PERCEVAL PLUS PVF-M (UDI 08022057015372)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08022057015372), received between Apr 5, 2022 and Sep 23, 2026 — classified as 24 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (8 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. How this data works · Data updated Oct 13, 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.

• InjurySep 23, 2026Deformation Due to Compressive Stress

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50868767 ↗
• InjurySep 11, 2026Degraded; Gradient Increase

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50740616 ↗
• InjuryMay 28, 2026Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE. A PERCEVAL PLUS VALVE PVF-M WAS ATTEMPTED TO BE IMPLANTED IN A FEMALE PATIENT ON (B)(6) 2026. DURING THE PROCEDURE, A BALLOON DILATATION WAS PERFORMED AT 6 BARS BY ANOTHER MEMBER OF THE SURGICAL TEAM. THE PRIMARY SURGEON WAS NOT DIRECTLY INVOLVED IN THIS STEP DUE TO THE COMPLEXITY OF THE PROCEDURE BUT REPORTED THAT THE PERFUSIONIST CONFIRMED THE PRESSURE USED. SUBSEQUENTLY, THE VALVE DEMONSTRATED CENTRAL INSUFFICIENCY, WHICH LED TO THE DECISION TO EXPLANT THE DEVICE. THE PATIENT UNDERWENT SURGERY FOR COMBINED AORTIC VALVE DISEASE (AORTIC INSUFFICIENCY AND AORTIC STENOSIS) ALONG WITH CORONARY ARTERY DISEASE REQUIRING BYPASS SURGERY. AFTER IMPLANTATION OF THE PERCEVAL VALVE, THREE PHYSICIANS ASSESSED THE RESULTING VALVE PERFORMANCE. THERE WAS UNCERTAINTY AMONG THEM REGARDING THE SEVERITY OF THE CENTRAL INSUFFICIENCY. INTRAOPERATIVE ULTRASOUND SUGGESTED ONLY MILD INSUFFICIENCY; HOWEVER, DUE TO THE LACK OF CONSENSUS AND CONCERN OVER THE VALVE FUNCTION, THE DECISION WAS MADE TO PROCEED WITH EXPLANTATION. FOLLOWING EXPLANTATI

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25314799 ↗
• InjuryMar 19, 2026Degraded

  THE MANUFACTURER WAS NOTIFIED OF A RE-INTERVENTION INVOLVING A PERCEVAL PLUS VALVE. BASED ON THE INFORMATION RECEIVED, ON (B)(6) 2021, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED IN A PATIENT. AFTER ABOUT 5 YEARS, THE PATIENT WAS COMING IN FOR SURGERY ON (B)(6) 2026 TO HAVE THE PERCEVAL VALVE EXPLANTED DUE TO AORTIC STENOSIS. WHILE GAINING ACCESS TO THE HEART, THE SURGEON REPORTED VERY DIFFICULT ADHESIONS, AND HE COULD NOT ACCESS THE AORTA SAFELY. THEY HAD TO ABORT THE REDO AVR SURGICAL APPROACH AND PLANNED FOR A TAVI PROCEDURE. THIS PATIENT HAD A TAVI COMPLETED ON (B)(6) 2026 AND RECEIVED A SAPIEN 26MM TAVI VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24645853 ↗
• InjuryFeb 12, 2026Degraded

  THE MANUFACTURER WAS NOTIFIED OF AN EARLY EXPLANT OF A PERCEVAL PLUS BIOPROSTHESIS THROUGH THE PUBLISHED PAPER "THE DEGENERATED SUTURELESS VALVE IN FULL ROOT PROSTHESIS: A TALE OF 2 APPROACHES" (MICHELE D¿ALONZO, ET AL. , JACC CASE REPORTS, 2026). THE FOLLOWING PROVIDES A SUMMARY OF THE INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. THE EVENT INVOLVED A YOUNG PATIENT WITH SEVERE AORTIC INSUFFICIENCY AND ANEURYSMAL DILATION, STEMMING FROM A BICUSPID AORTIC VALVE WHO, IN 2011, AT THE AGE OF 30, UNDERWENT A BENTALL PROCEDURE WITH IMPLANTATION OF A FREESTYLE N.25 VALVE AND AN INTERVASCULAR 26 VASCULAR PROSTHESIS VIA STERNOTOMY. DURING THE SAME INTERVENTION, A CORRECTION OF A THORACIC AORTIC COARCTATION WAS ALSO PERFORMED THROUGH THORACOTOMY. HOWEVER, THE PATIENT¿S COURSE WAS COMPLICATED BY INFECTIVE ENDOCARDITIS IN 2020, WHICH RESULTED IN SEVERE POSTENDOCARDITIS AORTIC INSUFFICIENCY DUE TO BIOPROSTHETIC DEGENERATION, ULTIMATELY NECESSITATING A REDO OPERATION. DURING THIS SECOND SURGERY, A PERCEVAL PLUS M BIOPROSTHESIS WAS IMPLANTED. AS REPORTED, AT THE TIME OF THE PERCEVAL IMPLANTATION THE PATIENT WAS INFECTION-FREE. THE POSTOPERATIVE COURSE OF THE REDO PROCEDURE WAS UNEVENTFUL.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24320622 ↗
• InjuryNov 27, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  MANUFACTURER WAS INFORMED ABOUT AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE, PVF-M (SERIAL # (B)(6)) THAT OCCURRED ON (B)(6) 2025. THE VALVE WAS IMPLANTED INTO A BICUSPID AORTIC VALVE WITH ELLIPTICAL SHAPE, PVL WERE PRESENT ON ECHO. AS SUCH, PATIENT WAS REOPENED AND THE VALVE WAS REMOVED. REPORTEDLY, PATIENT WAS NOT A GOOD CANDIDATE DUE TO PARTICULAR ANATOMY. BASED ON THE FURTHER INFORMATION RECEIVED, THERE WAS A PARAVALVULAR LEAK BUT NO CENTRAL LEAK. THERE WAS NO MIGRATION, DISLODGEMENT, OR MIS-SIZING. FURTHERMORE, IT WAS REPORTED THAT PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23667686 ↗
• InjuryNov 27, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  MANUFACTURER WAS INFORMED ABOUT AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE, PVF-M THAT OCCURRED ON (B)(6) 2025. THE VALVE WAS IMPLANTED INTO A BICUSPID AORTIC VALVE WITH ELLIPTICAL SHAPE, PVL WERE PRESENT ON ECHO. AS SUCH, PATIENT WAS REOPENED AND THE VALVE WAS REMOVED. REPORTEDLY, PATIENT WAS NOT A GOOD CANDIDATE DUE TO PARTICULAR ANATOMY. NO OTHER FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23667685 ↗
• InjuryNov 21, 2025Perivalvular Leak; Malposition of Device; Perivalvular Leak; Malposition of Device

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE PVF M-OCCURRED ON (B)(6) 2025 DURING AN ISOLATED AVR PROCEDURE PERFORMED VIA FULL STERNOTOMY. ACCORDING TO THE NOTIFICATION, DURING THE PREPARATION PHASE, AN ANOMALOUS ASPECT OF THE VALVE PERICARDIUM WAS OBSERVED ON THE VENTRICULAR SIDE OF THE VALVE, ALONG WITH A CLOUDY ASPECT OF THE SURROUNDING LIQUID. THE PROSTHESIS WAS NEVERTHELESS IMPLANTED, WITH NO DIFFICULTIES REPORTEDLY ENCOUNTERED AT THE COLLAPSING, RELEASING AND POSITIONING PHASE AND THE VALVE APPEARED FULLY EXPANDED ONCE POSITIONED. HOWEVER, AFTER THE DECLAMPING OF THE AORTA, A MODERATE PARAVALVULAR LEAK WAS DETECTED, REPORTEDLY CAUSED BY PARTIAL COLLAPSING OF THE PROSTHESIS AT THE NON-CORONARY SIDE, WHICH LED TO THE EXPLANT OF THE PROSTHESIS AND ITS REPLACEMENT WITH ANOTHER PERCEVAL PLUS OF THE SAME SIZE WITH EXCELLENT RESULTS. AS PER ADDITIONAL INFORMATION RECEIVED, NO BALLOONING HAD BEEN PERFORMED ON THE EXPLANTED PROSTHESIS ONCE IN PLACE AND NO FURTHER DECALCIFICATION WAS DEEMED NECESSARY PRIOR TO THE IMPLANTATION OF THE REPLACEMENT VALVE. THE PATIENT¿S NATIVE VALVE WAS REPORTED TO BE TRICUSPID WITH A 20 MM ANN

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23615723 ↗
• InjuryNov 21, 2025Perivalvular Leak; Deformation Due to Compressive Stress; Perivalvular Leak; Deformation Due to Compressive Stress

  MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE PVF-M THAT OCCURRED ON (B)(6) 2025. THE DEVICE WAS EXPLANTED DUE TO PARAVALVULAR LEAK CAUSED BY A VERY CALCIFIED ANNULUS. THE VALVE WAS REPLACED WITH ANOTHER SIMILAR DEVICE, SAME SIZE M. BASED ON THE FURTHER INFORMATION RECEIVED, THE PROCEDURE WAS FULL STERNOTOMY, PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF THE SURGERY. REPORTEDLY, THERE WAS ECCENTRIC/BULKY PROTRUDING INTRA-LUMINAL CALCIFICATIONS WHICH COULD HAVE CAUSED IMPAIRED STRUT EXPANSION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23613594 ↗
• InjuryNov 14, 2025Collapse; Deformation Due to Compressive Stress; Collapse; Deformation Due to Compressive Stress

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED IN THE PATIENT ON (B)(6) 2025. AN INFOLD OF THE PERCEVAL VALVE WAS IDENTIFIED ON (B)(6) 2025, BASED ON THE INFORMATION PROVIDED. THE SITE REPORTED THAT THE ADVERSE EVENT BEGAN ON (B)(6) 2025, AND THAT THE INFOLD WAS FIRST RECOGNIZED ON (B)(6) 2025. FURTHER DETAILS INDICATED THAT THE VALVE DEMONSTRATED GOOD FUNCTIONALITY IN BOTH THE POST-OPERATIVE AND DISCHARGE ECHOS, WITH NO INCREASE IN GRADIENTS OR SIGNS OF REGURGITATION. THE PATIENT¿S ANNULUS WAS REPORTED TO MEASURE AROUND 22/23 MM, LIKELY RULING OUT CONCERNS OF OVERSIZING. ACCORDING TO ADDITIONAL INPUT FROM THE SURGEON, THE PATIENT HAD A BICUSPID VALVE WITH A FIBROUS RAPHE, WITH THE INFOLD SUSPECTED TO BE LOCATED IN THAT AREA. ON (B)(6) 2025, A FEMORAL VALVULOPLASTY WAS PERFORMED USING A 23 MM BALLOON INFLATED TO 4.5 BAR IN AN EFFORT TO EXPAND THE PERCEVAL VALVE. A POST-PROCEDURE CT SCAN SHOWED SLIGHT IMPROVEMENT, ALTHOUGH THE DEFORMATION REMAINED VISIBLE. DESPITE THIS, THE ECHO FINDINGS CONTINUED TO SHOW GOOD VALVE PERFORMANCE, WITH NO HIGH GRADIENTS OR REGURGITATION. GIVEN THE VALVE¿S SATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552215 ↗
• InjuryNov 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER RECEIVED INFORMATION THROUGH DEVICE TRACKING DEPARTMENT. REPORTEDLY, ON (B)(6) 2025, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY DUE TO UNKNOWN REASON. NO INFORMATION REGARDING ANY ALLEGATION OF A DEVICE DYSFUNCTION OR PATIENT INJURY HAS YET BEEN RECEIVED FROM THE SITE OF AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23547689 ↗
• InjuryNov 13, 2025Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  MANUFACTURER RECEIVED INFORMATION THROUGH DEVICE TRACKING DEPARTMENT. REPORTEDLY, ON (B)(6) 2025, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY DUE TO UNKNOWN REASON. NO INFORMATION REGARDING ANY ALLEGATION OF A DEVICE DYSFUNCTION OR PATIENT INJURY HAS YET BEEN RECEIVED FROM THE SITE OF AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 23547681 ↗
• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION RECEIVED, A PERCIVAL PLUS VALVE (PVF-M) WAS IMPLANTED IN THE PATIENT ON (B)(6) 2025. ON THE SAME DAY, THE PATIENT DEVELOPED A COMPLETE ATRIOVENTRICULAR BLOCK, WHICH PERSISTED UNTIL (B)(6) 2025. AS THE CONDITION DID NOT RESOLVE, A PERMANENT PACEMAKER WAS IMPLANTED ON (B)(6) 2025. THE REPORTED OUTCOME IS "RECOVERED/RESOLVED W. SEQUELAE". THE PATIENT EXPERIENCED A STROKE ON POSTOPERATIVE DAY 1, WHICH, BASED ON THE AVAILABLE INFORMATION, WAS ATTRIBUTED TO BILATERAL CAROTID STENOSIS DIAGNOSED AFTER THE EVENT. BASED ON THE AVAILABLE INFORMATION, THE PATIENT'S MEDICAL HISTORY INCLUDED CORONARY ARTERY DISEASE, SYSTEMIC HYPERTENSION, DYSLIPIDAEMIA, PULMONARY HYPERTENSION, AND A RESOLVED MALIGNANCY. ATRIAL FLUTTER WAS REPORTED AND SURGICALLY TREATED IN 2024. THE PATIENT WAS CLASSIFIED AS NYHA FUNCTIONAL CLASS II. NO DEVICE DEFICIENCY HAS BEEN REPORTED FROM THE SITE. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND PROBABLY RELATED TO THE IMPLANTING PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 23533162 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION RECEIVED, A PERCEVAL PLUS VALVE, PVF-M WAS IMPLANTED IN THE PATIENT ON (B)(6) 2025, THROUGH MEDIAN STERNOTOMY. THREE CABG PROCEDURES WERE PERFORMED AS CONCOMITANT PROCEDURES PRIOR TO THE PERCEVAL VALVE IMPLANTATION. REPORTEDLY, THE PATIENT EXPERIENCED A STROKE ON POSTOPERATIVE DAY #1, WHICH REQUIRED CLOSE MONITORING, INCLUDING DIAGNOSTIC EXAMINATIONS AND TEST. MEDICAL JUDGMENT RECEIVED SUGGESTS THAT THE STROKE COULD POSSIBLY BE RELATED TO BILATERAL CAROTID STENOSIS, WHICH WAS DIAGNOSED AFTER THE EVENT. THE OUTCOME OF THE EVENT IS INDICATED AS RECOVERED/RESOLVED W. SEQUELAE. BASED ON THE AVAILABLE INFORMATION, THE PATIENT'S MEDICAL HISTORY INCLUDES CORONARY ARTERY DISEASE, SYSTEMIC HYPERTENSION, DYSLIPIDAEMIA, PULMONARY HYPERTENSION, AND A RESOLVED MALIGNANCY. ATRIAL FLUTTER WAS REPORTED AND SURGICALLY TREATED IN 2024. THE PATIENT WAS CLASSIFIED AS NYHA FUNCTIONAL CLASS II. NO DEVICE DEFICIENCY HAS BEEN REPORTED FROM THE SITE. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE, PROBABLY RELATED TO THE IMPLANTING PROCEDURE AND POSSIBLY RELATED TO OTHER MEDICAL CONDITIONS.

  Patient problems: Stroke/CVA

  MAUDE report 23533059 ↗
• InjurySep 9, 2025Collapse; Collapse

  THE MANUFACTURER WAS NOTIFIED OF AN INCIDENT INVOLVING A PERCEVAL PLUS AORTIC HEART VALVE. ACCORDING TO THE REPORT, THE VALVE WAS IMPLANTED ON (B)(6) 2025, IN A PATIENT WITH A HISTORY OF SHORTNESS OF BREATH CAUSED BY SEVERE AORTIC STENOSIS, AS CONFIRMED BY ECHOCARDIOGRAPHY. THE SURGICAL PROCEDURE WAS CONDUCTED VIA A MICS APPROACH, SPECIFICALLY AN ISOLATED AVR, WITH NO CONCOMITANT PROCEDURES PERFORMED. PROSTHESIS SIZING WAS CARRIED OUT INTRAOPERATIVELY AND ALSO BASED ON THE PREOPERATIVE ASSESSMENT PERFORMED VIA CT SCAN. BASED ON THE PRE-OPERATIVE REPORT, THE NATIVE VALVE WAS IDENTIFIED AS BICUSPID TYPE 1. BALLOONING WAS PERFORMED IN ACCORDANCE WITH THE IFUS. AS REPORTED, NO DEVICE MALPOSITIONING, MIS-SIZING, OR ABNORMAL ANNULAR GEOMETRIES WERE IDENTIFIED, AND NO DIFFICULTIES DURING POSITIONING WERE EXPERIENCED. POSTOPERATIVELY, THE PATIENT¿S ANTICOAGULATION TREATMENT WAS MANAGED BY ADMINISTERING ASPIRIN. A FOLLOW-UP ECHO PERFORMED THREE MONTHS LATER REVEALED MODERATE TO SEVERE AORTIC REGURGITATION IN THE FORM OF CENTRAL LEAK, ATTRIBUTED TO DYSFUNCTION OF THE RIGHT CORONARY CUSP. AS THROMBUS WAS SUSPECTED AS THE REASON FOR THE DYSFUNCTION, THE PATIENT WAS STARTED ON WARFARIN AND CLOP

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23002426 ↗
• InjuryAug 4, 2025Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS NOTIFIED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE, SIZE M (PVF-M), WHICH OCCURRED IN (B)(6) 2025. ACCORDING TO THE INFORMATION RECEIVED, FOLLOWING ANNULAR SIZING WITH AN ANNULAR SIZER, A SIZE M PROSTHESIS WAS DEEMED APPROPRIATE, AND A PERCEVAL VALVE OF THE CORRESPONDING SIZE WAS IMPLANTED. HOWEVER, SIGNIFICANT PARAVALVULAR LEAKAGE (PVL) WAS OBSERVED DURING INTRAOPERATIVE ECHOCARDIOGRAPHY, PROMPTING THE REPLACEMENT OF THE PVF-M VALVE WITH A CONVENTIONAL PROSTHESIS FROM A DIFFERENT MANUFACTURER (MODEL AND SIZE UNKNOWN). REPORTEDLY, THE EXPLANTED PVF-M VALVE WAS DISCARDED AT THE HOSPITAL DUE TO ITS USE IN AN INFECTED PATIENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22700710 ↗
• MalfunctionJul 24, 2025Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2025, THE AORTIC ANNULUS WAS PREPARED FOR USING THE PERCEVAL PLUS VALVE. THE ANNULUS WAS SIZED, AND MEDIUM SIZE VALVE WAS CHOSEN. THE MEDIUM PERCEVAL PLUS VALVE WAS COLLAPSED USING THE ACCESSORIES AND IMPLANTED INTO THE PATIENT. BALLOONING WAS PERFORMED, THE VALVE POSITIONING WAS CHECKED, AND THE AORTA WAS CLOSED. WHEN THEY WERE COMING OFF PUMP, A 25MMHG DIASTOLIC PRESSURES WAS NOTED AND THERE WAS AN ECCENTRIC CENTRAL JET FLOW LEAK AT THE NON-CORONARY CUSP LEAFLET AND THE LEAFLETS WERE NOT SEEN TO BE COAPTING ON THE ECHO IMAGES. AS SUCH, THEY WENT BACK ON PUMP, OPENED THE AORTA AND REMOVED THE VALVE. UPON EXAMINATION OF THE REMOVED VALVE THE SURGEON SAID THAT IT WAS NOT POSSIBLE TO BRING THE LEAFLETS TOGETHER TO COAPTATION WITH HIS INSTRUMENTS, BOTH AT THE MIDDLE AND AT THE COMMISSURAL STRUT ATTACHMENT, WHERE NORMALLY IS POSSIBLE. FURTHERMORE, MENTIONED THAT "THE LEAFLETS SEEM LIKE THEY ARE TOO SHORT". ULTIMATELY, A NEW PERCEVAL PLUS VALVE, ALSO A MEDIUM SIZE WAS OPENED. THE VALVE WAS PREPARED AND WAS IMPLANTED. THE VALVE POSITIONING AND LEAFLETS IN THIS NEW VALVE WAS CHECKED AND THE LEAFLETS WERE ABLE TO COAPT MUCH BETTER, AND AS DESIRED. BALLOONING WAS COMPLETED AND AOR

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22591322 ↗
• InjuryJul 24, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A PERCIVAL PLUS VALVE PVF-M WAS IMPLANTED DURING AN AORTIC DISSECTION CASE IN A PATIENT. FOLLOWING REPAIR OF THE DISSECTION, IT BECAME EVIDENT THAT THE NATIVE AORTIC VALVE WAS NOT FUNCTIONING AS EXPECTED, NECESSITATING AN AVR. A MEDIUM PERCIVAL PLUS WAS INITIALLY SIZED AND IMPLANTED; HOWEVER, IT WAS POSITIONED TOO DEEP AND DECIDED TO EXPLANT IT. AS THERE WAS ONLY ONE SET AVAILABLE ON SITE, THEY OPTED NOT TO REUSE THE MEDIUM SIZE AND INSTEAD IMPLANTED A LARGE SIZE. AFTER FURTHER CONSULTATION, A CLINICAL DECISION WAS MADE TO PROCEED WITH THE LARGE DEVICE PROVIDED THE POST-DEPLOYMENT ECHO WAS SATISFACTORY. THE POST-DEPLOYMENT ECHO RESULTS WERE FAVORABLE, AND THE LARGE PERCIVAL PLUS REMAINED IN IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22584750 ↗
• MalfunctionJul 17, 2025Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED OF THE INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS AORTIC HEART VALVE, SIZE M, WHICH OCCURRED ON (B)(6) 2025. AS REPORTED, AN ECHOCARDIOGRAM PERFORMED POST-IMPLANTATION REVEALED VALVE LEAKAGE AND THE PRESENCE OF A LEAFLET APPEARING SHORTER THAN EXPECTED. CONSEQUENTLY, THE PVF-M PROSTHESIS WAS EXPLANTED AND REPLACED WITH ANOTHER VALVE (UNKNOWN MODEL AND SIZE). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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

  MAUDE report 22532362 ↗
• InjuryJul 3, 2025Positioning Failure; Difficult to Open or Close; Positioning Failure; Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT RELATED TO A PERCEVAL PLUS SUTURLESS AORTIC HEART VALVE SIZE M THAT OCCURRED ON (B)(6) 2025. THE PATIENT¿S NATIVE VALVE HAD BEEN REPLACED DUE TO AORTIC INSUFFICIENCY. DURING IMPLANTATION, THE PROSTHETIC VALVE HAD BEEN REPOSITIONED TWICE DUE TO COMPLICATIONS DESCRIBED AS ¿POP-UP OF THE DEVICE¿. SUBSEQUENTLY, RESTRICTED LEAFLET MOTION WAS OBSERVED, RESULTING IN SEVERE CENTRAL VALVE INSUFFICIENCY, WHICH LED TO THE DECISION TO EXPLANT THE DEVICE. A SIZE 23 STENTED BIOLOGICAL VALVE WAS IMPLANTED AS A REPLACEMENT. THE EVENT RESULTED IN A SECOND AORTIC CROSS-CLAMPING AND A PROLONGED MYOCARDIAL ISCHEMIA TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22399597 ↗
• InjuryJun 13, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS NOTIFIED OF AN INTRA-OPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS AORTIC VALVE (PVF-M) THAT OCCURRED ON (B)(6) 2025. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT HAD A CARDIAC HISTORY OF DYSPNOEA ON MODERATE EXERTION (NYHA II), SINGLE-VESSEL CORONARY ARTERY DISEASE (SEVERE LESION IN THE LEFT ANTERIOR DESCENDING ARTERY) AND HAD BEEN DIAGNOSED WITH SEVERE AORTIC VALVE STENOSIS. THE PRE-OPERATIVE TTE REVEALED A NATIVE HEAVILY CALCIFIED AORTIC VALVE, EXHIBITING A PEAK AORTIC GRADIENT OF 96 MMHG AND A MEAN GRADIENT OF 62 MMHG. ADDITIONAL ASSESSMENTS REVEALED AN AORTIC VALVE AREA (AVA) OF 0.40 CM², A LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 63%, TRIVIAL TRICUSPID INSUFFICIENCY, AN UNAFFECTED MITRAL VALVE, NO GRADIENT IN THE AORTIC ISTHMUS, AN ASCENDING AORTA MEASURING 26 MM, AND A LEFT VENTRICULAR END-DIASTOLIC DIAMETER (LVEDD) OF 44 MM. AS REPORTED, THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT, ALONG WITH CORONARY ARTERY BYPASS GRAFTING DURING THE SAME SURGICAL PROCEDURE. THE AORTIC ANNULUS WAS SIZED FOR A PERCEVAL VALVE, WITH SIZE M DEEMED APPROPRIATE BASED ON THE SIZING TOOL. THE PROSTHESIS WAS COLLAPSED AND IMPLANTED WITHOUT INCIDENT, FOLLOWED BY BALLO

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22200794 ↗
• MalfunctionMar 27, 2025Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SIZE M PROSTHESIS OCCURRED ON (B)(6) 2025 DURING AN AVR SURGERY. REPORTEDLY, BY USING THE ANNULUS SIZER IT WAS DETERMINED THAT SIZE M WAS APPROPRIATE. HOWEVER, UPON ECHO CONFIRMATION, SEVERE PVL WAS OBSERVED. THEREFORE, THE IMPLANTED PERCEVAL PROSTHESIS WAS EXPLANTED AND THE SURGERY WAS COMPLETED USING A CONVENTIONAL VALVE FROM A DIFFERENT MANUFACTURER, WITHOUT REPORTED COMPLICATIONS AND WITH GOOD PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21705913 ↗
• InjuryJan 22, 2025Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2024 A PERCEVAL PLUS M SUTURELESS BIOPROSTHESIS WAS IMPLANTED IN A PATIENT REGISTERED WITH 3MENSIO, WITH NO CONTRAINDICATIONS OBSERVED. AS REPORTED, THE PATIENT¿S ANNULUS WAS HEAVILY CALCIFIED WITH NO ABNORMAL GEOMETRY. THE PATIENT'S AORTOMITRAL CONTINUITY AND THE AREA AROUND THE ANNULUS WERE RESECTED AND CLEANED FROM CALCIFICATION. REPORTEDLY, SIZING WAS PERFORMED ACCURATELY AND THERE WAS NO ISSUE OF OVER-SIZING OR UNDER-SIZING IDENTIFIED. A MITRAL VALVE REPLACEMENT WAS ALSO PERFORMED AS CONCOMITANT PROCEDURE BEFORE THE PERCEVAL VALVE IMPLANT, USING A PERICARBON MORE SIZE 27 BIOPROSTHESIS. DESPITE BEING STABLE DURING THE SURGERY, THE PATIENT WAS CONNECTED TO ECMO IN THE INTENSIVE CARE UNIT AND UNDERWENT A REDO PROCEDURE THE DAY AFTER THE INITIAL SURGERY DUE TO A CENTRAL LEAK DETECTED ON THE PERCEVAL PLUS PROSTHESIS. UPON ENTERING THE CASE, IT WAS OBSERVED THAT THE LEFT CORONARY LEAFLET DID NOT OPEN. AS SUCH, THE PERCEVAL PLUS VALVE WAS REMOVED, AND A CARBOMEDICS TOP HAT SIZE 21 MECHANICAL VALVE WAS IMPLANTED AS A REPLACEMENT. AT WEEK 4 AFTER THE REDO SURGERY, THE PATIENT WAS REPORTED TO HAVE A TRACHEOSTOMY, BE AWAKE, AND EXHIBIT VE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21205325 ↗
• MalfunctionNov 22, 2024Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED OF A FAILURE TO IMPLANT A PERCEVAL PLUS VALVE PVF-M OCCURRED ON (B)(6) 2024. REPORTEDLY THE PROSTHESIS WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT WITH A BI-CUSPID TYPE 1 NATIVE AORTIC VALVE. HOWEVER, DUE TO SEVERE CENTRAL LEAK DETECTED AT THE INTRA-OPERATIVE ECHO CHECK, THE DEVICE WAS EXPLANTED AND REPLACED WITH A CONVENTIONAL VALVE WITHOUT COMPLICATIONS. AS FURTHER REPORTED, THE EVENT CAUSED A DELAY IN SURGICAL TIME OF ABOUT 25-30 MINUTES WITH NO IMPACT ON THE PATIENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20756064 ↗
• MalfunctionNov 22, 2024Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF A FAILURE TO IMPLANT A PERCEVAL PLUS SIZE M PROSTHESIS THAT OCCURRED ON (B)(6) 2024 DURING AN AVR SURGERY PERFORMED THROUGH MINIMALLY INVASIVE APPROACH. REPORTEDLY, AFTER VALVE DEPLOYMENT, AN INCOMPLETE COAPTATION OF THE LEAFLETS WAS DETECTED. AS SUCH, THE PERCEVAL PROSTHESIS WAS REMOVED AND REPLACED WITH A CONVENTIONAL VALVE. REPORTEDLY, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES FROM THE EVENT, DESPITE THE VALVE REPLACEMENT BEING VERY CHALLENGING DUE TO THE MINIMALLY INVASIVE ACCESS. BASED ON THE INFORMATION RECEIVED, AFTER EXPLANT THE PERCEVAL VALVE WAS CAREFULLY EXAMINED AND LEAFLETS WERE APPEARING SHORTER THAN NORMAL, SHOWING SEVERE INCOMPETENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755804 ↗

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