVED, THE PERCEVAL PVS21 VALVE WAS IMPLANTED IN A PATIENT ON (B)(6) 2023. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH INSPIRIS VALVE 19MM. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20159973 ↗
• DeathJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL S SUTURELESS VALVE SIZE SMALL WAS IMPLANTED ON (B)(6) 2024. REPORTEDLY, PATIENT PASSED AWAY DUE TO UNKNOWN REASON. THE DATE IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19631384 ↗
• DeathJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL S SUTURELESS VALVE SIZE SMALL WAS IMPLANTED ON (B)(6) 2024. REPORTEDLY, PATIENT PASSED AWAY DUE TO UNKNOWN REASON. THE DATE IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19631341 ↗
• InjuryJun 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED THAT PERCEVAL VALVE PVS21 WAS IMPLANTED ON (B)(6) 2023 WITH CABG AS CONCOMITANT PROCEDURE. REPORTEDLY, ABOUT THREE MONTHS AFTER SURGERY, FEVER AND ENTEROCOCCUS INFECTION WERE NOTED. VEGETATION WAS ALSO NOTED ON THE LEAFLETS OF THE VALVE. AS REPORTED, IN THE WEEK OF 19 FEB 2024, REGURGITATION WAS NOTED. AS SUCH, THE VALVE WAS EXPLANTED ON (B)(6) 2024. PATIENT ALSO UNDERWENT MVR SINCE INFECTION WAS ALSO NOTED WITH MITRAL VALVE. FURTHER INFORMATION INDICATED THAT THE PATIENT HAS PREVIOUS HISTORY OF ENDOCARDITIS IN JAN 2024. REPORTEDLY, VERRUCAE WERE PRESENT THROUGHOUT THE VALVE DUE TO ENTEROCOCCAL INFECTION, AND THE VALVE HAD LOST ITS FUNCTION. REPORTEDLY, PATIENT WAS TREATED WITH ANTIBIOTICS PRIOR TO THE EXPLANT. THERE WAS NO IMPACT ON THE PATIENT AND OUTCOME WAS GOOD.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Bacterial Infection; Endocarditis; Fever

  MAUDE report 19442859 ↗
• DeathApr 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, A PATIENT WHO WAS PART OF THE PERCEVAL JAPAN STUDY WAS IMPLANTED A PERCEVAL PVS21 IN AORTIC POSITION. BASED ON INFORMATION RECEIVED, PATIENT EVENTUALLY PASSED AWAY ON (B)(6) 2023. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CHRONIC RENAL FAILURE AND DYSLIPIDEMIA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19146860 ↗
• InjuryMar 12, 2024Perivalvular Leak; Inadequacy of Device Shape and/or Size; Perivalvular Leak; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2024, A PERCEVAL VALVE PVS21 WAS IMPLANTED IN A PATIENT WITHOUT ANY PROBLEM. AFTER HEART-LUNG MACHINE WAS DISCONNECTED, PVL WAS NOTED BY ECHO. AS SUCH, VALVE WAS EXPLANTED AND EPIC 21MM WAS IMPLANTED INSTEAD. BASED ON THE FURTHER INFORMATION RECEIVED, ONLY 20 MINUTES WAS ADDED TO THE PROCEDURE, PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF SURGERY, THE OUTCOME WAS GOOD. REPORTEDLY, THE CAUSE OF THE EVENT WAS RELATED TO UNDER-SIZING AND WAS PROBABLY NOT RELATED TO THE DEVICE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18890780 ↗
• MalfunctionDec 6, 2023Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL S SUTURELESS AORTIC VALVE PVS21 / SIZE S THAT OCCURRED ON (B)(6) 2023 DURING AN ISOLATED AVR PROCEDURE PERFORMED THROUGH MINI STERNOTOMY. REPORTEDLY, ONE OF THE LEAFLETS WAS APPEARING MORE TENSIONED THAN THE OTHERS, RESULTING IN INSUFFICIENT COAPTATION. THE PROSTHESIS WAS THUS REPLACED WITH ANOTHER PERCEVAL VALVE OF THE SAME SIZE WITH A GOOD OUTCOME, AS CONFIRMED BY THE INTRAOPERATIVE TEE CHECK. APPROXIMATELY 30 MINUTES OF CLAMPING TIME AND 45 MINUTES OF PERFUSION TIME WERE ADDED TO THE PROCEDURE WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT, WHO REMAINED STABLE THROUGHOUT THE DELAY IN SURGERY. AS PER ADDITIONAL INFORMATION RECEIVED, PATIENT'S NATIVE VALVE WAS FUNCTIONAL BICUSPID AND THERE WERE NO ABNORMAL GEOMETRIES IN THE PATINET'S ANNULUS, AS CONFIRMED BY THE PRE-OPERATIVE ASSESSMENT PERFORMED THROUGH CT AND ULTRASOUND. PRE-OPERATIVE ASSESSMENT ALSO CONFIRMED AN STJ-ANNULUS RATIO < 1.3, WHICH IS IN ACCORDANCE TO THE PATIENT ANATOMICAL CHARACTERISTICS INIDCATED IN PERCEVAL VALVE IFUS. IT WAS CONFIRMED THAT THE SIZING PROCEDURE WAS PERFORMED ACCORDING TO PROTOCOL AND A COMPLETE DECALCIFICATION OF THE ANNULUS

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

  MAUDE report 18279748 ↗
• InjuryDec 4, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE MANUFACTURER WAS NOTIFIED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL S SUTURELESS AORTIC BIOPROSTHESIS. THE EVENT OCCURRED DURING AN AVR SURGERY PERFORMED THROUGH FULL STERNOTOMY ON A PATIENT SUFFERING FROM ENDOCARDITIS AND AORTIC INSUFFICIENCY GRADE III-IV. REPORTEDLY, A SIZE S WAS DEEMED APPROPRIATE AND FITTED PERFECTLY INTO THE ANNULUS. BALLOONING WAS PERFORMED ACCORDING TO THE VALVE¿S IFUS. AS REPORTED, SEVERE REGURGITATION WAS EXPERIENCED AFTER CLOSING THE AORTA, BOTH IN THE FORM OF CENTRAL AND PARAVALVULAR LEAK. THE REGURGITATION WAS ATTRIBUTED TO A DISTORTION OF THE UPPER RING OF THE PERCEVAL STENT, CAUSED BY THE COMPRESSION EXERTED BY THE SINOTUBULAR JUNCTION, WHICH WAS PARTICULARLY NARROW. NO DIAGNOSTIC IMAGES WERE SHARED WITH THE MANUFACTURER FOR ANALYSIS. AS PER ADDITIONAL INFORMATION RECEIVED, THE PERCEVAL VALVE WAS REPLACED WITH A CONVENTIONAL SUTURED BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (ST JUDE MEDICAL/ABBOTT EPIC SUPRA 19MM). ROOT ENLARGEMENT WAS PERFORMED TO ACCOMMODATE THE REPLACEMENT VALVE AND BENTALL PROCEDURE PLUS 2 VENOUS ANASTOMOSES (TO LAD AND RCA) WAS ALSO NEEDED. THE EVENT LED TO A SIGNIFICANT PROLONGATION OF SURGERY TIME, WITH 190 MINS OF CROS

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18254736 ↗
• InjuryNov 17, 2023Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2023, A PERCEVAL VALVE SIZE 21 WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. REPORTEDLY AFTER DE-CLAMPED, THE VALVE DID NOT WORK WELL AS LEAFLET DID NOT OPEN. AS SUCH, THE VALVE WAS EXPLANTED AND REPLACED WITH EPIC (UNKNOWN SIZE). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18165410 ↗
• InjuryNov 14, 2023Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PERCEVAL VALVE SIZE 21 WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED INTRA-OPERATIVELY SINCE PVL WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18136633 ↗
• InjuryNov 8, 2023Collapse; Collapse

  ON (B)(6) 2023, A PERCEVAL VALVE SIZE S WAS ATTEMPTED TO BE IMPLANTED. BASED ON THE ECHO PERFORMED, ANNULUS WAS MEASURED AS 19MM. STANDARD SIZING WAS CARRIED OUT, AND SMALL VALVE WAS DEPLOYED. REPORTEDLY, FOLLOWING DEPLOYMENT SURGEON NOTED PIN WHEELING AND INFOLDING OF NITINOL CAGE. THE PERCEVAL WAS EXPLANTED AND REPLACED BY STANDARD SUTURED VALVE. BASED ON FURTHER INFORMATION RECEIVED, A PERIMOUNT VALVE SIZE 19 WAS IMPLANTED INSTEAD. SURGEON BELIEVES IF SMALLER SIZE OF PERCEVAL EXISTED, IT WOULD HAVE WORKED BETTER IN THIS SITUATION. REPORTEDLY, THEY DID NOT GET TO THE BALLOONING STAGE AND PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE. THERE WAS NO IMPACT ON PATIENT, AND OVERALL OUTCOME WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 18097218 ↗
• InjuryAug 11, 2023Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2023, A PERCEVAL VALVE SIZE 21 WAS IMPLANTED IN A PATIENT. REPORTEDLY, DUE TO OBSERVED PVL AFTER DE-CLAMPED, THE VALVE WAS INTRAOPERATIVELY EXPLANTED AND REPLACED WITH ANOTHER SIMILAR PVS21 VALVE. THE SURGERY COMPLETED WITHOUT PROBLEM. BASED ON THE FURTHER INFORMATION RECEIVED, THE CONCOMITANT PROCEDURE WAS MVR, THERE WAS NO ABNORMAL GEOMETRIES IN PATIENT'S ANNULUS, PATIENT REMAINED STABLE THROUGH THE PROCEDURE AND OUTCOME WAS GOOD. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17515673 ↗
• DeathAug 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PERCEVAL JAPAN STUDY. REPORTEDLY, PERCEVAL VALVE SIZE S WAS IMPLANTED IN THE PATIENT ON (B)(6) 2019. THE SURGICAL APPROACH WAS MEDIAN STERNOTOMY AND THERE WERE TVP AND MAP CONCOMITANT PROCEDURES. BASED ON THE INFORMATION AVAILABLE, PATIENT DID THE 3 YEARS FOLLOW UP ON (B)(6) 2022. MEAN GRADIENT WAS 11 MMHG, AND NO REGURGITATION WAS OBSERVED, EOA= 1.37 CM2, AND THE DEVICE WAS FUNCTIONING WELL. BASED ON INFORMATION RECEIVED, PATIENT PASSED AWAY DUE TO UNKNOWN REASON ON (B)(6) 2023. REPORTEDLY, PATIENT HAD A HISTORY OF AV BLOCK GRADE III, PM IMPLANT, AND NYHA CLASSIFICATION III.

  Patient problems: Insufficient Information

  MAUDE report 17438375 ↗
• InjuryJul 21, 2023Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT OF A PERCEVAL S SUTURELESS AORTIC BIOPROSTHESIS PVS21 THAT OCCURRED ON (B)(6) 2023. REPORTEDLY, AT AN ULTRASOUND CHECK AFTER IMPLANTATION, THE VALVE WAS FUNCTIONING PROPERLY, BUT AFTER A FEW MINUTES, SEVERE AI APPEARED IN THE FORM OF A CENTRAL LEAK. THE VALVE WAS EXPLANTED AND REPLACED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17369085 ↗
• InjuryJun 8, 2023Leak/Splash; Perivalvular Leak; Leak/Splash; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PERCEVAL VALVE SIZE 21 WAS IMPLANTED IN A PATIENT BUT, AFTER DE-CLAMPING, PVL WAS NOTED AT RIGHT CORONARY APEX. AS SUCH, THE VALVE WAS EXPLANTED, AND REPLACED WITH INSPIRIS VALVE SIZE 19. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17093049 ↗
• InjuryMar 17, 2023Malposition of Device; Malposition of Device

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A MICS AVR SURGERY USING PERCIVAL HEAR VALVE SIZE S WAS PERFORMED AND THERE WAS NO CONCOMITANT PROCEDURE. REPORTEDLY, AFTER DE-CLAMP DURING THE SURGERY, MODERATE PVL WAS NOTED BETWEEN RCC AND LCC. AS SUCH, IT WAS CLAMPED AGAIN, AND IT WAS NOTICED THAT THE POSITION OF THE INFLOW RING WAS SLIGHTLY ABOVE ANNULUS. THE DEVICE WAS EXPLANTED, AND ANOTHER PERCIVAL VALVE SIZE S WAS IMPLANTED INSTEAD. REPORTEDLY, NO LEAKAGE WAS NOTED AFTER RE-IMPLANTATION, THE SURGICAL TIME WAS DELAYED ABOUT 60 MINUTES DUE TO THIS EVENT, PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF SURGERY, AND THE OUTCOME OF THE PATIENT WAS GOOD. BASED ON THE INFORMATION RECEIVED, PATIENT'S ANNULUS WAS 28MM. REPORTEDLY, POSITIONING DIFFICULTY WAS NOTED DURING VALVE IMPLANTATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16566988 ↗
• InjuryMar 2, 2023Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2023, PERCEVAL SUTURELESS AORTIC HEART VALVE PVS21 WAS IMPLANTED IN THE PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED INTRA-OPERATIVELY DUE TO HIGH CENTRAL LEAKAGE AND UNSATISFACTORY COAPTATION OF THE LEAFLETS. A DIFFERENT VALVE WAS ULTIMATELY IMPLANTED, AND PATIENT WAS NOT AFFECTED. BASED ON THE FURTHER INFORMATION RECEIVED, SURGEON INDICATED THAT ¿THE PERCEVAL VALVE WAS PRIMARILY DEFECTIVE WITH RETRACTION OF A POCKET AND THEREFORE HAD TO BE REPLACED." NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16474446 ↗
• InjuryFeb 22, 2023Degraded; Degraded

  THE MANUFACTURER RECEIVED FOLLOWING INFORMATION THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, PATIENT WHO WAS IMPLANTED A PERCEVAL SUTURELESS AORTIC HEART VALVE PVS21 ON (B)(6) 2019, IS UNDERGOING TAVR EVALUATION DUE TO AORTIC STENOSIS. NO FURTHER INFORMATION IS PROVIDED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16422488 ↗
• InjuryFeb 22, 2023Degraded; Degraded

  THE MANUFACTURER RECEIVED FOLLOWING INFORMATION THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, PATIENT WHO WAS IMPLANTED A PERCEVAL SUTURELESS AORTIC HEART VALVE PVS21 ON (B)(6) 2019, IS UNDERGOING TAVR EVALUATION DUE TO AORTIC STENOSIS. NO FURTHER INFORMATION IS PROVIDED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16422479 ↗