PERCEVAL PLUS PVF-S (UDI 08022057015365)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08022057015365), received between Sep 19, 2022 and Sep 27, 2026 — classified as 1 death, 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

1 other recall cover devices cleared under the same FDA submission (P150011); 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2026Leak/Splash

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50909496 ↗
• InjurySep 27, 2026Leak/Splash

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50909495 ↗
• InjuryMay 10, 2026Calcified

  THE MANUFACTURER WAS NOTIFIED THAT A PERCEVAL PLUS PVF-S VALVE WHICH WAS IMPLANTED IN PATIENT ON (B)(6) 2022, WAS EXPLANTED AFTER 4 YEARS, ON (B)(6) 2026 DUE TO ADVANCED DEGENERATION WITH SEVERE CALCIFICATION. REPORTEDLY, EDWARDS INSPIRIS 19MM WAS IMPLANTED INSTEAD. REPORTEDLY, PATIENT HAD TO COME BACK POST REOPERATION DUE TO SOME BLEEDING AND IS NOW RECOVERING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25133275 ↗
• InjuryApr 21, 2026Degraded

  THE MANUFACTURER WAS NOTIFIED FROM THE MANTRA STUDY DATABASE OF THE EARLY EXPLANT OF A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. A PERCEVAL PLUS PVF-S VALVE WAS SUCCESSFULLY IMPLANTED IN A FEMALE PATIENT ON (B)(6) 2022. AT THE 3-YEAR FOLLOW-UP VISIT, ECHOCARDIOGRAPHY REVEALED A MEAN AORTIC PRESSURE GRADIENT OF 68 MMHG, MODERATE CENTRAL REGURGITATION, AND A LEFT VENTRICULAR EJECTION FRACTION OF 50%. FUNCTIONALLY, THE PATIENT WAS CLASSIFIED AS NYHA CLASS III PRIOR TO THE INITIAL PERCEVAL VALVE IMPLANTATION, IMPROVED TO NYHA CLASS II FOLLOWING THE PROCEDURE, AND SUBSEQUENTLY DETERIORATED TO NYHA CLASS III AT THE 3-YEAR POSTOPERATIVE FOLLOW-UP. THE PATIENT PRESENTED AGAIN ON (B)(6) 2026 WITH SEVERE AORTIC STENOSIS. FOLLOWING DIAGNOSTIC EVALUATION AND HOSPITALIZATION, THE PROSTHETIC VALVE WAS EXPLANTED ON (B)(6) 2026 AND REPLACED VIA MEDIAN STERNOTOMY WITH A 19-MM BICARBON FITLINE VALVE (SN (B)(6)). THE PATIENT'S MEDICAL HISTORY INCLUDES SYSTEMIC HYPERTENSION, TYPE II NON-INSULIN-DEPENDENT DIABETES MELLITUS, DYSLIPIDEMIA, CURRENT TOBACCO USE, AND OBESITY.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24939216 ↗
• InjuryMar 13, 2026Malposition of Device; Migration

  THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLATATION OF A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. ON (B)(6) 2026, A PERCEVAL PLUS SIZE S VALVE WAS SUCCESSFULLY IMPLANTED IN A 63-YEAR-OLD FEMALE PATIENT. PRE-PROCEDURAL CT SCAN SIZING HAD BEEN PERFORMED AND REVEALED A 19 MM AORTIC ANNULUS, SUBSEQUENTLY CONFIRMED INTRAOPERATIVELY USING THE SIZERS ACCORDING TO THE IFU. NO SIZING NOR POSITIONING ISSUES WERE ENCOUNTERED. BALLOONING WAS REPORTEDLY PERFORMED AS PER IFU. UNFORTUNATELY, THERE WAS NO ECHOCARDIOGRAPHY AVAILABLE IN THE OPERATING ROOM, SO INTRAOPERATIVE ASSESSMENT COULD NOT BE PERFORMED. ON (B)(6) 2026, PARAVALVULAR LEAK WAS NOTED. THE SURGICAL TEAM AND PROCTOR DECIDED TO OBSERVE AND FOLLOW-UP WITH THE PATIENT FOR A WEEK BEFORE ANY RE-INTERVENTION. HOWEVER, THE REGURGITATION WORSENED, AND A REOPERATION WAS REQUIRED AND PERFORMED ON (B)(6) 2026. DURING THE REOPERATION, THE VALVE WAS EXPLANTED, THE ANNULUS WA RESIZED, AND ANOTHER PERCEVAL PLUS SIZE S WAS IMPLANTED ACHIEVING A MEAN GRADIENT OF 7 MMHG. UPON EXPLANTATION, IT WAS SEEN THAT PART OF THE EXPLANTED VALVE WAS SEATED WITHIN THE LVOT, WHICH LED TO FO

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24588202 ↗
• MalfunctionFeb 24, 2026Activation Failure

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM THE FACILITY. ON (B)(6) 2026, DURING AN ISOLATED AORTIC VALVE REPLACEMENT (AVR) PERFORMED THROUGH FULL STERNOTOMY, AN EXPLANT AND VALVE REPLACEMENT WERE REQUIRED DUE TO INCOMPLETE EXPANSION OF A PERCEVAL PLUS VALVE SIZE SMALL WAS EXPLANTED AND REPLACED WITH A CONVENTIONAL PROSTHESIS (UNKNOWN MODEL AND SIZE) DUE TO INCOMPLETE EXPANSION. PREOPERATIVE CT MEASUREMENTS INDICATED AN ANNULAR SIZE OF 20¿21 MM AND BASED ON INTRAOPERATIVE SIZING USING THE DEDICATED SIZER A PROSTHESIS OF SMALL SIZE WAS SELECTED. NO DIFFICULTIES WERE EXPERIENCED IN THE COLLAPSING PHASE. HOWEVER, IMMEDIATELY AFTER DEPLOYMENT, THE VALVE DID NOT EXPAND PROPERLY. DESPITE ADDITIONAL BALLOONING ATTEMPTS, ADEQUATE EXPANSION COULD NOT BE ACHIEVED. CONSEQUENTLY, THE PERCEVAL VALVE WAS PROMPTLY EXPLANTED AND REPLACED WITH A CONVENTIONAL VALVE. FOLLOWING THE REPLACEMENT, THE PROCEDURE PROCEEDED WITHOUT FURTHER COMPLICATIONS AND WAS SUCCESSFULLY COMPLETED. THE PATIENT REMAINED STABLE THROUGHOUT THE SURGERY AND HAS RECOVERED WELL ACCORDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426967 ↗
• InjuryFeb 23, 2026Degraded

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH MANTRA DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED ON (B)(6) 2023. AFTER MORE THAN 2 YEARS, THE PATIENT HAD SEVERE AORTIC STENOSIS THAT REQUIRED AV REINTERVENTION WITH TAVR ON (B)(6) 2026 TO RESOLVE THE ISSUE. THE OUTCOME WAS REPORTED AS RECOVERED/RESOLVED. PATIENT'S CLINICAL HISTORY INCLUDED SYSTEMIC HYPERTENSION; DIABETES MELLITUS: TYPE II, NON-INSULIN DEPENDENT; DYSLIPIDEMIA; HYPERTHYROIDISM; OTHER DISEASE: SLEEP APNEA; AORTIC VALVE REPLACEMENT: BIOLOGICAL 2013; AND WAS NYHA CLASS III.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24411377 ↗
• InjuryFeb 20, 2026Degraded

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH MANTRA DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED ON (B)(6) 2023. AFTER MORE THAN 2 YEARS, THE PATIENT HAD SEVERE AORTIC STENOSIS THAT REQUIRED AV REINTERVENTION WITH TAVR ON (B)(6) 2026 TO RESOLVE THE ISSUE. THE OUTCOME WAS REPORTED AS RECOVERED/RESOLVED. PATIENT'S CLINICAL HISTORY INCLUDED SYSTEMIC HYPERTENSION; DIABETES MELLITUS: TYPE II, NON-INSULIN DEPENDENT; DYSLIPIDEMIA; HYPERTHYROIDISM; OTHER DISEASE: SLEEP APNEA; AORTIC VALVE REPLACEMENT: BIOLOGICAL 2013; AND WAS NYHA CLASS III.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24408202 ↗
• InjuryFeb 10, 2026Inadequacy of Device Shape and/or Size; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED BY THE TURKISH MEDICINES AND MEDICAL DEVICES AGENCY OF A LEAK INVOLVING A PERCEVAL PLUS SIZE S PROSTHESIS. THE FOLLOWING PROVIDES A SUMMARY OF THE INFORMATION CURRENTLY MADE AVAILABLE TO THE MANUFACTURER BY THE HEALTHCARE FACILITY: THE REPORTED LEAK WAS RESULTING FROM AN INCOMPLETE COAPTATION OF ONE OF THE VALVE¿S LEAFLET DETECTED AT THE INTRAOPERATIVE TEE. BASED ON THE INFORMATION RECEIVED, THE PERCEVAL PLUS PROSTHESIS HAD BEEN IMPLANTED DURING A DOUBLE VALVE REPLACEMENT PROCEDURE PERFORMED THROUGH FULL STERNOTOMY TO TREAT AORTIC AND MITRAL VALVE STEONOSIS. THE PATIENT HAD A TRICUSPID STENOTIC NATIVE VALVE (PEAK GRADIENT 95 MMHG, MEAN GRADIENT 61 MMHG) WITH NO ABNORMAL GEOMETRIES OF THE ANNULUS IDENTIFIED. NO DIFFICULTIES IN THE VALVE PREPARATION WERE NOTED AND THE PERCEVAL PLUS PROSTHESIS WAS REPORTEDLY IMPLANTED FOLLOWING THE DEVICE IFUS AFTER PLACING A MECHANICAL PROSTHESIS IN THE MITRAL POSITION. AS RESULT OF THE EVENT, THE PERCEVAL PLUS VALVE WAS EXPLANTED AND REPLACED WITH A NEW PERCEVAL PLUS OF THE SAME SIZE. REPORTEDLY, NO FURTHER DECALCIFICATION WAS PERFORMED PRIOR TO IMPLANT THE REPLACEMENT DEVICE. THE MANUFACTURER IS FURTHER FOLLOWING UP WI

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24305973 ↗
• InjuryFeb 8, 2026Patient-Device Incompatibility

  THE MANUFACTURER WAS NOTIFIED OF A PACEMAKER IMPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. REPORTEDLY, ON (B)(6) 2026, A PERCEVAL PLUS PVF-S WAS IMPLANTED IN A PATIENT, ISSUE EVOLVED OVER TIME, AND THE PATIENT NEEDED TO HAVE A PERMANENT PACEMAKER IMPLANT WITHIN 48 HOURS POST OP. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Heart Block

  MAUDE report 24288485 ↗
• InjuryFeb 8, 2026Patient-Device Incompatibility

  THE MANUFACTURER WAS NOTIFIED OF A PACEMAKER IMPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. REPORTEDLY, ON (B)(6) 2026, A PERCEVAL PLUS PVF-S WAS IMPLANTED IN A PATIENT, ISSUE EVOLVED OVER TIME, AND THE PATIENT NEEDED TO HAVE A PERMANENT PACEMAKER IMPLANT WITHIN 48 HOURS POST OP. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Heart Block

  MAUDE report 24288484 ↗
• InjuryNov 13, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLANT OF A PERCEVAL PLUS AORTIC HEART VALVE, PVF-S. ACCORDING TO REPORTS, THE PATIENT INITIALLY HAD A 19 MM MAGNA EASE VALVE IMPLANTED IN 2011, WHICH WAS REPLACED WITH THE PERCEVAL VALVE ON (B)(6) 2025, VIA UPPER HEMISTERNOTOMY. THE IMMEDIATE POSTOPERATIVE ECHOCARDIOGRAM SHOWED GOOD VALVE FUNCTION WITH NO LEAKAGE. HOWEVER, A FOLLOW-UP ECHO SCAN PERFORMED ON (B)(6) 2025, REVEALED A PARAVALVULAR LEAK, AORTIC VALVE INSUFFICIENCY, AND VALVE'S DISPLACEMENT WAS SUSPECTED. DUE TO THE HIGHLY DETERIORATED PATIENT CONDITIONS, AN EMERGENCY REOPERATION WAS CONDUCTED ON THE SAME DAY. DURING THE REOPERATION, THE PERCEVAL VALVE WAS FOUND TO BE COMPLETELY INTACT AND WELL-POSITIONED, BUT A SIGNIFICANT TEAR IN THE ANNULUS WAS IDENTIFIED AS THE SOURCE OF THE PARAVALVULAR LEAK. THE PERCEVAL VALVE WAS EASILY REMOVED, THE TEAR ON ANNULUS WAS REPAIRED USING PROLENE 4/0 SUTURES AND A 19 MM EDWARDS INSPIRIS VALVE WAS IMPLANTED. BASED ON THE MEDICAL ASSESSMENT, THE EVENT WAS DEEMED UNRELATED TO THE PERCEVAL PROSTHESIS OR THE IMPLANTATION PROCEDURE. THE MOST PLAUSIBLE CAUSE, ACCORDING TO THE MEDICAL JUDGMENT, WAS THE PATIENT¿S DELICATE ANATOMICAL STRUCTURE ENCOUNT

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23543547 ↗
• InjuryNov 13, 2025Collapse; Collapse

  THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLANT OF A PERCEVAL PLUS AORTIC HEART VALVE, PVF-S. THE PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2025, IN A PATIENT WITH A STENO-INSUFFICIENT TRICUSPID NATIVE AORTIC VALVE. REPORTEDLY NO POSITIONING DIFFICULTIES OR OVERSIZING WERE IDENTIFIED DURING THE IMPLANTATION PROCEDURE. ACCORDING TO REPORTS, A HEMODYNAMICALLY SIGNIFICANT PARAPROSTHETIC LEAK DEVELOPED (B)(6) DAYS POST-IMPLANT, PROMPTING THE EXPLANTATION OF THE VALVE ON (B)(6) 2025. UPON REMOVAL, THE SITE OBSERVED A DEFORMATION CHARACTERIZED BY INWARD FOLDING LOCALIZED AT THE NON-CORONARY SINUS, SUGGESTING INCOMPLETE EXPANSION OVER APPROXIMATELY ONE CENTIMETER OF THE VALVE¿S CIRCUMFERENCE. ACCORDING TO THE SITE'S ASSESSMENT, AT THIS LOCATION, THE NITINOL STENT DEMONSTRATED AN ABNORMAL WEAKNESS. DURING THE REOPERATION, MANUAL RE-EXPANSION OF THE PROSTHESIS FOLLOWING SALINE IRRIGATION PROVED SUCCESSFUL, ALLOWING FOR PROPER ADHERENCE TO THE AORTIC ANNULUS. NEVERTHELESS, DUE TO CONCERNS REGARDING A POTENTIAL STRUCTURAL DEFECT, THE VALVE WAS EXPLANTED. ACCORDING TO THE INFORMATION RECEIVED, THE ABNORMAL BEHAVIOR OF THE NITINOL STENT COULD BE REPRODUCED AFTER THE REMOVAL. THE PERCEVAL VALVE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23542604 ↗
• InjuryNov 12, 2025Collapse; Collapse

  THE MANUFACTURER WAS INFORMED OF AN EVENT INVOLVING A PERCEVAL PLUS VALVE, SIZE S (PVF-S), REPORTEDLY IMPLANTED ON (B)(6) 2025. CONCOMITANT PROCEDURES INCLUDED MITRAL VALVE REPLACEMENT AND TRICUSPID VALVE REPAIR, WITH A MEDTRONIC MOSAIC PROSTHESIS PLACED IN THE MITRAL POSITION. DURING THE OPERATION, THE AORTA WAS OPENED AND EVALUATED. CALCIFICATIONS WERE REMOVED, AND THE ANNULUS WAS SIZED FOR THE PERCEVAL VALVE. THE SURGICAL TEAM THEN PROCEEDED WITH THE MITRAL VALVE PROCEDURE BEFORE RETURNING TO THE AORTA, RESIZING IT, AND ULTIMATELY IMPLANTING A SIZE SMALL PERCEVAL PLUS. BALLOONING WAS PERFORMED IN ACCORDANCE WITH THE IFU. TRICUSPID VALVE REPAIR WAS COMPLETED FOLLOWING THE IMPLANTATION OF THE PVF-S VALVE. POSTOPERATIVE TEE REVEALED NO ABNORMALITIES. HOWEVER, A SUBSEQUENT ECHO EVALUATION BY A CARDIOLOGIST INDICATED A SIGNIFICANTLY ELEVATED GRADIENT ONE WEEK AFTER SURGERY. THE MEAN GRADIENT WAS REPORTEDLY 12 MMHG IMMEDIATELY POSTOPERATIVELY IN THE OPERATING ROOM, RISING TO APPROXIMATELY 23 MMHG FOUR TO FIVE DAYS LATER. ADDITIONALLY, A LEAK WAS DETECTED, THOUGH ITS ORIGIN, CENTRAL OR PARAVALVULAR, COULD NOT BE CONFIRMED. A CT ANGIOGRAPHY REVEALED INFOLDING ON ONE SIDE OF THE INFLOW P

  Patient problems: Transvalvular Pressure Gradient Increased

  MAUDE report 23533567 ↗
• InjurySep 9, 2025Leak/Splash; Incomplete Coaptation; Leak/Splash; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF AN INCIDENT INVOLVING A PERCEVAL PLUS AORTIC HEART VALVE. ACCORDING TO THE REPORTS, ON (B)(6) 2025, A PERCEVAL PLUS, PVF-S, WAS IMPLANTED IN A PATIENT. ECHO DONE AFTER 3 MONTHS SHOWED A MODERATE TO SEVERE AORTIC REGURGITATION IN THE FORM OF CENTRAL LEAK, BECAUSE OF THE NON-CORONARY LEAFLET APPEARING STUCK. AS FURTHER REPORTED, THE SURGICAL APPROACH WAS A MICS, AN ISOLATED AVR WITH NO CONCOMITANT PROCEDURE PERFORMED. THE FOLLOW-UP ECHOCARDIOGRAMS CONDUCTED ON (B)(6), 2025, DEMONSTRATED A WELL-POSITIONED AND PROPERLY FUNCTIONING BIOPROSTHETIC AORTIC VALVE. THE RECORDED PEAK/MEAN SYSTOLIC GRADIENTS WERE 28/14 MMHG AND 35/16 MMHG, RESPECTIVELY. A POST-OPERATIVE CHEST X-RAY HAS BEEN PERFROMED ON THE PATIENT AND THE IMAGES WERE SHARED WITH THE MANUFACTURER. AS REPORTED, THE PATIENT'S NATIVE VALVE WAS TRICUSPID, AND THE ANNULUS SIZE WAS EVALUATED TO BE 19MM. BASED ON THE INFORMATION RECEIVED, NO DEVICE MAL-POSITIONING OR MIS-SIZING WAS IDENTIFIED, NOR POSITIONING DIFFICULTIES WERE NOTED, NOR ANY ABNORMAL GEOMETRIES IN THE PATIENT¿S ANNULUS OBSERVED. NO INFORMATION REGARDING THE POST-OP ANTICOAGULANT REGIMEN HAS BEEN PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23002637 ↗
• MalfunctionJul 31, 2025Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS PROSTHESIS OCCURRED ON (B)(6) 2025 DURING AN AVR CASE PERFORMED THROUGH FULL STERNOTOMY. ACCORDING TO THE INFORMATION RECEIVED, FOLLOWING THE SIZING PROCEDURE, IT WAS DETERMINED THAT A VALVE SIZE S WAS SUITABLE FOR THE PATIENT AND A PERCEVAL PLUS HEART VALVE SIZE S WAS IMPLANTED ACCORDINGLY. HOWEVER, SEVERE PARAVALVULAR LEAKAGE (PVL) WAS OBSERVED ON INTRA-OPERATIVE ECHOCARDIOGRAPHY, AND THE VALVE WAS SUBSEQUENTLY EXPLANTED. THE SURGERY WAS THEN COMPLETED USING A CONVENTIONAL VALVE FROM A DIFFERENT MANUFACTURER (UNKNOWN MODEL AND SERIAL NUMBER) WITHOUT REPORTED COMPLICATIONS ON THE PATIENT, WHO REMAINED RELATIVELY STABLE THROUGHOUT THE PROCEDURE. THE HOSPITAL REPORTED THAT THE DEVICE IN QUESTION WAS DISCARDED ON-SITE DUE TO THE PATIENT'S INFECTION, AND THEREFORE WILL NOT BE AVAILABLE FOR FURTHER ANALYSIS. THE MANUFACTURER WAS ALSO INFORMED THAT THE HEALTHCARE FACILITY WILL NOT DISCLOSE ANY INFORMATION REGARDING THE PATIENT. REPORTEDLY, NO POSITIONING PROBLEM WAS NOTED WHILE IMPLANTING THE PERCEVAL PROSTHESIS, AND THE NATIVE VALVE WAS TRICUSPID.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22673356 ↗
• InjuryJul 3, 2025Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS NOTIFIED VIA THE MANTRA STUDY DATABASE THAT ON (B)(6) 2025, DURING A SURGICAL PROCEDURE PERFORMED VIA MEDIAN STERNOTOMY ON A PATIENT WITH A TRICUSPID NATIVE AORTIC VALVE, A PERCEVAL PLUS PROSTHESIS SIZE S WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED INTRAOPERATIVELY DUE TO A PARAVALVULAR LEAK (PVL). FOLLOWING THE INITIAL IMPLANTATION, A SLIGHT FOLD WAS OBSERVED AT THE MITRAL-AORTIC JUNCTION OF THE PERCEVAL VALVE, WHICH RESULTED IN A SIGNIFICANT PVL AS DETECTED BY INTRAOPERATIVE ECHOCARDIOGRAPHY. AN ATTEMPT WAS MADE TO IMPLANT AN ALTERNATIVE AORTIC VALVE (EDWARDS LIFESCIENCES, SAPIEN VALVE, SIZE 23), BUT THE DEVICE MIGRATED INTO THE LEFT VENTRICLE. CONSEQUENTLY, THE SURGICAL TEAM OPTED TO RE-IMPLANT THE ORIGINAL PERCEVAL VALVE, SECURING IT TO THE ANNULUS WITH SUTURES AND PERFORMING BALLOON VALVULOPLASTY USING THE EDWARDS SAPIEN BALLOON. DUE TO THE COMPLEXITY OF THE PROCEDURE, THE PATIENT UNDERWENT THREE SEPARATE AORTIC CROSS-CLAMPINGS, WHICH CAUSED DAMAGE TO THE AORTIC WALL. AS A CORRECTIVE MEASURE, THE ANTERIOR SEGMENT OF THE ASCENDING AORTA WAS REPLACED WITH A DACRON PATCH, SUTURED USING TWO LAYERS OF PERICARDIUM, INTERNAL AND EXTERNAL, AS A CONCOMITANT PROCEDURE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22395969 ↗
• DeathMay 22, 2025Leak/Splash; Leak/Splash

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT: REPORTEDLY, ON (B)(6) 2025, PATIENT WAS PREPARED FOR BYPASS AND AORTIC VALVE REPLACEMENT. AFTER COMPLETING MULTIPLE BYPASSES, WHICH WERE REPORTED AS CHALLENGING DUE TO VERY DELICATE TISSUE, THE AORTA WAS OPENED, THE LEAFLETS AND CALCIUM WERE REMOVED, AND THE ANNULUS WAS SIZED AS A SMALL PERCEVAL PLUS VALVE. THE VALVE WAS COLLAPSED, IMPLANTED, AND THE BALLOONING WAS PERFORMED. THEN, THEY STARTED TO REWARM THE PATIENT AND COME OFF BYPASS, HOWEVER IT WAS SEEN ON THE ECHO THAT THERE WERE SEVERAL LEAKS AROUND THE VALVE, AND IT WAS SITTING ABOVE THE ANNULUS IN THE SINUSES. THEY WENT BACK ON BYPASS AND REMOVED THE VALVE. AS SUCH, THE ANNULUS WAS CHECKED AND A BIT MORE CALCIUM WAS REMOVED. THE VALVE WAS LOADED ON THE HOLDER AGAIN AND REIMPLANTED TAKING MORE CAREFUL STEPS TO ENSURE PROPER IMPLANT AND DEPLOYMENT OF THE VALVE. FURTHER CHECKS FOR VALVE SEATING POSITION WERE PERFORMED, AND BALLOONING WAS COMPLETED. THEN, THEY STARTED TO REWARM AND SLOWLY COME OFF BYPASS. REPORTEDLY, ON ECHO EVALUATION THE VALVE HAD NO LEAKS AND WAS SEEN TO BE IN THE CORRECT POSITION WITH GOOD COAPTATION OF THE LEAFLETS. THE PATIENT'S RIGHT VENTRICLE WAS SAID TO

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22073417 ↗
• InjuryJan 12, 2025Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE PVF-S OCCURRED ON (B)(6) 2024 DURING AN ISOLATED AVR SURGERY. REPORTEDLY, THE VALVE SIZE WAS SELECTED BASED ON PATIENT¿S ANNULUS SIZE, WHICH HAD BEEN DETERMINED THROUGH PRE-OPERATIVE CT SCAN PERFORMED BY THE HOSPITAL FACILITY. PATIENT¿S NATIVE VALVE WAS BICUSPID, STENOTIC WITH NO ABNORMAL GEOMETRIES IN THE ANNULUS. BASED ON THE INFORMATION RECEIVED, AFTER IMPLANT AND UPON ECHO CONFIRMATION, SEVERE PVL WAS OBSERVED, THEREFORE THE PERCEVAL VALVE WAS EXPLANTED, AND THE SURGERY WAS COMPLETED USING A CONVENTIONAL VALVE FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES INSPIRIS RESILIA). IT WAS REPORTED THAT NO DIFFICULTIES WERE ENCOUNTERED DURING THE COLLAPSING AND POSITIONING OF THE PERCEVAL VALVE. APPROXIMATELY 20 MINUTES WERE ADDED TO THE CROSS-CLAMP AND BYPASS TIME BECAUSE OF THE EVENT. AS REPORTED THE PATIENT WAS RELATIVELY STABLE THROUGHOUT THE SURGERY WHICH WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21134127 ↗
• InjuryMay 15, 2024Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS PVF-S PROSTHESIS OCCURRED ON (B)(6) 2023 DURING AN ISOLATED AORTIC VALVE REPLACEMENT SURGERY PERFORMED THROUGH FULL STERNOTOMY. REPORTEDLY THE PATIENT'S NATIVE VALVE WAS BICUSPID TYPE I AND ANNULUS SIZE WAS MEASURED TO BE 20 MM. THE PATIENT HAD AN HYPERTROPHIC LEFT VENTRICLE AND MYECTOMY WAS PERFORMED PRIOR TO PERCEVAL IMPLANTATION. AS REPORTED, NO DIFFICULTIES WERE ENCOUNTERED IN COLLAPSING AND POSITIONING THE PERCEVAL VALVE. AFTER IMPLANT, WHILE WEANING OFF FROM PUMP, PERIVALVULAR LEAK WAS OBSERVED AT THE TEE ECHO. AS SUCH, IT WAS DECIDED TO REPLACE THE PERCEVAL PROSTHESIS WITH A STENTED VALVE (CORCYM CROWN PRT 21 MM). THE PATIENT DIDN'T EXPERIENCE COMPLICATIONS AS A RESULT OF THE EXTENDED SURGICAL TIME (APPROXIMATELY 20 MINUTES WERE ADDED TO THE PROCEDURE) AND WAS DISCHARGED IN STABLE CONDITIONS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19326413 ↗
• InjuryMar 26, 2024Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SUTURELESS AORTIC BIOPROSTHESIS SIZE S THAT OCCURRED ON (B)(6) 2024 DURING AN ISOLATED AVR PERFORMED THROUGH MINI THORACOTOMY. REPORTEDLY, AT THE TRANSESOPHAGEAL ECHO CHECK PERFORMED INTRA-OPERATIVELY, A COAPTATION ISSUE WAS DETECTED WHICH RESULTED IN MASSIVE CENTRAL LEAK. THERE WERE NO SIGNS OF PERIVALVULAR LEAK. AS REPORTED, THE PERCEVAL VALVE WAS REPLACED WITH A NEW ONE OF THE SAME SIZE. THIS REQUIRED TO STOP THE HEART AGAIN, RESTART BYPASS WITH CLAMPING AND REOPENING OF THE AORTA AND RESULTED IN A LENGTHENING OF SURGICAL TIME OF APPROXIMATELY 1HR AND 30 MIN. BASED ON FURTHER DETAILS RECEIVED FROM THE IMPLANTING SITE, THE PATIENT ANATOMY WAS CHARACTERIZED BY A TRICUSPID AORTIC NATIVE VALVE WITH A VERY SMALL ANNULUS AND A SEPTAL BULGE. ACCORDING TO THE MEDICAL JUDGEMENT RECEIVED, IT WAS ASSESSED THAT THE VALVE WAS CONSTRAINED AND THIS COULD HAVE LED TO THE OBSERVED COAPTATION ISSUE. AT FIRST INSTANCE, A LEAFLET MALFUNCTION WAS SUSPECTED, BUT NO ANOMALIES WERE NOTED ON THE VALVE AT THE VISUAL INSPECTION. AS REPORTED, NO COLLAPSING DIFFICULTIES WERE EXPERIENCED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18980913 ↗
• InjuryNov 10, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT IMPLANTED WITH PERCEVAL PLUS VALVE SIZE S ON (B)(6) 2023 WAS DIAGNOSED WITH STENOSIS AND HIGH GRADIENTS (PMEAN: 38MMHG, PPEAK 63MMHG) AT A FOLLOW UP VISIT PERFORMED IN (B)(6) 2023. IT WAS REPORTED THAT VALVE FUNCTIONALITY WAS GOOD AFTER IMPLANT, WITH PMEAN OF 10MMHG AND PPEAK OF 22MMHG AT DISCHARGE. REPORTEDLY, THE PATIENT UNDERWENT AVR DUE TO HIGH-GRADE STENOSIS (PMEAN 20MMHG, PPEAK 23MMHG) IN ABSENCE OF INSUFFICIENCY. THE PATIENT SUFFERS FROM DIABETES MELLITUS TYPE II, NO OTHER RISK FACTORS WERE REPORTED, INCLUDING COAGULATION DISORDERS. PRE-OPERATIVE THE PATIENT WAS UNDER ASPIRIN AND INDICATION FOR TREATMENT WITH MARCUMAR FOR A PERIOD OF 3 WEEKS WAS POSED AFTER IMPLANT. INR AT DISCHARGE WAS 1.08 AND IT WAS 1.10 AT THE FOLLOW-UP VISIT PERFORMED IN SEPTEMBER. ACCORDING TO MEDICAL JUDGEMENT RECEIVED, THE ISSUE IS PROBABLY DUE TO THROMBOSIS. SINCE THERE IS NO WARRANTY THAT PATIENT WAS COMPLIANT TO ANTICOAGULATION THERAPY AFTER SURGERY. ONE STIFFENED LEAFLET WAS CLEARLY SEEN AT ECHO. A TEST ON BACTERIA WAS DONE IN SEPTEMBER WITH NEGATIVE RESULTS. POSSIBLE OVERSIZING WAS EXCLUDED BY CHECKING THE PRE-OPERATIVE IMAGES (CT WAS PERFORME

  Patient problems: Aortic Valve Stenosis

  MAUDE report 18109959 ↗
• MalfunctionJul 27, 2023Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SIZE S VALVE OCCURRED ON (B)(6) 2023, DURING AN ISOLATED AVR SURGERY VIA FULL STERNOTOMY. REPORTEDLY, AN INTRA-OPERATIVE ECHO CHECK PERFORMED AFTER CLOSING THE AORTA SHOWED SEVERE CENTRAL LEAK. AS PER MEDICAL JUDGMENT RECEIVED, IT SEEMED THAT ONE OF THE VALVE LEAFLETS WAS NOT CLOSING PROPERLY. AS REPORTED, NO DIFFICULTIES WERE ENCOUNTERED IN COLLAPSING THE VALVE, NEITHER DURING VALVE POSITIONING. SIZING WAS REPORTED TO BE ACCURATE AND NO MALPOSITION WAS IDENTIFIED. IT WAS REPORTED THAT PATIENT'S NATIVE ANNULUS DIDN'T PRESENT ABNORMAL GEOMETRIES. IT IS NOT KNOWN TO THE MANUFACTURER IF PATIENT'S NATIVE VALVE WAS BICUSPID AND IF IT WAS STENOTIC OR STENO-INSUFFICIENT. PATIENT'S NATIVE VALVE SIZE WAS NOT REPORTED AS WELL. ULTIMATELY, A SURGICAL TISSUE VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED WITHOUT ISSUES (EDWARDS PERIMOUNT SIZE 21). THE SURGERY WAS PROLONGED BY ADDITIONAL 1HRS AND 30 MINS IN CONSEQUENCE OF THIS EVENT WITH NO MAJOR IMPACT ON THE PATIENT, WHO REMAINED STABLE THROUGHOUT ALL THE DELAY IN PROCEDURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17406861 ↗
• InjuryJan 25, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH RECEIVED MANTRA STUDY DATABASE. BASED ON THE INFORMATION RECEIVED, ON 12 DEC 2022, SMALL PERCEVAL PLUS VALVE WAS IMPLANTED IN THE PATIENT. THE SURGICAL APPROACH WAS MINI THORACOTOMY AND THERE WAS NO CONCOMITANT PROCEDURE PERFORMED. THE SITE REPORTED ASYSTOLE ON (B)(6) 2022 WHICH LED TO 12 SECONDS OF CARDIAC MASSAGE. FURTHERMORE, A CONDUCTION DISTURBANCE THAT STARTED ON (B)(6) 2022 WAS ALSO REPORTED WHICH REQUIRED A TEMPORARY PACEMAKER TO BE INSERTED. BASED ON THE INFORMATION RECEIVED, A PERMANENT PACEMAKER WAS EVENTUALLY IMPLANTED ON (B)(6) 2022 TO ADDRESS THE COMPLETE AV BLOCK. THE OUTCOME WAS INDICATED AS RECOVERED/RESOLVED. BASED ON THE INFORMATION AVAILABLE IN THE DATABASE, PATIENT HAD A HISTORY OF ARRHYTHMIA (SINUS ARRHYTHMIA), CARDIAC CONDUCTION DISORDER, STROKE, AND PERIPHERAL VASCULAR DISEASE (CAROTID ARTERY DISEASE).

  Patient problems: Heart Block

  MAUDE report 16244687 ↗
• InjurySep 19, 2022Leak/Splash; Leak/Splash

  ON (B)(6) 2022, A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE PVF-S WAS IMPLANTED. AFTER THE IMPLANTATION OF THIS PERCEVAL PLUS VALVE, THERE WAS RESIDUAL AR. BASED ON THE 2D ECHOCARDIOGRAPHY REPORT, AORTIC ROOT DIAMETER, LEFT VENTRICLE ED AND ES DIMENSION, IVS ES, LEFT VENTRICULAR PW(ED AND ES) WAS WITHIN THE NORMAL VALUE RANGE (3.1, 4.7 AND 3.3, 1.5, 0.9 AND 1.1, RESPECTIVELY). LEFT ATRIAL DIMENSION AND IVS ED WAS LITTLE BIT OUT OF THE RAVAGE OF NORMAL VALUE (4.2 AND 1.3, RESPECTIVELY). 2D IMAGING IN PLAX, SAX AND APICAL VIEWS REVEALED CONCENTRIC LVH & NORMAL LV SYSTOLIC FUNCTION. MOVEMENT OF THE SEPTUM, ANTERIOR, INFERIOR POSTERIOR AND LATERAL WALLS ARE NORMAL. LVEF IS 55%. MITRAL VALVE OPENING IS NORMAL. NO EVIDENCE OF MITRAL VALVE PROLAPSE IS SEEN. MILDLY DILATED LA WITH NO APPARENT LA / LAA CLOT SEEN. AVD; AORTIC VALVE THICKENED & CALCIFIED WITH SEVERE CALCIFIC AS (AVA 0.41SQCM BY CONTINUITY EQUATION, SV 34ML, DVI 0.16, MPG 42MMHG, MAX PG 68MMHG, MAX VELOCITY 412CM/SEC) WITH MILD AR, AORTIC ANNULUS 20.5MM. TRICUSPID VALVE LEAFLETS MOVE NORMALLY. PULMONARY VALVE IS NORMAL. INTERATRIAL AND INTERVENTRICULAR SEPTUM ARE INTACT. NO INTRACARDIAC MASS OR THROMBUS IS SEEN. NO PERICARDI

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15447364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150011. One submission often covers many models, so check the product and lot details in each record.

• Z-0716-2017 · Oct 31, 2016 · Terminated
  Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart