PERCEVAL PLUS PVF-L (UDI 00896208000818)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00896208000818), received between Jan 9, 2021 and Dec 24, 2025 — classified as 2 deaths, 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT A PERCEVAL PLUS PVF-L PROSTHESIS. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. THE PROCEDURE WAS PERFORMED THROUGH A FULL STERNOTOMY WITHOUT ANY CONCOMITANT INTERVENTIONS ON (B)(6) 2025. AFTER SIZING, A SIZE L VALVE WAS SELECTED FOR IMPLANTATION; HOWEVER, THERE WAS CONCERN THAT ONE LEAFLET MIGHT NOT BE FUNCTIONING PROPERLY, AND A CENTRAL LEAK WAS DETECTED ON THE ECHO PERFORMED PRIOR TO WEANING FROM CARDIOPULMONARY BYPASS. THE PERCEVAL VALVE WAS THEREFORE EXPLANTED INTRAOPERATIVELY AND REPLACED WITH A 25-MM INSPIRIS VALVE. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN SURGERY. NO ISSUES RELATED TO POSITIONING OR SIZING WERE NOTED. THE PATIENT'S NATIVE AORTIC VALVE WAS TRICUSPID WITH NO ABNORMAL ANNULUS GEOMETRIES.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23886852 ↗
• InjurySep 2, 2025Perivalvular Leak; Malposition of Device; Perivalvular Leak; Malposition of Device

  ON (B)(6) 2025, THE PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED AND PVL WAS NOTED AFTER DE-CLAMPED. SINCE IT WAS NOTICED THAT THE PART OF THE VALVE WAS PLACED AT A LITTLE LOWER POSITION, THEY TRIED TO ADJUST THE POSITION OF THE VALVE, BUT PVL WAS STILL THERE. AS SUCH, THE VALVE WAS EXPLANTED AND EPIC 25MM WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22929840 ↗
• InjuryAug 27, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, AFTER CONCOMITANT PROCEDURE (TAP, MAZE AND MAP), THE PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED IN A PATIENT THROUGH AVR. AFTER DE-CLAMPED, A MILD PVL WAS NOTED. THEY WAITED TO SEE THE CONDITION FOR 30 MINUTES, BUT PVL REMAINED THE SAME. AS SUCH, THE VALVE WAS EXPLANTED AND REPLACED WITH INSPIRIS VALVE 25MM INSTEAD. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22903530 ↗
• InjuryJul 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED IN A PATIENT. THE VALVE WAS REMOVED ON (B)(6) 2025 DUE TO IE (INFECTIVE ENDOCARDITIS). BENTALL SURGERY WAS DONE USING INSPIRIS AS THE REPLACEMENT VALVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Endocarditis

  MAUDE report 22400873 ↗
• InjuryJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING DEPARTMENT. THE PATIENT REGISTRATION FORM INDICATED "A FAILURE TO IMPLANT" FOR A PERCEVAL PLUS VALVE, PVF-L WHICH ATTEMPTED TO BE IMPLANTED ON (B)(6) 2025. ANOTHER REGISTRATION FORM WAS RECEIVED, INDICATING THAT A SIMILAR DEVICE PVF-L WAS IMPLANTED INSTEAD DURING THE SAME DAY. NO ALLEGATION OF ANY DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 22197689 ↗
• InjuryMar 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION FROM DEVICE TRACKING. THE PATIENT REGISTRATION FORM INDICATED A "FAILURE TO IMPLANT" FOR A PERCEVAL PLUS VALVE, PVF-L ON (B)(6) 2025. ANOTHER SIMILAR DEVICE PVL-L WAS IMPLANTED SUCCESSFULLY INSTEAD. NO ALLEGATION OF DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21556101 ↗
• InjuryMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION FROM DEVICE TRACKING. THE PATIENT REGISTRATION FORM INDICATED A "FAILURE TO IMPLANT" FOR A PERCEVAL PLUS VALVE, PVF-L ON (B)(6) 2025. ANOTHER SIMILAR DEVICE PVL-L WAS IMPLANTED SUCCESSFULLY INSTEAD. NO ALLEGATION OF DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21554562 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN THE PATIENT THROUGH MINIMALLY INVASIVE PROCEDURE ON (B)(6) 2024. BASED ON THE INFORMATION RECEIVED, PATIENT HAD COAGULOPATHY AND RECEIVED ADMINISTRATION OF 4 FFPS AND ONE UNIT PLATELETS ON (B)(6) 2024 AND HAS RECOVERED ON (B)(6) 2024.

  Patient problems: Coagulation Disorder

  MAUDE report 20005886 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PERCEVAL PLUS SIZE L WAS ATTEMPTED TO BE IMPLANTED. REPORTEDLY, THE DEVICE WAS COLLAPSED WITH RELYON SYSTEM WITHOUT ANY ISSUES. GUIDING SUTURES WERE PLACED IN EYELETS AND VALVE WAS DEPLOYED INTO PLACE WITHOUT ISSUE. POSITION OF THE VALVE WAS INSPECTED, AND NO ISSUES WERE DETECTED. THUS, THE VALVE WAS BALLOONED FOR 30S AT 4 ATM¿S. THEN, AORTA WAS CLOSED, AND THEY BEGAN TO PERFORM THE CABG. ONCE CABG WAS PERFORMED CLAMP WAS REMOVED, AND THE REFILL PROCESS WAS STARTED. PATIENT REQUIRED 2-3 SHOCKS TO GET A RHYTHM. THEY DE-AIRED WITH A 19GA NEEDLE. NO LEAKS OR AR WAS OBSERVED IN THE ECHO. ALL OF THE SUDDEN SURGEON CALLED FOR A BALLON PUMP AND THE BALLON PUMP WAS INSERTED INTO THE PATIENT'S RT GROIN. AT THIS POINT, SIGNIFICANT REGURGITATION WAS NOTED. THE REASON FOR THIS REGURGITATION WAS UNKNOWN SINCE BEFORE INSERTING THE PUMP, NO LEAKAGE WAS PRESENT. AS SUCH, THEY DECIDED TO RE-CLAMP AND REPLACE THE PERCEVAL WITH A 23 MM INSPIRIS VALVE. BASED ON THE FURTHER INFORMATION RECEIVED, NO MALFUNCTION WITH THE DEVICE WAS NOTED, AND PATIENT'S OUTCOME WAS GOOD. REPORTEDLY, ANNULUS WAS MEASURED AS 22.0MM, STJ WAS 25.6, AND RATIO WAS 1.16.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19581187 ↗
• InjuryJun 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PERCEVAL PLUS SIZE L WAS ATTEMPTED TO BE IMPLANTED. REPORTEDLY, THE DEVICE WAS COLLAPSED WITH RELYON SYSTEM WITHOUT ANY ISSUES. GUIDING SUTURES WERE PLACED IN EYELETS AND VALVE WAS DEPLOYED INTO PLACE WITHOUT ISSUE. POSITION OF THE VALVE WAS INSPECTED, AND NO ISSUES WERE DETECTED. THUS, THE VALVE WAS BALLOONED FOR 30S AT 4 ATM¿S. THEN, AORTA WAS CLOSED, AND THEY BEGAN TO PERFORM THE CABG. ONCE CABG WAS PERFORMED CLAMP WAS REMOVED, AND THE REFILL PROCESS WAS STARTED. PATIENT REQUIRED 2-3 SHOCKS TO GET A RHYTHM. THEY DE-AIRED WITH A 19GA NEEDLE. NO LEAKS OR AR WAS OBSERVED IN THE ECHO. ALL OF THE SUDDEN SURGEON CALLED FOR A BALLON PUMP AND THE BALLON PUMP WAS INSERTED INTO THE PATIENT'S RT GROIN. AT THIS POINT, SIGNIFICANT REGURGITATION WAS NOTED. THE REASON FOR THIS REGURGITATION WAS UNKNOWN SINCE BEFORE INSERTING THE PUMP, NO LEAKAGE WAS PRESENT. AS SUCH, THEY DECIDED TO RE-CLAMP AND REPLACE THE PERCEVAL WITH A 23 MM INSPIRIS VALVE. BASED ON THE FURTHER INFORMATION RECEIVED, NO MALFUNCTION WITH THE DEVICE WAS NOTED, AND PATIENT'S OUTCOME WAS GOOD. REPORTEDLY, ANNULUS WAS MEASURED AS 22.0MM, STJ WAS 25.6, AND RATIO WAS 1.16.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19579591 ↗
• InjuryMar 8, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  THE MANUFACTURER WAS NOTIFIED OF A REOPERATION ON A PATIENT IMPLANTED WITH A PERCEVAL PLUS PROSTHESIS, SIZE L DUE TO VALVE DISPLACEMENT, THE PERCEVAL VALVE HAD BEEN IMPLANTED ON (B)(6) 2024 THROUGH LATERAL MINITHORACOTOMY SURGICAL APPROACH. THE PATIENT'S NATIVE AORTIC VALVE WAS TRISCUSPID, STENOTIC WITH ANNULAR CALCIFICATION. THE ANNULUS SIZE WAS EVALUATED TO BE 22 MM PRE-OPERATIVELY AND AORTA ASCENDENS 38-40MM. REPORTEDLY, NO ISSUES WERE EXPERIENCED DURING THE VALVE COLLAPSING AND RELEASE AND NO CONCOMITANT PROCEDURES WERE PERFORMED. THE INTRAOPERATIVE ECHO REVEALED TRACE OF PARAVALVULAR LEAKAGE WITH A COMPETENT PROSTHESIS. AFTER 48 HOURS, THE TROPONIN AND CK-MB WERE RAISED AND THE ECHO REVEALED A NEW LATERAL HYPOKINESIS. THE PATIENT WAS SENT TO THE CATH LAB, WHERE THE VALVE WAS FOUND MOVED OUT TO THE LEVEL OF THE LEFT MAIN VESSEL. URGENTLY AN AORTIC VALVE REPLACEMENT WAS CARRIED OUT WITH ECMO IMPLANTATION. THE PERCEVAL PLUS VALVE WAS REPLACED WITH A CORCYM BICARBON MECHANICAL AORTIC HEART VALVE, SIZE 21 (UNKNOWN MODEL). THE MECHANICAL PROSTHESIS WAS IMPLANTED INTRA-ANNULAR AFTER PERFORMING A SMALL FURTHER DECALCIFICATION. AS PER INFORMATION RECEIVED ON 9 FEB 2024, THE PATIENT WAS

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 18866173 ↗
• InjuryNov 24, 2023Material Too Rigid or Stiff; Insufficient Device Problem Information; Material Too Rigid or Stiff; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. CONCOMITANT PROCEDURE WAS CABG WHICH WAS PERFORMED BEFORE IMPLANT. BASED ON INFORMATION RECEIVED, PATIENT GOT THROMBOCYTOPENIA ON (B)(6) 2023. AS SUCH, PLATELETS TRANSFUSION WAS PERFORMED. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CAD, SYSTEMIC HYPERTENSION, DIABETES MELLITUS TYPE II - INSULIN DEPENDENT, DYSLIPIDEMIA, AND STROKE. PATIENT WAS NYHA CLASS II. BASED ON THE INFORMATION REPORTED, ASPIRIN WAS STOPPED BEFORE IMPLANT, PLATELET COUNT WAS REPORTED AS (152 109 /L) AT PRE-OP, AND (72 109 /L) AT DISCHARGE. PATIENT WAS DISCHARGED ON (B)(6) 2023. BASED ON THE TEE AND TTE, NO FUNCTIONALITY ISSUE WITH THE VALVE WAS NOTED AFTER PROCEDURE, AND NO REGURGITATION WAS NOTED AT THE TIME OF DISCHARGE. MEAN GRADIENT WAS11 MMHG.

  Patient problems: Thrombocytopenia

  MAUDE report 18203399 ↗
• InjuryNov 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PERCEVAL PLUS VALVE SIZE L WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. REPORTEDLY, WHEN THEY WENT OFF PUMP, THERE WAS NO HEARTBEAT. AS SUCH, THEY WENT BACK ON PUMP, EXPLANTED THE VALVE AND REPLACED IT WITH INTUITIVE 23MM VALVE. HOWEVER, OFF PUMP THERE WAS STILL NO HEARTBEAT. THUS, THE PATIENT WAS AIR FLIGHTED TO ANOTHER FACILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 18136624 ↗
• InjuryNov 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PERCEVAL PLUS VALVE SIZE L WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT. REPORTEDLY, WHEN THEY WENT OFF PUMP, THERE WAS NO HEARTBEAT. AS SUCH, THEY WENT BACK ON PUMP, EXPLANTED THE VALVE AND REPLACED IT WITH INTUITIVE 23MM VALVE. HOWEVER, OFF PUMP THERE WAS STILL NO HEARTBEAT. THUS, THE PATIENT WAS AIR FLIGHTED TO ANOTHER FACILITY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18136621 ↗
• DeathOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN THE PATIENT ON (B)(6)2023. BASED ON INFORMATION RECEIVED, PATIENT HAD HEMORRHAGIC SHOCK- CARDIAC ARREST ON (B)(6) 2023. THE PATIENT WENT INTO PEA DURING EGD - HYPOTENSION AND ANESTHESIA, ACUTE RESPIRATORY FAILURE AND INTUBATED AT THE TIME OF CODE. THE PATIENT UNDERWENT DIAGNOSTIC TESTS AND TRANSFUSION, BUT EVENTUALLY PASSED AWAY ON (B)(6) 2023. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; ARRHYTHMIA: ATRIAL FIBRILLATION; CARDIAC CONDUCTION DISORDER: RBBB; SYSTEMIC HYPERTENSION; AND DYSLIPIDEMIA. FURTHERMORE, PATIENT WENT UNDER ATRIAL FIBRILLATION TREATMENT IN 2003, AND WAS NYHA CLASS II.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18026022 ↗
• DeathOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE L WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON INFORMATION RECEIVED, PATIENT HAD HEMORRHAGIC SHOCK- CARDIAC ARREST ON (B)(6) 2023. THE PATIENT WENT INTO PEA DURING EGD - HYPOTENSION AND ANESTHESIA, ACUTE RESPIRATORY FAILURE AND INTUBATED AT THE TIME OF CODE. THE PATIENT UNDERWENT DIAGNOSTIC TESTS AND TRANSFUSION, BUT EVENTUALLY PASSED AWAY ON (B)(6) 2023. AS REPORTED, THE PATIENT'S CLINICAL HISTORY INCLUDED CORONARY ARTERY DISEASE; ARRHYTHMIA: ATRIAL FIBRILLATION; CARDIAC CONDUCTION DISORDER: RBBB; SYSTEMIC HYPERTENSION; AND DYSLIPIDEMIA. FURTHERMORE, PATIENT WENT UNDER ATRIAL FIBRILLATION TREATMENT IN 2003, AND WAS NYHA CLASS II.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18026016 ↗
• InjuryJul 13, 2023Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS MADE AWARE OF AN INTRAOPERATIVE EXPLANT OF A PERCIVAL PLUS SUTURELESS AORTIC BIOPROSTHESIS, PVF-L OCCURRED ON (B)(6) 2023 DURING AN ISOLATED AVR PROCEDURE. REPORTEDLY, AFTER THE IMPLANTATION THROUGH FULL STERNOTOMY, THE VALVE SHOWED A LEAFLET WHICH WAS NOT COAPTING CORRECTLY AND APPEARED STRETCHED AT THE VISUAL INSPECTION. NO ABNORMALITIES WERE NOTED ON THE PROSTHESIS PRIOR TO IMPLANT. THE COAPTATION ISSUE WAS CONFIRMED UPON PERFORMING INTRA-OPERATIVE TEE ONCE CARDIAC FUNCTION WAS RECOVERED. THE ECHO IMAGES ARE NOT AVAILABLE TO THE MANUFACTURER. IT WAS REPORTED THAT THE PATIENT HAD A STENOTIC TRICUSPID NATIVE VALVE, WITH NO ABNORMAL ANNULUS GEOMETRIES. AS REPORTED, NO DIFFICULTIES WERE ENCOUNTERED IN THE COLLAPSING PHASE NOR IN VALVE POSITIONING. NO VALVE MISPOSITIONING OR MIS-SIZING WAS IDENTIFIED BY THE SURGEON. ULTIMATELY, THE SURGEON DECIDED TO REPLACE THE VALVE WITH ANOTHER DEVICE OF THE SAME MODEL AND SIZE (PVF-L). THE SECOND VALVE WAS SUCCESSFULLY IMPLANTED WITHOUT THE NEED TO PERFORM ADDITIONAL DEBRIDEMENT OR ANNULAR RESTRUCTURING. LESS THAN 20 MINUTES OF CROSS-CLAMP TIME WAS ADDED AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE THROUGHOUT THE PROC

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17314578 ↗
• InjuryMay 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. REPORTEDLY, PERCEVAL PLUS SIZE L WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON INFORMATION RECEIVED, PATIENT HAD COMPLETE HEART BLOCK WITH UNDERLYING VENTRICULAR ESCAPE (AROUND 40 BPM) ON (B)(6) 2023 WHICH LED TO INSERTION OF A PERMANENT PACEMAKER ON (B)(6) 2023. BASED ON THE INFORMATION AVAILABLE, PATIENT HAS RECOVERED, AND THE EVENT HAS RESOLVED. AS REPORTED, PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE, SYSTEMIC HYPERTENSION, DYSLIPIDEMIA, AND NYHA CLASS II.

  Patient problems: Heart Block

  MAUDE report 16998041 ↗
• InjuryMay 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. REPORTEDLY, PERCEVAL PLUS SIZE L WAS IMPLANTED IN THE PATIENT ON (B)(6) 2023. BASED ON INFORMATION RECEIVED, PATIENT HAD COMPLETE HEART BLOCK WITH UNDERLYING VENTRICULAR ESCAPE (AROUND 40 BPM) ON (B)(6) 2023 WHICH LED TO INSERTION OF A PERMANENT PACEMAKER ON (B)(6) 2023. BASED ON THE INFORMATION AVAILABLE, PATIENT HAS RECOVERED, AND THE EVENT HAS RESOLVED. AS REPORTED, PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE, SYSTEMIC HYPERTENSION, DYSLIPIDEMIA, AND NYHA CLASS II.

  Patient problems: Heart Block

  MAUDE report 16998039 ↗
• InjuryApr 5, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION RECEIVED, A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE SIZE L WAS IMPLANTED IN THE PATIENT THROUGH MINI STERNOTOMY ON (B)(6) 2023. NO CONCOMITANT PROCEDURE WAS PERFORMED. REPORTEDLY, AS OF (B)(6) 2023, THERE WAS A COMPLETE HEART BLOCK REQUIRING PERMANENT PACEMAKER TO BE IMPLANTED ON (B)(6) 2023TO RESOLVE THE EVENT. REPORTEDLY, TVP PLACEMENT WAS ALSO PERFORMED ON (B)(6) 2023. AS INDICATED IN THE STUDY DATABASE, PATIENT HAD A HISTORY OF INFECTIVE ENDOCARDITIS WHICH WAS RESOLVED; CONGENITAL SEPTAL DEFECT, HEART MURMUR, BICUSPID AV, AV STENOSIS, AND NYHA CLASS II.

  Patient problems: Heart Block

  MAUDE report 16685840 ↗
• InjuryApr 5, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION RECEIVED, A PERCEVAL PLUS SUTURELESS AORTIC HEART VALVE SIZE L WAS IMPLANTED IN THE PATIENT THROUGH MINI STERNOTOMY ON (B)(6) 2023. NO CONCOMITANT PROCEDURE WAS PERFORMED. REPORTEDLY, AS OF (B)(6) 2023, THERE WAS A COMPLETE HEART BLOCK REQUIRING PERMANENT PACEMAKER TO BE IMPLANTED ON (B)(6) 2023 TO RESOLVE THE EVENT. REPORTEDLY, TVP PLACEMENT WAS ALSO PERFORMED ON (B)(6) 2023. AS INDICATED IN THE STUDY DATABASE, PATIENT HAD A HISTORY OF INFECTIVE ENDOCARDITIS WHICH WAS RESOLVED; CONGENITAL SEPTAL DEFECT, HEART MURMUR, BICUSPID AV, AV STENOSIS, AND NYHA CLASS II.

  Patient problems: Heart Block

  MAUDE report 16683658 ↗
• InjurySep 24, 2022Positioning Failure; Positioning Failure

  ON (B)(6) 2022, PATIENT WAS PREPARED FOR A STANDALONE AORTIC VALVE REPLACEMENT SURGERY. AFTER REMOVING THE DISEASED LEAFLETS AND CALCIUM THE AORTA WAS SIZED AND A LARGE SIZE PERCEVAL PLUS VALVE WAS CHOSEN. THE VALVE WAS PREPARED AND IMPLANTED AS DESIRED. THERE WAS A PORTION OF THE AORTA THAT WAS A TUCKED A BIT BELOW THE HEIGHT OF THE STENT OF THE VALVE, SO AS THE TISSUE WERE PULLING ABOVE THE STENT AND THE VALVE WAS SEEN TO DISLODGE FROM THE ANNULUS. THE VALVE WAS REMOVED FROM THE PATIENT AND THE SURGEON REQUESTED THE VALVE TO BE PREPARED AGAIN FOR IMPLANT. ON THE SECOND IMPLANT, THE VALVE WAS FOUND TO BE HIGH ON THE NON CORONARY CUSP SIDE OF THE ANNULUS. IT WAS REPORTED THAT THERE WAS A GOOD SIZE CHUNK OF CALCIUM ON THE AORTOMITRAL EDGE. SURGEON FELT THAT IT WAS TOO RISKY TO REMOVE THIS CALCIUM DUE TO ITS LOCATION. 3RD ATTEMPT WAS MADE TO IMPLANT THE VALVE BUT THEY HAD SAME FINDINGS, THE VALVE WAS DISLODGING AT THE NON- CORONARY CUSP SIDE LIKELY DUE TO THIS CALCIUM SEEN. AS SUCH, THE PERCEVAL PLUS VALVE WAS REMOVED AND AN EDWARDS INSPIRIS VALVE WAS IMPLANTED INSTEAD. THE PROCEDURE WAS THEN COMPLETED AS DESIRED AND PATIENT WAS DOING WELL. REPORTEDLY, ON ECHO THERE WAS SOME LVOT HYP

  Patient problems: Insufficient Information

  MAUDE report 15480312 ↗
• InjuryAug 2, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  ON (B)(6) 2022, PERCEVAL PLUS VALVE PVF-L WAS CRIMPED AND DEPLOYED WITHOUT INCIDENT. THEN IT WAS NEEDED TO REMOVE THE VALVE AND REDEPLOY. WHEN THE VALVE WAS REMOVED AND THE ATTEMPT WAS MADE TO RECRIMP THE VALVE USING ICV1351 - PVS SINGLE USE ACC.KIT MICS SIZE L, THE VALVE WAS NOT COLLAPSING. ANOTHER CRIMPER (ICV1351 - PVS SINGLE USE ACC.KIT MICS SIZE L) WAS OPENED BUT STILL THEY WERE UNABLE TO RECRIMP THE VALVE. ANOTHER VALVE WAS OPENED, SUCCESSFULLY CRIMPED AND DEPLOYED. REPORTEDLY, THE PATIENT WAS NOT AFFECTED, NO SERIOUS HARM REPORTED, AND NO PROLONGED CARE WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154063 ↗
• InjuryJun 7, 2022Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2022, A LARGE PERCEVAL PLUS VALVE WAS SUPPOSED TO BE IMPLANTED. AFTER THE BALLOONING, IT WAS NOTICED THAT THE LEAFLETS DID NOT FULLY COME TOGETHER. WHILE ATTEMPTING TO COME OFF THE HEART LUNG BYPASS MACHINE, A MILD CENTRAL LEAK WAS NOTED. THUS, WENT BACK OFF PUMP, THE PERCEVAL PLUS VALVE WAS REMOVED AND INSPIRIS SIZE 25 WAS IMPLANTED INSTEAD. BASED ON THE MEDICAL JUDGEMENT RECEIVED, THE VALVE MAY HAVE UNDERSIZED INITIALLY.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14623356 ↗
• InjuryJun 3, 2022Malposition of Device; Malposition of Device

  ON (B)(6) 2022, PATIENT HAD AN AORTIC VALVE REPLACEMENT PERFORMED WITH A LARGE SIZE PERCEVAL PLUS VALVE. THE PATIENT WAS BROUGHT BACK TO OR THE FOLLOWING DAY (MONDAY, (B)(6)) AS THE VALVE WAS FOUND TO BE ROCKING IN POSITION AND HAD A SIGNIFICANT PERIVALVULAR LEAK AROUND THE PORTION OF THE VALVE THAT SAT AGAINST THE NON-CORONARY CUSP. AS REPORTED, THE LEAK WAS DIFFICULT TO SEE AND COULD ONLY BE PICTURED IN ONE VIEW. PATIENT'S CHEST WAS REOPENED, AND PATIENT WAS PUT ON PUMP WITH NO ISSUES. UPON OPENING THE AORTA AND INSPECTING THE VALVE, IT COULD BE SEEN THAT THE POSTERIOR PORTION OF THE VALVE WAS SITTING ABOVE THE ANNULUS, CONFIRMING THE PRE-OP AND INTRA-OP ECHOS. THE VALVE WAS REMOVED WITHOUT ANY ISSUE AND INSPECTED AND IT WAS COMMENTED THAT THE PERCEVAL VALVE ITSELF LOOKED FINE. SOME ADDITIONAL DEBRIDEMENT OF THE ANNULUS WAS PERFORMED, AND THE ANNULUS WAS SIZED FOR A CROWN, SIZE 25. THE CROWN WAS IMPLANTED INTRA-ANNULAR WITHOUT INCIDENT. SURGEONS MENTIONED THAT THE PATIENT'S AORTIC VALVE CUSPS WERE VERY SCALLOPED, MORE THAN USUAL, AND MOST DRAMATICALLY ON THE NON-CORONARY CUSP WHICH COULD HAVE BEEN PART OF THE CAUSE FOR THE ISSUE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THER

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14598876 ↗