PERCEVAL PLUS PVF-XL (UDI 00896208000825)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00896208000825), received between Dec 16, 2021 and Sep 27, 2026 — classified as 29 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2026Inadequacy of Device Shape and/or Size

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50909497 ↗
• InjuryDec 24, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS NOTIFIED OF A FAILURE TO IMPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. REPORTEDLY, IN A REDO CASE FOLLOWING TAVI, PERCEVAL PLUS VALVE PVF-XL WAS USED ON (B)(6) 2025. HOWEVER, FOLLOWING BYPASS REMOVAL, PVL OCCURRED, NECESSITATING CONVERSION TO A CONVENTIONAL VALVE INSTEAD. BASED ON THE FURTHER INFORMATION RECEIVED, THE SURGICAL APPROACH WAS A FULL STERNOTOMY WITH NO CONCOMITANT PROCEDURE. THE NATIVE VALVE WAS STENOTIC. BALLOONING WAS PERFORMED ACCORDING TO THE IFU. APPROXIMATELY 30 MINUTES WAS ADDED TO THE CROSS-CLAMP TIME AND BYPASS TIME. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE. THE PATIENT¿S IMPACT AND OUTCOME WERE REPORTED AS IMPROVING AND PROGRESSING WELL. THERE WERE NO REPORTED ABNORMAL GEOMETRIES IN THE PATIENT'S ANNULUS, NO DEVICE MALPOSITIONING OR MISSIZING IDENTIFIED. NO POSITIONING DIFFICULTY WAS NOTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23889316 ↗
• InjurySep 13, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2025, A RE-AVR IN A PATIENT WHO HAD AN SJM 27 MM IMPLANTED IN 1989 WAS PERFORMED. AFTER SJM VALVE WAS EXPLANTED, SIZING WAS PERFORMED AS FOLLOWS: WITH SIZE XL, WHITE HEAD OF THE SIZER PASSED THROUGH WITH SLIGHT RESISTANCE. AS SUCH, PERCEVAL PLUS SIZE XL WAS SELECTED AND IMPLANTED IN THE PATIENT. ECHOCARDIOGRAPHIC EVALUATION AFTER OCCLUSION RELEASE, REVEALED A SLIGHT GAP ON THE N SIDE OF THE VALVE AND PVL AT LCC. AFTER RE-OCCLUSION, THE AREA WAS EXAMINED UNDER DIRECT VISUALIZATION AND WAS REPAIRED. THIS WAS FOLLOWED BY AORTIC CLOSURE AFTER RE-BALLOONING. BASED ON THE POST-OCCLUSION ECHOCARDIOGRAM, SINCE NO DISAPPEARANCE OR IMPROVEMENT OF THE PVL WAS OBSERVED, THE PERCEVAL PLUS WAS EXPLANTED, AND EPIC VALVE SIZE 27 WAS IMPLANTED INSTEAD. IN THE POSTOPERATIVE COMMENTS, IT WAS NOTED THAT SINCE THE VALVE WAS UNDERSIZED, FURTHER REPAIRS OR ADJUSTMENTS WERE DEEMED FUTILE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23047538 ↗
• MalfunctionNov 1, 2024Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2024, A PERCEVAL PLUS VALVE PVF-XL WAS IMPLANTED IN A PATIENT. WHEN CHECKING THE VALVE ON ECHO POST IMPLANT, IT APPEARED THAT ONE OF THE LEAFLETS WAS NOT MOVING PROPERLY AND WAS CAUSING A LEAK. AS FURTHER REPORTED, THE SITE CONFIRMED THAT THE SURGEON IMPLANTED AN XL AND SAID EVERYTHING LOOKED FINE UNTIL ECHO. REPORTEDLY, IT LOOKED LIKE ONE OF THE LEAFLETS WAS NOT MOVING. AS SUCH, THEY WENT BACK ON PUMP TO ADJUST IT BUT HAD THE SAME ISSUE. AS SUCH, THE PERCEVAL VALVE WAS EXPLANT AND A METRONIC AVALUS VALVE WAS IMPLANTED INSTEAD. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT HAD AN UNEVENTFUL POST OP, IT WAS AN ISOLATED SURGERY, PATIENT'S ANNULUS WAS 27, NO POSITIONING DIFFICULTY WAS NOTED AND THERE WERE NO ABNORMAL GEOMETRIES IN PATIENT'S ANNULUS. FURTHERMORE, ABOUT 30 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT OF THIS EVENT BUT PATIENT REMAINED STABLE DURING THE PROLONGATION OF SURGERY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20593618 ↗
• InjuryOct 4, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED THROUGH THE MANTRA STUDY OF A PACEMAKER IMPLANT PERFORMED ON A PATIENT WHO HAD RECEIVED A PERCEVAL VALVE 10 DAYS EARLIER. AS PER INFORMATION RETRIEVED FROM THE STUDY DATABASE, THE PERCEVAL VALVE WAS IMPLANTED THROUGH MEDIAN STERNOTOMY AND CABG (3 VESSELS) WAS PERFORMED BEFORE PERCEVAL IMPLANT. THE PATIENT¿S NATIVE VALVE WAS TRICUSPID, CALCIFIED, AND EXHIBITED BOTH STENOSIS AND INSUFFICIENCY DUE TO DEGENERATIVE AETIOLOGY. PATIENT¿S MEDICAL HISTORY INCLUDED DYSLIPIDAEMIA, SYSTEMIC HYPERTENSION, CORONARY ARTERY DISEASE TREATED WITH PTCA IN 2020, TRANSIENT ISCHEMIC ATTACK. NO CONDUCTION DISORDERS WERE REPORTED. PATIENT WAS IN NYHA CLASS III. BASED ON THE AVAILABLE INFORMATION, INTERMITTENT THIRD-DEGREE AV BLOCK AROSE ON DAY 8 POST-SURGERY, WHICH WAS ADDRESSED WITH A PACEMAKER IMPLANT 2 DAYS LATER. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE DEVICE AND TO THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 20366819 ↗
• InjurySep 18, 2024Incomplete Coaptation; Difficult to Open or Close; Incomplete Coaptation; Difficult to Open or Close

  MANUFACTURER WAS INFORMED THAT PERCIVAL PLUS SIZE XL WAS IMPLANTED ON (B)(6) 2024 BUT WAS EXPLANTED INTRA-OPERATIVELY SINCE LEAFLET DID NOT FUNCTION. BASED ON THE FURTHER INFORMATION RECEIVED, VALVE LEAFLETS DIDN¿T CLOSE AFTER VALVE WAS IMPLANTED. REPORTEDLY, NO MALFUNCTION WITH THE DEVICE WAS NOTED PRIOR TO THIS EVENT. BASED ON THE INFORMATION RECEIVED FROM THE SITE, THEY THINK THAT PATIENT SIZED OUT NOT ENABLING THE VALVE TO COLLAPSE ENOUGH TO MAKE LEAFLETS CLOSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20252766 ↗
• InjuryAug 27, 2024Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE MANUFACTURER BECAME AWARE OF THIS EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT IMPLANT FORM, PATIENT HAS RECEIVED TWO PERCEVAL PLUS AORTIC VALVES (PVF-L AND PVF-XL) ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, PVF-L WAS IMPLANTED IN THE PATIENT AND PVF-XL WAS NOT USED. REPORTEDLY, PATIENT WAS SIZED IN BETWEEN L AND XL, BOTH VALVES WERE OPENED, AND ULTIMATELY PVF-L WAS CHOSEN TO BE IMPLANTED. AS REPORTED, THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE AND NO MALFUNCTION WITH THE DEVICES WERE NOTED.

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

  MAUDE report 20080157 ↗
• InjuryAug 27, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER BECAME AWARE OF THIS EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT IMPLANT FORM, PATIENT HAS RECEIVED TWO PERCEVAL PLUS AORTIC VALVES (PVF-L AND PVF-XL) ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, PVF-L WAS IMPLANTED IN THE PATIENT AND PVF-XL WAS NOT USED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20080008 ↗
• InjuryJul 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THROUGH MANTRA STUDY OF A PERCEVAL PLUS VALVE EXPLANT OCCURRED LESS THAN 2 MONTHS AFTER IMPLANT. AS PER INFORMATION AVAILABLE, THE DEVICE HAD BEEN IMPLANTED ON (B)(6) 2024 THROUGH MEDIAN STERNOTOMY IN A PATIENT WITH A STENO-INSUFFICIENT TRICUSPID AORTIC VALVE WITH DEGENERATIVE ETIOLOGY. CABG (2 VESSELS) AND ATRIAL APPENDAGE EXCISION/CLIPPING FOR AF TREATMENT WERE PERFORMED AS CONCOMITANT SURGERY PRIOR TO PERCEVAL VALVE IMPLANT. CPB TIME WAS 2 HOURS AND CROSS-CLAMP TIME APPROX. 90 MINUTES. THE PATIENT WAS HOSPITALIZED FOR 1 MONTH PRIOR TO BE DISCHARGED TO REHAB FACILITY. PERCEVAL VALVE FUNCTIONALITY WAS GOOD AT THE ECHO EVALUATION PERFORMED PRE-DISCHARGE. AS PER INFORMATION RECEIVED, THE PATIENT WAS RE-ADMITTED TO HOSPITAL DUE TO MULTIVALVE ENDOCARDITIS (MITRAL, TRICUSPID AND AORTIC VALVE PROSTHESIS) AND THE PERCEVAL VALVE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (MEDTRONIC FREESTYLE PROSTHESIS SIZE 25). ADDITIONAL MEDICAL TREATMENT WAS REQUIRED (BLOOD TRANSFUSION AND DIALYSIS). AS PER ADDITIONAL INFORMATION RECEIVED, THE BACTERIA ISOLATED IN THE MICROBIOLOGICAL TESTS WAS ENTEROCOCCUS FAECALIS. THE SITE ASSESSED THE

  Patient problems: Endocarditis

  MAUDE report 19784907 ↗
• InjuryJun 21, 2024Gradient Increase; Gradient Increase

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL PLUS PVF-XL VALVE WHICH WAS IMPLANTED ON (B)(6) 2023 THROUGH FULL STERNOTOMY, IS NOW WITH SEVERE AI AND MEAN GRADIENT OF 25 MM HG. REPORTEDLY, PATIENT HAD MEAN GRADIENT OF 8 IN THE OR. THE EF DROPPED AFTER SURGERY. BASED ON FURTHER INFORMATION RECEIVED, PATIENT'S ANNULUS WAS 27MM. THE DEVICE REMAINED IMPLANTED, AND THE PATIENT IS STILL BEING TREATED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19589141 ↗
• InjuryJun 21, 2024Gradient Increase; Gradient Increase

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL PLUS PVF-XL VALVE WHICH WAS IMPLANTED ON (B)(6) 2023 THROUGH FULL STERNOTOMY, IS NOW WITH SEVERE AI AND MEAN GRADIENT OF 25 MM HG. REPORTEDLY, PATIENT HAD MEAN GRADIENT OF 8 IN THE OR. THE EF DROPPED AFTER SURGERY. BASED ON FURTHER INFORMATION RECEIVED, PATIENT'S ANNULUS WAS 27MM. THE DEVICE REMAINED IMPLANTED, AND THE PATIENT IS STILL BEING TREATED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19588880 ↗
• MalfunctionJun 6, 2024Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SUTURELESS AORTIC VALVE SIZE XL THAT OCCURRED ON (B)(6) 2024. REPORTEDLY, THE PROSTHESIS SEEMED TO SHOW A FAILURE AND WAS REPLACED BY A CONVENTIONAL BIOLOGICAL VALVE FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES MAGNA EASE). NO FURTHER INFORMATION IS AVAILABLE AT THIS STAGE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 19478662 ↗
• InjuryMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT REGISTRATION FORM, ON (B)(6) 2024, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 19226897 ↗
• InjuryMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT REGISTRATION FORM, ON (B)(6) 2024, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. NO ALLEGATION OF ANY DEVICE DYSFUNCTION OR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 19226881 ↗
• InjuryMar 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2024. BASED ON INFORMATION RECEIVED, PATIENT HAD CHB WITH AFIB ON (B)(6) 2024. THE PATIENT NEEDED A PERMANENT PACEMAKER WHICH WAS IMPLANTED ON (B)(6) 2024 TO RESOLVE THE ISSUE. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; ARRHYTHMIA: AFIB; SYSTEMIC HYPERTENSION; DIABETES MELLITUS: TYPE II, INSULIN DEPENDENT; DYSLIPIDEMIA; RENAL INSUFFICIENCY / RENAL DISORDER (DIALYSIS ONGOING); PERCUTANEOUS CORONARY INTERVENTION (STENTING 2019); AND WAS IN NYHA CLASS III. BASED ON THE INFORMATION AVAILABLE, PRIOR AND CONCOMITANT ANTICOAGULANT/ANTIPLATELET MEDICATIONS ARE WARFARIN, ELIQUIS AND ASPIRIN.

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 18861790 ↗
• InjuryMar 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2024. BASED ON INFORMATION RECEIVED, PATIENT HAD CHB WITH AFIB ON (B)(6) 2024. THE PATIENT NEEDED A PERMANENT PACEMAKER WHICH WAS IMPLANTED ON (B)(6) 2024 TO RESOLVE THE ISSUE. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; ARRHYTHMIA: AFIB; SYSTEMIC HYPERTENSION; DIABETES MELLITUS: TYPE II, INSULIN DEPENDENT; DYSLIPIDEMIA; RENAL INSUFFICIENCY / RENAL DISORDER (DIALYSIS ONGOING); PERCUTANEOUS CORONARY INTERVENTION (STENTING 2019); AND WAS IN NYHA CLASS III. BASED ON THE INFORMATION AVAILABLE, PRIOR AND CONCOMITANT ANTICOAGULANT/ANTIPLATELET MEDICATIONS ARE WARFARIN, ELIQUIS AND ASPIRIN.

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 18861785 ↗
• InjuryJan 15, 2024Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE SIZE XL WAS IMPLANTED ON (B)(6) 2023. REPORTEDLY, SIZING AND POSITIONING WAS GOOD. NO POSITIONING DIFFICULTIES WERE NOTED. DURING THE INSPECTION, NO FLUTTERING OR SIGN OF OVERSIZING ON THE LEAFLET WERE NOTED. AFTER DE-CLAMP, A SEVERE CENTRAL LEAK WAS DETECTED. AS SUCH, THE VALVE WAS EXPLANTED, AND A MAGNA VALVE SIZE 27 WAS SUCCESSFULLY IMPLANTED IN THE PATIENT INSTEAD. IT WAS REPORTED THAT AFTER EXPLANATION, VISUAL INSPECTION WAS PERFORMED, AND IT WAS MENTIONED THAT ONE OF THE LEAFLETS (NON-CORONARY LEAFLET) IS ASYMMETRIC. BASED ON THE FURTHER INFORMATION RECEIVED, A LITTLE ABNORMAL GEOMETRY WAS NOTED IN THE PATIENT'S ANNULUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18514958 ↗
• InjuryDec 28, 2023Perivalvular Leak; Malposition of Device; Perivalvular Leak; Malposition of Device

  ON (B)(6) 2023, A PERCEVAL PLUS PVF-XL WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. AFTER IMPLANTATION, A PERIVALVULAR LEAK WAS NOTED. AS SUCH, THE VALVE WAS REPLACED WITH THE VALVE WITH OTHER MODEL AND SIZE DURING THE SAME DAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18414798 ↗
• InjuryDec 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT IMPLANT FORM, ON (B)(6) 2023, A PERCEVAL PLUS VALVE SIZE XL WAS ''DISPOSED''. FURTHER INFORMATION FROM THE SITE CONFIRMED THAT THE DEVICE WAS IMPLANTED EARLIER, AND WITHIN 2 MONTHS POST OP, A PERMANENT PACEMAKER WAS IMPLANTED. AS PVE WITH SEVERE PARAVALVULAR INSUFFICIENCY, SUBANNULAR ABSCESS, AND DISCONNECTION OF THE AV REGION WERE DEVELOPED, THE PERCEVAL VALVE WAS EXPLANTED ON (B)(6) 2023. REPORTEDLY, WHILE EXPLANTING THE VALVE, EXTENSIVE VEGETATIVE MATERIAL WAS NOTED, AND ENDOCARDITIS WAS EXTENSIVE. INSPIRIS VALVE SIZE 27 WAS ULTIMATELY IMPLANTED INSTEAD, AND THE PACEMAKER WAS ALSO REMOVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 18361141 ↗
• InjuryDec 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT IMPLANT FORM, ON 10 OCT 2023, A PERCEVAL PLUS VALVE SIZE XL WAS ''DISPOSED''. FURTHER INFORMATION FROM THE SITE CONFIRMED THAT THE DEVICE WAS IMPLANTED EARLIER, AND WITHIN 2 MONTHS POST OP, A PERMANENT PACEMAKER WAS IMPLANTED. AS PVE WITH SEVERE PARAVALVULAR INSUFFICIENCY, SUBANNULAR ABSCESS, AND DISCONNECTION OF THE AV REGION WERE DEVELOPED, THE PERCEVAL VALVE WAS EXPLANTED ON (B)(6) 2023. REPORTEDLY, WHILE EXPLANTING THE VALVE, EXTENSIVE VEGETATIVE MATERIAL WAS NOTED, AND ENDOCARDITIS WAS EXTENSIVE. INSPIRIS VALVE SIZE 27 WAS ULTIMATELY IMPLANTED INSTEAD, AND THE PACEMAKER WAS ALSO REMOVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Endocarditis

  MAUDE report 18361139 ↗
• InjuryNov 10, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT IMPLANTED WITH PERCEVAL PLUS VALVE SIZE XL ON (B)(6) 2023 WAS DIAGNOSED WITH STENOSIS, WORSENING AND HIGH GRADIENTS. (PMEAN: 31 MMHG; PPEAK 49MMHG) AT A FOLLOW UP VISIT PERFORMED IN SEPTEMBER. AT THE VISIT THE PATIENT PRESENTED SHORTNESS OF BREATH. REPORTEDLY, THE DEVICE FUNCTIONALITY WAS GOOD AFTER IMPLANT. HIGH GRADIENTS WERE NOTED THOUGH SINCE THEN (DISCHARGE: PMEAN 18MMHG; PPEAK 32MMHG; 30 DAYS VISIT: PMEAN 14MMHG; PPEAK 34MMHG), STILL WITH THE VARC3 EXPECTATION INDICATING NO FAILED IMPLANT. REPORTEDLY, THE PATIENT UNDERWENT AVR DUE TO HIGH-GRADE STENOSIS IN ABSENCE OF INSUFFICIENCY. PATIENT PRESENTED THE FOLLOWING RISK FACTORS: DIABETES MELLITUS II, HYPERCHOLESTEROLEMIA, OBESITY. NO COAGULATION DISORDERS WERE REPORTED. PATIENT WAS UNDER ASPIRIN PRIOR TO IMPLANT AND TREATMENT WITH ASPIRIN + MARCUMAR WAS INDICATED FOR 3 WEEKS AFTER IMPLANT. PATIENT'S INR WAS 1.1 AT DISCHARGE AND 1.12 AT THE FOLLOW UP VISIT PERFORMED IN SEPTEMBER. AS PER MEDICAL JUDGEMENT RECEIVED, BY CHECKING THE PRE-OPERATIVE MEASUREMENTS, AN OVERSIZING OF THE PERCEVAL VALVE CANNOT BE EXCLUDED. THERE IS ALSO A SUSPECT FOR HALT AND THROMBOSIS, SINCE THERE IS N

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 18109369 ↗
• InjuryNov 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON THE INFORMATION AVAILABLE, PATIENT HAD JUNCTIONAL / CONVERSION PAUSES FOLLOWING ATRIAL FIBRILLATION THAT STARTED ON (B)(6) 2023. AS SUCH, A PERMANENT PACEMAKER WAS IMPLANTED ON THE SAME DAY TO RESOLVE THE EVENT. THE EVENT SEVERITY WAS CONSIDERED MODERATE. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED SYSTEMIC HYPERTENSION; DYSLIPIDEMIA; LAA THROMBUS; PEPTIC ULCER DISEASE; AND NYHA CLASS II.

  Patient problems: Atrial Fibrillation

  MAUDE report 18068121 ↗
• InjuryNov 3, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON THE INFORMATION AVAILABLE, PATIENT HAD JUNCTIONAL / CONVERSION PAUSES FOLLOWING ATRIAL FIBRILLATION THAT STARTED ON (B)(6) 2023. AS SUCH, A PERMANENT PACEMAKER WAS IMPLANTED ON THE SAME DAY TO RESOLVE THE EVENT. THE EVENT SEVERITY WAS CONSIDERED MODERATE. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED SYSTEMIC HYPERTENSION; DYSLIPIDEMIA; LAA THROMBUS; PEPTIC ULCER DISEASE; AND NYHA CLASS II.

  Patient problems: Atrial Fibrillation

  MAUDE report 18068098 ↗
• InjuryMay 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. REPORTEDLY, PERCEVAL PLUS SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON INFORMATION RECEIVED, PATIENT HAD COMPLETE HEART BLOCK ON (B)(6) 2023 WHICH REQUIRED A PERMANENT PACEMAKER TO BE INSERTED ON THE SAME DAY. REPORTEDLY, PATIENT HAS RECOVERED, AND THE EVENT HAS RESOLVED. BASED ON THE INFORMATION AVAILABLE, PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE, SYSTEMIC HYPERTENSION, DYSLIPIDEMIA, STROKE, RENAL INSUFFICIENCY / RENAL DISORDER WITHOUT ANY DIALYSIS ONGOING; SLEEP APNEA, NYHA CLASS II. FURTHERMORE, PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) IN 2014.

  Patient problems: Heart Block

  MAUDE report 17014906 ↗
• InjuryMay 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. REPORTEDLY, PERCIVAL PLUS SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON INFORMATION RECEIVED, PATIENT HAD COMPLETE HEART BLOCK ON (B)(6) 2023 WHICH REQUIRED A PERMANENT PACEMAKER TO BE INSERTED ON THE SAME DAY. REPORTEDLY, PATIENT HAS RECOVERED, AND THE EVENT HAS RESOLVED. BASED ON THE INFORMATION AVAILABLE, PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE, SYSTEMIC HYPERTENSION, DYSLIPIDEMIA, STROKE, RENAL INSUFFICIENCY / RENAL DISORDER WITHOUT ANY DIALYSIS ONGOING; SLEEP APNEA, NYHA CLASS II. FURTHERMORE, PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) IN 2014.

  Patient problems: Heart Block

  MAUDE report 17014903 ↗