PERCEVAL PLUS PVF-M (UDI 00896208000801)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00896208000801), received between Nov 16, 2020 and Jul 30, 2026 — classified as 1 death, 41 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Leak/Splash

  The manufacturer was notified of an intraoperative explant involving a Perceval Plus valve. Based on the information received, on (b)(6) 2026, the patient underwent AVR + CABG. During sizing, the medium (M) white sizer passed through the annulus with slight resistance, while the large (L) white sizer could not pass through the annulus. Therefore, a Perceval Plus size M valve was selected. Patient¿s annulus size was 25mm. After aortic cross-clamp removal, intraoperative TEE revealed severe paravalvular leakage (PVL) near the left-noncoronary (LN) commissure. Consequently, the Perceval Plus M valve was explanted and was replaced with a 19-mm Magna valve. The operation was then completed successfully. Approximately, 40 minutes was added to the procedure as a result of this complication. The patient remained stable throughout the delay in procedure.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50085939 ↗
• InjuryJan 21, 2026Perivalvular Leak

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS AORTIC HEART VALVE IN SIZE M. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. THE PROSTHESIS WAS IMPLANTED THOUGH A MEDIAN STERNOTOMY IN A TYPE 0 BICUSPID AORTIC VALVE WITH A CIRCULAR ANATOMY, WHITHOUT CONCOMITANT PROCEDURES. NO COLLAPSING, RELEASING, MALPOSITIONING NOR SIZING ISSUES WERE REPORTED. AFTER AORTIC CROSS-CLAMPING, A PARAVALVULAR LEAK (NEAR THE RCC) WAS DETECTED. FOLLOWING RE-OCCLUSION, STENT INFOLDING WAS CONFIRMED. THE PERCEVAL VALVE WAS THEN EXPLANTED, THE ANNULUS WAS FURTHER DECALCIFIED, AND THE SAME PERCEVAL VALVE WAS RE-IMPLANTED AND HIGH-PRESSURE BALLOONING (4.5 ATM) WAS PERFORMED, BEFORE CLOSING THE AORTA. HOWEVER, ANOTHER PARAVALVULAR LEAK OCCURRED AFTER AORTIC OCCLUSION IN THE SAME RCC REGION. AFTER A SECOND RE-OCCLUSION, THE VALVE WAS EXPLANTED AGAIN AND REPLACED WITH AN ABBOT EPIC ULTRA 21MM. GIVEN THE BICUSPID ANATOMY OF THE PATIENT¿S NATIVE AORTIC VALVE, THE SURGEON NOTED THAT THE POSSIBILITY OF THE INFOLDING CAUSED BY A FIBROUS RAPHE COULD NOT BE RULED OUT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24127839 ↗
• InjuryNov 3, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED WITH MICS PROCEDURE. AFTER DE-CLAMPED, PVL (MILD) WAS NOTED, AND THE VALVE POSITION WAS SLIGHTLY ADJUSTED. HOWEVER, SINCE MODERATE PVL WAS NOTED AGAIN AFTER DE-CLAMPED, THE VALVE WAS EXPLANTED. THE ANNULUS WAS RE-SIZED, BUT SIZE L COULD NOT GO THROUGH. AS SUCH, THE SAME VALVE WAS RE-IMPLANTED. MILD PVL WAS NOTED AFTER DE-CLAMPED, AND THE SURGERY WAS COMPLETED. THE CONDITION WAS BETTER IN THE NEXT MORNING THOUGH PVL WAS STILL NOTED. AS FURTHER REPORTED, NO POSITIONING DIFFICULTY WAS NOTED, AND BALLOONING WAS PERFORMED ACCORDING TO THE IFU. MORE THAN 60 MINUTES WAS ADDED TO THE CROSS-CLAMP TIME AND BYPASS TIME. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE AND PATIENT¿S OUTCOME WAS GOOD. BASED ON THE MEDICAL JUDGMENT, THE SIZE SELECTION SHOULD HAVE BEEN CORRECT (M WHITE PASSED WITH SLIGHT RESISTANCE, L WHITE FAILED TO PASS), AND THE PLACEMENT POSITION SHOULD ALSO BE FINE. REPORTEDLY, THE ANNULAR SHAPE WAS DISTORTED WITH A SIGNIFICANT DIFFERENCE BETWEEN THE MAJOR AND MINOR DIAMETERS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23446055 ↗
• InjuryJul 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2025, A PATIENT RECEIVED PERCEVAL PLUS VALVE PVF-M IN AORTIC POSITION. A PACEMAKER WAS IMPLANTED DUE TO COMPLETE AV BLOCK AT UNKNOWN DATE POST OP. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Heart Block

  MAUDE report 22473283 ↗
• InjuryJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING. THE PATIENT REGISTRATION FORM INDICATED "DEVICE EXPLANTED" FOR A PERCEVAL PLUS VALVE, PVF-M WHICH ATTEMPTED TO BE IMPLANTED ON (B)(6) 2025. NO ALLEGATION OF ANY DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22198167 ↗
• InjuryJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING. THE PATIENT REGISTRATION FORM INDICATED "DEVICE EXPLANTED" FOR A PERCEVAL PLUS VALVE, PVF-M WHICH ATTEMPTED TO BE IMPLANTED ON (B)(6) 2025. NO ALLEGATION OF ANY DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22197741 ↗
• MalfunctionJun 12, 2025Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF AN EVENT RELATED TO A PERCEVAL PLUS SUTURELESS HEART VALVE PVF-M WHICH WAS IMPLANTED ON (B)(6) 2025. REPORTEDLY, THE IMPLANTATION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS, AND NO PARAVALVULAR LEAK (PVL) WAS DETECTED AT THE TIME. HOWEVER, THE ECHOCARDIOGRAM PERFORMED DURING IMPLANTATION RAISED CONCERNS ABOUT THE NON-CORONARY CUSP (NCC), WHICH APPEARED TO EXHIBIT RESTRICTED OR ABSENT MOTION. A POSTOPERATIVE CT SCAN CONDUCTED ON (B)(6) CONFIRMED THAT THE NCC WAS INDEED NOT MOVING, ALTHOUGH NO PVL WAS DETECTED. NO ECHOCARDIOGRAPHIC EVALUATION WAS PERFORMED AT THE TIME OF THE CT SCAN. NO EXPLANT SURGERY HAS BEEN SCHEDULED AT THIS TIME. REPORTEDLY, NO POSITIONING DIFFICULTIES, MIS-SIZING, OR ABNORMAL PATIENT'S ANNULUS WAS NOTED DURING THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22195033 ↗
• InjuryJun 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2025, PERCEVAL PLUS VALVE SIZE M WAS IMPLANTED IN THE PATIENT. REPORTEDLY, THE VALVE WAS VISUALLY INSPECTED TO EXCLUDE ANOMALOUS LEAFLET SHAPE OR STENT IN-FOLDING, AND THEN AORTA WAS CLOSED. UPON AORTIC UNCLAMPING, BLEEDING WAS OBSERVED NEAR THE ANNULUS, BUT NO PARAVALVULAR LEAK (PVL) WAS PRESENT. THE AORTA WAS RE-CLAMPED, AND A VISUAL INSPECTION REVEALED THAT THE BLEEDING ORIGINATED FROM THE LOWER PART OF THE ANNULUS ON THE RIGHT CORONARY CUSP (RCC) SIDE. AS THIS AREA HAD NOT BEEN MANIPULATED DURING DECALCIFICATION PRIOR TO VALVE IMPLANTATION, IT WAS SUSPECTED THAT INTERFERENCE FROM THE PERCEVAL INFLOW RING MAY HAVE CONTRIBUTED TO THE BLEEDING. CONSEQUENTLY, THE PERCEVAL VALVE WAS EXPLANTED AND REPLACED WITH A CONVENTIONAL VALVE. REPORTEDLY, THE SURGICAL PROCEDURE WAS EXTENDED BY APPROXIMATELY ONE HOUR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22146519 ↗
• InjuryMay 9, 2025Collapse; Inadequacy of Device Shape and/or Size; Collapse; Inadequacy of Device Shape and/or Size

  MANUFACTURER WAS INFORMED THAT ON (B)(6) 2025, THE WHITE HEAD OF THE PERCEVAL SIZER S PASSED THROUGH WITH SOME SPACE AND THE WHITE HEAD OF THE PERCEVAL SIZER M DID NOT PASS AT STJ. THEN THE TRANSLUCENT HEAD OF THE PERCEVAL SIZER M WAS PLACED AT VALVE RING PART AND SINCE THERE WAS SOME SPACE, IT WAS DECIDED TO USE PERCEVAL PLUS VALVE SIZE M. AFTER DE-CLAMPED, PVL WAS NOTED. REPORTEDLY, STENT IN-FOLDING WAS NOTED AFTER RE-CLAMPED AROUND RIGHT CORONARY CUSP. AS SUCH, THE VALVE WAS EXPLANTED AND PERCEVAL PLUS VALVE SIZE S WAS USED AS A REPLACEMENT. THE SURGERY WAS EXTENDED ABOUT 1 HOUR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21997266 ↗
• InjuryMar 5, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE PVF-M WAS IMPLANTED. AFTER DE-CLAMPED, PVL WAS NOTED, AND THE VALVE WAS EXPLANTED. INSPIRIS 23MM WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21521904 ↗
• InjuryMar 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING. THE PATIENT REGISTRATION FORM REPORTED A FAILURE TO IMPLANT OF THE PERCEVAL PLUS PVF-M IN A PATIENT ON (B)(6) 2025. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21499550 ↗
• InjuryFeb 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING. THE PATIENT REGISTRATION FORM REPORTED A FAILURE TO IMPLANT OF THE PERCEVAL PLUS PVF-M IN A PATIENT ON (B)(6) 2025. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21499483 ↗
• InjuryFeb 7, 2025Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A PERCEVAL PLUS VALVE, PVF-M WAS USED FOR A DOUBLE VALVE (MITRAL AND AORTIC) PROCEDURE ON (B)(6) 2025. THE AORTA WAS REPORTED AS PORCELAIN AND HEAVILY CALCIFIED. PERCEVAL WAS USED TO HELP GET THE PATIENT OUT OF THE OR AS PATIENT WAS NOT TOLERATING THE SURGERY WELL. A MEDIUM PERCEVAL WAS IMPLANTED, AND IT WAS FOUND THAT THERE WAS A PARAVALVULAR LEAK FOLLOWING THE IMPLANT. FOLLOWING SURGERY, A BALLOON WAS USED TO OPEN THE VALVE IN THE CATH LAB, WHICH HELPED A LITTLE BUT WAS NOT ENOUGH TO STOP THE LEAK. AS SUCH, PATIENT WAS BROUGHT BACK FOR A SURGERY AND THE PERCEVAL VALVE WAS EXPLANTED AND COMPLETE AORTIC ROOT REPLACEMENT WAS PERFORMED. IT IS REPORTED THAT THE PATIENT IS STILL RECOVERING FROM THIS PROCEDURE AT THIS TIME. BASED ON THE MEDICAL JUDGMENT RECEIVED, THE ISSUE MOST LIKELY OCCURRED DUE TO THE AMOUNT OF CALCIUM AND NO ISSUE WITH THE PERCEVAL VALVE WAS REPORTED. BASED ON THE FURTHER INFORMATION RECEIVED, THE SURGERY WAS FULL STERNOTOMY, AND THE PERCEVAL IMPLANT OCCURRED AFTER MITRAL VALVE REPLACEMENT AND BALLOONING WAS PERFORMED. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21339508 ↗
• InjuryNov 15, 2024Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2024, A PERCEVAL PLUS VALVE SIZE M WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, IT WAS NOTICED THAT THE LEAFLET WAS NOT MOVING AND HAD AI. AS SUCH, THEY WENT BACK ON BYPASS AND ENDED UP REMOVING THE PERCEVAL VALVE TO SEW IN AN INSPIRUS SIZE 23MM. REPORTEDLY, 30 MINUTES WAS ADDED TO THE CROSS-CLAMP TIME AND BYPASS TIME AS A RESULT OF THE EVENT. PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE AND IS RECOVERING FINE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20700721 ↗
• MalfunctionSep 19, 2024Leak/Splash; Perivalvular Leak; Leak/Splash; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN ATTEMPT TO IMPLANT A PERCEVAL PLUS SIZE M SUTURELESS AORTIC BIOPROSTHESIS. REPORTEDLY, A PARAVALVULAR LEAK WAS OBSERVED AFTER VALVE DEPLOYMENT AND FOR THIS REASON THE PROSTHESIS WAS REMOVED AND REPLACED WITH A BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES MAGNA EASE 21 MM). REPORTEDLY, THE PATIENT WAS NOT AFFECTED IN CONSEQUENCE OF THE EVENT, WHICH CAUSED A DELAY IN SURGICAL TIME OF APPROXIMATELY 1 HOUR. ACCORDING TO THE PRELIMINARY MEDICAL JUDGEMENT RECEIVED, IT IS SUSPECTED THAT ONE OF THE VALVE LEAFLETS WAS LOWER THAN THE OTHERS. IN ADDITION, IT WAS REPORTED THAT MORE TIME SHOULD HAVE BEEN DEDICATED TO THE SIZING OF THE PROSTHESIS. NO FURTHER DETAILS ARE AVAILABLE TO THE MANUFACTURER TO DATE. THE MANUFACTURER IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO OBTAIN ADDITIONAL INFORMATION ON THE EVENT AND THE DEVICE INVOLVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20260632 ↗
• InjuryAug 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT REGISTRATION FORM, A PERCEVAL PLUS VALVE PVF-M WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2024 DUE TO MIS-SIZING. BASED ON THE FURTHER INFORMATION RECEIVED, A PERCEVAL PLUS VALVE PVF-S WAS ULTIMATELY IMPLANTED IN THE PATIENT. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19932924 ↗
• InjuryJul 9, 2024Positioning Failure; Positioning Failure

  BASED ON THE INFORMATION RECEIVED, THE PATIENT WAS BOOKED FOR SURGERY TO HAVE AN AORTIC VALVE REPLACEMENT AND MULTIPLE BYPASS GRAFTS (2 VIA SAPHENOUS VEIN AND ONE FROM THE LIMA). THE BYPASSES WERE PERFORMED FIRST. REPORTEDLY, THEY WERE VERY CHALLENGING. THEN, THE DISEASED VALVE WAS DEBRIDED AND REMOVED IN THE USUAL FASHION AND SIZING WAS PERFORMED. IT WAS DETERMINED A MEDIUM PERCEVAL WAS THE CORRECT SIZE. THERE WAS A LOT OF FLOODING OF THE HEART FROM BLOOD NOT CAPTURED BY THE LV VENT, WHICH ADDED TO THE DIFFICULTY IN REPLACING THE AORTIC VALVE. THE GUIDING SUTURES WERE PLACED, AND THE VALVE WAS DEPLOYED. UNDER INSPECTION, THEY FELT THAT THEY COULDN'T CONFIRM THAT THE VALVE WAS PROPERLY SEATED ALL THE WAY DOWN ON THE SIDE OF THE LEFT CORONARY AND FELT IT IS BEST TO REMOVE THE VALVE AND TRY FOR A SECOND DEPLOYMENT. AFTER THE SECOND ATTEMPT, IT WAS DETERMINED THAT THE VALVE WAS NOT PROPERLY SEATED ON THE NON-CORONARY SIDE. IT WAS SITTING TOO HIGH. THE PERCEVAL WAS REMOVED, AND AN EDWARDS STENTED DEVICE WAS IMPLANTED INSTEAD. THE CASE CONTINUED WITH THE PATIENT COMING OFF BYPASS "EASILY" WITHOUT ISSUE, HOWEVER, PATIENT WAS PACEMAKER DEPENDENT AT THE TIME (THE PATIENT HAD A PRE-EXISTING

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Rupture

  MAUDE report 19706954 ↗
• MalfunctionApr 17, 2024Perivalvular Leak; Device Handling Problem; Perivalvular Leak; Device Handling Problem

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SUTURELESS AORTIC VALVE SIZE M. REPORTEDLY, THE IMPLANTING SURGEON OBSERVED A POSSIBLE PARAVALVULAR LEAK AND REPLACED THE PROSTHESIS WITH ANOTHER VALVE OF THE SAME MODEL AND SIZE. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT WAS NOT AFFECTED BY THE PROLONGATION OF SURGICAL TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19124369 ↗
• InjuryApr 12, 2024Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE M WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON THE INFORMATION RECEIVED, PATIENT HAD AORTIC INSUFFICIENCY THAT STARTED ON (B)(6) 2024 WHICH REQUIRED CHANGE DOSE/SCHEDULE OF MEDICATION AS WELL AS DIAGNOSTIC EXAMINATIONS AND/OR TESTS. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; STABLE ANGINA; MYOCARDIAL INFARCTION (REMOTE (> 90 DAYS)); LEFT VENTRICULAR HYPERTROPHY; ISCHEMIC HEART FAILURE; ARRHYTHMIA (ATRIAL FIBRILLATION); SYSTEMIC HYPERTENSION; DYSLIPIDEMIA; OTHER NEUROLOGICAL DYSFUNCTION; PULMONARY HYPERTENSION; RESOLVED MALIGNANCY; AND COVID-19. FURTHERMORE, PERCUTANEOUS CORONARY INTERVENTION: STENTING; AND AORTIC VALVE REPLACEMENT: BIOLOGICAL 2018 WERE ALSO REPORTED, AND NYHA CLASS WAS IV. BASED ON THE FURTHER COMMUNICATION RECEIVED, PATIENT WAS DISCHARGED AND IS FEELING BETTER. THERE IS NO PLAN FOR THE RE-INTERVENTION AND REGULAR FOLLOW UPS WILL BE PERFORMED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19094346 ↗
• InjuryApr 12, 2024Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE M WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON THE INFORMATION RECEIVED, PATIENT HAD AORTIC INSUFFICIENCY THAT STARTED ON (B)(6) 2024 WHICH REQUIRED CHANGE DOSE/SCHEDULE OF MEDICATION AS WELL AS DIAGNOSTIC EXAMINATIONS AND/OR TESTS. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; STABLE ANGINA; MYOCARDIAL INFARCTION (REMOTE (> 90 DAYS)); LEFT VENTRICULAR HYPERTROPHY; ISCHEMIC HEART FAILURE; ARRHYTHMIA (ATRIAL FIBRILLATION); SYSTEMIC HYPERTENSION; DYSLIPIDEMIA; OTHER NEUROLOGICAL DYSFUNCTION; PULMONARY HYPERTENSION; RESOLVED MALIGNANCY; AND COVID-19. FURTHERMORE, PERCUTANEOUS CORONARY INTERVENTION: STENTING; AND AORTIC VALVE REPLACEMENT: BIOLOGICAL 2018 WERE ALSO REPORTED, AND NYHA CLASS WAS IV. BASED ON THE FURTHER COMMUNICATION RECEIVED, PATIENT WAS DISCHARGED AND IS FEELING BETTER. THERE IS NO PLAN FOR THE RE-INTERVENTION AND REGULAR FOLLOW UPS WILL BE PERFORMED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19094344 ↗
• DeathDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PATIENT UNDERWENT AN AORTIC HEART VALVE REPLACEMENT WITH PERCEVAL PLUS, SIZE M ON (B)(6) 2023. THE SURGICAL APPROACH WAS A MEDIAN STERNOTOMY. A CABG PROCEDURE WAS PERFORMED BEFORE THE VALVE IMPLANT WITH 1 VESSEL INVOLVED. BASED ON THE INFORMATION RECEIVED, PATIENT PASSED AWAY ON (B)(6) 2023 FOR UNKNOWN CAUSE. THE PATIENT HAD MISSED PREVIOUS APPOINTMENTS, INCLUDING ECHOCARDIOGRAPHIC CHECK AND HAD EXPERIENCED A CARDIOGENIC SHOCK ON THE SAME DAY OF SURGERY, ASSESSED BY THE SITE AS NOT RELATED TO THE DEVICE BUT PROBABLY RELATED TO IMPLANT PROCEDURE. THE CARDIOGENIC SHOCK EPISODE HAD BEEN TREATED WITH MEDICATIONS AND WAS RESOLVED ON (B)(6) 2023. AS REPORTED, THE PATIENT WAS IN NYHA CLASS III AND CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE, NON-ISCHEMIC HEART FAILURE, SYSTEMIC HYPERTENSION, DIABETES MELLITUS TYPE II, NON-INSULIN DEPENDENT, DYSLIPIDEMIA, AND LUPUS.

  Patient problems: Insufficient Information

  MAUDE report 18379436 ↗
• InjuryNov 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING INFORMATION THROUGH DEVICE TACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT REGISTRATION FORM, A PERCEVAL PLUS SIZE M WAS NOT IMPLANTED DUE TO WRONG SIZE, AND PERCEVAL PLUS S WAS ULTIMATELY IMPLANTED. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 18188260 ↗
• InjurySep 12, 2023Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED FROM THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT FORM, A PERCEVAL PLUS VALVE SIZE M WAS REPORTED TO BE "USED BUT NOT IMPLANTED" IN A PATIENT ON (B)(6) 2023. BASED ON 5THE FURTHER INFORMATION RECEIVED, PATIENT HAD A CONGENITALLY BICUSPID AORTIC VALVE WITH AN OVAL ANNULUS. IT WAS INITIALLY THOUGHT IT WOULD BE APPROPRIATE FOR THE PERCEVAL BUT THERE WAS A MILD TO MODERATE PARAVALVULAR LEAK AFTER DEPLOYMENT. AS SUCH, THE VALVE WAS EXPLANTED, AND A MAGNA EASE SUTURED VALVE WAS SEWED IN PLACE INSTEAD. REPORTEDLY, PATIENT DID WELL.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 17730675 ↗
• MalfunctionMay 8, 2023Difficult to Fold, Unfold or Collapse; Insufficient Device Problem Information; Difficult to Fold, Unfold or Collapse; Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF THE FOLLOWING INFORMATION THROUGH PATIENT TRACKING. THE PATIENT REGISTRATION FORM INDICATED THAT A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE, PVF-M WAS "NOT IMPLANTED DUE TO DEFICIENT EQUIPMENT" ON 15 MARCH 2023 AND ANOTHER SIMILAR DEVICE PVF-M WAS ULTIMATELY IMPLANTED IN THE PATIENT. BASED ON THE FURTHER INFORMATION RECEIVED, DIFFICULTY WAS ENCOUNTERED DURING LOADING THE DEVICE ON THE HOLDER. AFTER MULTIPLE ATTEMPTS, THE WHOLE SET (INCLUDING THE VALVE) WAS CHANGED, AND THE NEW VALVE WAS COLLAPSED AND LOADED UNEVENTFULLY. AS REPORTED, IT SEEMED THAT THE COLLAPSING DEVICE WAS NOT ABLE TO COLLAPSE THE VALVE ENOUGH. BASED ON FURTHER INFORMATION RECEIVED, THE VALVE WAS LOADED CORRECTLY, ALL CHECKS WERE DONE BUT THE VALVE APPEARED TO BE TOO FAR ADVANCED IN THE HOLDER, AND THEY WERE UNABLE TO PLACE THE SLEEVE OVER THE BLACK CRIMPING SUPPORT. REPORTEDLY, APPROXIMATELY 15 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT OF THIS EVENT. PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF SURGERY, DID WELL AND WAS DISCHARGED FROM THE HOSPITAL UNEVENTFULLY.

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

  MAUDE report 16892269 ↗
• InjuryApr 5, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A PERCEVAL PLUS SIZE M VALVE WAS IMPLANTED IN A PATIENT. SIZING WAS PERFORMED ACCORDING TO IFU, SIZER S WAS TRIED AT FIRST STAGE BUT BOTH SIDES WERE PASSING THROUGH THE ANNULUS SO SIZER M WAS CHECKED AND WAS ASSESSED TO BE ADEQUATE (TRANSPARENT SIDE PASSING THROUGH THE ANNULUS; WHITE SIDE SEATING OVER THE ANNULUS). AFTER CLOSING THE AORTA, TEE WAS PERFORMED AND PARAVALVULAR LEAKAGE (PVL) WAS FOUND. BASED ON THE MEDICAL JUDGEMENT PROVIDED, THE REASON FOR THE PVL SEEMED TO BE THAT THE VALVE DISPLACED FROM THE ORIGINAL POSITION. AS A CONSEQUENCE, PERCEVAL VALVE WAS EXPLANTED AND AN ATTEMPT TO IMPLANT A TAVI TRANSAPICALLY WAS PERFORMED BUT FAILED, SINCE THE TAVI VALVE DISPLACED AS WELL. ULTIMATELY, A PERIMOUNT SIZE 21 FROM EDWARDS WAS IMPLANTED AFTER PERFORMING ROOT ENLARGEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16686407 ↗