PERCEVAL PVS25 (UDI 00896208000436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00896208000436), received between Aug 31, 2016 and Apr 16, 2026 — classified as 13 deaths, 176 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (53 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 192 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Material Split, Cut or Torn

  THE MANUFACTURER WAS NOTIFIED OF AN ENDOCARDITIS EVENT INVOLVING A PERCEVAL VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE. A PERCEVAL VALVE PVS25/L WAS IMPLANTED IN A PATIENT ON (B)(6) 2021 THROUGH MICS APPROACH, TYPE 0. ONE OF THE VALVE LEAFLETS WAS TORN AND THE SURGEON INDICATED THAT IT IS DUE TO ENDOCARDITIS. THE VALVE WAS EVENTUALLY EXPLANTED ON (B)(6) 2026. NO OTHER FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Endocarditis

  MAUDE report 24904074 ↗
• InjuryJul 17, 2025Degraded; Degraded

  A PATIENT WITH PRIOR AORTIC STENOSIS SIP SURGICAL AVR IN 2017 AT THE (B)(6) VA WITH A LARGE PERCEVAL PROSTHESIS· AND TAVR (EVOLUTE, UNKNOWN SIZE) IN (B)(6) 2019 AT (B)(6) FOR PROSTHETIC VALVE STENOSIS WITH A MILD-MODERATE PERIVALVULAR LEAK, STABLE MILD CARDIOMYOPATHY WITH NORMAL LV DIMENSIONS. BIOTRONIC DUAL CHAMBER PACEMAKER FOR COMPLETE HEART BLOCK AFTER TAVR, CAD WITH VERY RECENT ATHERECTOMY/PCI TO MID LAD, PAF IN NSR, IDDM, CIRRHOSIS, PRESBYCUSIS, AND OTHER MEDICAL ISSUES. PATIENT WAS EVALUATED INITIALLY FOR ANGINA/DYSPNEA S/P LAD ATHERECTOMY/PCI LAST WEEK AND MEDICAL OPTIMIZATION WHICH HAS BEEN SUCCESSFUL TO RESOLVE THE SYMPTOMS. PATIENT'S EF HAS BEEN MILDLY DEPRESSED/STABLE SINCE 2022 WITH NO LV DILATION, AND NO SIGN OF INFECTION OF THE VALVE COMPLEX. PATIENT IS ALSO NEWLY ANEMIC POSSIBLY FROM HOMOLYSIS ALONG WITH AMS WITH UNCLEAR CAUSE. THERE IS NO CURRENT INDICATION FOR REPEAT VALVULAR INTERVENTION, AND SURGERY CANNOT BE PERFORMED GIVEN THE RECENT CORONARY INTERVENTION AND THE NEED FOR DAPT. REPORTEDLY, PATIENT WAS EVALUATED A MONTH AGO BY CARDIOLOGY FOR CHEST PAIN, DYSPNEA, AND DIZZINESS. TTE SHOWED EF 45-50%, LVIDD 4.5/LVIPS 3.1, SEPTAL WALL MOTION FROM PACING, MOD-SEVERE

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22536119 ↗
• InjuryJul 17, 2025Degraded; Degraded

  A PATIENT WITH PRIOR AORTIC STENOSIS SIP SURGICAL AVR IN 2017 AT THE TAMPA VA WITH A LARGE PERCEVAL PROSTHESIS· AND TAVR (EVOLUTE, UNKNOWN SIZE) IN (B)(6) 2019 AT (B)(6) FOR PROSTHETIC VALVE STENOSIS WITH A MILD-MODERATE PERIVALVULAR LEAK, STABLE MILD CARDIOMYOPATHY WITH NORMAL LV DIMENSIONS. BIOTRONIC DUAL CHAMBER PACEMAKER FOR COMPLETE HEART BLOCK AFTER TAVR, CAD WITH VERY RECENT ATHERECTOMY/PCI TO MID LAD, PAF IN NSR, IDDM, CIRRHOSIS, PRESBYCUSIS, AND OTHER MEDICAL ISSUES. PATIENT WAS EVALUATED INITIALLY FOR ANGINA/DYSPNEA S/P LAD ATHERECTOMY/PCI LAST WEEK AND MEDICAL OPTIMIZATION WHICH HAS BEEN SUCCESSFUL TO RESOLVE THE SYMPTOMS. PATIENT'S EF HAS BEEN MILDLY DEPRESSED/STABLE SINCE 2022 WITH NO LV DILATION, AND NO SIGN OF INFECTION OF THE VALVE COMPLEX. PATIENT IS ALSO NEWLY ANEMIC POSSIBLY FROM HOMOLYSIS ALONG WITH AMS WITH UNCLEAR CAUSE. THERE IS NO CURRENT INDICATION FOR REPEAT VALVULAR INTERVENTION, AND SURGERY CANNOT BE PERFORMED GIVEN THE RECENT CORONARY INTERVENTION AND THE NEED FOR DAPT. REPORTEDLY, PATIENT WAS EVALUATED A MONTH AGO BY CARDIOLOGY FOR CHEST PAIN, DYSPNEA, AND DIZZINESS. TTE SHOWED EF 45-50%, LVIDD 4.5/LVIPS 3.1, SEPTAL WALL MOTION FROM PACING, MOD-SEVERE

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22536117 ↗
• InjuryJan 7, 2025Calcified; Degraded; Calcified; Degraded

  THE MANUFACTURER WAS NOTIFIED OF AN EARLY EXPLANT OF A PERCIVAL S VALVE PVS25 THAT OCCURRED ON (B)(6) 2024. THE PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2020, VIA THE RAT APPROACH DUE TO SEVERE AORTIC VALVE STENOSIS AND INSUFFICIENCY. THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE AND TYPE 2 DIABETES MELLITUS, DIAGNOSED AT THE TIME OF THE PERCIVAL VALVE IMPLANT. THE PATIENT HAD SUFFERED AN INFERIOR MYOCARDIAL INFARCTION IN (B)(6) 2010, TREATED WITH PCI AND A BARE METAL STENT IN THE RIGHT CORONARY ARTERY (RCA), WITH VENTRICULAR FIBRILLATION AS A COMPLICATION. IN (B)(6) 2015, A 90% OCCLUSION OF THE RCA WAS TREATED AGAIN WITH PCI (BMS 4.0/22). IN (B)(6) 2020, CORONARY ANGIOGRAPHY (CAG) SHOWED A MID-LAD (50-69%) LESION, GROWTH IN THE STENT-RCA BUT SUFFICIENTLY PATENT, NO AORTIC INSUFFICIENCY, NO CALCIFICATION IN THE ASCENDING AORTA, AND SLIGHT DILATION. IN (B)(6) 2023, A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED MODERATE STENOSIS OF THE PERCIVAL VALVE, WITH AN AORTIC VALVE AREA OF 1.43 CM² AND SLIGHT PLAQUE FORMATION IN THE DESCENDING AORTA. IN (B)(6) 2024, A NON-ST ELEVATION MYOCARDIAL INFARCTION REQUIRED PCI ON THE RIGHT POSTERIOR LATERAL AND DISTAL RCA WITH THE APPLICATION OF TWO D

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Coronary obstruction/occlusion; Obstruction/Occlusion; Syncope/Fainting; Transvalvular Pressure Gradient Increased

  MAUDE report 21089090 ↗
• InjuryNov 7, 2024Degraded; Degraded

  THE MANUFACTURER WAS INFORMED THAT A TAVI WAS RECENTLY PERFORMED INSIDE A PERCEVAL S SIZE 25 PROSTHESIS IMPLANTED IN 2020. THE MANUFACTURER HAS FOLLOWED UP WITH THE IMPLANTING SURGEON TO RETRIEVE ADDITIONAL DETAILS ON THE EVENT AND THE DEVICE INVOLVED BUT HAS BEEN INFORMED THAT NO FURTHER INFORMATION WILL BE DISCLOSED.

  Patient problems: Insufficient Information

  MAUDE report 20636426 ↗
• DeathOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE THROUGH DEVICE TRACKING INFORMATION THAT A PATIENT IMPLANTED ON (B)(6) 2022 WITH A PERCEVAL SUTURELESS AORTIC PROSTHESIS PVS25 PASSED AWAY ON THE SAME DAY AS THE PROCEDURE. BASED ON THE INFORMATION RETRIEVED FROM THE OPERATIONAL REPORT, PRE-PROCEDURE DIAGNOSIS WAS AORTIC VALVE ENDOCARDITIS AND RETAINED AICD HARDWARE. THE SURGERY WAS PERFORMED THROUGH MEDIAN STERNOTOMY. AFTER OPENING THE AORTA, THE POSTERIOR LEAFLET OF THE NATIVE AORTIC VALVE WAD FOUND TOTALLY ENGULFED WITH VEGETATION. THIS WAS CAREFULLY DEBRIDED AND ALL LEAFLETS WERE EXCISED. 99% ALCOHOL WAS THEN ADMINISTERED TOPICALLY TO THE AORTIC ANNULUS TO KILL ANY OTHER MICROSCOPIC DISEASE THAT MIGHT HAD BEEN PRESENT. THE VENTRICLE WAS THEN THOROUGHLY IRRIGATED WITH ANTIBIOTIC CONTAINING NORMAL SALINE SOLUTION. THE VALVE WAS SIZED AND THE PERCEVAL SIZE L PROSTHESIS WAS IMPLANTED. IT WAS NOTED THAT THERE WAS ALMOST AN ABSCESS IN THE AORTIC VALVE ANNULUS WHICH HAD TO BE CLOSED. SUBSEQUENTLY, THE 2 LEADS PART OF AICD HARDWARE WERE LOCATED AND REMOVED IN THEIR SCAR SLEEVE. THE CORKSCREW IN THE ATRIUM AND THE CORKSCREW IN THE VENTRICLE WERE THOROUGHLY REMOVED. ACCORDING TO THE OPERATIONAL REPORT, THERE

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20479432 ↗
• DeathOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE THROUGH DEVICE TRACKING INFORMATION THAT A PATIENT IMPLANTED ON (B)(6) 2022 WITH A PERCEVAL SUTURELESS AORTIC PROSTHESIS PVS25 PASSED AWAY ON THE SAME DAY AS THE PROCEDURE. BASED ON THE INFORMATION RETRIEVED FROM THE OPERATIONAL REPORT, PRE-PROCEDURE DIAGNOSIS WAS AORTIC VALVE ENDOCARDITIS AND RETAINED AICD HARDWARE. THE SURGERY WAS PERFORMED THROUGH MEDIAN STERNOTOMY. AFTER OPENING THE AORTA, THE POSTERIOR LEAFLET OF THE NATIVE AORTIC VALVE WAD FOUND TOTALLY ENGULFED WITH VEGETATION. THIS WAS CAREFULLY DEBRIDED AND ALL LEAFLETS WERE EXCISED. 99% ALCOHOL WAS THEN ADMINISTERED TOPICALLY TO THE AORTIC ANNULUS TO KILL ANY OTHER MICROSCOPIC DISEASE THAT MIGHT HAD BEEN PRESENT. THE VENTRICLE WAS THEN THOROUGHLY IRRIGATED WITH ANTIBIOTIC CONTAINING NORMAL SALINE SOLUTION. THE VALVE WAS SIZED AND THE PERCEVAL SIZE L PROSTHESIS WAS IMPLANTED. IT WAS NOTED THAT THERE WAS ALMOST AN ABSCESS IN THE AORTIC VALVE ANNULUS WHICH HAD TO BE CLOSED. SUBSEQUENTLY, THE 2 LEADS PART OF AICD HARDWARE WERE LOCATED AND REMOVED IN THEIR SCAR SLEEVE. THE CORKSCREW IN THE ATRIUM AND THE CORKSCREW IN THE VENTRICLE WERE THOROUGHLY REMOVED. ACCORDING TO THE OPERATIONAL REPORT, THERE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20479383 ↗
• MalfunctionOct 15, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A PERCIVAL S SIZE L SUTURELESS AORTIC BIOPROSTHESIS OCCURRED ON (B)(6) 2024. REPORTEDLY, THE VALVE HAD BEEN IMPLANTED ON (B)(6) 2019 DURING AN ISOLATED AVR SURGERY PERFORMED THROUGH RAT SURGICAL APPROACH. NO DIFFICULTIES IN VALVE SIZING OR POSITIONING WERE REPORTED. BALLOONING WAS PERFORMED ACCORDING TO IFU. AS REPORTED, PATIENT¿S NATIVE VALVE WAS STENOTIC AND FUNCTIONALLY BICUSPID, WITH A RAPHE BETWEEN THE RCC AND THE LCC. ACCORDING TO THE INFORMATION RECEIVED, DUE TO SYMPTOMS OF PROGRESSIVE FATIGUE THE PATIENT UNDERWENT THE FIRST ECHO EXAMINATION IN 2024 AND SEVERE AORTIC REGURGITATION COMBINED WITH LV DILATATION WAS DETECTED. AS SUCH THE PERCEVAL VALVE WAS EXPLANTED AND REPLACED WITH A SUTURED BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (MEDTRONIC AVALUS 23 MM). AS REPORTED, THE PATIENT REMAINED STABLE THROUGHOUT THE REDO SURGERY, WHICH WAS COMPLETED WITH A SUCCESSFUL OUTCOME. REPORTEDLY, AT THE VISUAL INSPECTION PERFORMED ON THE EXPLANTED PROSTHESIS, PART OF THE RCC LEAFLET APPEARED TORN; BASED ON MEDICAL JUDGMENT RECEIVED, THE VALVE DIDN¿T SHOW SIGNS OF DEGENERATIVE MALFORMATIONS OR ENDOCARDITIS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20452431 ↗
• InjuryJul 12, 2024Calcified; Material Too Rigid or Stiff; Calcified; Material Too Rigid or Stiff

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A PERCEVAL S SUTURELESS AORTIC PROSTHESIS SIZE LARGE. REPORTEDLY, THE VALVE HAD BEEN IMPLANTED ON (B)(6) 2021 THROUGH RIGHT UPPER HEMISTERNOTOMY AND WAS EXPLANTED AND REPLACED WITH A MECHANICAL PROSTHESIS FROM A DIFFERENT MANUFACTURER (SJM REGENT #21) ON (B)(6) 2024. NO CONCOMITANT SURGERIES WERE PERFORMED AT THE TIME OF THE INITIAL AVR PROCEDURE. REPORTEDLY, THE RE-DO SURGERY WAS PERFORMED WITH TECHNICAL SUCCESS AND NO INTRA OR POST-PROCEDURAL COMPLICATIONS WERE REPORTED. AS PER MEDICAL JUDGMENT RECEIVED, WHILE NO PANNUS GROWTH WAS OBSERVED, THE EXPLANTED PERCEVAL PROSTHESIS SHOWED AN ABNORMAL COMPLETE HARDENING OF TWO OF THE LEAFLETS, LEADING TO FIXED LEAFLETS, AND A PARTIAL HARDENING OF THE THIRD ONE. AS REPORTED, NO STRUCTURAL DAMAGE WAS OBSERVED ON THE PROSTHESIS. AS PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD A HISTORY OF TYPE 2 DIABETES MELLITUS, TABLET CONTROLLED, HYPERCHOLESTEROLAEMIA, ISCHEMIC HEART DISEASE (SEVERE DISTAL LAD DISEASE), FIBROMYALGIA, OESOPHAGITIS, ANXIETY/DEPRESSION AND HAD HEART FAILURE SYMPTOMS, BREATHLESS ON MINIMAL EXERTION, PRIOR TO THE RE-DO SURGERY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19727820 ↗
• InjuryJul 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PERCEVAL VALVE PVS25 WAS IMPLANTED ON (B)(6) 2024 AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. REPORTEDLY, PATIENT WAS NOT STABLE, BUT A PACEMAKER WAS NOT NEEDED RIGHT AFTER THE OPERATION. THE PATIENT'S CONDITION GOT WORSE OVER THE WEEKEND AND A PACEMAKER WAS ULTIMATELY IMPLANTED ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19707094 ↗
• InjuryJun 13, 2024Positioning Failure; Migration; Positioning Failure; Migration

  THE MANUFACTURER WAS INFORMED OF A PERCEVAL PVS SIZE L VALVE EXPLANT OCCURRED ON (B)(6) 2024 DUE TO SEVERE AORTIC INSUFFICIENCY. THE PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2024. AS PER MEDICAL JUDGEMENT RECEIVED, THERE WAS NO ANOMALY OR MALFUNCTION OF THE PERCEVAL PROSTHESIS NOTED OR SUSPECTED AND THE INSUFFICIENCY OCCURRED BECAUSE THE VALVE SLIPPED INTO THE LEFT VENTRICLE DUE TO EXCESSIVE DECALCIFICATION PERFORMED ON THE PATIENT'S AORTIC ANNULUS AT THE TIME OF IMPLANT. REPORTEDLY, THE NATIVE ANNULUS WAS VERY CALCIFIC, AND AN EXTREME DECALCIFICATION NEEDED TO BE PERFORMED WHICH LED TO A DAMAGE OF THE ANNULUS. THIS PREVENTED AN ADEQUATE ANCHORING OF THE PERCEVAL PROSTHESIS DESPITE THE CORRECT SIZING PERFORMED. THE REOPERATION WAS CONDUCTED WITH NO COMPLICATIONS TO THE PATIENT AND THE PERCEVAL VALVE WAS ULTIMATELY REPLACED WITH A SUTURED BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES MAGNA EASE SIZE 25). THE PATIENT UNDERWENT STANDARD MEDICATION AND TREATMENT AFTER REINTERVENTION. THE HEALTHCARE FACILITY DID NOT DEEM IT NECESSARY TO PERFORM ANY SPECIFIC ANALYSIS ON THE EXPLANTED PERCEVAL PROSTHESIS, AND THE MANUFACTURER WAS INFORMED THAT THE DEVICE WILL NOT BE RET

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19534051 ↗
• InjuryJun 4, 2024Perivalvular Leak; Perivalvular Leak

  THE PERCEVAL VALVE PVS25 WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS GOOD AFTER THE SURGERY BUT ON (B)(6) 2024, LEFT HEART FAILURE AND PULMONARY EDEMA WAS NOTED. PVL WAS ALSO FOUND BY ECHO. AS SUCH, THE VALVE WAS EXPLANTED. BASED ON THE FURTHER INFORMATION RECEIVED, AFTER PERCEVAL WAS IMPLANTED, THROMBOCYTOPENIA WAS NOTED (2.5 L) AND PLATELET TRANSFUSION WAS DONE REPEATEDLY. AT THE REOPERATION, THROMBUS IN THE LEFT VENTRICLE AND DAMAGE TO THE AORTIC WALL WERE FOUND. THE CAUSE OF THE THROMBUS IS UNKNOWN, AND THE DAMAGE TO THE AORTIC WALL COULD HAVE BEEN CAUSED BY A PERCEVAL VALVE STENT, BUT IT COULD ALSO HAVE BEEN CAUSED BY DAMAGE DURING REMOVAL OF PERCEVAL. REOPERATION WAS COMPLETED BY IMPLANTING INSPRIS VALVE, ALTHOUGH BLEEDING CONTROL WAS DIFFICULT. REPORTEDLY, PATIENT PASSED AWAY EVENTUALLY AT AN UNKNOWN DATE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure; Pulmonary Edema; Thrombocytopenia; Valvular Insufficiency/ Regurgitation

  MAUDE report 19464109 ↗
• InjuryApr 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  MANUFACTURER WAS INFORMED THAT ON (B)(6) 2024 A PERCEVAL VALVE PVS25 WAS IMPLANTED IN A PATIENT. REPORTEDLY, AV BLOCK WAS NOTED WHEN THE PATIENT LEFT THE OPERATING ROOM BUT WAS STOPPED AT ICU ON (B)(6) 2024. HOWEVER, ON (B)(6) 2024, AV BLOCK WAS NOTED AGAIN, AND TEMPORAL PACING WAS STARTED. ON (B)(6) 2024, AV BLOCK WAS NOTED AGAIN. AS SUCH, PACEMAKER WAS IMPLANTED. BASED ON THE FURTHER INFORMATION RECEIVED, OUTCOME WAS GOOD, AND NO DEVICE MALFUNCTION WAS NOTED. REPORTEDLY, LOW POSITIONING OF THE VALVE AT N/R COMMISSURE DURING IMPLANT IS POSSIBLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Heart Block

  MAUDE report 19076060 ↗
• InjuryJan 15, 2024Material Too Rigid or Stiff; Insufficient Device Problem Information; Material Too Rigid or Stiff; Insufficient Device Problem Information

  ON (B)(6) 2023, A PERCIVAL VALVE PVS25 WAS IMPLANTED IN A PATIENT. BLOOD PLATELET HAS DECREASED RIGHT AFTER THE SURGERY AND THE PATIENT REQUIRED ALL TYPES OF TRANSFUSION. HOWEVER, THE THINGS DID NOT GO WELL. REPORTEDLY, BLOOD PLATELET WAS MORE THAN 100,000 /L BEFORE THE SURGERY, WHICH IS UNDER 10,000/L NOW. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT HAD NO SYMPTOMS BEFORE HOSPITALIZATION. DURING HOSPITALIZATION, PAIGG ANTIBODIES WERE ELEVATED, AND PATIENT WAS DIAGNOSED WITH ITP THROMBOCYTOPENIA (WHICH IS COMPLICATED BY MYASTHENIA GRAVIS). AS SUCH, TREATMENT WAS STARTED. HAPTOGLOBIN WAS MEASURED FOR SUSPECTED HEMOLYSIS, AND THE VALUE DROPPED, LEADING TO SUSPICION OF HEMOLYSIS DUE TO ARTIFICIAL VALVE, BUT THERE WERE NO PROBLEMS WITH PVL OR PRESSURE GRADIENT (NO ABNORMALITIES IN PERCIVAL FUNCTION). CARDIOPULMONARY BYPASS AND CROSS-CLAMP TIME WAS REPORTED AS 111MIN AND 83 MIN RESPECTIVELY. REPORTEDLY, PATIENT HAS A HISTORY OF MYASTHENIA GRAVIS, COPD ASTHMA, DIABETES, COMPLETE ATRIOVENTRICULAR BLOCK WHICH REQUIRED DDD PACEMAKER IMPLANTED PRIOR TO PERCIVAL OPERATION. PATIENT'S MEDICATIONS HAVE BEEN REPORTED AS: MYASTHENIA GRAVIS MEDICINE, ANTIHYPERTENSIVE MEDICINE, COPD ANTIPHLOG

  Patient problems: Thrombocytopenia

  MAUDE report 18514982 ↗
• InjuryOct 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT: A PERCEVAL VALVE SIZE 25 WAS IMPLANTED IN A PATIENT ON (B)(6) 2023. ON THE NEXT DAY AFTER THE SURGERY, THE THROMBOCYTE LEVEL GOT DOWN TO 60000 AND DECREASED TO 19000 TWO DAYS AFTER SURGERY. BLOOD TRANSFUSION WAS STARTED, AND THE LEVEL WAS INCREASED UP TO 30000 AND REMAINED THE SAME AFTER THAT. REPORTEDLY, THE PATIENT HAS NOT BEEN RECOVERED YET. BASED ON THE ADDITIONAL INFORMATION RECEIVED, PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS UNDER FOLLOW-UP. AS REPORTED, PLATELETS TRANSFUSION WAS PERFORMED 2 TIMES.

  Patient problems: Thrombocytopenia

  MAUDE report 17978699 ↗
• InjuryJul 21, 2023Calcified; Degraded; Calcified; Degraded

  THE MANUFACTURER WAS NOTIFIED THAT A PERCEVAL S SUTURELESS AORTIC BIOPROSTHESIS PVS25 WAS IMPLANTED ON (B)(6) 2018 WAS EXPLANTED ON (B)(6) 2023 DUE TO EARLY DEGENERATION. AS REPORTED, THE DEVICE WAS REPLACED BY A SURGICAL SUTURED BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (MAGNA EASE SIZE 25).

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 17369171 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, AFTER A PERCEVAL VALVE SIZE M WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY IN THE PATIENT WHOSE NATIVE VALVE WAS BICUSPID TYPE 1 DUE TO PVL NOTED AND LOW BLOOD PRESSURE (REF. (B)(4)), PERCEVAL VALVE SIZE L (THIS CASE) WAS IMPLANTED IN THE PATIENT. HOWEVER, IT WAS REPORTED THAT THE VALVE WAS SLIGHTLY POPPED UP SINCE THE NON-CORONARY PART WAS PROTRUDED. AS SUCH, THIS VALVE WAS ALSO EXPLANTED AND EPIC (UNKNOWN SIZE) WAS ULTIMATELY IMPLANTED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17295103 ↗
• InjuryMay 26, 2023Calcified; Calcified

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE SIZE 25MM WHICH WAS IMPLANTED IN THE PATIENT ON (B)(6) 2019, WAS EXPLANTED ON (B)(6) 2023 DUE TO SVD. REPORTEDLY, THE VALVE HAD INTER-COMMISSURAL CALCIFICATION AND REDUCE LEAFLETS MOTION. REPORTEDLY, HEMODYNAMICS POST-IMPLANT WERE AS FOLLOWS: MEAN GRADIENT: 12MMHG, MAX GRADIENT 22.4MMHG. FURTHERMORE, PATIENT HAS DIABETES TYPE II, DYSLIPIDEMIA, CONSERVED EJECTION FRACTION, AND MODERATE HYPERTROPHY LEFT VENTRICLE. PATIENT IS TAKING ADIRO 100, VOKANAMET JANUVIA AND CRESTOR 10MG. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2023 DUE TO CENTRAL THORACIC AND EPIGASTRIC PAIN, ALONG WITH DYSPNEA. ETE WAS PERFORM ON (B)(6) 2023 WHERE THE PERCEVAL L WAS EVIDENCED IN THE AORTIC POSITION. SIGNIFICANT PROSTHETIC DYSFUNCTION WITH GMAX 95MMHG, MEDIUM GRADIENT 60MMHG. ITV RATIO OF 0.18 AND MILD-MODERATE AORTIC REGURGITATION WAS NOTED. AS SUCH, AORTIC VALVE REPLACEMENT WAS REQUIRED.

  Patient problems: Abdominal Pain; Aortic Valve Insufficiency/ Regurgitation; Dyspnea; Insufficient Information

  MAUDE report 17014975 ↗
• InjuryApr 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO HAD A PERCEVAL SUTURELESS AORTIC HEART VALVE, PVS25/SIZE L IMPLANTED ON (B)(6) 2018 WENT UNDER TAVI SURGERY ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16670585 ↗
• InjuryMar 18, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED THAT ON 01 FEB 2023, A PATIENT RECEIVED A PERCEVAL VALVE SIZE L. ABOUT A WEEK AFTER OPERATION, COMPLETE ATRIOVENTRICULAR BLOCK WAS NOTED, AND PACEMAKER WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON FURTHER INFORMATION, OUTCOME WAS GOOD. THE DOCTOR COMMENTED THAT PATIENT WAS CHD AND HAD PCI IN THE PAST WHICH MIGHT HAVE AFFECTED THE EVENT, BUT IT IS UNKNOWN.

  Patient problems: Heart Block

  MAUDE report 16569511 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2022, A PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 WAS IMPLANTED. REPORTEDLY, THE PLATELET COUNT WAS15,000 AS OF (B)(6) 2022, WHICH REQUIRED A BLOOD TRANSFUSION. AS REPORTED, PATIENT IS RECOVERING. NO FURTHER INFORMATION IS PROVIDED AT THIS TIME.

  Patient problems: Thrombocytopenia

  MAUDE report 15992824 ↗
• InjuryDec 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. THE PATIENT WENT UNDER AORTIC VALVE REPLACEMENT ON (B)(6) 2022 DUE TO DEGENERATION AND PERCEVAL SUTURELESS AORTIC HEART VALVE PVS25 WAS IMPLANTED IN THE PATIENT THROUGH MEDIAN STERNOTOMY. THE CONCOMITANT PROCEDURE WAS CABG. REPORTEDLY, PATIENT HAD MODERATE STROKE WITH HEMISINDROM AND EPILEPSY ON (B)(6) 2022. BASED ON THE INFORMATION RECEIVED, ACTION TAKEN WAS ADDING MEDICATIONS AS WELL AS PERFORMING DIAGNOSTIC EXAMINATIONS AND/OR TESTS. PATIENT WAS NYHA CLASS III.

  Patient problems: Stroke/CVA

  MAUDE report 15992447 ↗
• InjurySep 29, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2022, A PERCEVAL SUTURELESS AORTIC HEART VALVE, PVS25 WAS ATTEMPTED TO BE IMPLANTED. THE VALVE WOULD NOT CLOSE AND THERE WAS A MAJOR AORTIC INSUFFICIENCY, AS REPORTED. BLOOD WAS GOING BACK INTO HEART AFTER CLAMP WAS REMOVED. ONCE THE CROSS CLAMP WAS REMOVED AND THEY WENT BACK ¿ON PUMP¿ AT 5 L/M THE LT VENTRICLE BEGAN TO FILL WITH BLOOD TO THE POINT THAT IT LOOKED LIKE IT WOULD BURST. IT WAS MENTIONED THAT THE VALVE SEEMED TO BE IN GOOD POSITION FROM THE TEE AND UPON VISUAL INSPECTION, BUT IT APPEARED TO BE TOTALLY INCOMPETENT ONCE THE CROSS CLAMP WAS REMOVED. THE AORTOTOMY WAS OPENED TO RECHECK THE PERCEVAL VALVE IT LOOKED TO BE IN GOOD POSITION AND ALIGNMENT. THE LEAFLETS DID NOT COAPT, BUT IT WAS POSSIBLE TO PULL THEM TOGETHER. THUS, T WAS BELIEVED AT THAT TIME THAT ONCE THE SYSTEM IS UNDER PRESSURE THAT THEY WOULD COAPT APPROPRIATELY. SO, THE AORTOTOMY WAS CLOSED TO TRY ONE MORE TIME. THIS BROUGHT THE SAME RESULT OF THE VENTRICLE FILLING WITH BLOOD AND THE VALVE APPEARING TO BE TOTALLY INCOMPETENT. AS SUCH, THE VALVE WAS EXPLANTED AND A MEDTRONIC MOSAIC 23MM VALVE WAS IMPLANTED INSTEAD. REPORTEDLY, THE NATIVE VALVE WAS BICUSPID WITH S

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15505212 ↗
• InjurySep 29, 2022Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2022, A PERCEVAL SUTURELESS AORTIC HEART VALVE, PVS25 WAS ATTEMPTED TO BE IMPLANTED. THE VALVE WOULD NOT CLOSE AND THERE WAS A MAJOR AORTIC INSUFFICIENCY, AS REPORTED. BLOOD WAS GOING BACK INTO HEART AFTER CLAMP WAS REMOVED. ONCE THE CROSS CLAMP WAS REMOVED AND THEY WENT BACK ¿ON PUMP¿ AT 5 L/M THE LT VENTRICLE BEGAN TO FILL WITH BLOOD TO THE POINT THAT IT LOOKED LIKE IT WOULD BURST. IT WAS MENTIONED THAT THE VALVE SEEMED TO BE IN GOOD POSITION FROM THE TEE AND UPON VISUAL INSPECTION, BUT IT APPEARED TO BE TOTALLY INCOMPETENT ONCE THE CROSS CLAMP WAS REMOVED. THE AORTOTOMY WAS OPENED TO RECHECK THE PERCEVAL VALVE IT LOOKED TO BE IN GOOD POSITION AND ALIGNMENT. THE LEAFLETS DID NOT COAPT, BUT IT WAS POSSIBLE TO PULL THEM TOGETHER. THUS, T WAS BELIEVED AT THAT TIME THAT ONCE THE SYSTEM IS UNDER PRESSURE THAT THEY WOULD COAPT APPROPRIATELY. SO, THE AORTOTOMY WAS CLOSED TO TRY ONE MORE TIME. THIS BROUGHT THE SAME RESULT OF THE VENTRICLE FILLING WITH BLOOD AND THE VALVE APPEARING TO BE TOTALLY INCOMPETENT. AS SUCH, THE VALVE WAS EXPLANTED AND A MEDTRONIC MOSAIC 23MM VALVE WAS IMPLANTED INSTEAD. REPORTEDLY, THE NATIVE VALVE WAS BICUSPID WITH S

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15504928 ↗
• DeathAug 17, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT THE PATIENT WHO HAD PERCEVAL SUTURELESS AORTIC HEART VALVE SIZE L IMPLANTED ON (B)(6) 2022, HAS PASSED AWAY DUE TO SEPTIC SHOCK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Septic Shock

  MAUDE report 15245945 ↗