CROWN PRT CNA21Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00896208000511), received between Jul 27, 2016 and Dec 14, 2023 — classified as 3 deaths, 28 injuries.

The most frequently reported specific device problem is “Calcified” (9 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2023Calcified; Degraded; Calcified; Degraded

  THE MANUFACTURER WAS INFORMED THAT IN MARCH 2020, A CROWN VALVE (UNKNOWN SIZE) WAS IMPLANTED IN THE PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 SINCE AS AND AR WERE NOTED AT THE FOLLOW-UP EXAMINATION (I.E., AVA: 0.72, VMAX: OVER 5M/SEC, PG:71MMHG), AND THE LEAFLETS OF THE VALVE WAS NOT WORKING CORRECTLY. INSPIRIS 21MM WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 18330585 ↗
• InjuryOct 24, 2023Calcified; Calcified

  THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2018, A CROWN PRT HEART VALVE SIZE 21 WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED AND REPLACED WITH PERCEVAL S VALVE SIZE 21 ON (B)(6) 2023 SINCE SVD WAS NOTED. BASED ON THE FURTHER INFORMATION RECEIVED, THERE WAS OVERGROWTH OF PANNUS AND CALCIFICATION ON THE VALVE. AS SUCH, THE VALVE WAS NOT FUNCTIONING PROPERLY. AS REPORTED, OUTCOME WAS GOOD. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17997230 ↗
• InjuryMay 16, 2022Calcified; Calcified

  ON 7 APRIL 2022, A CROWN VALVE CNA21 WHICH WAS IMPLANTED ON (B)(6) 2017 WAS EXPLANTED DUE TO SEVERE CALCIFICATION AND INSPIRIS 21MM VALVE WAS IMPLANTED INSTEAD. BASED ON THE ADDITIONAL INFORMATION RECEIVED, AFTER IMPLANTING THE DEVICE, A SLIGHT PARAVALVULAR LEAK WAS OBSERVED. IN THE FOLLOW UPS, IT WAS NOTED THAT THE PRESSURE GRADIENT AND PEAK AORTIC JET VELOCITY IS INCREASING AND AORTIC VALVE AREA IS DECREASING EACH YEAR. PATIENT IS UNDER DOAC (EDOXABAN TOSILATE HYDRATE) MEDICATION. NO ILLNESS FOR THE PATIENT HAS BEEN REPORTED. BASED ON THE INFORMATION RECEIVED, PATIENT IS DOING WELL. IT WAS DECIDED TO CONDUCT A PATHOLOGICAL EXAMINATION AT THE HOSPITAL. THEREFORE, THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14410135 ↗
• InjuryMay 7, 2021Calcified; Calcified

  ON (B)(6) 2017, A CROWN VALVE CNA21 WAS IMPLANTED IN AORTIC POSITION. THE PATIENT HAD AN EARLY HEART VALVE FAILURE AND UNDERWENT A RE-DO SURGERY ON (B)(6) 2021. AS REPORTED, THE VALVE HAD STIFFENING OF THE LEAFLETS WITH RETRACTION THAT RESULTED IN FUNCTIONAL AORTIC STENOSIS AND INSUFFICIENCY SIMULTANEOUSLY. THE PATIENT ULTIMATELY RECEIVED A EDWARDS INSPIRIS 21 WAS DISCHARGED ON (B)(6) 2021. THE EXPLANTED CROWN VALVE WAS SENT TO THE PATHOLOGY DEPARTMENT. THE RESULTS OF THE PATHOLOGY EXAMINATION SHOWED CALCIFIED VEGETATIONS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 11795187 ↗
• InjuryApr 8, 2021Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2021, A PATIENT WITH AORTIC STENOSIS WAS INTENDED TO RECEIVE A CROWN CNA21. IT WAS REPORTED THAT POST-PUMP, THE TRANSESOPHAGEAL ECHO WAS PERFORMED, FINDING DYSFUNCTION OF THE NEWLY IMPLANTED PROSTHESIS DUE TO MODERATE CENTRAL INSUFFICIENCY, NO LEAKAGE. IT WAS DECIDED TO CHANGE THE NEWLY IMPLANTED PROSTHESIS, CONCLUDING STRUCTURAL AND FUNCTIONAL DAMAGE; A PORCINE PERICARDIUM IS PLACED (HANCOCK II PORCINE VALVE, NUMBER 21). THE EXPLANTED VALVE IS REVIEWED AND STRUCTURAL DAMAGE IS OBSERVED IN ONE OF ITS LEAFLETS, WHICH DOES NOT ALLOW ADEQUATE COAPTATION. AS A RESULT OF THE EVENT, THE SURGICAL TIMES WERE PROLONGED (PROLONGATION OF THE PUMP TIME AND PROLONGATION OF THE AORTIC CLAMP TIME). HOWEVER, IT WAS REPORTED THAT THE PATIENT PROGRESSED WELL. THE PATIENT HAD A SATISFACTORY RECOVERY. PER ADDITIONAL INFORMATION RECEIVED, THE SURGEON CLAIMS TO HAVE MADE THE CORRECT MEASUREMENT AND VALVE PLACEMENT, NO SUSPECTED ROOT CAUSES WERE IDENTIFIED. THE PRE-OPERATIVE CONDITIONS OF THE PATIENT SHOWED SEVERE CALCIFIC AORTIC STENOSIS WITH A MEAN GRADIENT OF 100 MMHG, WITH AN EJECTION FRACTION OF 50%, VALVE AREA 0.4 CM2; NORMAL CORONARIES. AT INTRAOPERATIVE EVALUATION WITH TRANSESOPHAGEAL E

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11639013 ↗
• InjuryApr 8, 2021Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2021, A PATIENT WITH AORTIC STENOSIS WAS INTENDED TO RECEIVE A CROWN CNA21. IT WAS REPORTED THAT POST-PUMP, THE TRANSESOPHAGEAL ECHO WAS PERFORMED, FINDING DYSFUNCTION OF THE NEWLY IMPLANTED PROSTHESIS DUE TO MODERATE CENTRAL INSUFFICIENCY, NO LEAKAGE. IT WAS DECIDED TO CHANGE THE NEWLY IMPLANTED PROSTHESIS, CONCLUDING STRUCTURAL AND FUNCTIONAL DAMAGE; A PORCINE PERICARDIUM IS PLACED (HANCOCK II PORCINE VALVE, NUMBER 21). THE EXPLANTED VALVE IS REVIEWED AND STRUCTURAL DAMAGE IS OBSERVED IN ONE OF ITS LEAFLETS, WHICH DOES NOT ALLOW ADEQUATE COAPTATION. AS A RESULT OF THE EVENT, THE SURGICAL TIMES WERE PROLONGED (PROLONGATION OF THE PUMP TIME AND PROLONGATION OF THE AORTIC CLAMP TIME). HOWEVER, IT WAS REPORTED THAT THE PATIENT PROGRESSED WELL. THE PATIENT HAD A SATISFACTORY RECOVERY. PER ADDITIONAL INFORMATION RECEIVED, THE SURGEON CLAIMS TO HAVE MADE THE CORRECT MEASUREMENT AND VALVE PLACEMENT, NO SUSPECTED ROOT CAUSES WERE IDENTIFIED. THE PRE-OPERATIVE CONDITIONS OF THE PATIENT SHOWED SEVERE CALCIFIC AORTIC STENOSIS WITH A MEAN GRADIENT OF 100 MMHG, WITH AN EJECTION FRACTION OF 50%, VALVE AREA 0.4 CM2; NORMAL CORONARIES. AT INTRAOPERATIVE EVALUATION WITH TRANSESOPHAGEAL E

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11639006 ↗
• InjuryFeb 12, 2021Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON AN EARLY VALVE FAILURE OF A CROWN CNA21. NO FURTHER INFORMATION HAS BEEN PROVIDED ON IMPLANT DURATION TIME, VALVE EXPLANT, EXPECTED THERAPY OR PATIENT IMPACT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 11325790 ↗
• InjuryFeb 2, 2021Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RECEIVED INFORMATION ON A PATIENT, IMPLANTED WITH A CROWN PRT VALVE, MODEL CNA21, ON (B)(6) 2020 THAT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) WITH HEART FAILURE/AORTIC REGURGITATION. THE TRANSTHORACIC ECHOCARDIOGRAM (TOE) SHOWED A LEAFLET DYSFUNCTION. SPECIFICALLY, IT WAS REPORTED THAT THERE APPEARS TO BE RESTRICTED MOTION OF ONE OF THE VALVE CUSPS. THERE WAS NO THROMBUS/PANNUS IDENTIFIED AS ROOT CAUSE OF THE STUCK LEAFLET. THE PATIENT WAS TREATED WITH VALVE IN VALVE (TAVI) ON (B)(6) 2020 AND THE PATIENT RECEIVED 23MM MEDTRONIC EVOLUT PRO. AS REPORTED, IN THEATRE ON THE TOE THAT ONE LEAFLET WAS A BIT STRANGE BUT WAS MILD AORTIC REGURGITATION AT THE TIME.

  Patient problems: Aortic Regurgitation

  MAUDE report 11270534 ↗
• InjuryFeb 2, 2021Difficult to Open or Close; Difficult to Open or Close

  THE MANUFACTURER RECEIVED INFORMATION ON A PATIENT, IMPLANTED WITH A CROWN PRT VALVE, MODEL CNA21, ON (B)(6) 2020 THAT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) WITH HEART FAILURE/AORTIC REGURGITATION. THE TRANSTHORACIC ECHOCARDIOGRAM (TOE) SHOWED A LEAFLET DYSFUNCTION. SPECIFICALLY, IT WAS REPORTED THAT THERE APPEARS TO BE RESTRICTED MOTION OF ONE OF THE VALVE CUSPS. THERE WAS NO THROMBUS/PANNUS IDENTIFIED AS ROOT CAUSE OF THE STUCK LEAFLET. THE PATIENT WAS TREATED WITH VALVE IN VALVE (TAVI) ON (B)(6) 2020 AND THE PATIENT RECEIVED 23MM MEDTRONIC EVOLUT PRO. AS REPORTED, IN THEATRE ON THE TOE THAT ONE LEAFLET WAS A BIT STRANGE BUT WAS MILD AORTIC REGURGITATION AT THE TIME.

  Patient problems: Aortic Regurgitation

  MAUDE report 11270531 ↗
• InjuryJan 21, 2021Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR DATABASE. ON (B)(6) 2016, A PATIENT RECEIVED A CROWN VALVE MODEL CNA21 THROUGH MEDIAN STERNOTOMY. DURING THE SAME PROCEDURE, A MITRAL VALVE REPLACEMENT AND A TRICUSPID VALVE REPAIR WERE ALSO PERFORMED. THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2016, THE FOLLOWING ADVERSE EVENT OCCURRED: NON STRUCTURAL DYSFUNCTION/PARAVALVULAR LEAK 3+. ON (B)(6) 2016, A RE-INTERVENTION (SUTURE OF THE LEAK) WAS PERFORMED AND THE DEVICE WAS NOT EXPLANTED. THE PATIENT EXPERIENCED ALSO HAEMODYNAMIC INSTABILITY DUE TO PARAVALVULAR LEAK/LOW CARDIAC OUTPUT SYNDROME ON (B)(6) 2016, REPORTEDLY RESOLVED AFTER THE PARAVALVULAR LEAK WAS RE-OPERATED. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 WITH A GOOD DEVICE FUNCTIONALITY (MEAN GRADIENT WAS 8MMHG, NO PERIVALVULAR/CENTRAL LEAK). PER ADDITIONAL INFORMATION RECEIVED, THERE ARE NO REPORTED FACTORS RELATED TO THE PATIENT'S ANATOMY OR TO THE MALFUNCTION OF THE PROSTHESIS THAT CAUSED / CONTRIBUTED TO THE EVENT OF PVL. NO OTHER CAUSES HAVE BEEN IDENTIFIED. UP TO (B)(6) 2016, THE POSTOPERATIVE COURSE HAD INITIALLY BEEN REGULAR. ON DAY (B)(6) 2016, THE PATIENT HAD COMPLETE ATRIOVENTRICULAR BLOCK, DOBUTA

  Patient problems: Aortic Insufficiency; Low Cardiac Output

  MAUDE report 11211120 ↗
• InjuryJan 21, 2021Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR DATABASE. ON (B)(6) 2016, A PATIENT RECEIVED A CROWN VALVE MODEL CNA21 THROUGH MEDIAN STERNOTOMY. DURING THE SAME PROCEDURE, A MITRAL VALVE REPLACEMENT AND A TRICUSPID VALVE REPAIR WERE ALSO PERFORMED. THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2016, THE FOLLOWING ADVERSE EVENT OCCURRED: NON STRUCTURAL DYSFUNCTION/PARAVALVULAR LEAK 3+. ON (B)(6) 2016, A RE-INTERVENTION (SUTURE OF THE LEAK) WAS PERFORMED AND THE DEVICE WAS NOT EXPLANTED. THE PATIENT EXPERIENCED ALSO HAEMODYNAMIC INSTABILITY DUE TO PARAVALVULAR LEAK/LOW CARDIAC OUTPUT SYNDROME ON (B)(6) 2016, REPORTEDLY RESOLVED AFTER THE PARAVALVULAR LEAK WAS RE-OPERATED. THE PATIENT WAS DISCHARGED ON (B)(6) 2016 WITH A GOOD DEVICE FUNCTIONALITY (MEAN GRADIENT WAS 8MMHG, NO PERIVALVULAR/CENTRAL LEAK). PER ADDITIONAL INFORMATION RECEIVED, THERE ARE NO REPORTED FACTORS RELATED TO THE PATIENT'S ANATOMY OR TO THE MALFUNCTION OF THE PROSTHESIS THAT CAUSED / CONTRIBUTED TO THE EVENT OF PVL. NO OTHER CAUSES HAVE BEEN IDENTIFIED. UP TO (B)(6) 2016, THE POSTOPERATIVE COURSE HAD INITIALLY BEEN REGULAR. ON DAY (B)(6) 2016, THE PATIENT HAD COMPLETE ATRIOVENTRICULAR BLOCK, DOBUTA

  Patient problems: Aortic Insufficiency; Low Cardiac Output

  MAUDE report 11211097 ↗
• InjuryDec 17, 2020Degraded; Degraded

  ON (B)(6) 2016, A PATIENT RECEIVED A CROWN CNA21 IN AORTIC POSITION. THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT DUE TO SUSPECTED VALVE FAILURE, AND RECEIVED A MITROFLOW DLA21.

  Patient problems: No Information

  MAUDE report 11033640 ↗
• InjuryDec 17, 2020Degraded; Degraded

  ON (B)(6) 2016, A PATIENT RECEIVED A CROWN CNA21 IN AORTIC POSITION. THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT DUE TO SUSPECTED VALVE FAILURE, AND RECEIVED A MITROFLOW DLA21.

  Patient problems: No Information

  MAUDE report 11033637 ↗
• InjuryOct 1, 2020Calcified; Calcified

  ON (B)(6) 2018, A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT. THE OPERATIVE DIAGNOSIS WAS OF AORTIC VALVE STENOSIS (AORTIC VALVE HEAVILY CALCIFIED). THE RECEIVED A CNA21 IN AORTIC POSITION. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THE MANUFACTURER WAS INFORMED THAT THE DEVICE WENT INTO EARLY DEGENERATION. AN ECHO WAS PERFORMED ON (B)(6) 2020, WHERE IT WAS CONFIRMED THAT THE PROSTHESIS APPEARED CALCIFIED WITH SYSTOLIC GRADIENTS MEAN/MAX OF 80 MMHG/120 MMHG. IT WAS CONFIRMED THAT THE PATIENT REQUIRES A RE-INTERVENTION.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10618165 ↗
• InjuryOct 1, 2020Calcified; Calcified

  ON (B)(6) 2018, A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT. THE OPERATIVE DIAGNOSIS WAS OF AORTIC VALVE STENOSIS (AORTIC VALVE HEAVILY CALCIFIED). THE RECEIVED A CNA21 IN AORTIC POSITION. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THE MANUFACTURER WAS INFORMED THAT THE DEVICE WENT INTO EARLY DEGENERATION. AN ECHO WAS PERFORMED ON (B)(6) 2020, WHERE IT WAS CONFIRMED THAT THE PROSTHESIS APPEARED CALCIFIED WITH SYSTOLIC GRADIENTS MEAN/MAX OF 80MMHG/120MMHG. IT WAS CONFIRMED THAT THE PATIENT REQUIRES A RE-INTERVENTION.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10618144 ↗
• InjuryFeb 7, 2020Calcified; Calcified

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020 A PATIENT WITH A CROWN CNA21 RECEIVED A RE-OPERATION DUE TO CALCIFICATION AND THE DEVICE WAS EXPLANTED. THE REPORT INDICATED THE VALVE WAS IMPLANTED FOR 3 YEARS BUT THERE IS NO INDICATION OF THE EXACT DATE WHEN THE DEVICE WAS IMPLANTED. THE PATIENT IS RECEIVING DIALYSIS.

  Patient problems: Calcium Deposits/Calcification; Corneal Pannus

  MAUDE report 9684758 ↗
• InjuryFeb 7, 2020Calcified; Calcified

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020 A PATIENT WITH A CROWN CNA21 RECEIVED A RE-OPERATION DUE TO CALCIFICATION AND THE DEVICE WAS EXPLANTED. THE REPORT INDICATED THE VALVE WAS IMPLANTED FOR 3 YEARS BUT THERE IS NO INDICATION OF THE EXACT DATE WHEN THE DEVICE WAS IMPLANTED. THE PATIENT IS RECEIVING DIALYSIS.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 9684706 ↗
• InjuryDec 3, 2019Degraded; Degraded

  THE MANUFACTURER RECEIVED THE FOLLOWING UPDATED INFORMATION ON (B)(6) 2019: A 26-YEAR-OLD PATIENT FROM THE PHILIPPINES, A FORMER SMOKER FOR 5 YEARS, 160 CM AND 56KG, SUFFERED AORTIC ENDOCARDITIS IN 2015 DUE TO STREPTOCOCCUS ORALIS ON THE NATIVE AORTIC VALVE. THE PATIENT ALSO HAD A PERSISTENT DUCTUS ARTERIOSUS WHICH WAS CLOSED PERCUTANEOUSLY IN 2016 AND A SMALL SUBVALVULAR MEMBRANOUS CIV. THE PATIENT DID NOT HAVE HYPERTENSION, DM, DYSLIPIDEMIA OR KIDNEY FAILURE. ON (B)(6) 2016 A VALVE REPLACEMENT WAS PERFORMED USING A CROWN CNA21 BIOLOGICAL PROSTHESIS FOR SEVERE AORTIC INSUFFICIENCY. THE PATIENT RECEIVED A REOPERATION AGAIN ON (B)(6) 2019 DUE TO VALVE DEGENERATION AND A ON-X SIZE 21 MECHANICAL HEART VALVE WAS IMPLANTED. THE DEVICE WAS SENT TO PATHOLOGY AND ANALYZED BY THE SITE. THE GRAM STAINING AND CULTIVATION WERE BOTH NEGATIVE. THE PATIENT RECEIVED 5 ECHOCARDIOGRAPHY FOLLOW-UP ANALYSIS. ON (B)(6) 2016 THE PATIENT HAD A SIGNIFICANTLY DILATED LEFT VENTRICLE WITHOUT THICKENING. THE AORTIC BIOPROSTHESIS WAS FUNCTIONING NORMALLY. ON (B)(6) 2016 THE PATIENT HAD A MEAN GRADIENT OF 20 MMHG AND A TRIVIAL REGURGITATION. ON (B)(6) 2016 THE PATIENT HAD LEFT VENTRICLE GLOBULAR, DILATED, WITH

  Patient problems: Aortic Insufficiency

  MAUDE report 9402924 ↗
• InjuryDec 3, 2019Degraded; Degraded

  A 26-YEAR-OLD PATIENT FROM THE PHILIPPINES, A FORMER SMOKER FOR 5 YEARS, 160 CM AND 56KG, SUFFERED AORTIC ENDOCARDITIS IN 2015 DUE TO STREPTOCOCCUS ORALIS ON THE NATIVE AORTIC VALVE. THE PATIENT ALSO HAD A PERSISTENT DUCTUS ARTERIOSUS WHICH WAS CLOSED PERCUTANEOUSLY IN 2016 AND A SMALL SUBVALVULAR MEMBRANOUS CIV. THE PATIENT DID NOT HAVE HYPERTENSION, DM, DYSLIPIDEMIA OR KIDNEY FAILURE. ON (B)(6) 2016 A VALVE REPLACEMENT WAS PERFORMED USING A CROWN CNA21 BIOLOGICAL PROSTHESIS FOR SEVER AORTIC INSUFFICIENCY. THE PATIENT RECEIVED A REOPERATION AGAIN ON (B)(6) 2019 DUE TO VALVE DEGENERATION AND A ON-X SIZE 21 MECHANICAL HEART VALVE WAS IMPLANTED. THE DEVICE WAS SENT TO PATHOLOGY AND ANALYZED BY THE SITE. THE GRAM STAINING AND CULTIVATION WERE BOTH NEGATIVE. THE PATIENT RECEIVED 5 ECHOCARDIOGRAPHY FOLLOW-UP ANALYSIS. ON (B)(6) 2016 THE PATIENT HAD A SIGNIFICANTLY DILATED LEFT VENTRICLE WITHOUT THICKENING. THE AORTIC BIOPROSTHESIS WAS FUNCTIONING NORMALLY. ON (B)(6) 2016 THE PATIENT HAD A MEAN GRADIENT OF 20 MMHG AND A TRIVIAL REGURGITATION. ON (B)(6) 2016 THE PATIENT HAD LEFT VENTRICLE GLOBULAR, DILATED, WITH ECCENTRIC SLIGHT ECCENTRIC HYPERTROPHY AND SIGNIFICANT REDUCTION IN GLOBAL FE

  Patient problems: Aortic Insufficiency

  MAUDE report 9402825 ↗
• InjuryJun 10, 2019Degraded; Gradient Increase; Degraded; Gradient Increase

  ON (B)(6) 2018 A PATIENT RECEIVED A CROWN PRT CNA21 IMPLANT. THE MANUFACTURER WAS NOTIFIED THAT SIX MONTHS AFTER THE DEVICE WAS IMPLANTED THE SITE IDENTIFIED CALCIFICATION ON ONE OF THE LEAFLETS. PATIENT HAD IMMEDIATE POST OP GRADIENT OF 55. PATIENT HAD AN EPISODE OF VENTRICULAR TACHYCARDIA POST-OPERATIVELY (4 MONTHS), AT THIS TIME GRADIENT WAS 75. 3 MONTHS LATER - AFTER THIS EPISODE THE PATIENT WAS RE-OPERATED. THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT RECEIVED A REPLACEMENT VALVE. THE PATIENT OUTCOME WAS GOOD.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 8685048 ↗
• InjuryApr 26, 2019Calcified; Calcified

  ON (B)(6) 2016, A FEMALE PATIENT WITH A HISTORY OF DIABETES, HYPERTENSION, AND HYPERCHOLESTEROLEMIA RECEIVED A CROWN CNA21 IN AORTIC POSITION. THE DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO VALVE STENOSIS, WITH THE PRESENCE OF CALCIFICATION. THE EXPLANTED CROWN WAS REPLACED BY A CARBOMEDICS 19MM. THE PATIENT IS STABLE AND IN A REGULAR FOLLOW-UP COURSE. IN THE MEDICAL RECORDS OF THE PATIENT, THERE IS NO INFORMATION ON THERAPIES WITH THE INTEGRATION OF CALCIUM.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 8557298 ↗
• InjuryDec 19, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  ON (B)(6) 2018, A PATIENT RECEIVED AN AORTIC VALVE REPLACEMENT AND A CROWN PRT CNA21 WAS IMPLANTED. A CONCOMITANT MITRAL VALVE REPLACEMENT WAS PERFORMED AND A PERICARBON MORE 27MM MITRAL VALVE WAS IMPLANTED. 2 MONTHS AFTER THE IMPLANT THE PATIENT'S AORTIC VALVE BECAME STENOTIC AND THE LEAFLETS WERE REPORTED TO BE THICKENED AND NON-MOVING. IT WAS REPORTED THERE WAS A LARGE AMOUNT OF VEGETATION AROUND THE ANNULUS. THE PERICARBON VALVE WAS WORKING FINE. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Stenosis

  MAUDE report 8182726 ↗
• InjuryAug 2, 2018Incomplete Coaptation; Incomplete Coaptation

  WHEN WEANING FROM BYPASS AFTER MITROFLOW VALVE IMPLANT, CENTRAL LEAK WAS IDENTIFIED VIA TEE. THE RIGHT CORONARY LEAFLET SEEMED TO BE STIFF AND DID NOT COAPT DURING DIASTOLE. CPB WAS RESUMED, AND THE VALVE WAS EXAMINED. NO DEFECTS WERE IDENTIFIED, AND NOTHING WAS IDENTIFIED THAT MIGHT BE INTERFERING WITH THE LEAFLET'S MOBILITY. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MITROFLOW VALVE OF THE SAME SIZE. THE PATIENT WAS WEANED FROM BYPASS, AND THE PATIENT RECOVERED WITHOUT INCIDENT.

  Patient problems: Aortic Regurgitation

  MAUDE report 7744635 ↗
• InjuryJul 21, 2018Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2018 A PATIENT RECEIVED AN AORTIC VALVE REPLACEMENT TO REPLACE AM EDWARDS MAGNA 19MM ASCENDING AORTIC VALVE IMPLANT. IT WAS REPLACED WITH A CROWN PRT CNA21 DUE TO AN ISSUE WITH VALVE FUNCTIONALITY CAUSED BY ADHERED PANNUS. IT WAS A BISCUSPID VALVE CASE. AFTER IMPLANTING THE VALVE A TRANSVALVULAR LEAK WAS OBSERVED DURING RE-CIRCULATION. A RE-OPERATION WAS SCHEDULED FOR 2 DAYS LATER. ON (B)(6) 2018 THE CROWN PRT CNA21 WAS EXPLANTED AND REPLACED WITH A SJM REGENT MECHANICAL VALVE. THE PATIENT WAS DISCHARGED AND THE OUTCOME WAS REPORTED AS GOOD.

  Patient problems: Aortic Insufficiency

  MAUDE report 7708694 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN 2002 A PATIENT RECEIVED AN AVR AND ASCENDING AORTA REPLACEMENT. IT WAS BICUSPID VALVE CASE. THE DETAIL OF IMPLANTED VALVE IS UNKNOWN. IN 2014 AN AORTIC VALVE REPLACEMENT WAS PERFORMED. THE REASON OF RE-OPERATION IS UNKNOWN. A NEW BIOPROSTHETIC VALVE WAS IMPLANTED, BUT ITS DETAIL (MODEL AND SERIAL#) ARE UNKNOWN. ON (B)(6) 2018 THE PATIENT RECEIVED ANOTHER AORTIC VALVE REPLACEMENT BECAUSE AN INFECTION WAS SUSPECTED. A CROWN PRT 21 WAS IMPLANTED. DURING A REGULAR FOLLOW-UP IN (B)(6) 2018 THE PATIENT VISITED THE HOSPITAL DUE TO HAVING A FEVER. ECHO SHOWED VEGETATION ON THE VALVE. INFECTION WAS SUSPECTED ON THE CROWN PRT AORTIC IMPLANT. ON (B)(6) 2018 A RE-OPERATION WAS PERFORMED. THE CROWN PRT 21 MM WAS EXTRACTED. VEGETATION WAS CONFIRMED ON THE EXTRACTED CROWN PRT. STAPHYLOCOCCUS CAPITIS, A (B)(6), WAS IDENTIFIED AS THE INFECTIOUS BACTERIA PRESENT ON THE DEVICE. A NEW CROWN PRT 19 MM (SN: (B)(4)) WAS IMPLANTED.

  Patient problems: Endocarditis; Fever

  MAUDE report 7695514 ↗