PERCEVAL PVS27 (UDI 00896208000443)Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00896208000443), received between Sep 1, 2016 and Oct 25, 2024 — classified as 11 deaths, 114 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (39 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 126 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT REGISTRATION FORM, ON (B)(6) 2021, PVS27 WAS EXPLANTED INTRA-OPERATIVELY. REPORTEDLY, PATIENT IS NOW DECEASED. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY DEVICE MALFUNCTION NOR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20530403 ↗
• InjuryOct 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT REGISTRATION FORM, ON (B)(6) 2021, PVS27 WAS EXPLANTED INTRA-OPERATIVELY. REPORTEDLY, PATIENT IS NOW DECEASED. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY DEVICE MALFUNCTION NOR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20518298 ↗
• DeathOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED THE EVENT THROUGH DEVICE TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM PATIENT IMPLANT FORM, A PERCEVAL VALVE SIZE 27 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2020. REPORTEDLY, PATIENT PASSED AWAY ON (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20434146 ↗
• DeathOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURE WAS INFORMED THE EVENT THROUGH DEVICE TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM PATIENT IMPLANT FORM, A PERCEVAL VALVE SIZE 27 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2020. REPORTEDLY, PATIENT PASSED AWAY ON (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20434103 ↗
• InjuryJul 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, A PVS27 WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT. AFTER THE VALVE WAS IMPLANTED, ANNULAR RAPTURE WAS NOTED. AS SUCH, THE VALVE WAS EXPLANTED, AND REPLACED WITH INSPIRIS 25MM. BASED ON THE FURTHER INFORMATION RECEIVED, ADDITIONAL TREATMENT IS DONE FOR TISSUE DAMAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Rupture

  MAUDE report 19685483 ↗
• InjuryAug 25, 2023Degraded; Degraded

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PERCEVAL JAPAN STUDY. REPORTEDLY, PERCEVAL VALVE SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6) 2019. THE SURGICAL APPROACH WAS MEDIAN STERNOTOMY AND THERE WAS A CONCOMITANT CABG PROCEDURE PERFORMED. BASED ON THE INFORMATION RECEIVED, DUE TO SEVERE STRUCTURAL VALVE DETERIORATION THE DEVICE WAS EXPLANTED ON (B)(6) 2022. THE PATIENT OUTCOME IS INDICATED AS RECOVERING/RESOLVING. AS REPORTED, PATIENT HAD HISTORY OF ATRIAL FIBRILLATION; ATRIAL FLUTTER; BUNDLE BRANCH BLOCK; LEFT VENTRICULAR DYSFUNCTION; PAROXYSMAL ATRIAL FIBRILLATION; PULMONARY HYPERTENSION; STROKE; SUSTAINED VENTRICULAR FIBRILLATION; SUSTAINED VENTRICULAR FLUTTER; ANGINA (STABLE, 2019); CABG; CORONARY ANGIOGRAPHY (2017); PCI (2017); AND IS NYHA CLASS III.

  Patient problems: Insufficient Information

  MAUDE report 17625048 ↗
• InjuryMay 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023 A PATIENT WAS IMPLANTED WITH A PERCEVAL SIZE XL VALVE DUE TO STENOSIS OF THE NATIVE VALVE LEAFLETS. THERE WAS CONCOMITANT CABG SURGERY PERFORMED (1 VESSEL). THE PATIENT WAS IN SINUS RHYTHM POST-OPERATIVELY BUT WAS PUT UNDER TEMPORARY PACEMAKER AS PER HOSPITAL PROTOCOL. CORCYM REPRESENTATIVE WAS INFORMED ON (B)(6) 2023 THAT THE PATIENT WAS UNABLE TO GET OFF TEMPORARY PACING AND WAS SCHEDULED FOR A PERMANENT PACEMAKER IMPLANT. AS PER ADDITIONAL IFORMATION RECEIVED, PERMANENT PACEMAKER WAS IMPLANTED ON (B)(6) 2023 WITH NO COMPLICATIONS. AS PER MEDICAL JUDGEMENT RECEIVED, IT'S POSSIBLE THAT THE PATIENT SINUS RHYTHM WILL RECOVER, HENCE THE PATIENT WILL BE MONITORED BY THE CARDIOLOGISTS ACCORDINGLY. THE SITE DIDN'T IDENTIFY ANY PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATIENT'S MEDICAL HISTORY AND RELEVANT RISK FACTORS, INCLUDING A HISTORY OF CONDUCTION DISORDERS, ARE UNKNOWN AND NO INFORMATION WAS SHARED WITH THE MANUFACTURER ON PATIENT'S MEDICATION. IT WAS REPORTED THAT AFTER IMPLANT THE VALVE SHOWED GOOD FLOW, NO REGURGITATION AND IMPROVED LOWER MEAN AND PEAK PRESSURE GRADIENTS. NO DEVICE MALFUNCTION IS REPORTED

  Patient problems: Heart Block

  MAUDE report 16924964 ↗
• InjuryMar 28, 2023Calcified; Calcified

  THE MANUFACTURER WAS INFORMED THAT PERCEVAL SUTURELESS AORTIC HEART VALVE SIZE XL WHICH WAS IMPLANTED ON (B)(6) 2020 WAS EXPLANTED ON (B)(6) 2023 DUE TO DEGENERATION. BASED ON THE INFORMATION RECEIVED, AT THE END OF 2022, A SEVERE, SYMPTOMATIC AORTIC STENOSIS WAS DIAGNOSED. AS REPORTED, DURING THE RE-DO SURGERY ON (B)(6) 2023, THE PERCEVAL PROSTHESIS REVEALED CALCIFIED LEAFLETS CONFIRMING THE STENOSIS SHOWN IN ECHO. AFTER THE DEVICE WAS REMOVED, DUE TO DENSE ADHESIONS WITH THE AORTIC WALL, THE AORTIC ROOT NEEDED TO BE REPLACED AS WELL. AS SUCH, MECHANICAL CONDUIT WAS USED AS A REPLACEMENT. REPORTEDLY, SURGERY WAS COMPLETED WITH NO COMPLICATIONS AND NO ENDOCARDITIS WAS REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16632052 ↗
• InjuryFeb 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. BASED ON THE INFORMATION RECEIVED, ON (B)(6) 2022, A PERCEVAL SUTURELESS AORTIC HEAR VALVE PVS27 WAS IMPLANTED IN THE PATIENT THROUGH MEDIAN STERNOTOMY. THE CONCOMITANT PROCEDURE WAS CABG. REPORTEDLY, ON (B)(6) 2022, THIRD DEGREE AV BLOCK STARTED AND ON (B)(6) 2022, A TEMPORARY PACEMAKER WAS IMPLANTED. BASED ON THE UPDATE RECEIVED FROM THE SITE, ON (B)(6) 2022, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT, AND PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME WAS REPORTED AS RECOVERED/RESOLVED. PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE, ANGINA (STABLE CCS CLASS II), SYSTEMIC HYPERTENSION, AND DIABETES MELLITUS TYPE II. PATIENT ALSO UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (STENTING) IN 2011.

  Patient problems: Heart Block

  MAUDE report 16321367 ↗
• InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER WAS INFORMED THAT PERCIVAL HEART VALVE SIZE 27 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. REPORTEDLY, THE ANNULUS DIAMETER WAS 28.8MM ON PREOPERATIVE CT. DURING THE SIZING PROCEDURE, THE XL WHITE OBTURATOR WAS MODERATELY RESISTANT, SO THE XL SIZE VALVE WAS IMPLANTED. HOWEVER, AFTER DE-CLAMP, ECHO SHOWED PARAVALVULAR LEAKAGE. AFTER RE-CLAMP, IT WAS FOUND THAT THE PART OF THE DEVICE HAS FALLEN TO THE LVOT SIDE. AS SUCH, DEVICE WAS EXPLANTED AND EPIC 27MM WAS IMPLANTED INSTEAD. BASED ON THE MEDICAL JUDGEMENT RECEIVED, THE FALL OF THE DEVICE WAS PROBABLY DUE TO A LARGER NATIVE ANNULUS. MORE THAN 20 MINUTES WAS ADDED TO THE CROSS CLAMP TIME AS A RESULT OF THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED, THERE WAS NO CONCOMITANT PROCEDURE AND ECHO IS UNAVAILABLE. THERE WAS NO POSITIONING DIFFICULTY, NO ABNORMAL GEOMETRY IN THE PATIENT'S ANNULUS, AND NO PROBLEM WITH THE DEVICE FUNCTIONALITY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15287295 ↗
• InjuryNov 24, 2021Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  ON (B)(6) 2021, A PERCEVAL VALVE PVS27 WAS IMPLANTED IN AORTIC POSITION. THE DEVICE WAS EXPLANTED ON (B)(6) 2021 DUE DISLODGED AORTIC VALVE. THE PATIENT ULTIMATELY RECEIVED A 25 MM CARPENTIER-EDWARDS VALVE. NO CPR OR OTHER MANIPULATION OF THE HEART WERE PERFORMED AFTER THE PERCEVAL VALVE IMPLANT. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021. THE DEVICE FUNCTIONALITY WAS CHECKED AT THE TIME OF IMPLANT, AND POSTOPERATIVELY, WITH THE FOLLOWING FINDINGS. FROM THE OPERATIONAL NOTE, IT IS REPORTED THAT THE VALVE FUNCTIONED WELL WITH MILD PERIPROSTHETIC LEAK IN THE EXPECTED LOCATION OF SEVERE CALCIFICATION. THE INTRAOPERATIVE TEE POST-BYPASS SHOWED THAT A WELL SEATED BIOPROSTHETIC AORTIC VALVE. THERE WAS NO PROSTHETIC VALVULAR REGURGITATION AND MILD-MODERATE PERIVALVULAR REGURGITATION WAS PRESENT. IN THE MIDESOPHAGEAL AORTIC VALVE SHORT AXIS VIEW THIS WAS NOTED BY WHERE THE NATIVE RIGHT CORONARY CUSP AND THE NATIVE RIGHT-LEFT CUSP JUNCTION WOULD LIE ANATOMICALLY. IN THE MIDESOPHAGEAL LONG AXIS VIEW, THE PERIVALVULAR REGURGITATION WAS NOTED ALONG WHERE THE VALVE ABUTS THE INTERVENTRICULAR SEPTUM. NO HOLODIASTOLIC REVERSALS WERE NOTED WITH PULSE WAVE DOPPLER IN THE DESCENDING THORACI

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Thrombocytopenia

  MAUDE report 12869582 ↗
• InjuryNov 24, 2021Perivalvular Leak; Device Dislodged or Dislocated; Perivalvular Leak; Device Dislodged or Dislocated

  ON (B)(6) 2021, A PERCEVAL VALVE PVS27 WAS IMPLANTED IN AORTIC POSITION. THE DEVICE WAS EXPLANTED ON (B)(6) 2021 DUE DISLODGED AORTIC VALVE. THE PATIENT ULTIMATELY RECEIVED A 25 MM CARPENTIER-EDWARDS VALVE. NO CPR OR OTHER MANIPULATION OF THE HEART WERE PERFORMED AFTER THE PERCEVAL VALVE IMPLANT. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021. THE DEVICE FUNCTIONALITY WAS CHECKED AT THE TIME OF IMPLANT, AND POSTOPERATIVELY, WITH THE FOLLOWING FINDINGS. FROM THE OPERATIONAL NOTE, IT IS REPORTED THAT THE VALVE FUNCTIONED WELL WITH MILD PERIPROSTHETIC LEAK IN THE EXPECTED LOCATION OF SEVERE CALCIFICATION. THE INTRAOPERATIVE TEE POST-BYPASS SHOWED THAT A WELL SEATED BIOPROSTHETIC AORTIC VALVE. THERE WAS NO PROSTHETIC VALVULAR REGURGITATION AND MILD-MODERATE PERIVALVULAR REGURGITATION WAS PRESENT. IN THE MIDESOPHAGEAL AORTIC VALVE SHORT AXIS VIEW THIS WAS NOTED BY WHERE THE NATIVE RIGHT CORONARY CUSP AND THE NATIVE RIGHT-LEFT CUSP JUNCTION WOULD LIE ANATOMICALLY. IN THE MIDESOPHAGEAL LONG AXIS VIEW, THE PERIVALVULAR REGURGITATION WAS NOTED ALONG WHERE THE VALVE ABUTS THE INTERVENTRICULAR SEPTUM. NO HOLODIASTOLIC REVERSALS WERE NOTED WITH PULSE WAVE DOPPLER IN THE DESCENDING THORACIC

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Thrombocytopenia

  MAUDE report 12869546 ↗
• InjurySep 8, 2021Perivalvular Leak; Inadequacy of Device Shape and/or Size; Perivalvular Leak; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2021 A PERCEVAL PVS7 WAS IMPLANTED INTO A PATIENT WHO NEEDED AN AVR. A HIGH AORTOTOMY WAS PERFORMED AND THERE WAS SIGNIFICANT CALCIFICATION OF THE VALVE, AND THE RIGHT AND LEFT CORONARY CUSPS WERE FUSED. EXTENSIVE DEBRIDEMENT WAS REQUIRED. THE ANNULUS WAS SIZED TO A 23MM INSPIRIS EDWARDS VALVE, INITIALLY A PERCEVAL XL WAS SELECTED TO BE IMPLANTED. THE PERCEVAL XL WAS DEPLOYED AND LOOKED TO BE IN EXCELLENT POSITION AND THE RIGHT AND LEFT MAIN CORONARY ARTERIES WERE UNOBSTRUCTED. AGGRESSIVE DEAIRING WAS PERFORMED AND THE PATIENT STILL REQUIRED SOME DEFIBRILLATION, AS THE PATIENT STABILIZED A MODERATE CENTRAL AORTIC INSUFFICIENCY WAS NOTED. CROSS-CLAMP WAS REAPPLIED AND A CARDIOPLEGIC ARREST WAS REPERFORMED. DISTORTION AND A CRESCENT-SHAPING PERCEVAL VALVE WAS NOTED AND THE VALVE WAS EXPLANTED. BASED ON ADDITIONAL INFORMATION NO CPR WAS PERFORMED AND THE PATIENTS ANNULUS WAS 25MM.

  Patient problems: Insufficient Information

  MAUDE report 12438745 ↗
• InjurySep 7, 2021Leak/Splash; Perivalvular Leak; Inadequacy of Device Shape and/or Size; Material Deformation; Leak/Splash; Perivalvular Leak; Inadequacy of Device Shape and/or Size; Material Deformation

  ON (B)(6) 2021 A PERCEVAL PVS7 WAS IMPLANTED INTO A PATIENT WHO NEEDED AN AVR. A HIGH AORTOTOMY WAS PERFORMED AND THERE WAS SIGNIFICANT CALCIFICATION OF THE VALVE, AND THE RIGHT AND LEFT CORONARY CUSPS WERE FUSED. EXTENSIVE DEBRIDEMENT WAS REQUIRED. THE ANNULUS WAS SIZED TO A 23MM INSPIRIS EDWARDS VALVE, INITIALLY A PERCEVAL XL WAS SELECTED TO BE IMPLANTED. THE PERCEVAL XL WAS DEPLOYED AND LOOKED TO BE IN EXCELLENT POSITION AND THE RIGHT AND LEFT MAIN CORONARY ARTERIES WERE UNOBSTRUCTED. AGGRESSIVE DEAIRING WAS PERFORMED AND THE PATIENT STILL REQUIRED SOME DEFIBRILLATION, AS THE PATIENT STABILIZED A MODERATE CENTRAL AORTIC INSUFFICIENCY WAS NOTED. CROSS-CLAMP WAS REAPPLIED AND A CARDIOPLEGIC ARREST WAS REPERFORMED. DISTORTION AND A CRESCENT-SHAPING PERCEVAL VALVE WAS NOTED AND THE VALVE WAS EXPLANTED. BASED ON ADDITIONAL INFORMATION NO CPR WAS PERFORMED AND THE PATIENTS ANNULUS WAS 25MM.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 12436798 ↗
• InjuryJul 30, 2021Perivalvular Leak; Inadequacy of Device Shape and/or Size; Perivalvular Leak; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A PERCEVAL VALVE MODEL PVS27 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THE REPORTED EVENT. THE MANUFACTURER OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT. THE PATIENT WAS REFERRED FOR AN ELECTIVE AORTIC VALVE REPLACEMENT DUE TO AORTIC VALVE STENOSIS. THE AORTIC VALVE WAS TRICUSPID IN NATURE WITH SEVERE LEAFLET AND MODERATE ANNULAR CALCIFICATIONS. THE ANNULUS WAS MEASURED AT AROUND 25MM AND A PERCEVAL XL WAS SELECTED. DURING REPERFUSION, IT WAS APPARENT THAT THERE WAS A MODERATE TO SEVERE AMOUNT OF PERIVALVULAR AORTIC VALVE REGURGITATION IN THE REGION OF THE LEFT CORONARY SINUS. IT WAS THEREFORE DECIDED TO REMOVE THE PERCEVAL VALVE AND TO INSERT A SUTURED VALVE (CARPENTIER EDWARDS PERIMOUNT MAGNA EASE 25MM). THE PATIENT HAS DONE WELL POSTOPERATIVELY. BASED ON THE MEDICAL JUDGMENT ON THE EVENT, THE MAIN PROBLEM WAS A LARGE ANNULAR DIAMETER.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 12251547 ↗
• InjuryJul 27, 2021Perivalvular Leak; Inadequacy of Device Shape and/or Size; Perivalvular Leak; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A PERCEVAL VALVE MODEL PVS27 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THE REPORTED EVENT. THE MANUFACTURER OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT. THE PATIENT WAS REFERRED FOR AN ELECTIVE AORTIC VALVE REPLACEMENT DUE TO AORTIC VALVE STENOSIS. THE AORTIC VALVE WAS TRICUSPID IN NATURE WITH SEVERE LEAFLET AND MODERATE ANNULAR CALCIFICATIONS. THE ANNULUS WAS MEASURED AT AROUND 25MM AND A PERCEVAL XL WAS SELECTED. DURING REPERFUSION, IT WAS APPARENT THAT THERE WAS A MODERATE TO SEVERE AMOUNT OF PERIVALVULAR AORTIC VALVE REGURGITATION IN THE REGION OF THE LEFT CORONARY SINUS. IT WAS THEREFORE DECIDED TO REMOVE THE PERCEVAL VALVE AND TO INSERT A SUTURED VALVE (CARPENTIER EDWARDS PERIMOUNT MAGNA EASE 25MM). THE PATIENT HAS DONE WELL POSTOPERATIVELY. BASED ON THE MEDICAL JUDGMENT ON THE EVENT, THE MAIN PROBLEM WAS A LARGE ANNULAR DIAMETER.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 12235146 ↗
• InjuryJun 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A PERCEVAL VALVE MODEL PVS27 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12023546 ↗
• InjuryJun 17, 2021Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT.BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A PERCEVAL VALVE MODEL PVS27 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE IDENTIFYING THE FOLLOWING. THE PATIENT REQUIRED AORTIC VALVE REPLACEMENT DUE TO SEVERE CALCIFICATION OF THE NATIVE VALVE. THE VALVE WAS SIZED FOR A EXTRA LARGE PERCEVAL WHICH WAS BROUGHT TO THE FIELD. THREE GUIDING SUTURES WERE PLACED AT THE COMMISSURE NADIRS AND THE VALVE DELIVERED. POSITIONING APPEARED EXCELLENT WITH NO SIGNIFICANT EVIDENCE FOR UNDER OVERSIZING. PER THE IFU, BALLOON DILATION OF THE VALVE WAS PERFORMED. THE AORTA WAS THEN CLOSED IN A DOUBLE LAYER FASHION. HOWEVER DURING THE DE-AIRING PROCESS, IT WAS NOTED THE VALVE POSITIONING WAS EXTREMELY ALTERED AND WAS NOW NOTED IN THE LEFT VENTRICULAR CAVITY. IT REQUIRED THE PATIENT TO BE PLACED ON CARDIO PULMONARY BYPASS AGAIN. THE PERCEVAL VALVE WAS RETRIEVED AND REPLACED BY ANOTHER MANUFACTURER' S VALVE (MEDTRONIC AVALUS 25 MM VALVE). THE PATIENT REMAINED STABLE DURING THE ENTIRE PROCEDURE AND WAS ON CARDIOPULMONARY BYPASS AT THE T

  Patient problems: Insufficient Information

  MAUDE report 12021281 ↗
• InjuryMay 7, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2021, A PATIENT RECEIVED A PERCEVAL PVS27 THROUGH A RAT PROCEDURE. AFTER 5 DAYS, THE PATIENT WAS DISCHARGED. SEVERE PARAVALVULAR LEAKAGE AND TRANSVALVULAR AORTIC REGURGITATION WAS OBSERVED AT THE ECHO ON (B)(6) 2021. REDO CASE WAS PLANNED ON (B)(6). THE PERCEVAL PVS27 VALVE WAS EXPLANTED AND A ST JUDE 21 MM MECHANICAL VALVE WAS IMPLANTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11795140 ↗
• InjuryMay 7, 2021Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2021, A PATIENT RECEIVED A PERCEVAL PVS27 THROUGH A RAT PROCEDURE. AFTER 5 DAYS, THE PATIENT WAS DISCHARGED. SEVERE PARAVALVULAR LEAKAGE AND TRANSVALVULAR AORTIC REGURGITATION WAS OBSERVED AT THE ECHO ON (B)(6) 2021. REDO CASE WAS PLANNED ON 1ST APR. THE PERCEVAL PVS27 VALVE WAS EXPLANTED AND A ST JUDE 21 MM MECHANICAL VALVE WAS IMPLANTED. NO STENT FOLDING WAS REPORTEDLY IDENTIFIED ALONG WITH THE PVL, AND NO POSSIBLE ROOT CAUSE WAS IDENTIFIED BASED ON THE INFORMATION RECEIVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11795136 ↗
• InjuryMay 7, 2021Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT WAS RECEIVED: THE PERCEVAL EXTRA LARGE WAS IMPLANTED AND WAS REPORTEDLY TOO SMALL, SO THE VALVE WAS THEN REPLACED WITH A 25 SUTURED EDWARDS VALVE. AS REPORTED, THERE WAS NO PROBLEM WITH THE PRODUCT. NO FURTHER INFORMATION WAS RECEIVED ON THE PATIENT IMPACT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11793070 ↗
• InjuryMay 7, 2021Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT WAS RECEIVED: THE PERCEVAL EXTRA LARGE WAS IMPLANTED AND WAS REPORTEDLY TOO SMALL, SO THE VALVE WAS THEN REPLACED WITH A 25 SUTURED EDWARDS VALVE. AS REPORTED, THERE WAS NO PROBLEM WITH THE PRODUCT. NO FURTHER INFORMATION WAS RECEIVED ON THE PATIENT IMPACT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11792938 ↗
• InjuryApr 28, 2021Insufficient Device Problem Information; Device Contaminated at the User Facility; Insufficient Device Problem Information; Device Contaminated at the User Facility

  PER ADDITIONAL INFORMATION RECEIVED, 40 MINUTES WERE ADDED FOR BOTH SURGERY AND X-CLAMP TIME INCLUDED. FURTHERMORE, ACCORDING TO THE SURGEON, IT WAS CONFIRMED THAT THE HAIR WAS NOT INSIDE THE SEALED CONTAINER ACCORDING TO THE SURGEON, AND THE HAIR COME PROBABLY FROM AN OPERATOR DURING THE VALVE PREPARATION. THE REMAINDER OF THE INFORMATION PREVIOUSLY SUBMITTED REMAINS UNCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742682 ↗
• InjuryApr 28, 2021Insufficient Device Problem Information; Device Contaminated at the User Facility; Insufficient Device Problem Information; Device Contaminated at the User Facility

  PER ADDITIONAL INFORMATION RECEIVED, 40 MINUTES WERE ADDED FOR BOTH SURGERY AND X-CLAMP TIME INCLUDED. FURTHERMORE, ACCORDING TO THE SURGEON, IT WAS CONFIRMED THAT THE HAIR WAS NOT INSIDE THE SEALED CONTAINER ACCORDING TO THE SURGEON, AND THE HAIR COME PROBABLY FROM AN OPERATOR DURING THE VALVE PREPARATION. THE REMAINDER OF THE INFORMATION PREVIOUSLY SUBMITTED REMAINS UNCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742679 ↗
• InjuryApr 8, 2021Unintended Movement; Unintended Movement

  THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT REGISTRATION FORM, ON (B)(6) 2020, A PATIENT WAS INTENDED TO RECEIVE A PERCEVAL PVSXL IN AORTIC POSITION. THE DEVICE WAS REPORTEDLY EXPLANTED INTRAOPERATIVELY. ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL CONFIRMED THAT THE VALVE WAS EXPLANTED DUE TO VALVE ROCKING ON POST-IMPLANT TEE. THE PERCEVAL XL VALVE WAS REPLACED BY A 27 MM ST. JUDE TRIFECTA TISSUE VALVE. NO DEVICE MALFUNCTIONS WERE IDENTIFIED, AND THE PATIENT HAD AN EXCELLENT OUTCOME AFTER THE PROCEDURE. THE DEVICE DISPOSITION AFTER THE EXPLANT IS UNKNOWN. DURING THE SAME PROCEDURE, THE FOLLOWING CONCOMITANT PROCEDURES WERE PERFORMED: BI-ATRIAL COX-4 MAZE, AND LAA CLIP. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT DUE TO SEVERE AORTIC STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638188 ↗