PERCEVAL PLUS PVF-S (UDI 00896208000795)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00896208000795), received between Jan 9, 2021 and Jul 30, 2026 — classified as 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Degraded

  The manufacturer was notified of an explant (redo surgery) involving a Perceval Plus valve. Based on the information received, the Perceval Plus valve size S was implanted via MICS-AVR on (b)(6)2025. Symptoms of AS/R (aortic stenosis/regurgitation) were observed starting around three or four months ago. By June, the AS had progressed, and as one valve leaflet was immobile, a reoperation was performed on (b)(6)2026. It was determined that the leaflet corresponding to the right coronary cusp was immobile because it was folded outward and had become rigid due to degeneration. As the area near the immobile valve leaflets had become difficult to excise due to pannus proliferation and other factors, the stent in that region was cut, and the Perceval Plus was removed. After explanting the Perceval Plus, the Inspiris 19 was implanted, and the surgery was concluded. The patient presents no factors, such as dialysis, that would cause degeneration of the valve leaflets. There was no reported adverse event or outcome for the patient.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50085798 ↗
• InjuryMay 12, 2026Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. BASED ON THE INFORMATION RECEIVED, A PERCEVAL PLUS PVF-S VALVE WAS IMPLANTED IN A PATIENT ON (B)(6) 2026 DURING A SINGLE-LEAFLET AVR PROCEDURE PERFORMED VIA THE TAX APPROACH. ALTHOUGH NO ABNORMALITIES WERE OBSERVED ON THE TEE FOLLOWING IMPLANTATION, BLEEDING WAS CONFIRMED AT THE AORTIC ROOT DURING CLOSURE. THIS WAS JUDGED TO BE AN ANNULAR RUPTURE, SO THE PROCEDURE WAS CONVERTED TO A MEDIAN INCISION; THE PRODUCT WAS REMOVED, THE DAMAGED SITE WAS REPAIRED WITH BOVINE PERICARDIUM, AND AN INSPIRIS DEVICE WAS IMPLANTED DUE TO CONCERNS ABOUT RE-RUPTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 25151028 ↗
• InjuryFeb 5, 2026Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS NOTIFIED OF A PARAVALVULAR LEAK INVOLVING A PERCEVAL PLUS PROSTHESIS. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED ON (B)(6) 2025 DURING AN AVR SURGERY WITH NO CONCOMITANT PROCEDURES. NO POSITIONING PROBLEMS WERE ENCOUNTERED DURING THE IMPLANTATION PROCEDURE. THE PATIENT DID NOT PRESENT ANY ABNORMAL GEOMETRY OF THE NATIVE AORTIC VALVE. PARAVALVULAR LEAK WAS CONFIRMED ON (B)(6) 2025, AND SURGERY WAS PERFORMED AGAIN. THE PERCEVAL PLUS IN SIZE S WAS REPLACED WIH A PERCEVAL PLUS IN SIZE M. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE COURSE AND GOOD OUTCOME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24266846 ↗
• InjuryFeb 4, 2026Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. BASED ON THE INFORMATION RECEIVED, ON (B)(6) 2025, PERCEVAL PLUS SIZE S WAS IMPLANTED. CENTRAL LEAK (MILD-MODERATE) DEVELOPED AFTER AORTIC CROSS-CLAMP REMOVAL; OBSERVATION WAS INITIATED AND THE PROCEDURE CONCLUDED. ON (B)(6) 2025, REOPERATION WAS PERFORMED TO REPLACE THE PERCEVAL WITH ANOTHER MANUFACTURER'S ARTIFICIAL HEART VALVE. FURTHER INFORMATION INDICATED THAT THE RIGHT CORONARY CUSP PORTION OF THE PERCEVAL VALVE WAS SHORTER IN HEIGHT (AND SMALLER IN AREA) COMPARED WITH THE OTHER TWO CUSPS, LIKELY RESULTING IN TETHERING. IMMEDIATELY AFTER REMOVAL OF THE AORTIC CROSS CLAMP FOLLOWING PERCEVAL IMPLANTATION, THE RIGHT CORONARY CUSP SHOWED ALMOST NO MOVEMENT, AND THE CENTRAL LEAK WAS ALSO OBSERVED ORIGINATING FROM THE RIGHT CORONARY CUSP REGION. DURING PERCEVAL SIZING, THE WHITE SIZER DID NOT PASS THROUGH THE ANNULUS, WHILE THE WHITE HEAD OF THE SIZER (SIZER S) PASSED THROUGH EASILY. IN THE PERCEVAL OPERATION ON (B)(6), THE PATIENT¿S CARDIAC FUNCTION WAS POOR AFTER AORTIC CROSS CLAMP REMOVAL, REQUIRING ECMO AND IABP INSERTION BEFORE CLOSING THE OPERATION (ECMO AND IABP ARE STILL ONGOING). AS OF (B)(6)

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24259126 ↗
• InjuryAug 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE PERCEVAL PLUS VALVE, PVF-S WAS IMPLANTED IN AVR SURGERY CONCOMITANT PROCEDURE WITH CABG 3-VESSEL. THE VALVE WAS PLACED WITHOUT ANY PROBLEM, BUT THE PATIENT WAS ON SEVERE DIALYSIS AND HAD DIFFICULTY WITH CENTRAL BYPASS ANASTOMOSIS AND SUTURING THE AORTA INCISION SITE. AFTER ADMINISTRATION OF PROTAMINE IN THE POSTOPERATIVE ICU, PATIENT'S BLOOD PRESSURE DECREASED. AS SUCH, PATIENT WAS PLACED ON ECMO. AFTER THAT, BLEEDING OCCURRED FROM VARIOUS POINTS, AND IT WAS JUDGED THAT HEMOSTASIS WAS DIFFICULT, SO THE PATIENT UNDERWENT REOPERATION, AND PERCEVAL PLUS WAS REMOVED AND BENTALL SURGERY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22881466 ↗
• InjuryAug 15, 2025Migration; Migration

  ON (B)(6) 2025, THE PERCEVAL PLUS VALVE, PVF-S, WAS IMPLANTED IN THE PATIENT WITHOUT ANY PROBLEM. HOWEVER, THE VALVE MIGRATED WHEN THE HEART MOVED. AS SUCH, THE VALVE WAS EXPLANTED AND REPLACED WITH INSPIRIS (UNKNOWN SIZE). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22820275 ↗
• InjuryAug 7, 2025Migration; Migration

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED IN A PATIENT. PCI WAS ALSO PERFORMED, BUT THEY WERE UNABLE TO CANNULATE CORONARY ARTERY. ECHOCARDIOGRAPHY CONFIRMED THAT THE PERCEVAL PLUS VALVE POPPED UP (I.E., INFLOW RING POPPED UP TO THE LEVEL OF THE CORONARY ARTERY). PVL DID NOT GET WORSEN. REPORTEDLY, THE PROCEDURE WAS PROBLEMATIC. TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH TRANSFEMORAL APPROACH (TA) APPROACH WAS PERFORMED. THE PERCEVAL PLUS VALVE WAS PULLED UP INTO THE ASCENDING AORTA WITH A SNARE CUFF AND A TAVI VALVE WAS IMPLANTED. SUBSEQUENTLY, PCI WAS PERFORMED WITHOUT ANY PROBLEMS. THE REMAINING PERCEVAL PLUS VALVE IS NOW FIXED TO SOME EXTENT AND THERE IS NO HEMODYNAMIC PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 22741965 ↗
• InjuryAug 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED WITH MICS AVR. AFTER CONFIRMING NO PVL BY (B)(6), BLEEDING WAS NOTED IN UNKNOWN PLACE. A MEDIAN INCISION WAS MADE TO FIND THE BLEEDING POINT, AND THE LEFT ATRIAL AREA WAS SUSPECTED. REPORTEDLY, THE WHITE SIZER WAS NOT INSERTED, BUT IT WAS DECIDED TO IMPLANT A S SIZE SIZER, WHICH WAS DILATED 4ATM 60 SECONDS LATER. THE FOLLOWING WERE SUGGESTED: (1) RUPTURE OF THE ARTERIAL VALVE RING DUE TO PERCEVAL PLACEMENT; (2) RUPTURE BY THE DUCT CATHETER IN THE LEFT ATRIUM; AND (3) RUPTURE OF PA. THEREAFTER, CLAMPING AND DE-CLAMPING WAS REPEATED TO STOP BLEEDING, BUT HEMOSTASIS WAS NOT COMPLETED. HEMOSTASIS WITH GAUZE PACKING WAS PERFORMED AS BEST AS POSSIBLE, AND THE PATIENT LEFT THE ROOM AFTER IT WAS CONFIRMED THAT THE CHEST CAN BE CLOSED UNDER ECMO. SUBSEQUENT STATUS COULD NOT BE CONFIRMED. THE SURGERY TIME WAS EXTENDED 5 HOURS DUE TO THIS INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 22741777 ↗
• InjuryJul 30, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A PERCEVAL PLUS HEART VALVE, PVF-S WAS IMPLANTED IN A PATIENT, BUT PVL WAS NOTED AFTER DE-CLAMPED. IT WAS TRIED TO RE-IMPLANT THE VALVE FOR A COUPLE OF TIMES, BUT THEY ENDED UP IMPLANTING A COMPETITOR'S MHV INSTEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22669487 ↗
• InjuryJun 17, 2025Collapse; Collapse

  MANUFACTURER WAS INFORMED THAT A PERCEVAL PLUS VALVE SIZE S WAS IMPLANTED IN THE PATIENT ON (B)(6) 2025. REPORTEDLY, THE VALVE WAS EXPLANTED THE DAY AFTER, ON (B)(6) 2025. ACCORDING TO THE REPORT PROVIDED, THE PROSTHESIS HAD BEEN IMPLANTED DURING A DOUBLE VALVE REPLACEMENT (DVR) PROCEDURE, FOLLOWING A MITRAL VALVE REPLACEMENT USING A VALVE FROM AN EPIC 29 MM VALVE. BASED ON THE INFORMATION RECEIVED, DIFFICULTIES WERE ENCOUNTERED DURING THE DEPLOYMENT OF THE PERCEVAL VALVE, WITH SIGNIFICANT FORCE REQUIRED TO OPERATE THE RELYON DELIVERY SYSTEM. DESPITE THIS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CONFIRMING THAT THE PERCEVAL VALVE WAS PROPERLY ALIGNED. ON THE FIRST POSTOPERATIVE DAY, AN ECHOCARDIOGRAM REVEALED A PARAVALVULAR LEAK (PVL) ASSOCIATED WITH THE PERCEVAL PROSTHESIS. A SUBSEQUENT CT SCAN CONFIRMED THE PRESENCE OF STENT INFOLDING. THEREFORE, THE PERCEVAL PROSTHESIS WAS EXPLANTED AND REPLACED WITH MOSAIC SIZE 19 VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22236609 ↗
• MalfunctionJun 14, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED IN A PATIENT. AFTER DE-CLAMPED, PVL WAS NOTED. THE VALVE WAS EXPLANTED AND REPLACED WITH EPIC VALVE 19MM INSTEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22208201 ↗
• InjuryJun 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER RECEIVED THE INFORMATION FROM PATIENT/DEVICE TRACKING. THE PATIENT REGISTRATION FORM INDICATED "A FAILURE TO IMPLANT-MIS-SIZING" FOR A PERCEVAL PLUS VALVE, PVF-S ON (B)(6) 2025 IMPLANT DATE. THE DEVICE STATUS IS ALSO INDICATED AS INACTIVE. NO ALLEGATION OF ANY DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 22198523 ↗
• InjuryJun 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER RECEIVED THE INFORMATION FROM PATIENT/DEVICE TRACKING. THE PATIENT REGISTRATION FORM INDICATED "A FAILURE TO IMPLANT-MIS-SIZING" FOR A PERCEVAL PLUS VALVE, PVF-S ON (B)(6) 2025 IMPLANT DATE. THE DEVICE STATUS IS ALSO INDICATED AS INACTIVE. NO ALLEGATION OF ANY DEVICE DYSFUNCTION NOR PATIENT INJURY HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 22198054 ↗
• InjuryMay 14, 2025Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 20225, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED AT MICS AVR SURGERY. AFTER IMPLANTED, SLIGHT CENTRAL LEAK WAS NOTED BUT THE PATIENT WAS WEANED OFF OF THE CARDIOPULMONARY SUPPORT AFTER IT WAS DETERMINED THAT THERE WAS NO PROBLEM. THE REGURGITATION SUBSEQUENTLY INCREASED, AND THE RIGHT VALVE LEAFLET WAS NOT MOVING, WHICH WAS CONFIRMED BY ECHO. AS SUCH, THE CHEST WAS REOPENED. THE PERCIVAL VALVE WAS REMOVED, AND EPIC 19 MM WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22023061 ↗
• InjuryJan 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2024, PATIENT UNDERWENT A SURGERY WITH PERCEVAL PLUS SIZE S. AS REPORTED, PATIENT'S ANNULUS SIZE WAS 20MM. THE WHITE SIZER DID NOT GO THROUGH, BUT THE TRANSLUCENT SIZER DID GO THROUGH, AND A PERCEVAL PLUS VALVE SIZE S WAS CHOSEN TO BE IMPLANTED. AFTER DE-CLAMPED, TRIVIA-SEVERE REGURGITATION WAS NOTED. AS SUCH, THE VALVE WAS EXPLANTED AND REPLACED WITH INSPIRIS VALVE 19MM. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21233783 ↗
• InjurySep 19, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A PERCEVAL PLUS VALVE PVF-S OCCURRED FEW DAYS AFTER IMPLANT DUE TO INCREASED GRADIENTS. THE DEVICE HAD BEEN SUCCESSFULLY IMPLANTED ON (B)(6) 2024 IN AN ISOLATED AVR SURGERY PERFORMED THROUGH MINI STERNOTOMY. REPORTEDLY, NO COLLAPSING OR POSITIONING DIFFICULTIES WERE EXPERIENCED, NOR ISSUES WHILE RELEASING THE VALVE, AND BALLOONING WAS PERFORMED AS PER PERCEVAL VALVE IFUS. A PRE-OPERATIVE ASSESSMENT WAS PERFORMED THROUGH CORCYM CT SERVICE; BASED ON THE RESULTS OF THE ASSESSMENT, IT WAS INDICATED THAT THE ANNULUS WAS SMALL, BORDERLINE FOR PERCEVAL IMPLANT AND A CAREFUL INTRA-OPERATIVE ASSESSMENT WAS RECOMMENDED. AT THE INTRA-OPERATIVE CHECK, GOOD VALVE FUNCTION WAS CONFIRMED. DIFFICULTIES IN RESTORING PATIENT'S RHYTHM WERE ENCOUNTERED WHEN EXITING FROM PUMP, WITH THE PATIENT REQUIRING MULTIPLE DEFIBRILLATIONS. MEDICATIONS WERE ADMINISTERED TO INCREASE BLOOD PRESSURE AS PER PROCTOR'S INDICATION AND VF WAS SUCCESSFULLY STOPPED AND PACED RHYTHM EMERGED. THE PATIENT WAS TRANSFERRED FROM THE ICU TO THE WARD THE DAY AFTER SURGERY WITH NORMAL SINUS RHYTHM RESTORED. AS FURTHER REPORTED, AT THE ECHO FOLLOW-UP PERFORMED FEW DAYS AFTER IMPLAN

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Thrombocytopenia; Transvalvular Pressure Gradient Increased

  MAUDE report 20254831 ↗
• InjuryAug 4, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT REGISTRATION FORM, A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2024. BASED ON THE INFORMATION AVAILABLE, A PERCEVAL PLUS VALVE PVF-M WAS ULTIMATELY IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT. BASED ON THE FURTHER INFORMATION RECEIVED, ABOUT 30 MINUTES WAS ADDED TO THE CROSS-CLAMP TIME, PATIENT WAS STABLE THROUGH THE SURGERY AND THE PATIENT DID WELL AFTER THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19902564 ↗
• InjuryMar 19, 2024Leak/Splash; Leak/Splash

  ON (B)(6) 2024, A PERCEVAL PLUS VALVE PVF-S WAS ATTEMPTED TO BE IMPLANTED AS FOLLOWS: PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS. ANNULUS MEASUREMENT OF 21.4, STJ OF 26.5-27.4 VIA TEE. THE USUAL AORTOTOMY WAS CONDUCTED AS WELL AS DEBRIDEMENT OF THE CALCIUM. SIZING WAS CONDUCTED. CLEAR END OF A SMALL SIZER FELL THROUGH, WHITE PASSED WITH LITTLE RESISTANCE. AFTER THE SMALL VALVE WAS IMPLANTED, THEY WERE UNABLE TO GET PRESSURES UP ABOVE 79MM AND SEEING A SMALL CENTRAL LEAK ON TEE. AS SUCH, IT WAS DECIDED TO RECESS THE VALVE TO SWAP FOR A SUTURED VALVE. AS REPORTED, UPON OPENING AND PERCEVAL REMOVAL, THERE WAS SOME ADDITIONAL CALCIUM PRESENT ON THE ANNULUS. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT WAS EXTREMELY WELL THROUGHOUT THE PROCEDURE AND CONTINUES TO DO WELL.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18937898 ↗
• InjuryMar 19, 2024Leak/Splash; Leak/Splash

  ON (B)(6) 2024, A PERCEVAL PLUS VALVE PVF-S WAS ATTEMPTED TO BE IMPLANTED AS FOLLOWS: PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS. ANNULUS MEASUREMENT OF 21.4, STJ OF 26.5-27.4 VIA TEE. THE USUAL AORTOTOMY WAS CONDUCTED AS WELL AS DEBRIDEMENT OF THE CALCIUM. SIZING WAS CONDUCTED. CLEAR END OF A SMALL SIZER FELL THROUGH, WHITE PASSED WITH LITTLE RESISTANCE. AFTER THE SMALL VALVE WAS IMPLANTED, THEY WERE UNABLE TO GET PRESSURES UP ABOVE 79MM AND SEEING A SMALL CENTRAL LEAK ON TEE. AS SUCH, IT WAS DECIDED TO RECESS THE VALVE TO SWAP FOR A SUTURED VALVE. AS REPORTED, UPON OPENING AND PERCEVAL REMOVAL, THERE WAS SOME ADDITIONAL CALCIUM PRESENT ON THE ANNULUS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18937895 ↗
• InjuryJan 15, 2024Difficult to Open or Close; Difficult to Open or Close

  ON 16 DEC 2023, A PERCEVAL PLUS VALVE PVF-S WAS COLLAPSED WITH NO ISSUE AND DEPLOYED. AFTER AORTA WAS CLOSED, ECHO SHOWED THAT THE LEAFLETS WERE NOT OPENING PROPERLY LEADING TO AORTIC REGURGITATION. AS SUCH, THE VALVE WAS EXPLANTED, AND REPLACED WITH PERIMOUNT EASE 19MM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18514939 ↗
• InjuryDec 22, 2023Collapse; Collapse

  MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PERCEVAL PLUS VALVE SIZE S WAS IMPLANTED AND UPON COMING OFF OF PUMP, VALVE APPEARED TO HAVE BUCKLED ONTO ITSELF IN THE ECHO. IT WAS REPORTED THAT THE VALVE WAS TOO LARGE FOR THE ANNULUS. AS SUCH, THE VALVE WAS EXPLANTED, AND A STENTED VALVE WAS IMPLANTED. REPORTEDLY, PATIEN'TS ANNULUS WAS 19.8 PER THE CT ANALYSIS REPORT. AS REPORTED, PATIENT ULTIMATELY WAS PLACED ON ECMO.

  Patient problems: Insufficient Information

  MAUDE report 18387807 ↗
• InjuryDec 22, 2023Collapse; Collapse

  MANUACTURER WAS INFORMED THAT ON 22 NOV 2023, A PERCEVAL PLUS VALVE SIZE S WAS IMPLANTED AND UPON COMING OFF OF PUMP, VALVE APPEARED TO HAVE BUCKLED ONTO ITSELF IN THE ECHO. IT WAS REPORTED THAT THE VALVE WAS TOO LARGE FOR THE ANNULUS. AS SUCH, THE VALVE WAS EXPLANTED, AND A STENTED VALVE WAS IMPLANTED. REPORTEDLY, PATIEN'S ANNULUS WAS 19.8 PER THE CT ANALYSIS REPORT. AS REPORTED, PATIENT ULTIMATELY WAS PLACED ON ECMO. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18387805 ↗
• InjuryDec 14, 2023Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PATIENT WAS HAVING A REDO AVR/CABG. THE ORIGINAL PROSTHESIS (UNKNOWN MODEL, SIZE 25) WAS EXPLANTED, AND A COMPLETE DEBRIDEMENT WAS PERFORMED. THEN, SIZING WAS STARTED WITH THE SMALL SIZER. THE SMALL SIZER WAS FALLING THROUGH THE ANNULUS ON THE CLEAR END AND JUST BARELY CATCHING ON THE OPAQUE END. AS SUCH, THEY MOVED TO MEDIUM SIZER WHERE THE CLEAR END WAS JUST BARELY CATCHING, AND THE OPAQUE END WOULD NOT GO THROUGH THE ANNULUS AT ALL. AS SUCH, THEY WENT BACK AND FORTH WITH THE SIZERS 1 OR 2 MORE TIMES AND DECIDED TO PROCEED WITH SIZE SMALL PERCEVAL PLUS VALVE. THUS, COLLAPSING WAS STARTED WHILE THE SURGEON BEGAN TO PLACE THE GUIDING SUTURES. AFTER THE SMALL VALVE WAS COLLAPSED APPROPRIATELY, DEPLOYMENT BEGAN. AFTER THE VALVE WAS DEPLOYED, CHECKS WERE PERFORMED AND BALLOONED WITH WARM SALINE; AND FURTHER CHECKS WERE PERFORMED AGAIN. SURGEON STATED THAT THE GUIDING SUTURE COULD BE SEEN ON THE NON-CORONARY CUSP. IT WAS RECOMMENDED TO TAKE IT OUT AND RE-IMPLANT, BUT THIS DID NOT HAPPEN AS THEY STATED THAT IT DID NOT MATTER WHERE THE GUIDING SUTURE WAS BECAUSE IT WAS A REDO AND AS LONG AS IT WAS SEATED, THEY COULD MAKE THE ANNULUS AN

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18330149 ↗
• InjuryDec 14, 2023Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, A PATIENT WAS HAVING A REDO AVR/CABG. THE ORIGINAL PROSTHESIS (UNKNOWN MODEL, SIZE 25) WAS EXPLANTED, AND A COMPLETE DEBRIDEMENT WAS PERFORMED. THEN, SIZING WAS STARTED WITH THE SMALL SIZER. THE SMALL SIZER WAS FALLING THROUGH THE ANNULUS ON THE CLEAR END AND JUST BARELY CATCHING ON THE OPAQUE END. AS SUCH, THEY MOVED TO MEDIUM SIZER WHERE THE CLEAR END WAS JUST BARELY CATCHING, AND THE OPAQUE END WOULD NOT GO THROUGH THE ANNULUS AT ALL. AS SUCH, THEY WENT BACK AND FORTH WITH THE SIZERS 1 OR 2 MORE TIMES, AND DECIDED TO PROCEED WITH SIZE SMALL PERCEVAL PLUS VALVE. THUS, COLLAPSING WAS STARTED WHILE THE SURGEON BEGAN TO PLACE THE GUIDING SUTURES. AFTER THE SMALL VALVE WAS COLLAPSED APPROPRIATELY, DEPLOYMENT BEGAN. AFTER THE VALVE WAS DEPLOYED, CHECKS WERE PERFORMED AND BALLOONED WITH WARM SALINE; AND FURTHER CHECKS WERE PERFORMED AGAIN. SURGEON STATED THAT THE GUIDING SUTURE COULD BE SEEN ON THE NON-CORONARY CUSP. IT WAS RECOMMENDED TO TAKE IT OUT AND RE-IMPLANT, BUT THIS DID NOT HAPPEN AS THEY STATED THAT IT DID NOT MATTER WHERE THE GUIDING SUTURE WAS BECAUSE IT WAS A REDO AND AS LONG AS IT WAS SEATED, THEY COULD MAKE THE ANNULUS A

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18330146 ↗
• InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION IN PATIENT REGISTRATION FORMS, ON 19 APRIL 2023, PATIENT RECEIVED A PERCEVAL PLUS VALVE SIZE S. REPORTEDLY, ON 10 MAY 2023, THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR DEVICE PVF-S. NO INDICATION OF DEVICE MALFUNCTION HAS BEEN RECEIVED FROM THE SITE. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18234639 ↗