CROWN PRT CNA25Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00896208000535), received between Aug 25, 2016 and Jul 23, 2024 — classified as 2 deaths, 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• DeathJul 23, 2024Degraded; Gradient Increase; Insufficient Device Problem Information; Degraded; Gradient Increase; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF A PATIENT¿S DEATH OCCURRED DURING A RE-DO AVR SURGERY PERFORMED TO EXPLANT A CROWN BIOPROSTHESIS SIZE 25 DUE TO AN INFECTION WHICH COULD NOT BE SUCCESSFULLY TREATED WITH ANTIBIOTIC THERAPY. REPORTEDLY, PATIENT HAD 3 POSITIVE BLOOD CULTURES WITH STREPTOCOCCUS EPIDERMIDIS. DATE WHEN INFECTION WAS DIAGNOSED IS NOT KNOWN TO THE MANUFACTURER AT THIS TIME. AS REPORTED, THE PATIENT HAD NO PREVIOUS HISTORY OF INFECTIVE ENDOCARDITIS. THE CROWN PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2024 AND AN AORTIC PATCH HAD ALSO BEEN INSERTED FOR ROOT WIDENING AT THE TIME OF INITIAL IMPLANT, WITH A TOTAL BYPASS TIME OF 243 MINS. ACCORDING TO THE INFORMATION RECEIVED, AFTER THE INITIAL SURGERY THE PATIENT WAS READMITTED TO OR FOR CARDIAC TAMPONADE REPAIR AND VENTRICLE PACING WIRE INSERTION. THE CROWN VALVE WAS REPORTED TO BE FULLY FUNCTIONAL, WITH NORMAL GRADIENTS AND NO REGURGITATION, AFTER THIS SECOND SURGICAL PROCEDURE. LENGTH OF STAY IS NOT KNOWN TO THE MANUFACTURER AT THIS TIME. BASED ON THE INFORMATION RECEIVED, AT THE TIME OF RE-DO AVR SURGERY THE PATIENT PRESENTED WITH A HEART BLOCK ON A BACKGROUND OF SEVERE AORTIC STENOSIS. AS REPORTED, AFTER REMOVAL OF THE CROWN

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 19804027 ↗
• InjurySep 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  CNA25 WAS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, IT WAS EXPLANTED DUE TO INFECTION AND A NEW VALVE FROM ANOTHER MANUFACTURER WAS INDWELLED. INFECTIOUS BACTERIA ARE UNKNOWN. VEGETATION WAS FOUND IN THE RIGHT APEX OF THE CNA25 AT THE TIME OF EXPLANT. THE ACTUAL PRODUCT WILL BE SENT FROM THE HOSPITAL TO AN OUTSIDE CULTURE COMPANY FOR INSPECTION.

  Patient problems: Bacterial Infection

  MAUDE report 10551410 ↗
• InjurySep 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 A PATIENT RECEIVED A CROWN PRT PERICARDIAL HEART VALVE CNA25. THREE WEEKS AFTER THE IMPLANTATION, WHEN THE PATIENT WAS ALMOST DISCHARGED, THE PATIENT DEVELOPED A FEVER. THE PATIENT WAS THEN DIAGNOSED WITH PROSTHETIC VALVE ENDOCARDITIS. ON (B)(6) 2020, IT WAS EXPLANTED DUE TO INFECTION AND A NEW VALVE FROM ANOTHER MANUFACTURER WAS INDWELLED. VEGETATION WAS FOUND IN THE RIGHT APEX OF THE CNA25 AT THE TIME OF EXPLANT. THE MITRAL VALVE RING (FOREIGN BODY) REMOVED AT THE SAME TIME. THE INFECTIOUS BACTERIA IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 10551398 ↗
• InjuryJun 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CROWN CNA25 WAS IMPLANTED ON (B)(6) 2016, AND WAS FUNCTIONING WELL AT DISCHARGE. ON (B)(6) 2017, AN ADVERSE EVENT CLASSIFIED AS ENDOCARDITIS WAS REPORTED. THE PATIENT'S BLOOD CULTURES WERE POSITIVE FOR E. FAECALIS. ECHOCARDIOGRAPHY PERFORMED AT THE TIME OF THE EVENT SHOWED GOOD FUNCTIONALITY OF THE VALVE (MEAN GRADIENT OF 10 MMHG, NO CENTRAL OR PARAVALVULAR LEAK). ON (B)(6) "2018" THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS.

  Patient problems: Endocarditis

  MAUDE report 7574606 ↗
• InjuryMay 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A CROWN PRT CNA25 WAS IMPLANTED. ON (B)(6) 2018 THE PATIENT COMPLAINED OF DISCOMFORT DURING A DENTAL TREATMENT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. ON (B)(6) 2018 THE PATIENT RECEIVED A RE-OPERATION AND THE VALVE WAS EXPLANTED AND AN SJM ABBOTT/REGENT 21 MM MECHANICAL VALVE WAS IMPLANTED. IT WAS INCLUDED IN THE REPORT THAT INFECTIVE ENDOCARDITIS WAS PRESENT. IN ADDITION IT WAS REPORTED THAT VALVE MALFUNCTION WAS NOT SUSPECTED.

  Patient problems: Endocarditis

  MAUDE report 7501385 ↗
• DeathJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED CONFIRMATION ON (B)(6) 2018 THAT NO AUTOPSY WAS PERFORMED, BUT WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION ABOUT THE EVENT.

  Patient problems: Aortic Valve Stenosis; Death

  MAUDE report 7180732 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT: A CROWN PRT PERICARDIAL HEART VALVE SIZE 25MM THAT WAS IMPLANTED ON (B)(6) 2017 WAS EXPLANTED ON (B)(6) 2017 DUE TO THROMBOSIS. PRIOR TO EXPLANT THE PATIENT PRESENTED WITH FEVER, CLOTS IN LEGS AND SHORTNESS OF BREATH. PATIENT MEDICATION INCLUDED ELOQUIS THEN ASPIRIN. THE PATIENT WAS OF NORMAL BODY HABITUS AS PER PHYSICIAN. ALL BLOOD CULTURES PERFORMED WERE (B)(6) AND THERE WAS NO EVIDENCE OF ENDOCARDITIS. AFTER EXPLANT OF THE CROWN DEVICE A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE SIZE (B)(6) WAS THEN IMPLANTED. THE PATIENT IS ON ECMO AT PRESENT.

  Patient problems: Dyspnea; Fever; Thrombosis

  MAUDE report 7007036 ↗
• InjurySep 1, 2017Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2017 THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF A CROWN PRT PERICARDIAL HEART VALVE THAT WAS IMPLANTED AND EXPLANTED ON (B)(6) 2017. ON FOLLOW UP WITH THE PHYSICIAN THE FOLLOWING INFORMATION WAS DETERMINED. ON (B)(6) 2017 A CROWN PRT PERICARDIAL HEART VALVE SIZE 25 WAS IMPLANTED. ONCE THE X CLAMP WAS REMOVED AORTIC INSUFFICIENCY WAS OBSERVED AND THE PHYSICIAN COMMENTED THAT THE LEAFLETS WERE NOT FUNCTIONING PROPERLY. THE CROWN PRT WAS EXPLANTED AND AN EDWARDS MAGNA EASE SIZE 25 MM WAS IMPLANTED. THERE WAS AN ADDITIONAL 30 MINUTES APPROXIMATELY TO THE X CLAMP TIME. THE PATIENT RECOVERED AS EXPECTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 6839847 ↗
• InjuryAug 23, 2017Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  ON JULY 24TH THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING: ON (B)(6) 2015, A CROWN PRT PERICARDIAL HEART VALVE SIZE 25 AND AORTIC CONDUIT WERE IMPLANTED, AND POST-OPERATIVE ANTICOAGULATION THERAPY WAS RECOMMENDED. AT THE TIME OF OPERATION, A POPLITEAL EMBOLISM WAS EVIDENT. THE POST-OPERATIVE PATIENT OUTCOME WAS GOOD, AND THE VALVE WAS FUNCTIONING NORMALLY PER ECHOCARDIOGRAPHIC REVIEW SEVEN DAYS POST-OPERATIVELY. THE PATIENT WAS ADMITTED ON SUSPICION OF ENDOCARDITIS ON (B)(6) 2017. DURING THE ADMISSION, THROMBUS OF THE VALVE WAS IDENTIFIED. ANTIBIOTIC AND ANTICOAGULATION THERAPY WERE PROVIDED. THE THROMBUS WAS RESOLVED FOLLOWING ANTICOAGULATION THERAPY. THE ENDOCARDITIS WAS NOT CONFIRMED. A POPLITEAL EMBOLECTOMY WAS ALSO PERFORMED ON (B)(6) 2017. THE PATIENT IS PRESENTLY DOING WELL AND IS BOOKED FOR FOLLOW-UP ECHOCARDIOGRAPHY.

  Patient problems: Thrombus

  MAUDE report 6815782 ↗
• InjuryAug 23, 2017Obstruction of Flow; Insufficient Device Problem Information; Obstruction of Flow; Insufficient Device Problem Information

  ON JULY 24TH THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING: ON (B)(6) 2016 A CROWN PRT PERICARDIAL HEART VALVE SIZE 25 WAS IMPLANTED FOR HIGH GRADE AORTIC STENOSIS DUE TO SEVERE CALCIFICATION WITH CONCOMITANT CABG PROCEDURE, WITH UNEVENTFUL POSTOPERATIVE COURSE, EXCEPT FOR A LEG WOUND DEHISCENCE THAT WAS TREATED WITH NO FURTHER COMPLICATIONS NOR INFECTIONS. THE PATIENT WAS RECOMMENDED FOR ANTICOAGULATION THERAPY FOR THE FIRST TWO MONTHS POST-SURGERY (INR RECOMMENDED: 2.0-3.0; MEDIAN: 2.5) THE PATIENT¿S PLATELET COUNT AT DISCHARGE WAS NORMAL.. ON (B)(6) 2017, THE PATIENT EXPERIENCED A STROKE RESULTING IN CEREBRAL INSULT WITH HEMIPLEGIA, APHASIA, AND DYSPHASIA. ON (B)(6) 2017 THROMBOSIS OF THE VALVE WAS IDENTIFIED. THE THROMBOSIS WAS RESOLVED, AND WAS NOT VISIBLE IN A FOLLOW-UP VISIT. NO INFECTION WAS IDENTIFIED. ON (B)(6) THE PATIENT DEVELOPED ATRIAL FIBRILLATION IN THE CONTEXT OF HYPERTHYROIDISM. THE PATIENT WAS TREATED SUCCESSFULLY WITH ELECTROCARDIOVERSION. GRADE II MITRAL REGURGITATION AND ATRIAL SEPTAL ANEURYSM WITH PATENT FORAMEN OVALE (PFO) OF 3 MM WERE ALSO IDENTIFIED. THE PATIENT WAS ULTIMATELY DIAGNOSED WITH DEMENTIA AND WAS DISCHARGED TO A NURSING HOME ON (B)(6) IN GENER

  Patient problems: Thromboembolism; Thrombus

  MAUDE report 6815734 ↗
• InjuryMay 4, 2017Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT THE PATIENT HAD A MITROFLOW VALVE IMPLANTED ON (B)(6) 2017 AND EXPLANTED TWO WEEKS LATER ON (B)(6) 2017. IT WAS STATED THAT AT IMPLANTATION THE VALVE SEEMED FINE. AFTER W WEEKS BEFORE DISCHARGE, THERE WAS AORTIC INSUFFICIENCY. THE PATIENT HAD A PROLONGED HOSPITAL STAY DUE TO DECOMPENSATION. IT WAS ALSO STATED THAT ON THE TEE THE LEAFLETS SEEMED TO BE ASYMMETRIC AND ONE (RIGHT) CORONARY CUSP SEEMED OPEN. A PERIMOUNT MAGNA EASE VALVE WAS IMPLANTED INSTEAD.

  Patient problems: Aortic Insufficiency

  MAUDE report 6545852 ↗
• InjuryApr 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO THE MANUFACTURER THAT THERE WAS THROMBOSIS WITH IN THE CONDUIT/VALVE POST OPERATIVELY. THE PATIENT WAS HAVING AN AORTIC ROOT REPLACEMENT. THE PATIENT RETURNED FROM INITIAL OPERATION AND HAD SOME PROBLEMS WITH BLEEDING. THE PATIENT SETTLED WITH PRODUCTS. A FEW HOURS LATER THE PATIENT HAD A SUDDEN DROP IN BLOOD PRESSURE NOT RESPONSIVE TO INITIAL ATTEMPTS TO RESTORE PRESSURE AND THEN PROCEEDED TO HAVE A PEA ARREST. CHEST WAS OPENED AND PLACED ON BYPASS. DUE TO HIS ECG CHANGES THE SURGEON DECIDED TO OPEN THE ASCENDING AORTA AND INSPECT THE CORONARY BUTTONS. HE FOUND A LARGE CLOT IN THE LEFT MAIN STEM ORIFICE WHICH HE EVACUATED. THE AORTA WAS CLOSED AND AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AND INOTROPIC SUPPORT WAS RECOMMENCED. HE STEADILY IMPROVED AND HE WAS ANTICOAGULATED TO PREVENT FURTHER CLOT FORMATION. NO DEVICES WERE EXPLANTED.

  Patient problems: Blood Loss; Thrombosis

  MAUDE report 6492348 ↗
• InjurySep 29, 2016Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 THAT MITROFLOW VALVE WITHIN 3 WEEKS AFTER VALVE REPLACEMENT AS PART OF A BENTALL PROCEDURE, THE LEFT CORONARY CUSP (LCC) OF CROWN PRT CNA25 BECAME IMMOVABLE IN A CLOSED STATE. THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION: ON (B)(6) 2016 WITH THE FOLLOWING DEVICES, THE PATIENT UNDERWENT AORTIC ROOT REPLACEMENT SURGERY (BENTALL PROCEDURE) FOR ANNULOAORTIC ECTASIA, AORTIC ANEURYSM, AND AORTIC INSUFFICIENCY: AORTIC PROSTHESIS VALVE: CROWN PRT CNA25 - THE PRODUCT IN QUESTION ASCENDING AORTIC GRAFT: J GRAFT SHIELD NEO VALSALVA JNVT-2809 (B)(4). IN THIS SURGERY, THE AORTIC VALVE REPLACEMENT WITH THE CROWN PRT WAS PERFORMED AS FOLLOWS: SUTURE THREAD WAS PLACED THROUGH THE PATIENT'S AORTIC ANNULUS. THE SUTURE THREAD WAS PLACED THROUGH THE SEWING CUFF OF THE CROWN PRT, AND THEN AT SEVERAL MM FROM THE PROXIMAL END OF THE AORTIC GRAFT. THE VALVE AND AORTIC GRAFT WERE SUTURED INTO THE PATIENT TOGETHER. FOR PREVENTION OF BLEEDING, THE PROXIMAL END OF THE AORTIC GRAFT WAS SUTURED INTO THE REMAINING PART OF THE NATIVE AORTIC ROOT WALL, WHICH WAS AROUND 1 CM (CONTINUOUS SUTURE TECHNIQUE WAS EMPLOYED). USING PIEHLER'S METHOD, BOTH LEFT AND RIGHT CO

  Patient problems: No Information

  MAUDE report 5989082 ↗
• InjuryAug 25, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 THAT A CROWN VALVE IMPLANTED ON (B)(6) 2015 WAS EXPLANTED AFTER 11 MONTHS DUE TO REPORTED ENDOCARDITIS AND WAS REPLACED WITH ANOTHER DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Endocarditis

  MAUDE report 5905001 ↗