CROWN PRT CNA23Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00896208000528), received between Jul 16, 2016 and Jan 15, 2026 — classified as 1 death, 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Calcified” (8 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Degraded

  THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLANT OF A CROWN VALVE IN SIZE 23 WHICH OCCURRED ON (B)(6) 2025. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. AFTER REVIEWING THE CASE, IT WAS CONFIRMED THAT THE CROWN 23 VALVE WAS NOT WORKING PROPERLY, AND THE DECISION WAS MADE TO REPLACE IT. THE PATIENT¿S HEIGHT AND WEIGHT AT THE TIME OF THE ORIGINAL IMPLANT ARE UNKNOWN. THE CROWN 23 VALVE HAD BEEN IMPLANTED IN (B)(6) 2023 WITH A GOOD IMMEDIATE POSTOPERATIVE OUTCOME AND AN INITIALLY FAVORABLE EVOLUTION. HOWEVER, DURING SUBSEQUENT FOLLOW-UP ECHOCARDIOGRAMS, A PROGRESSIVE INCREASE IN TRANSVALVULAR VELOCITIES WAS OBSERVED. WHAT BEGAN AS MILD STENOSIS GRADUALLY WORSENED OVER TIME. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE OUTPATIENT CLINIC WITH DYSPNEA THAT HAD PROGRESSED OVER THE PREVIOUS 15 DAYS. THE PATIENT WAS EVALUATED BY THE CARDIOLOGY TEAM, AND HOSPITALIZATION WAS INDICATED. ECHOCARDIOGRAPHY REVEALED SEVERELY IMPAIRED LEAFLET MOBILITY, IMPROPER VALVE OPENING, MILD REGURGITATION, AND SEVERE STENOSIS WITH VELOCITIES EXCEEDING 5 M/S. ANTICOAGULATION WITH HEPARIN FOLLOWED BY WARFARIN WAS INITIATED TO RULE OUT THROMBOTIC OB

  Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased

  MAUDE report 24080176 ↗
• InjuryMar 19, 2025Degraded; Degraded

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A CROWN BIOPROSTHESIS CNA23 OCCURRED ON (B)(6) 2024 DUE TO AORTIC STENOSIS. ADDITIONAL INDICATIONS FOR THE RE-DO PROCEDURE WERE ASCENDING AORTA AS WELL AS AORTIC ANNULUS DILATION. AS REPORTED, THE VALVE HAD BEEN IMPLANTED ON (B)(6) 2020 THROUGH MINISTERNOTOMY DUE TO SEVERE AORTIC STENOSIS. AT THE TIME OF INITIAL SURGERY THE HEART WAS FOUND ENLARGED IN ALL FOUR CHAMBERS AND THE AORTIC NATIVE VALVE APPEARED SEVERELY COMPROMISED BY CALCIFICATION. THE ASCENDING AORTA WAS MEASURED AT 41 MM, SO IT WAS DECIDED NOT TO REPLACE IT. BASED ON THE INFORMATION RECEIVED, AT THE TIME OF THE RE-DO SURGERY THE HEART WAS FOUND ENLARGED AND THE ASCENDING AORTA SEVERELY DILATED. THE AORTA WAS COMPLETELY SECTIONED, AND SEVERE AORTIC ANNULUS DILATION WAS OBSERVED. A BIOLOGICAL PROSTHESIS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED (ST JUDE FREESTYLE SIZE 23) IN COMBINATION WITH DACRON TUBE SIZE 26 AND SIZE 28 WITHOUT REPORTED COMPLICATIONS.

  Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased

  MAUDE report 21641349 ↗
• InjuryMar 19, 2025Calcified; Calcified

  THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT INVOLVING A CROWN VALVE CNA23 BIOPROSTHESIS. THE DEVICE HAD BEEN IMPLANTED ON (B)(6) 2022 IN A PATIENT DIAGNOSED WITH SEVERE AORTIC STENOSIS AND INSUFFICIENCY, WITH A BICUSPID NATIVE VALVE, ALONG WITH MODERATE MITRAL AND TRICUSPID INSUFFICIENCY. THE PATIENT HAD A MEDICAL HISTORY OF HEART FAILURE AND CHRONIC RENAL DISEASE. AS REPORTED, MITRAL VALVE REPAIR WITH A MEMO 3D RECHORD SIZE 34 AND IMPLANTATION OF 2 ARTIFICIAL CHORDAE TENDINEAE, AS WELL AS TRICUSPID ANNULOPLASTY USING THE DE VEGA TECHNIQUE WERE PERFORMED AS CONCOMITANT PROCEDURES. REPORTEDLY THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. BASED ON THE INFORMATION RECEIVED, ON 12 FEBRUARY 2025 THE CROWN PROSTHESIS WAS EXPLANTED DUE TO PROSTHETIC DYSFUNCTION AND REPLACED WITH A CARBOMEDICS TOP HAT MECHANICAL VALVE S5-023. DURING THE SAME SURGERY, A MITRAL VALVE REPLACEMENT WITH A MECHANICAL PROSTHESIS FROM A DIFFERENT MANUFACTURER (MEDTRONIC SIZE 27) WAS PERFORMED DUE TO RECURRENT INSUFFICIENCY, DESPITE THE MEMO 3D RING FUNCTIONING PROPERLY. ACCORDING TO THE INFORMATION RECEIVED, THE CROWN PROSTHESIS APPEARED SEVERELY CALCIFIED UPON REOPERATION. THE SURGERY WAS COMPLETED WITHO

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

  MAUDE report 21640828 ↗
• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CROWN VALVE CNA23 WAS IMPLANTED ON (B)(6) 2019. THIS VALVE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS TOP HAT VALVE S5-025 (THIS DEVICE WAS ULTIMATELY EXPLANTED ON (B)(6) 2021, REF 3005687633-2021-00131). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11894812 ↗
• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A CROWN VALVE CNA23 WAS IMPLANTED ON (B)(6) 2019,. THIS VALVE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS TOP HAT VALVE S5-025 (THIS DEVICE WAS ULTIMATELY EXPLANTED ON (B)(6) 2021, REF 3005687633-2021-00131). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11894774 ↗
• InjuryOct 28, 2020Calcified; Calcified

  A CROWN VALVE CNA23 WAS IMPLANTED IN 2018, BECAME CALCIFIED, THEN EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A MECHANICAL PROSTHESIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 10752944 ↗
• InjuryOct 28, 2020Calcified; Calcified

  A CROWN VALVE CNA23 WAS IMPLANTED IN 2018, BECAME CALCIFIED, THEN EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A MECHANICAL PROSTHESIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 10752941 ↗
• InjuryApr 9, 2020Calcified; Calcified

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR REGISTRY.ON (B)(6) 2017, A PATIENT RECEIVED A CROWN CNA23 IN AORTIC POSITION. THE PATIENT WAS DISCHARGED TO A REHABILITATION CLINIC ON (B)(6) 2017. THE ECHO PERFORMED AT DISCHARGED SHOWED A MEAN GRADIENT OF 19MMHG, ON (B)(6) 2020, THE SITE REPORTED THE FOLLOWING ADVERSE EVENT: RE-INTERVENTION DUE TO STRUCTURAL VALVE DETERIORATION, LEAFLET STIFFENING (CALCIFIED) LEADING TO STENOSIS AND INSUFFICIENCY. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THE STRUCTURAL VALVE DETERIORATION OF THE CROWN VALVE WAS FIRSTLY NOTED ON (B)(6) 2020. THE PRE-OPERATIVE ECHO (B)(6) 2020 SHOWED SEVERE STENOSIS OF THE CROWN PRT VALVE (MEAN TRANSVALVULAR GRADIENT OF 50MMHG) AND SEVERE ECCENTRIC MITRAL INSUFFICIENCY. A GOOD SYSTOLIC FUNCTION IS REPORTED (EF 67%). AT THE TIME OF THE RE-INTERVENTION (B)(6)2020, A MITRAL VALVE REPLACEMENT WAS ALSO PERFORMED. IT IS REPORTED THAT THE PATIENT HAS A HISTORY OF TWO PREVIOUS AORTIC VALVE REPLACEMENTS (IN 2013 AND 2017). THE INTRA-OPERATIVE FINDINGS CONFIRMED THAT THE AORTIC VALVE PROSTHESIS WAS SEVERELY CALCIFIED. THE PATIENT ULTIMATELY RECEIVED TWO COMPETITOR'S VALVES IN THE AORTIC AND MI

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 9943668 ↗
• InjuryApr 9, 2020Calcified; Calcified

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR REGISTRY. ON (B)(6) 2017, A PATIENT RECEIVED A CROWN CNA23 IN AORTIC POSITION. THE PATIENT WAS DISCHARGED TO A REHABILITATION CLINIC ON (B)(6) 2017. THE ECHO PERFORMED AT DISCHARGED SHOWED A MEAN GRADIENT OF 19MMHG, ON (B)(6) 2020, THE SITE REPORTED THE FOLLOWING ADVERSE EVENT: RE-INTERVENTION DUE TO STRUCTURAL VALVE DETERIORATION, LEAFLET STIFFENING (CALCIFIED) LEADING TO STENOSIS AND INSUFFICIENCY. A RE-INTERVENTION WAS PERFORMED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 9943647 ↗
• InjuryFeb 21, 2020Calcified; Difficult to Open or Close; Calcified; Difficult to Open or Close

  ON (B)(6) 2018 A PATIENT RECEIVED A CROWN CNA23 AORTIC HEART VALVE AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6), 2020, THE CNA23 WAS REMOVED BECAUSE THE RCC AND LCC STOPPED WORKING. AND INSPIRIS WAS IMPLANTED INSTEAD.

  Patient problems: Aortic Insufficiency; Calcium Deposits/Calcification

  MAUDE report 9742281 ↗
• InjuryFeb 21, 2020Calcified; Difficult to Open or Close; Calcified; Difficult to Open or Close

  ON (B)(6) 2018 A PATIENT RECEIVED A CROWN CNA23 AORTIC HEART VALVE AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2020, THE CNA23 WAS REMOVED BECAUSE THE RCC AND LCC STOPPED WORKING. AND INSPIRIS WAS IMPLANTED INSTEAD.

  Patient problems: Aortic Insufficiency; Calcium Deposits/Calcification

  MAUDE report 9742271 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PERSIST DATABASE.ON 24 JUL 2017, A FEMALE PATIENT RECEIVED A CROWN PRT IN AORTIC POSITION. AT DISCHARGE, A GOOD VALVE FUNCTIONALITY IS REPORTED (NO REGURGITATION, MEAN GRADIENT 6MMHG). ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FEVER. IT WAS OBSERVED PERIPROSTHETIC ABSCESS EVIDENT AT THE LEVEL OF THE MITRAL-AORTIC JUNCTION AND EXTENDING TO THE MEMBRANOUS INTERVENTRICULAR SEPTUM WITH MOBILE ENDOCARDITIC MASS JUTTING INTO THE RIGHT ATRIUM (MASS LENGTH 1.6 CM). NO JET, NEITHER SHUNT WAS OBSERVED. NO ENDOCARDITIS SIGNS WERE DETECTED IN THE OTHER VALVES. THE SITE JUDGED THE EVENT RELATED TO THE PROCEDURE AND NOT TO THE DEVICE. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2017 AND THE DEVICE WAS EXPLANTED. THE SUBJECT SURVIVED AT THE END OF THE PROCEDURE. THE PROSTHESIS WAS EXPLANTED IN ANOTHER SITE, THEREFORE IT IS IMPOSSIBLE TO RETRIEVE ADDITIONAL DOCUMENTATION; THE DEVICE DISPOSITION ALSO REMAINS UNCONFIRMED. HOWEVER, BASED ON INFORMATION CURRENTLY AVAILABLE, NO HISTOPATHOLOGICAL EXAM WAS PERFORMED ON THE EXPLANTED PROSTHESIS AS THE DIAGNOSIS OF CANDIDA INFECTIVE ENDOCARDITIS WAS CERTAIN.

  Patient problems: Endocarditis

  MAUDE report 8689806 ↗
• InjuryDec 3, 2018Gradient Increase; Material Too Rigid or Stiff; Material Split, Cut or Torn; Gradient Increase; Material Too Rigid or Stiff; Material Split, Cut or Torn

  A CROWN CNA23 WAS IMPLANTED ON (B)(6) 2015. ON (B)(6) 2018, THE PATIENT PRESENTED WITH DYSPNEA. TTE REVEALED HIGH GRADIENT, AND RE-DO AORTIC VALVE REPLACEMENT WAS PERFORMED. IT WAS REPORTED THAT THE VALVE HAD AN IMMOBILE CUSP, WITH LARGE CALCIFICATION AT THE STENT POSTS. A CARPENTIER 21 MM VALVE WAS IMPLANTED AND THE PATIENT WAS RECOVERING WELL WHEN THE EVENT WAS REPORTED. THE PATIENT'S MEDICATIONS ARE SUGGESTIVE OF HYPERLIPIDEMIA, HYPERTENSION, AND DIABETES.

  Patient problems: Dyspnea

  MAUDE report 8127265 ↗
• InjuryNov 6, 2018Calcified; Calcified

  ON (B)(6) 2016 THE PATIENT WAS IMPLANTED WITH A CROWN PRT IN AORTIC POSITION. ON (B)(6) 2018, THE VALVE WAS EXPLANTED DUE TO VALVE DYSFUNCTION. CALCIFICATION WAS OBSERVED IN ALL TISSUES (LEAFLETS, AORTA, PERICARDIUM).

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis; No Information

  MAUDE report 8044620 ↗
• DeathOct 25, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  A MITROFLOW VALSALVA CONDUIT AND CROWN CNA23 WERE IMPLANTED ON (B)(6) 2018. ON (B)(6), 2018, THE PATIENT EXPERIENCED ENDOCARDITIS. ON (B)(6) 2018, THE PATIENT DIED OF SEPSIS. THE FUNCTIONALITY OF THE VALVE AT IMPLANT AND DISCHARGE WERE NOT REPORTED. HOWEVER, IT WAS INDICATED THAT THERE WAS NO CENTRAL OR PARAVALVULAR LEAK AT THE TIME OF IMPLANT.

  Patient problems: Death; Endocarditis; Sepsis

  MAUDE report 8005747 ↗
• InjuryOct 25, 2018Gradient Increase; Material Too Rigid or Stiff; Gradient Increase; Material Too Rigid or Stiff

  ON (B)(6) 2017 A CROWN CNA23 WAS IMPLANTED. ON (B)(6) 2018 THE SITE INFORMED THE MANUFACTURER THAT LEAFLET IMMOBILITY AND INCREASED PRESSURE GRADIENT (50 MMHG) WERE CONFIRMED IN CROWN IMPLANTED PATIENT. A RE-OPERATION WAS PERFORMED ON (B)(6) 2018 AND THE DEVICE WAS EXPLANTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 8005340 ↗
• InjuryJun 22, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A CROWN PERICARDIAL AORTIC HEART VALVE WAS IMPLANTED ON (B)(6) 2014. A TAVI WAS PERFORMED ON (B)(6) 2018 DUE TO STRUCTURAL VALVE DETERIORATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Angina; Aortic Insufficiency; Aortic Valve Stenosis; Mitral Insufficiency; No Information

  MAUDE report 7630543 ↗
• InjuryJun 4, 2018Material Deformation; Material Deformation

  A CROWN CNA23 WAS IMPLANTED ON (B)(6) 2015, AND CONCOMITANT CABGX3 WAS PERFORMED. THE MEAN GRADIENT AT DISCHARGE AND AT FOLLOW UP ON (B)(6) 2017 WERE 10 MMHG AND 13.7 MMHG, RESPECTIVELY. THE PATIENT WAS ADMITTED TO THE HOSPITAL IN (B)(6) 2018 WITH DECOMPENSATED HEART FAILURE REQUIRING IV DIURESIS AND INOTROPES. ECHOCARDIOGRAPHY ON (B)(6) 2018 SHOWED A MEAN GRADIENT OF 27 MMHG WITH MODERATE AR. THE VALVE WAS WELL SEATED WITH CALCIFIED CUSPS AND REDUCED EXCURSION. ON (B)(6) 2018, THE PATIENT UNDERWENT URGENT TAVI DUE TO STRUCTURAL VALVE DETERIORATION.

  Patient problems: Aortic Regurgitation

  MAUDE report 7567805 ↗
• InjuryApr 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITROFLOW CROWN CNA23 WAS IMPLANTED IN (B)(6). DURING THE PROCEDURE THE VALVE WAS EXPLANTED DUE TO AN UNSPECIFIED LEAFLET MALFUNCTION. ANOTHER VALVE WAS USED IN REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 7459083 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A MITROFLOW CROWN CNA23 WAS IMPLANTED. DURING THE PROCEDURE THE DEVICE WAS INTRA-OPERATIVELY EXPLANTED AND A MITROFLOW CROWN CNA21 WAS IMPLANTED. PATIENT OUTCOME IS PRESENTLY UNKNOWN.

  Patient problems: No Information

  MAUDE report 7401561 ↗
• MalfunctionSep 19, 2017Gradient Increase; Incomplete Coaptation; Device Operates Differently Than Expected; Gradient Increase; Incomplete Coaptation; Device Operates Differently Than Expected

  ON (B)(6) 2017 A CROWN PRT AORTIC HEART VALVE SIZE 23MM WAS IMPLANTED. AFTER THE PROCEDURE (ON THE SECOND DAY) AN ECHO DISPLAYED ABNORMAL FINDINGS WHERE THE PHYSICIAN NOTED THAT THE TIP OF ONE OF THE LEAFLETS WAS NOT FUNCTIONING AS EXPECTED. ON (B)(6) 2017 RE-OPERATION WAS PERFORMED AND THE CROWN VALVE WAS EXPLANTED. THE PHYSICIAN NOTED THAT THE VALVE APPEARED TO BE FUNCTIONING AS BI-CUSPID AS ONE LEAFLET WAS NOT OPENING AND APPEARED DAMAGED.

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis; No Information

  MAUDE report 6877356 ↗
• InjuryJul 7, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON THE (B)(6) THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF BOTH A CROWN PRT SIZE 23 AND CROWN PRT SIZE25 VALVE THAT WERE IMPLANTED IN A PATIENT ON (B)(6) 2017.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6694573 ↗
• InjuryMay 26, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017 A CROWN PRT 23MM WAS IMPLANTED VIA FULL-STERNOTOMY. ON (B)(6) 2017 THE PATIENT EXHIBITED ARRHYTHMIAS AND CONDUCTION DISORDERS-AV BLOCK III. A PACEMAKER WAS REQUIRED POSTOPERATIVELY.

  Patient problems: Arrhythmia

  MAUDE report 6595441 ↗
• InjuryMar 15, 2017Fluid/Blood Leak; Fluid/Blood Leak

  DURING AORTIC VALVE REPLACEMENT, A CROWN VALVE SIZE 23 WAS IMPLANTED USING A RUNNING SUTURE TECHNIQUE. IN THE INTRA-OPERATIVE TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE), A LEAK WAS DETECTED. THE SURGEON DECIDED TO REMOVE THE VALVE AND RE-IMPLANT IT USING A NON EVERTING INTERRUPTED SUTURE WITH PLEDGETS, BUT AGAIN THE INTRA-OPERATIVE TEE SHOWED A REGURGITATION SIMILAR TO THE PREVIOUS ONE WITH REGARD TO LOCATION AND SEVERITY. DURING THIS SECOND ATTEMPT, IT WAS CLARIFIED THAT THE REGURGITATION WAS LOCATED CENTRALLY. DUE TO HIGH RISK PATIENT, THE SURGEON DECIDED TO EXPLANT THE DEVICE AND DID NOT TRY TO IMPLANT ANOTHER CROWN 23MM (IN ORDER TO PREVENT A FOURTH CROSS-CLAMPING IN CASE OF FAILURE). HE EVENTUALLY IMPLANTED A DIFFERENT VALVE (MOSAIC). THE SURGEON EXCLUDED ANY RELATIONSHIP BETWEEN THE ANATOMICAL FEATURES OF THE PATIENT AND THE DEVICE. HE THINKS THAT THE PROBLEM WAS MOST LIKELY RELATED TO THAT SPECIFIC DEVICE.

  Patient problems: Aortic Regurgitation

  MAUDE report 6408387 ↗
• InjuryOct 21, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON 21 SEP 2016 ABOUT THE FOLLOWING EVENT: AFTER SPONTANEOUS CIRCULATION WAS RESUMED FOLLOWING VALVE REPLACEMENT, REGURGITATION OCCURRED: ON (B)(6) 2016: AN AORTIC VALVE REPLACEMENT PROCEDURE WAS STARTED FOR THE PATIENT, WHO WAS DIAGNOSED WITH AORTIC REGURGITATION AND AS BEING SUSPICIOUS FOR TAKAYASU'S ARTERITIS; AS THE 25-MM SIZER WAS ABLE TO PASS THROUGH THE PATIENT'S ANNULUS, THE CNA23 MODEL WAS SELECTED; AFTER THE PATIENT WAS CONFIRMED TO HAVE TAKAYASU'S ARTERITIS, THE CROWN PRT CNA23 WAS IMPLANTED USING EVERTING MATTRESS SUTURE TECHNIQUE; AFTER THE PATIENT'S SPONTANEOUS CIRCULATION WAS RESUMED, AORTIC REGURGITATION OCCURRED AND THE PATIENT HAD VENTRICULAR TACHYCARDIA. THE RIGHT CORONARY CUSP OF THE VALVE APPEARED TO BE DEFORMED AND SHOWED ABNORMALITY IN ITS MOTION. REGURGITATION FROM THE RIGHT SIDE OF THE VALVE WAS CONFIRMED; WITH EXTRACORPOREAL CIRCULATION STARTED AGAIN, THE CROWN PRT VALVE WAS EXPLANTED. THE PATIENT'S AORTIC WALL WAS WEAK, AND A TEAR WAS FOUND ON THE RIGHT SIDE OF THE AORTIC WALL. THE LENGTH OF THIS TEAR WAS CORRESPONDING TO ONE STITCH OF THE SUTURE THAT WAS SEWN TO IMPLANT THE CROWN PRT VALVE; CROWN PRT VALVE, SIZE 23 WAS EXPLAN

  Patient problems: Aortic Regurgitation

  MAUDE report 6049311 ↗