PERCEVAL PVS23 (UDI 00896208000429)Recalls & reported problems

Summary

The FDA's MAUDE database contains 337 adverse event reports that list this exact device (DI 00896208000429), received between Jul 22, 2016 and Jun 17, 2025 — classified as 26 deaths, 299 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (88 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 337 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Calcified; Calcified

  ON (B)(6) 2022, A PERCEVAL VALVE PVS23 WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2025, DUE TO SVD (CALCIFICATION) AND THE VALVE WAS REPLACED WITH INSPRIS VALVE SIZE 23MM INSTEAD. BASED ON THE INFORMATION PROVIDED, PATIENT WAS ON DIALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22242886 ↗
• DeathMar 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION FROM PATIENT TRACKING SYSTEM. A PERCEVAL VALVE PVS23 WAS IMPLANTED IN A PATIENT ON (B)(6) 2024. THE PATIENT PASSED AWAY AT UNKNOWN DATE DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21673668 ↗
• InjuryNov 1, 2024Degraded; Degraded

  MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE SIZE 23 WHICH WAS IMPLANTED ON (B)(6) 2019, WAS EXPLANTED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20593645 ↗
• DeathOct 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DATABASE. ON (B)(6) 2024, A PATIENT RECEIVED A PERCEVAL VALVE PVS23. REPORTEDLY, PATIENT PASSED AWAY AT AN UNKNOWN DATE DUE TO UNKNOWN REASON. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20373667 ↗
• InjuryAug 28, 2024Incomplete Coaptation; Incomplete Coaptation

  MANUFACTURER WAS INFORMED THAT ON (B)(6) 2024, DURING THE IMPLANT OF A PERCEVAL VALVE PVS23, IT WAS NOTED THAT THE RIGHT LEAFLET IS LOWER THAN THE NON-CORONARY AND LEFT LEAFLET, CREATING A STEP AT THE TOP OF THE LEAFLET. REPORTEDLY, THIS CAUSED A CENTRAL LEAK. THE DEVICE REMAINED IMPLANTED AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20089110 ↗
• InjuryJul 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, A PERCIVAL VALVE SIZE M WAS IMPLANTED. AFTER DE-CLAMPED, ABNORMALITY AND BLEEDING WERE NOTED BY ECHO, THUS, THE VALVE WAS DIRECTLY OBSERVED, AND TISSUE DAMAGE WAS OBSERVED NEAR THE MITRAL VALVE JUST BELOW ANNULUS. SINCE THE PATIENT SEEMED WEAK, IT HAD BEEN REINFORCED WITH THREAD BEFORE PERCIVAL IMPLANTATION. BUT THE REINFORCEMENT WAS DAMAGED DURING DEPLOYMENT AND BALLOONING, LEADING TO HEMORRHAGE. THE IMPLANTED PERCIVAL VALVE WAS REMOVED AND REPLACED WITH A 19MM INSPRIS INSTEAD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19675055 ↗
• InjuryJun 19, 2024Positioning Failure; Migration or Expulsion of Device; Positioning Failure; Migration or Expulsion of Device

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL S VALVE SIZE M THAT OCCURRED ON (B)(6) 2024 DURING AN ISOLATED AVR SURGERY PERFORMED THROUGH MICS APPROACH. REPORTEDLY, THE VALVE WAS ATTEMPTED TO BE IMPLANTED FOR THREE TIMES BUT A STABLE POSITION COULD NOT BE ACHIEVED AND, FOLLOWING EACH ATTEMPT, THE VALVE WAS FOUND TO BE DISLOCATED TO THE DISTAL PART OF THE ANNULUS AT THE INTRA-OPERATIVE CHECK PERFORMED UPON RELEASE OF AORTIC CROSS-CLAMP. REPORTEDLY, THE PATIENT NATIVE VALVE WAS STENOTIC TRICUSPID, WITH A NORMAL GEOMETRY OF THE COMMISSURES WITH MINIMAL RAPHE OF THE LCC AND RCC. PATIENT¿S ANNULUS SIZE HAD BEEN EVALUATED TO BE 23 MM IN SIZE AT THE PRE-OPERATIVE ECHO. AT EACH ATTEMPT, THE VALVE WAS REMOVED AND RECOLLAPSED, AND THE ANULUS SIZED. BASED ON THE INFORMATION RECEIVED, A SUTURED BIOLOGICAL PROSTHESIS SIZE 23 (EDWARDS LIFESCIENCES PERIMOUNT MAGNA EASE) WAS ULTIMATELY IMPLANTED. NO FURTHER DECALCIFICATION WAS PERFORMED PRIOR TO IMPLANTING THE REPLACEMENT VALVE. AS REPORTED, THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND WAS NOT AFFECTED BY THE DELAY IN SURGICAL TIME, WHICH WAS 187 MIN OF BYPASS TIME AND 122 MIN OF CROSS-CLAMP TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19565589 ↗
• DeathMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, THE PERCEVAL PVS23/M VALVE WAS IMPLANTED IN A PATIENT WITH TYPE1 BICUSPID VALVE. THE SURGERY WAS MICS AVR, AND AORTIC ROOT RUPTURE WAS NOTED AFTER DE-CLAMPED. AS SUCH, THEY CLAMPED AGAIN, REPAIRED THE HOLE WITH A PERICARDIAL PATCH AND DE-CLAMPED AGAIN, BUT THE BLEEDING DID NOT STOP AND WAS RE-CLAMPED. THE VALVE RING AND BASAL HALF WERE RECONSTRUCTED WITH ARTIFICIAL VESSELS AND RE-SIZED, BUT THE WHITE HEAD OF MEDIUM SIZER DID NOT PASS THROUGH. AS SUCH, THEY DOWNSIZED AND IMPLANTED A PVS SIZE 21/S NO L. REPORTEDLY, NO LEAK WAS NOTED AFTER IMPLANT. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT REMAINED STABLE THROUGHOUT THE SURGERY. REPORTEDLY, PATIENT EVENTUALLY PASSED AWAY ON (B)(6) 2024. BASED ON THE MEDICAL JUDGMENT RECEIVED, IT IS POSSIBLE THAT THE DAMAGE TO THE AORTIC ROOT AROUND THE TOP OF THE RCC OCCURRED BE BY CUSA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 19263491 ↗
• DeathMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF A PATIENT'S DEATH THROUGH THE JAPAN PERCEVAL HEART VALVE STUDY DATABASE. AS REPORTED IN THE DATABASE, A PERCEVAL S VALVE, SIZE 23 WAS IMPLANTED ON (B)(6) 2019 WITH MEDIAN STERNOTOMY SURGICAL APPROACH. THE CONDITION OF THE AORTIC VALVE WAS TRICUSPID, THE AORTIC ANNULUS WAS CALCIFIED, AND THE ASCENDING AORTA WAS NORMAL. THE OPERATION WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2019; AT DISCHARGE THE PATIENT WAS NYHA II, THE CARDIAC RHYTHM WAS ATRIAL FIBRILLATION AND THE ECHOCARDIOGRAFIC EXAM DID NOT SHOW ANY AORTIC REGURGITATION AND REPORTED A SEVERE HYPERTROPHY OF THE LVOT. THE PATIENT UNDERWENT AN LAA LIGATION CONCOMITANT PROCEDURE AS ATRIAL FIBRILLATION TREATMENT ON 10 DECEMBER 2019. REPORTEDLY, PATIENT PASSED AWAY ON (B)(6) 2021 AND THE CAUSE IS UNKNOWN. PATIENT'S CLINICAL HISTORY INCLUDED ATRIAL FIBRILLATION AND WAS NYHA CLASS II.

  Patient problems: Insufficient Information

  MAUDE report 18914276 ↗
• DeathMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF A PATIENT'S DEATH THROUGH THE JAPAN PERCEVAL HEART VALVE STUDY DATABASE. AS REPORTED IN THE DATABASE, A PERCEVAL S VALVE, SIZE 23 WAS IMPLANTED ON (B)(6) 2019 WITH MEDIAN STERNOTOMY SURGICAL APPROACH. THE CONDITION OF THE AORTIC VALVE WAS TRICUSPID, THE AORTIC ANNULUS WAS CALCIFIED, AND THE ASCENDING AORTA WAS NORMAL. THE OPERATION WAS SUCCESSFUL, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2019; AT DISCHARGE THE PATIENT WAS NYHA II, THE CARDIAC RHYTHM WAS ATRIAL FIBRILLATION AND THE ECHOCARDIOGRAFIC EXAM DID NOT SHOW ANY REGURGITATION. THE PATIENT UNDERWENT AN LAA AMPUTATION PROCEDURE AS ATRIAL FIBRILLATION TREATMENT ON (B)(6) 2019, BEFORE VALVE SURGERY. REPORTEDLY, PATIENT DIED ON (B)(6) 2023 AND THE CAUSE IS UNKNOWN. PATIENT'S CLINICAL HISTORY INCLUDED ATRIAL FIBRILLATION; STROKE ON (B)(6) 2019, AND WAS NYHA CLASS II.

  Patient problems: Insufficient Information

  MAUDE report 18914246 ↗
• InjuryNov 17, 2023Degraded; Degraded

  THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO HAD A PERCEVAL VALVE SIZE M IMPLANTED ON (B)(6) 2018, WENT UNDER TAVI WITH MEDTRONIC EVOLUTE (FX-23) DEVICE ON (B)(6) 2023 DUE TO THE VALVE FAILURE. BASED ON THE FURTHER INFORMATION RECEIVED, AT THE TIME OF FOLLOW-UP VISIT WITH THE PATIENT ON (B)(6) 2023, PATIENT WAS NYHA III, HAD MILD AORTIC REGURGITATION, AN AORTIC MEAN GRADIENT OF 16.8MMGH AND AN AORTIC VALVE AREA OF 1.1CM SQUARED. LEFT VENTRICULAR EJECTION FRACTION WAS 50%. THERE WERE ISSUES WITH HIGH BLOOD PRESSURE THAT WAS NOT CONTROLLED, MITRAL VALVE STENOSIS WITH A MEAN GRADIENT OF 6.7MMGH, SOME MITRAL REGURGITATION AS WELL AS SOME TRICUSPID VALVE REGURGITATION. REPORTEDLY, PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2023 WITH A WORSENING CONDITION. THE ECHO STATED THAT THE AORTIC INSUFFICIENCY WAS MORE SIGNIFICANT AND SHOWED AN AORTIC VALVE DEGENERATION. ON (B)(6) 2023, EJECTION FRACTION WAS 45%, LV FUNCTION AND AORTIC REGURGITATION WAS GOTTEN WORSEN. AS SUCH, TAVI WAS PERFORMED. AS REPORTED, SURGEON MENTIONED THAT CLINICALLY PATIENT SEEMED WORSE THAN THE AMOUNT OF SVD FROM THE ECHO, AND THAT OTHER ISSUES WITH THE MITRAL AND TRICUSPID VALVE CONTRIBUTED TO PATIENT'S CONDITION

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 18165288 ↗
• InjuryOct 27, 2023Calcified; Degraded; Calcified; Degraded

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A PERCEVAL S VALVE SIZE M OCCURRED ON (B)(6)2023. REPORTEDLY, THE PROSTHESIS WAS IMPLANTED ON (B)(6)2019 AND EXPLANT OCCURRED BECAUSE OF SEVERE STENOSIS AND RESULTANT MODERATE REGURGITATION. THE PERCEVAL VALVE WAS REPLACED WITH A BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES INSPIRIS, SIZE M) WITH NO REPORTED COMPLICATIONS. AS PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD THE FOLLOWING RISK FACTORS AND CLINICAL CONDITIONS : DISLIPIDEMIA, HYPERTENSION, DIABETES MELLITUS TYPE II ON ORAL TREATMENT AND WAS OBESE AT THE TIME OF IMPLANT. AS REPORTED, EARLY FUNCTIONALITY OF THE PERCEVAL VALVE WAS GOOD BUT A RAPID DETERIORATION OF HAEMODYNAMICS WAS DETECTED WITH PATIENT PRESENTING WITH SHORTNESS OF BREATH ON EXERTION AT THE TIME OF RE-DO SURGERY.

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

  MAUDE report 18017978 ↗
• MalfunctionOct 17, 2023Incomplete Coaptation; Incomplete Coaptation

  A PERCEVAL VALVE SIZE 23 WAS IMPLANTED IN A PATIENT ON 04 SEP 2023. IT WAS NOTED BY ECHO THAT 2 OF THE LEAFLETS OF THE VALVE WERE NOT WORKING. BASED ON THE INFORMATION RECEIVED, THE TYPE OF RE-INTERVENTION THAT GOING TO BE PERFORMED IS STILL UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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

  MAUDE report 17954302 ↗
• InjuryOct 12, 2023Collapse; Perivalvular Leak; Collapse; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE PVS SIZE 23, IMPLANTED FOR ISOLATED AVR THROUGH FULL STERNOTOMY ON (B)(6) 2023, WAS EXPLANTED AND REPLACED WITH A CONVENTIONAL BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (MEDTRONIC AVALUS SIZE 21) ON (B)(6) 2023 DUE TO PERIVALVULAR LEAK AND HIGH GRADIENTS DETECTED BY THE SURGEON AT AN ECHO CHECK. AS REPORTED, THE PATIENT'S NATIVE VALVE WAS BICUSPID TYPE I AND WAS APPARENTLY SYMMETRICAL WITH RESPECT TO COMMISSURAL ALIGNMENT, WITH THREE WELL-DIFFERENTIATED RAPHES AND FUSION OF INTERCORONARY LEAFLETS. BASED ON THE FURTHER INFORMATION RECEIVED, NO COLLAPSING ISSUES NOR DIFFICULTIES IN VALVE POSITIONING HAD BEEN ENCOUNTERED AT THE TIME OF PERCEVAL VALVE IMPLANT. THE INTRA-OPERATIVE TEE CHECK, HAD SHOWN A GOOD FUNCTIONALITY OF THE IMPLANTED PROSTHESIS, WHICH SEEMED WELL EXPANDED, ALTHOUGH THE OUTFLOW TRACT WAS NOT VISUALIZED. REPORTEDLY, AT THE TIME OF INITIAL SURGERY, THE PATIENT WAS IN A VERY ADVANCED FUNCTIONAL CLASS AND EVACUATION OF BILATERAL PLEURAL EFFUSION WAS PERFORMED IN THE SAME PROCEDURE. INITIAL PATIENT'S OUTCOME WAS GOOD, WITH AN IMPROVEMENT IN CLINICAL CONDITIONS UNTIL PROSTHESIS DYSFUNCTION WAS DETECTED, WITH THE VALVE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17918388 ↗
• InjuryOct 5, 2023Calcified; Calcified

  THE MANUFACTURER WAS INFORMED THAT AN INDICATION FOR A VALVE IN VALVE (VIV) PROCEDURE WAS PLACED ON AN 84-YEAR-OLD PATIENT WHO HAD BEEN IMPLANTED WITH A PVS 23MM PERCEVAL BIOPROSTHESIS ON (B)(6) 2020. REPORTEDLY, PATIENT'S NATIVE VALVE WAS TRICUSPID AND PERCEVAL VALVE HAD BEEN IMPLANTED BECAUSE THE NATIVE VALVE WAS CALCIFIED ESPECIALLY ON THE NON-CORONARY LEAFLET. PATIENT HAD A HISTORY OF ISCHEMIC CARDIOMYOPATHY. THE SURGERY WAS PERFORMED WITHOUT REPORTED COMPLICATIONS THROUGH MEDIAN STERNOTOMY AND CABG (3 VESSELS) WAS EXECUTED AS CONCOMITANT SURGERY. AS REPORTED, AT THE TTE PERFORMED PRIOR TO THE VIV PROCEDURE, THE PERCEVAL VALVE SHOWED A VMAX OF 4.4M/S AND A MEAN GRADIENT OF 47MMHG. AS PER ADDITIONAL INFORMATION RECEIVED, THE VIV PROCEDURE WAS PERFORMED IN THE WEEK OF (B)(6) USING A SAPIEN SIZE 23 VALVE (EDWARDS LIFESCIENCES) WITH A GOOD OUTCOME.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17874858 ↗
• DeathSep 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING. BASED ON THE INFORMATION RECEIVED, A PERCEVAL VALVE SIZE 23 WAS IMPLANTED ON (B)(6) 2023. AS REPORTED, THE PATIENT PASSED AWAY ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17848564 ↗
• InjurySep 15, 2023Leak/Splash; Leak/Splash

  MANUFACTURER WAS INFORMED THAT AFTER PERCIVAL SIZE 23 WAS IMPLANTED ON 26 JULY 2023, THE AORTA WAS CLOSED WITH A DOUBLE LINE OF SUTURES. AORTIC CLAMP WAS REMOVED, BUT INEFFECTIVE EXIT FROM ECC WAS NOTED. DUE TO MASSIVE AORTIC REGURGITATION, I.E., OVERFLOWING HEART, RECURRENT VENTRICULAR FIBRILLATION AND A LARGE VOLUME OF BLOOD REQUIRING DRAINAGE, THE AORTIC CLAMP WAS REINSERTED. THE AORTA WAS OPENED, NO ABNORMALITY OF THE PROSTHESIS POSITION WAS FOUND. THE DECISION WAS MADE TO EXPLANT THE VALVE AND REPLACE IT WITH THE C-E PERIMOUNT MAGNA EASE 21MM BIOPROSTHESIS. REPORTEDLY, THE AORTA WAS CLOSED BY THE BLALOCK METHOD. OUTPUT FROM ECC WAS SMOOTH. REPORTEDLY, DURING THE VISUAL ASSESSMENT OF THE VALVE AFTER EXPLANATION, A CLEAR SEPARATION OF THE PETALS AT THE POINT OF FITTING WAS FOUND.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Ventricular Fibrillation

  MAUDE report 17761018 ↗
• InjurySep 13, 2023Migration; Migration

  ON (B)(6) 2023, A PERCEVAL VALVE SIZE 23 WAS IMPLANTED IN A PATIENT. SINCE THE VALVE WAS MIGRATED POST-SURGERY, IT WAS EXPLANTED ON (B)(6) 2023 AND CHANGED TO COMPETITOR'S VALVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17741745 ↗
• InjurySep 8, 2023Degraded; Degraded

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY A PATIENT WHO RECEIVED A PERCEVAL VALVE SIZE 23 ON (B)(6) 2019, IS BEING EVALUATED FOR POSSIBLE TAVR DUE TO AORTIC STENOSIS. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT DEVELOPED WORSENING DYSPNEA AND ACUTE DIASTOLIC HEART FAILURE DUE TO SEVERE AORTIC STENOSIS. PATIENT HAD SURGICAL BIOPROSTHETIC AVR (MEDIUM PERCEAVAL) AND MILD RCA, LAD AND MODERATE-SEVERE LCX. STATUS POST CABGX1 WITH SVG-OM (2019 N. CAROLINA). CAROTID DUPLEX ((B)(6) 2021) B ICA 50-69% STENOSIS. AAA DUPLEX ((B)(6) 2021) 4.9×4.6 CM. BLE ARTERIAL DUPLEX ((B)(6) 2021) NORMAL PRESSURES, RLE POPLITEAL STENOSIS. VENOUS DUPLEX ((B)(6) 2021) NO DVT, NO REFLUX. PATIENT HAD CTA AORTA WITH RUNOFF ((B)(6) 2022) INFRARENAL AAA MEASURES 5.7CM WITH BILATERAL ILIAC DILATION, BLE POPLITEAL WITH MINIMAL DILATION. PATIENT HAD EVAR ((B)(6) 2022) DEPLOYMENT OF 29 MM ALTO AORTIC BODY DEVICE WITH SUBSEQUENT POST DILATATION, INJECTION POLYMER WITHIN THE GRAFT, PLACEMENT OF LEFT AND RIGHT ILIAC LIMB ENDOGRAFT. PATIENT HAD ABDOMINAL PAIN AND LOWER BACK PAIN POST PROCEDURE. CTA AORTA ((B)(6) 2022) POST EVAR WITHOUT LEAK AND WAS DISCHAR

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17714304 ↗
• InjurySep 8, 2023Degraded; Degraded

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY A PATIENT WHO RECEIVED A PERCEVAL VALVE SIZE 23 ON (B)(6) 2019, IS BEING EVALUATED FOR POSSIBLE TAVR DUE TO AORTIC STENOSIS. NO FURTHER INFORMATION IS AVAILABLE. NO OTHER ALLEGATION OF DEVICE DYSFUNCTION OR ADVERSE EVENT ON THE PATIENT HAS YET BEEN RECEIVED FROM THE SITE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17714303 ↗
• MalfunctionSep 1, 2023Collapse; Material Deformation; Collapse; Material Deformation

  THE MANUFACTURER WAS NOTIFIED BY ANSM OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL S SIZE M VALVE OCCURRED ON (B)(6) 2023. REPORTEDLY, A DEFORMATION OF THE VALVE STENT WAS OBSERVED UPON VALVE DEPLOYMENT WHICH WAS NOT RESOLVED AFTER DILATATION WITH THE BALLOON. AS REPORTED, ONLY 15 MINUTES WERE ADDED TO THE SURGICAL TIME DUE TO THIS EVENT, WITH NO CLINICAL CONSEQUENCES ON THE PATIENT. AS PER ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER, POSITIONING DIFFICULTIES WERE EXPERIENCED SINCE THE SHEATH WAS DIFFICULT TO SHIFT. NO DEVICE MALPOSITIONING OR MISSIZING WERE IDENTIFIED AND THE PROSTHESIS WAS ULTIMATELY REPLACED WITH A NEW ONE OF THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670665 ↗
• InjuryJul 10, 2023Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2023, A PERCEVAL VALVE SIZE M (THIS CASE) WAS IMPLANTED IN THE PATIENT WHOSE NATIVE VALVE WAS BICUSPID TYPE 1. AFTER IMPLANTATION AND DE-CLAMP, MILD PVL IN NON-CORONARY PART WAS NOTED. REPORTEDLY, SURGICAL SITE WAS CLOSED BUT WAS RE-OPENED BECAUSE BLOOD PRESSURE WENT LOW. AS SUCH, THE VALVE WAS EXPLANTED, AND ANOTHER PERCEVAL VALVE SIZE L WAS IMPLANTED INSTEAD (B)(4).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Low Blood Pressure/ Hypotension

  MAUDE report 17295049 ↗
• InjuryJun 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PERCEVAL VALVE SIZE M WAS IMPLANTED IN THE PATIENT. REPORTEDLY, WHILE PATIENT WAS UNDER OBSERVATION, ARRHYTHMIA WAS NOTED, AND A PACEMAKER WAS IMPLANTED ON (B)(6) 2023. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION REGARDING THIS EVENT WILL BE PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 17194363 ↗
• MalfunctionJun 12, 2023Material Too Rigid or Stiff; Incomplete Coaptation; Material Too Rigid or Stiff; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 AN ATTEMPT TO IMPLANT A PERCEVAL S AORTIC SUTURELESS VALVE SIZE MEDIUM WAS MADE. REPORTEDLY, THE DECISION TO IMPLANT A PERCEVAL VALVE WAS MADE BECAUSE OF THE SMALL PATIENT'S ANNULUS (21 MM AS PER TEE ASSESSMENT). AS PER INDICATION FROM THE SIZING PROCEDURE, A VALVE SIZE M WAS SELECTED AND IMPLANTED. DURING REPERFUSION, AN INSUFFICIENCY WAS FOUND WHICH REQUIRED TO STOP THE HEART AGAIN (2ND CROSS-CLAMP). THE VALVE WAS INSPECTED AND IT SEEMED IT HAD NOT EXPANDED CORRECTLY ON THE RIGHT CORONAL SIDE; HENCE THE DECISION WAS MADE TO RE-IMPLANT THE VALVE. IN THE RENEWED REPERFUSION, THE TEE SHOWED AGAIN A VALVULAR INSUFFICIENCY, SO IT WAS DECICED TO REMOVE THE PERCEVAL VALVE AND IMPLANT A BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (21 MM INTUITY, EDWARDS LIFESCIENCES) (3RD CROSS-CLAMP). TOTAL SURGERY TIME WAS 3 HRS 50 MINS; ADDITIONAL CROSS CLAMP TIME WAS 1 HR 47 MINS AND BY-PASS TIME WAS 2 HRS 39 MINS. AS REPORTED, FURTHER INSPECTION OF THE EXPLANTED PERCEVAL VALVE SHOWED THAT ONE LEAFLET WAS APPEARING SIGNIFICANTLY STIFFER THAN THE OTHERS. THE MANUFACTURER WAS INFORMED THAT THE PATIENT DIDN'T EXPERIENCE ANY COMPLICATION AS A CONSEQUENCE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17114380 ↗
• InjuryJun 12, 2023Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2023, A PERCEVAL VALVE SIZE 23 WAS ATTEMPTED TO BE IMPLANTED. WHEN THE VALVE WAS IMPLANTED, THE POSITION WAS A LITTLE FAR FROM WHERE IT SUPPOSED TO BE. THEY TRIED TO REPOSITION THE VALVE BY FORCEPS, BUT IT WAS NOTED THAT THE RCC LEAFLET OF THE VALVE WAS NOT WORKING PROPERLY AFTER DE-CLAMPED. AS SUCH, IT WAS DECIDED TO IMPLANT ANOTHER SIMILAR PERCEVAL VALVE SIZE 23. IT WAS MENTIONED THAT THE LEAFLET OF RCC WAS FLAT AND THAT CAUSED THE LIMITATION OF ITS MOVEMENT, BUT IT IS UNKNOWN WHY THAT HAPPENED. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT'S ANNULUS WAS 22 MM. CONCOMITANT PROCEDURE WAS CABG, WHICH WAS PERFORMED BEFORE THE IMPLANT, THE PROCEDURE WAS FULL STERNOTOMY. REPORTEDLY, NO CENTRAL OR PARAVALVULAR LEAK WAS NOTED AND PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 17111687 ↗