PERCEVAL PLUS PVF-L (UDI 08022057015389)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08022057015389), received between Mar 5, 2024 and Jun 20, 2026 — classified as 1 death, 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 other recall cover devices cleared under the same FDA submission (P150011); they may or may not involve this specific model.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2026Migration

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A PERCEVAL PLUS VALVE. ON (B)(6) 2026, A PERCEVAL PLUS PVF-L VALVE WAS IMPLANTED IN A PATIENT. SHORTLY AFTER THE IMPLANTATION, THE PROSTHESIS BECAME LOOSENED AND MIGRATED FROM ITS INTENDED ANNULAR POSITION, RESULTING IN MALPOSITION WITHIN THE AORTA. THE PATIENT REQUIRED SECOND SURGERY SHORTLY AFTER THE FIRST SURGERY, AND THE VALVE WAS REPLACED WITH A TRADITIONAL SUTURE VALVE MAGNA EASE 23 MM. IT WAS INDICATED THAT THE ANNULUS WAS MEASURED THE THREE TIMES PRIOR CHOOSING LARGE (L) SIZE FOR THE PATIENT, THE PLACEMENT OF VALVE WAS VERIFIED AND ASSESSED USING TEE BEFORE THE WOUND WAS CLOSED. SURGICAL APPROACH WAS MICS, AND ISOLATED AVR WITH NO CONCOMITANT PROCEDURE. PATIENT¿S ANNULUS SIZED AS 26 X 21 MM, AREA OF 7.42 CM SQUARE. NO DEVICE MIS-SIZING WAS IDENTIFIED, NO ABNORMAL GEOMETRIES IN THE PATIENT¿S ANNULUS MENTIONED. NO POSITIONING DIFFICULTY NOTED AS THE IMPLANTATION OF THE VALVE WAS SUCCESSFUL IN THE FIRST TRY AFTER TRIPLE CHECKING THE SIZE WITH SIZER. REPORTEDLY, PATIENT WAS TAKEN INTO THE OR FOR THE SECOND TIME ON THE SAME DAY. NO DELAY IN THE FIRST SURGERY AND FOR THE SECOND SURGERY (REOPEN) THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25569071 ↗
• InjuryMar 25, 2026Deformation Due to Compressive Stress

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM THE FACILITY. ON (B)(6) 2026, A PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED AND THE AORTA WAS CLOSED. DUE TO ECHO RESULTS, THE AORTA WAS RE-OPENED AND IT WAS OBSERVED THAT THE PERCEVAL VALVE WAS NOT EXPANDED PROPERLY. CONSEQUENTLY, THE VALVE WAS EXPLANTED AND REPLACED WITH A MEDTRONIC HANCOCK II 25 MM VALVE. THE ORIGINAL VALVE WAS SUBSEQUENTLY DISPOSED OF BY THE SITE. NO ADDITIONAL DETAILS REGARDING THE EVENT, PATIENT OUTCOME, OR DIAGNOSTIC IMAGES DEMONSTRATING THE REPORTED INFOLDING ARE AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24687539 ↗
• InjuryMar 14, 2026Malposition of Device

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE THROUGH DEVICE TRACKING. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN A PATIENT ON (B)(6) 2026. DUE TO A VALVE DISLOCATION, IT WAS EXPLANTED AND REPLACED WITH MEDTRONIC MOSAIC ULTRA 25MM DURING THE SAME DAY. AS REPORTED, PATIENT HAD CHALLENGING ANATOMY AND SURGEON DECIDED TO SUTURE IN A STENTED VALVE. PATIENT DID WELL AS FURTHER REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24600317 ↗
• InjuryFeb 14, 2026Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF AN INTRA-OPERATIVE EXPLANT INVOLVING A PERCIVAL PLUS PROSTHESIS. ON (B)(6) 2026, A PERCIVAL PLUS PVF-M WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE PERCEVAL VALVE DID NOT PERFORM ADEQUATELY AND WAS EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24340394 ↗
• InjuryFeb 12, 2026Migration

  A PERCEVAL PLUS SIZE L VALVE WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2025 THROUGH MINI-STERNOTOMY. THE PATIENT PRESENTED WITH AORTIC VALVE INSUFFICIENCY. PRE-OPERATIVE ASSESSMENT WAS CONDUCTED THROUGH CT AND THE PATIENT WAS INITIALLY INDICATED FOR AORTIC REPAIR. HOWEVER, AFTER OPENING THE AORTA, IT WAS ASSESSED THAT THE LEAFLETS WERE TOO HEAVILY CALCIFIED, THEREFORE IT WAS DECIDED TO PROCEED WITH LEAFLET RESECTION AND PERCEVAL VALVE IMPLANTATION. THE EVALUATION OF PRE-OPERATIVE CT SCANS WAS SUGGESTIVE OF A SIZE L AND CONFIRMED THAT STJ/ANNULUS RATIO WAS ADEQUATE FOR PERCEVAL VALVE IMPLANT. THE PATIENT¿S NATIVE VALVE WAS TRICUSPID. SIZING WAS PERFORMED INTRA-OPERATIVELY AND SIZE L WAS CONFIRMED TO BE ADEQUATE. NO ISSUES WERE REPORTED DURING VALVE PREPARATION OR POSITIONING. THE VALVE POSITION WAS CHECKED, AND THE VALVE APPEARED WELL SEATED ACCORDING TO THE SURGEON¿S ASSESSMENT (NO ANULUS VISIBLE, NO CORONARY OSTIA OBSTRUCTION, GOOD VALVE APPEARANCE IN SITU). AFTER AORTOTOMY CLOSURE, TEE REVEALED ABNORMAL PROSTHETIC MOVEMENT, WITH THE VALVE FLUCTUATING IN THE LCC AREA ABOVE THE LEFT CORONARY COMMISSURE. THE PATIENT WAS PUT BACK ON-PUMP. REOPENING OF THE AORTA SHOWED PARTIAL VALVE MIG

  Patient problems: Aortic dissection

  MAUDE report 24321711 ↗
• InjuryDec 31, 2025Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLANT OF A PERCEVAL PLUS SIZE L, WHICH OCCURRED ON (B)(6) 2025. REPORTEDLY, THE PATIENT RECEIVED THE PVF-L VALVE IN AORTIC POSITION ON (B)(6) 2023. BASED ON THE AVAILABLE INFORMATION, THE PATIENT IS AFFECTED BY MYELODYSPLASTIC/MYELOPROLIFERATIVE SYNDROME WITH SF3B1 AND JAK2 MUTATIONS AND IS ON TREATMENT WITH ONCOCARBIDE. ON (B)(6) 2025, THE VALVE WAS EXPLANTED AND REPLACED BY A BICARBON SLIMLINE VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23935101 ↗
• InjuryDec 24, 2025Leak/Splash; Leak/Splash

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE SIZE L WAS ATTEMPTED TO BE IMPLANTED THROUGH FULL STERNOTOMY DURING AN AVR+CABG PROCEDURE. REPORTEDLY, A LARGE SIZE WAS USED; HOWEVER, A MEDIUM SIZE WAS REFERENCED. THE VALVE WAS IMPLANTED, THEN REMOVED DUE TO A PARAVALVULAR LEAK, AND EDWARDS INSPIRIS SIZE 23 WAS IMPLANTED INSTEAD. BASED ON THE FURTHER INFORMATION RECEIVED, DISTAL WAS PERFORMED FIRST, THEN VALVE WAS IMPLANTED, THEN PROXIMAL WAS PERFORMED. THE VALVE WAS BICUSPID CLASS 1, AND HEAVILY CALCIFIED. APPROXIMATELY 60 MIN WAS ADDED TO THE PROCEDURE AND FURTHER DEACIDIFICATION WAS PERFORMED PRIOR TO IMPLANT OF THE SECOND VALVE. REPORTEDLY, PATIENT HAD A LONG PUMP RUN DURING THE SURGERY, PATIENT EXPERIENCED AV BLOCK POST OP, HAD TO GO THROUGH TREATMENT FOR ACUTE RESPIRATORY DISTRESS, PULMONARY EDEMA, RIGHT PLURAL EFFUSION DRAINS, FEBRILE, PNEUMONIA, AND LARGE ASPIRATION PNEUMONIA. PATIENT WAS ON VENTILATOR IN (B)(6) 2026 AND IS CURRENTLY IN CCU CURRENTLY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23889344 ↗
• InjuryDec 16, 2025Malposition of Device; Malposition of Device

  THE MANUFACTURER WAS INFORMED OF THE INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS, PVF-L, WHICH OCCURRED ON (B)(6) 2025. REPORTEDLY, THE ANNULUS WAS INITIALLY SIZED FOR A LARGE VALVE. HOWEVER, THE SURGEON INDICATED THAT THE VALVE HAD MOVED SO IT WAS EXPLANTED AND A SIZE 23MM INSPIRIS VALVE WAS IMPLANTED INSTEAD. ADDITIONAL BYPASS TIME WAS REQUIRED, THOUGH THE EXACT DURATION COULD NOT BE CONFIRMED. THE EXPLANTED VALVE WILL NOT BE RETURNED. ATTEMPTS TO OBTAIN FURTHER DETAILS WERE UNSUCCESSFUL, AS THE SURGEON DECLINED ADDITIONAL FOLLOW UP, AND NO FURTHER INFORMATION IS AVAILABLE REGARDING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23814129 ↗
• InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE, PVF-L, THAT OCCURRED ON (B)(6) 2025. AS REPORTED, THERE WAS PVL AT THE NON-CORONARY SINUS, AND THERE WAS NO IMPACT TO PATIENT. BASED ON THE INFORMATION RECEIVED, THE VALVE WAS EXPLANTED THROUGH FULL STERNOTOMY. ANNULUS SIZE WAS AROUND 24 MM. ABOUT 60 MINUTES WAS ADDED TO THE PROCEDURE. PATIENT WAS STABLE THROUGH THE PROCEDURE. REPORTEDLY, PERCEVAL VALVE WAS EXPLANTED AND INSPIRIS WAS IMPLANTED INSTEAD. BASED ON THE MEDICAL JUDGMENT RECEIVED, THERE COULD BE A MALPOSITIONING OR THE VALVE MAY HAVE DISLODGED DURING BALLOONING.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23628480 ↗
• InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS VALVE, PVF-L, THAT OCCURRED ON (B)(6) 2025. AS REPORTED, THERE WAS PVL AT THE NON-CORONARY SINUS, AND THERE WAS NO IMPACT TO PATIENT. BASED ON THE INFORMATION RECEIVED, THE VALVE WAS EXPLANTED THROUGH FULL STERNOTOMY. ANNULUS SIZE WAS AROUND 24 MM. ABOUT 60 MINUTES WAS ADDED TO THE PROCEDURE. PATIENT WAS STABLE THROUGH THE PROCEDURE. REPORTEDLY, PERCEVAL VALVE WAS EXPLANTED AND INSPIRIS WAS IMPLANTED INSTEAD. BASED ON THE MEDICAL JUDGMENT RECEIVED, THERE COULD BE A MALPOSITIONING OR THE VALVE MAY HAVE DISLODGED DURING BALLOONING.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23628479 ↗
• InjurySep 18, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, DURING AN AVR CASE, THE PATIENT'S ANNULUS WAS ASSESSED USING AN ANNULUS SIZER AND A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN THE PATIENT. HOWEVER, POSTOPERATIVE ECHOCARDIOGRAPHY REVEALED SIGNIFICANT PVL, NECESSITATING EXPLANTATION OF THE PERCEVAL VALVE. THE PROCEDURE WAS THEN COMPLETED USING A 23MM CONVENTIONAL VALVE FROM ANOTHER MANUFACTURER. REPORTEDLY, IT WAS AN ISOLATED MICS SURGERY, PATIENT'S ANNULUS WAS AROUND 23 MM, PATIENT REMAINED STABLE THROUGH THE SURGERY, AND PATIENT'S OUTCOME WAS GOOD. AS REPORTED, NO MIS-SIZING NOR POSITIONING DIFFICULTY WAS NOTED AND THERE WAS NO ABNORMAL GEOMETRY IN PATIENT'S ANATOMY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23092027 ↗
• InjuryAug 27, 2025Perivalvular Leak; Migration; Perivalvular Leak; Migration

  THE MANUFACTURER RECEIVED AN OFFICIAL NOTIFICATION FROM THE TURKISH MEDICINES AND MEDICAL DEVICES AGENCY (TITCK) REGARDING A SITE-REPORTED ADVERSE EVENT. ACCORDING TO THE NOTIFICATION, A PERCEVAL PLUS PVF-L WAS EXPLANTED FEW MONTHS AFTER IMPLANT DUE TO PARAVALVULAR LEAK AND THROMBOCYTOPENIA DEVELOPED IN THE PATIENT. STRUCTURAL ABNORMALITIES WERE REPORTEDLY OBSERVED IN THE ANNULAR REGION OF THE PROSTHESIS UPON EXPLANT, CORRESPONDING TO THE LOCATION OF THE LEAK, AND THE REDO PROCEDURE WAS COMPLETED USING A MECHANICAL PROSTHESIS (CARBOMEDICS MODEL A5-23, SN (B)(6)). ACCORDING TO FURTHER INFORMATION RECEIVED, THERE WAS A CONCERN THAT THE PROSTHESIS COULD HAVE BEEN DAMAGED DURING THE EXPLANT MANOEUVRES. REPORTEDLY, THE INITIAL SURGICAL PROCEDURE WAS PERFORMED VIA FULL STERNOTOMY ON (B)(6) 2025 AND INCLUDED A CONCOMITANT CORONARY ARTERY BYPASS GRAFTING (CABG) PERFORMED AFTER THE PERCEVAL PLUS VALVE IMPLANT, INVOLVING A LIMA-TO-LAD GRAFT. IT WAS NOTED THAT THE PATIENT HAD A HEAVILY CALCIFIED TRICUSPID NATIVE VALVE, AND THERE WAS UNCERTAINTY BETWEEN SELECTING SIZE XL OR L OF THE PERCEVAL PROSTHESIS. THIS HAD THOUGH NEGLIGIBLE IMPACT ON SURGICAL DURATION. ULTIMATELY, SIZE L WAS IMPLANTED DU

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

  MAUDE report 22906612 ↗
• MalfunctionJul 31, 2025Leak/Splash; Leak/Splash

  ON (B)(6) 2025, A PERCEVAL PLUS HEART VALVE, PVF-L WAS IMPLANTED IN THE PATIENT. REPORTEDLY, PVL WAS NOTED. AS FURTHER REPORTED, THE SURGICAL APPROACH WAS A FULL STERNOTOMY, AND THE PATIENT ANNULUS WAS SIZED AS 25MM. A CABG WAS ALSO PERFORMED AS A CONCOMITANT PROCEDURE. THE NATIVE VALVE WAS NOT BICUSPID NOR STENO INSUFFICIENT. THE VALVE WAS EXPLANTED DUE TO SEVERE PVL AND MILD CENTRAL LEAK. HOWEVER, THERE WAS NO MAL-POSITIONING OR MIS-SIZING IDENTIFIED, NOR ANY POSITIONING DIFFICULTY NOTED. AN INSPIRIS 25MM WAS FINALLY IMPLANTED INSTEAD. THERE WAS AN ADDITIONAL CROSS-CLAMP TIME AND BY-PASS TIME OF 20 MINUTES. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE, AND THE PATIENT IS DOING WELL.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22680750 ↗
• InjuryJul 16, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED OF A FAILURE TO IMPLANT A PVF-L. REPORTEDLY, THE VALVE WAS IMPLANTED ON (B)(6) 2025, BUT CENTRAL AI AND PVL WAS NOTED WHEN THE PATIENT WENT OFF PUMP. THEREFORE, THE PROSTHESIS WAS EXPLANTED AND REPLACED WITH A DIFFERENT VALVE. BASED ON THE FURTHER INFORMATION RECEIVED, THE VALVE WAS IMPLANTED THROUGH FULL STERNOTOMY, THE VALVE WAS REPLACED WITH INSPIRIS 23, CONCOMITANT PROCEDURE WAS AVR AND MVR. REPORTEDLY, THERE WAS NO IMPACT ON THE PATIENT AND PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF THE SURGERY. THE PATHOLOGY TEAM INDICATED THAT THE EXPLANTED DEVICE WAS INADVERTENTLY DISCARDED BEFORE IT COULD BE PRESERVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22524249 ↗
• InjuryJul 16, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED OF A FAILURE TO IMPLANT A PVF-L. REPORTEDLY, THE VALVE WAS IMPLANTED BUT CENTRAL AI AND PVL WAS NOTED WHEN THE PATIENT WENT OFF PUMP. THEREFORE, THE PROSTHESIS WAS EXPLANTED AND REPLACED WITH A DIFFERENT VALVE. BASED ON THE FURTHER INFORMATION RECEIVED, THE VALVE WAS IMPLANTED THROUGH FULL STERNOTOMY, THE VALVE WAS REPLACED WITH INSPIRIS 23, CONCOMITANT PROCEDURE WAS AVR AND MVR. REPORTEDLY, THERE WAS NO IMPACT ON THE PATIENT AND PATIENT REMAINED STABLE THROUGH THE PROLONGATION OF THE SURGERY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22524248 ↗
• InjuryJun 19, 2025Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE, SIZE L (PVF-L), WHICH OCCURRED ON (B)(6) 2025. REPORTS INDICATE THAT A WHEAT PROCEDURE WAS CARRIED OUT VIA A FULL STERNOTOMY, INVOLVING THE REPLACEMENT OF BOTH THE AORTIC VALVE AND A PORTION OF THE ASCENDING AORTA. FOLLOWING IMPLANTATION, A PARAVALVULAR LEAK WAS DETECTED, LEADING TO THE REMOVAL OF THE PVF-L VALVE AND ITS REPLACEMENT WITH A SUTURED INSPIRIS VALVE SIZE 23. CONSEQUENTLY, THE DURATION OF THE SURGERY WAS EXTENDED BY APPROXIMATELY 35-40 MINUTES. ACCORDING TO THE INFORMATION RECEIVED, THE VALVE'S COLLAPSING AND IMPLANTATION PROCEEDED WITHOUT ISSUES. THE EXPLANTED PROSTHESIS WAS DISPOSED OF AT THE SITE, MAKING IT UNAVAILABLE FOR RETURN TO THE MANUFACTURER FOR FURTHER ASSESSMENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22294348 ↗
• InjuryJun 6, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE, SIZE L, WHICH OCCURRED ON (B)(6) 2025 DURING A COMBINED AVR + CABG SURGERY (3 VESSELS) PERFORMED THROUGH FULL STERNOTOMY. REPORTS INDICATE THAT AFTER IMPLANTATION, PERFORMED FOLLOWING THE CABG PROCEDURE, THE VALVE EXHIBITED PARAVALVULAR LEAKAGE IN THE LEFT CORONARY SINUS. AS A RESULT, THE PROSTHESIS WAS EXPLANTED AND RE-IMPLANTED DURING THE SAME PROCEDURE. HOWEVER, FOLLOWING THE SECOND IMPLANTATION, THE VALVE DEVELOPED A CENTRAL LEAK AND APPEARED STRETCHED, LEADING TO ANOTHER EXPLANTATION WITHOUT REPORTED COMPLICATIONS. BASED ON THE INFORMATION RECEIVED, THE PATIENT¿S NATIVE VALVE WAS TRICUSPID WITH NO ABNORMAL GEOMETRIES IDENTIFIED AND NO DIFFICULTIES WERE ENCOUNTERED IN SIZING OR POSITIONING THE PROSTHESIS. IT WAS NOTED THAT AT THE INTRA-OPERATIVE TEE THE PERCEVAL VALVE WAS APPEARING SLIGHTLY ABOVE THE ANNULUS ON THE RCS. REPORTEDLY, THE PROSTHESIS WAS ULTIMATELY REPLACED WITH A SUTURED BIOLOGICAL VALVE FROM A DIFFERENT MANUFACTURER (ABBOTT, EPIC MAX 23MM) AND THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY ON DAY 10 POST SURGERY WITH A REPORTED EXCELLENT OU

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22156745 ↗
• InjuryFeb 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED THROUGH THE MANTRA STUDY OF A PATIENT WHO HAD A PERCIVAL SUTURELESS AORTIC BIOPROSTHESIS IMPLANTED AND RECEIVED A PERMANENT PACEMAKER TWO DAYS AFTER SURGERY. AS REPORTED, THE PATIENT DEVELOPED A THIRD-DEGREE AV BLOCK DESPITE HAVING NO PRE-EXISTING CONDUCTION DISTURBANCES. CABG (2 VESSELS) WAS PERFORMED AS CONCOMITANT PROCEDURE BEFORE VALVE TREATMENT. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD A MEDICAL HISTORY OF DYSLIPIDEMIA, SYSTEMIC HYPERTENSION, CORONARY ARTERY DISEASE, STABLE ANGINA, MODERATE CHRONIC LUNG DISEASE, DIABETES MELLITUS TYPE II, INSULIN DEPENDENT AND HAD UNDERGONE PERCUTANEOUS CORONARY INTERVENTION WITH STENTING IN 2020. NYHA CLASS WAS ASSESSED AS II AT THE TIME OF SURGERY. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE INITIAL IMPLANT PROCEDURE AND POSSIBLY RELATED TO THE DEVICE AND PRIMARY CONDITION BEING TREATED. THE MANUFACTURER IS FOLLOWING UP WITH THE SITE TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE EVENT AND THE DEVICE INVOLVED. AS FURTHER REPORTED IN THE STUDY DATABASE, THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2024, DUE TO A NON-DEVICE-RELATED EVENT. THIS EVENT INVOLVED A STERNAL WOUND INFECTIO

  Patient problems: Heart Block

  MAUDE report 21460257 ↗
• DeathMay 15, 2024Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS PVF-L PROSTHESIS OCCURRED ON (B)(6) 2023 DURING AN ISOLATED AORTIC VALVE REPLACEMENT SURGERY PERFORMED THROUGH FULL STERNOTOMY. AS REPORTED, THE PATIENT'S NATIVE VALVE WAS TRICUSPID, STENOTIC AND HEAVILY CALCIFIED. AT THE PRE-OPERATIVE CT SCAN, THE ANNULUS SIZE WAS MEASURED TO BE 23.5 MM. REPORTEDLY, NO DIFFICULTIES WERE ENCOUNTERED IN THE COLLAPSING AND POSITIONING OF THE PERCEVAL PROSTHESIS AND NO MALPOSITIONING OR MIS-SIZING WERE NOTED. POST IMPLANTATION, PERIVALVULAR LEAK WAS OBSERVED AROUND THE VALVE, THEREFORE THE PROSTHESIS WAS EXPLANTED AND RE-IMPLANTED BUT THE SAME ISSUE WAS OCCURRING. SO, IT WAS DECIDED TO IMPLANT A STENTED VALVE FROM A DIFFERENT MANUFACTURER (MEDTRONIC AVALUS 25MM) INSTEAD. REPORTEDLY, THE PATIENT WAS FRAIL AND, DESPITE BEING STABLE DURING THE RE-EXPLORATION, DID NOT SURVIVE DUE THE PROLONGED CPB TIME (OVER 3 HOURS) AND MULTIPLE EXPOSURES.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19326405 ↗
• InjuryMar 5, 2024Degraded; Degraded

  THE MANUFACTURER WAS INFORMED OF A TAVI PROCEDURE PERFORMED ON A PATIENT WHO WAS IMPLANTED WITH A PERCEVAL PLUS VALVE PVF-L ON (B)(6) 2020. THE DIAGNOSIS WHICH LED TO THE PERCEVAL IMPLANT WAS AORTIC VALVE STENOSIS. THE DIAGNOSIS ALSO INCLUDED SEVERE 3-VESSELS CORONARY DISEASE AND LEFT VENTRICULAR DYSFUNCTION. A PERCEVAL VALVE SIZE L WAS IMPLANTED THROUGH MEDIAN STERNOTOMY SURGICAL APPROACH. A CONCOMITANT PROCEDURE (4-VESSELS CABG) WAS PERFORMED BEFORE THE VALVE REPLACEMENT. THE AORTIC NATIVE VALVE WAS TRICUSPID. THE HEART WAS FOUND WITH INCREASED DIMENSION WITH FIBROTIC LEFT VENTRICLE. ON (B)(6) 2024, A TAVI PROCEDURE WAS PERFORMED WITH EDWARDS SAPIEN ULTRA SIZE 26 VALVE, VIA RIGHT FEMORAL ARTERY, WITH GOOD OUTCOME. THE PRE-OPERATIVE TEE ASSESSMENT REPORTED MEAN GRADIENT 40 MMHG, PEAK GRADIENT 67 MMHG AND EF 53%, TRICUSPID REGURGITATION GRADE II TYPE I, MITRAL REGURGITATION GRADE III, LEFT AND RIGHT VENTRICULAR DYSFUNCTION. THE PATIENT MEDICAL HISTORY INCLUDES AHT, DYSLIPIDEMIA, DIABETES T2, TUMORECTOMY OF THE PANCREAS IN 2019, AND PAROXYSMAL ATRIAL FIBRILLATION SINCE JUL 2020. THE PATIENT DAILY MEDICATIONS INCLUDE APIXABAN 5MG, ATORVASTATIN 20MG, PROPRANOLOL CHLORHYDRATE 40MG, FLE

  Patient problems: Aortic Valve Stenosis; Mitral Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18839191 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150011. One submission often covers many models, so check the product and lot details in each record.

• Z-0716-2017 · Oct 31, 2016 · Terminated
  Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart