CROWN PRT CNA19Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00896208000504), received between Jul 14, 2016 and Jul 1, 2025 — classified as 4 deaths, 21 injuries.

The most frequently reported specific device problem is “Incomplete Coaptation” (5 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Calcified; Calcified

  THE MANUFACTURER WAS NOTIFIED OF AN EARLY EXPLANT INVOLVING A CROWN PRT BIOLOGICAL AORTIC HEART VALVE (UNKNOWN SIZE AND SERIAL #) WHICH WAS IMPLANTED IN A JUVENILE PATIENT. AS REPORTED, THE PROSTHESIS WAS EXPLANTED AFTER ABOUT 12 MONTHS DUE TO AORTIC STENOSIS . ACCORDING TO THE INFORMATION RECEIVED, THE VALVE WAS FULLY CALCIFIED. THIS PROSTHESIS WAS REPLACED WITH A CARBOMEDICS STANDARD MECHANICAL AORTIC VALVE SIZE 21. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME AND THE EXPLANTED VALVE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22370559 ↗
• InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH COMPETITOR'S PATIENT TRACKING. BASED ON THE INFORMATION RECEIVED, THE CROWN PRT VALVE CNA19 WAS IMPLANTED IN A PATIENT ON (B)(6) 2022. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH INSPIRIS VALVE 19MM. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20161232 ↗
• InjuryDec 29, 2023Degraded; Material Deformation; Degraded; Material Deformation

  THE MANUFACTURER WAS INFORMED THAT A CROWN CNA 19 VALVE WAS IMPLANTED IN A PATIENT ABOUT 4 MONTHS AGO IN (B)(6) 2023. SINCE SVD AND PVL WERE NOTED, THE VALVE IS PLANNED TO BE EXPLANTED IN (B)(6) 2023. REPORTEDLY, THE DETAILS WILL BE PROVIDED AFTER RE-OPERATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18422161 ↗
• InjuryDec 1, 2023Degraded; Degraded

  A CROWN VALVE SIZE 19 WAS IMPLANTED IN 2018. REPORTEDLY, ON (B)(6) 2023, THE VALVE WAS EXPLANTED SINCE AORTIC STENOSIS AND AORTIC REGURGITATION DUE TO SVD WERE NOTED. BASED ON THE INFORMATION AVAILABLE, REGENT 19 WAS IMPLANTED INSTEAD AS THE REPLACEMENT. THERE WAS NO IMPACT ON THE PATIENT AND OUTCOME WAS GOOD. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

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

  MAUDE report 18250721 ↗
• InjuryJul 11, 2022Leak/Splash; Leak/Splash

  ON (B)(6) 2022, INSPIRIS VALVE WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, THE DEVICE CROWN PRT PERICARDIAL HEART VALVE CNA19 WAS SELECTED AND IMPLANTED BECAUSE THE INSPIRIS SIZER 19MM WAS TIGHT. AFTER DE-CLAMP, ECHO SHOWED REGURGITATION. ECHO COULD NOT DETERMINE WHETHER IT WAS PARAVALVULAR LEAKAGE OR TRANSVALVULAR LEAKAGE. IT SEEMED TO BE PVL OR TVL CLOSER TO THE STENT POST. SINCE THE LEAKAGE WAS MILD, THE DEVICE WAS EXPLANTED AND THE INSPIRIS 19MM WAS IMPLANTED INSTEAD FINALLY. AFTER DE-CLAMP, ECHO SHOWED NO LEAKAGE AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEM. THE CONCOMITANT PROCEDURE WAS AN ASCENDING AORTA REPLACEMENT. OPERATION TIME WAS ADDED 60 MINUTES BECAUSE OF THIS EVENT. THE PATIENT REMAINED STABLE THROUGHOUT DELAY IN PROCEDURE. THE PATIENT OUTCOME IS NO PROBLEM, THE PATIENT WEANED UNEVENTFULLY AND THERE WAS NO PATIENT IMPACT. AS REPORTED, THE PATIENT¿S ANNULUS DIMENSIONS MEASURED PRE-OPERATIVELY WAS APPROXIMATELY 19MM. THE CROWN 19 WAS IMPLANTED SUPRA ANNULARLY. NO DECALCIFICATION WAS PERFORMED AFTER THE CROWN VALVE EXPLANT AND THE INSPIRIS VALVE IMPLANT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14981328 ↗
• InjuryApr 4, 2022Degraded; Degraded

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT: THE PATIENT WHO HAD CROWN VALVE IMPLANTATION SURGERY WITH MIDLINE INCISION SIMULTANEOUS WITH CABG (LITA-LAD, AO-SVG-RCA) ON (B)(6) 2016, UNDERWENT THE EMERGENCY SURGERY DUE TO SEVERE AORTIC REGURGITATION CAUSED BY SVD ON (B)(6) 2022. THE VALVE WAS EXPLANTED AND PVS21 WAS IMPLANTED INSTEAD. ECHO PREFORMED AFTER RE-AVR SHOWED NO LEAKAGE AND NO MALFUNCTION OF THE PERCEVAL VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14003924 ↗
• InjuryMar 8, 2022Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2022, THE CNA19 CROWN VALVE WAS IMPLANTED SUPRA ANNULAR BY MIDLINE INCISION. THE CONCOMITANT PROCEDURE WAS TRICUSPID ANNULOPLASTY. AFTER DE-CLAMPING, THE DEVICE FUNCTIONALITY WAS CHECKED BY THE ECHO AND CENTRAL LEAKAGE WAS DETECTED. THEY RE-CLAMPED AND PERFORMED ADDITIONAL STITCHES USING THE SUTURE WITH FELT, BUT IT WAS NOT SUCCESSFUL. ULTIMATELY, THE DEVICE WAS EXPLANTED AND INSPIRIS 19 MM WAS IMPLANTED INSTEAD WITH NO ISSUE. BASED ON THE INFORMATION RECEIVED, THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13690870 ↗
• InjuryJan 11, 2022Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2021 A CROWN PRT VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY DUE TO THE REGURGITATION. BASED ON THE REPORT WRITTEN BY THE SURGEON, POST IMPLANTATION OF THE VALVE, ONE OF THE VALVE LEAFLET TISSUE APPEARED A BIT TOUGHER THAN THE OTHER TWO LEAFLETS. AFTER THE VALVE REPLACEMENT AND COMING OFF OF CARDIOPULMONARY BYPASS, THE TEE ON TABLE SHOWED A CENTRAL JET MODERATE TO SEVER AORTIC PROSTHESIS REGURGITATION AND COAPTATION FAILURE. SURGEON RE-OPENED THE AORTA AND FOUND THAT NCC LEAFLET WAS STRETCHED BY THE TWO COMMISSURES AND IT WAS NOT COAPTING AT THE SAME LEVEL AS THE OTHER TWO.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13231589 ↗
• InjuryJan 11, 2022Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2021 A CROWN PRT VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY DUE TO THE REGURGITATION. BASED ON THE REPORT WRITTEN BY THE SURGEON, POST IMPLANTATION OF THE VALVE, ONE OF THE VALVE LEAFLET TISSUE APPEARED A BIT TOUGHER THAN THE OTHER TWO LEAFLETS. AFTER THE VALVE REPLACEMENT AND COMING OFF OF CARDIOPULMONARY BYPASS, THE TEE ON TABLE SHOWED A CENTRAL JET MODERATE TO SEVER AORTIC PROSTHESIS REGURGITATION AND COAPTATION FAILURE. SURGEON RE-OPENED THE AORTA AND FOUND THAT NCC LEAFLET WAS STRETCHED BY THE TWO COMMISSURES AND IT WAS NOT COAPTING AT THE SAME LEVEL AS THE OTHER TWO.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13231295 ↗
• InjuryDec 31, 2021Leak/Splash; Incomplete Coaptation; Leak/Splash; Incomplete Coaptation

  THE MANUFACTURER WERE INFORMED ABOUT THE CROWN PRT VALVE-SIZE 19 LEAKAGE AND REGURGITATION. THIS VALVE WAS IMPLANTED ON (B)(6) 2021, AFTER THE IMPLANT OF THE VALVE THE REGURGITATION FROM THE LEAFLET CLOSURE WERE FOUND BY ECHO. BASED ON THE ECHOCARDIOGRAPHY RESULTS THE EJECTION FRACTION WAS 34% (MOD 4) WITH IMPAIRED SYSTOLIC FUNCTION IN SEPTAL, ANTEROSEPTAL AND ANTERIOR WALL AKINESIA DUE TO THE HEART FAILURE. HEMOLYSIS AND THE HEMATURIA WAS REPORTED FOR THIS PATIENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13129066 ↗
• InjuryDec 31, 2021Leak/Splash; Leak/Splash

  THE MANUFACTURER WERE INFORMED ABOUT THE CROWN PRT VALVE-SIZE 19 LEAKAGE AND REGURGITATION. THIS VALVE WAS IMPLANTED ON (B)(6) 2021, AFTER THE IMPLANT OF THE VALVE THE REGURGITATION FROM THE LEAFLET CLOSURE WERE FOUND BY ECHO. BASED ON THE ECHOCARDIOGRAPHY RESULTS THE EJECTION FRACTION WAS 34% (MOD 4) WITH IMPAIRED SYSTOLIC FUNCTION IN SEPTAL, ANTEROSEPTAL AND ANTERIOR WALL AKINESIA DUE TO THE HEART FAILURE. HEMOLYSIS AND THE HEMATURIA WAS REPOSTED FOR THIS PATIENT BUT THE RELATIONSHIP IS UNKNOWN.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13128978 ↗
• DeathDec 30, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION IDENTIFYING THE FOLLOWING: AFTER THE IMPLANT OF THE CROWN VALVE, ON THE SECOND POSTOPERATIVE DAY, THE PATIENT WAS TRANSFERRED FROM THE ICU TO A STANDARD HOSPITAL WARD, STABLE AND ALERT. THE NEXT DAY, A DROP IN HEMATOCRIT AND WEAKNESS WAS OBSERVED. AT THE SAME TIME, A LARGE HEMATOMA WAS OBSERVED IN THE LEFT GROIN, DUE TO A POSSIBLE RUPTURE OF THE FEMORAL ARTERY (PATIENT WITH SEVERE PERIPHERAL VASCULAR DISEASE, WHO HAD BEEN REJECTED FOR TAVI). THE PATIENT WAS FEELING GREAT DISCOMFORT. THE PATIENT WAS TAKEN TO THE ICU AGAIN WHERE THE PASSED AWAY DUE TO POSSIBLE INTRA-ABDOMINAL BLEEDING FROM THE RUPTURE OF THE PELVIC-FEMORAL ARTERY. BASED ON THE MEDICAL ASSESSMENT RECEIVED, THE CAUSE OF DEATH WAS THE RAPTURE OF THE FEMORAL ARTERY AND IT WAS NOT RELATED TO THE RE-DO AORTIC VALVE REPLACEMENT.

  Patient problems: Death

  MAUDE report 11099012 ↗
• DeathDec 30, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION IDENTIFYING THE FOLLOWING: AFTER THE IMPLANT OF THE CROWN VALVE, ON THE SECOND POSTOPERATIVE DAY, THE PATIENT WAS TRANSFERRED FROM THE ICU TO A STANDARD HOSPITAL WARD, STABLE AND ALERT. THE NEXT DAY, A DROP IN HEMATOCRIT AND WEAKNESS WAS OBSERVED. AT THE SAME TIME, A LARGE HEMATOMA WAS OBSERVED IN THE LEFT GROIN, DUE TO A POSSIBLE RUPTURE OF THE FEMORAL ARTERY (PATIENT WITH SEVERE PERIPHERAL VASCULAR DISEASE, WHO HAD BEEN REJECTED FOR TAVI). THE PATIENT WAS FEELING GREAT DISCOMFORT. THE PATIENT WAS TAKEN TO THE ICU AGAIN WHERE THE PASSED AWAY DUE TO POSSIBLE INTRA-ABDOMINAL BLEEDING FROM THE RUPTURE OF THE PELVIC-FEMORAL ARTERY. BASED ON THE MEDICAL ASSESSMENT RECEIVED, THE CAUSE OF DEATH WAS THE RAPTURE OF THE FEMORAL ARTERY AND IT WAS NOT RELATED TO THE RE-DO AORTIC VALVE REPLACEMENT.

  Patient problems: Death

  MAUDE report 11099008 ↗
• InjuryDec 8, 2020Material Deformation; Material Deformation

  ON (B)(6) 2019, A MITROFLOW CNA19 WAS IMPLANTED IN AORTIC POSITION; THE PATIENT HAS ALSO RECEIVED A COMPETITOR'S VALVE IN THE MITRAL POSITION. THE MANUFACTURER WAS INFORMED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 DUE INCREASE IN PRESSURE DIFFERENCE. AT THE TIME OF THE RE-INTERVENTION, WHEN THE AORTA WAS OPENED, THE STENT POST OF CROWN CNA19 VALVE WAS FOUND FALLEN INWARD AND THE VALVE ITSELF HAD TWISTED RESULTING IN STENOSIS. THE PATIENT ULTIMATELY RECEIVED A PERCEVAL PVS21.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10972655 ↗
• InjuryDec 8, 2020Material Deformation; Material Deformation

  ON (B)(6) 2019, A MITROFLOW CNA19 WAS IMPLANTED IN AORTIC POSITION; THE PATIENT HAS ALSO RECEIVED A COMPETITOR'S VALVE IN THE MITRAL POSITION. THE MANUFACTURER WAS INFORMED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 DUE INCREASE IN PRESSURE DIFFERENCE. AT THE TIME OF THE RE-INTERVENTION, WHEN THE AORTA WAS OPENED, THE STENT POST OF CROWN CNA19 VALVE WAS FOUND FALLEN INWARD AND THE VALVE ITSELF HAD TWISTED RESULTING IN STENOSIS. THE PATIENT ULTIMATELY RECEIVED A PERCEVAL PVS21.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10972608 ↗
• DeathMay 16, 2020Material Deformation; Material Deformation

  ON (B)(6) 2019, CROWN/PRT (CNA19, SN# (B)(4)) WAS INDWELLED THROUGH A MIDLINE INCISION, AT THE SAME TIME, CORONALLY ARTERY BYPASS GRAFT SURGERY WAS PERFORMED. THE PATIENT HAD A SMALL ANNULUS AND HAD AN AORTIC REGURGITATION. AT THE TIME OF IMPLANTING SURGERY, THE SURGEON INTENDED TO IMPLANT EDWARDS' MAGNA 21 MM, BUT THE SIZER DIDN'T EASILY PASS THE ANNULUS. THEREFORE CROWN 19 MM WAS SELECTED. NO ABNORMALITIES WERE OBSERVED AT THE TIME OF IMPLANTATION. AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT'S CONDITION DID NOT IMPROVE SO MUCH, AND AN ABNORMALITY WAS CONFIRMED BY ECHO. CROWN WAS REMOVED ON (B)(6) 2020, AND PART OF THE STENT WAS DEFORMED INTO AN ELLIPTICAL SHAPE. EDWARDS INSPRIRS WAS IMPLANTED AFTER THE CROWN WAS REMOVED, AND THE PATIENT SUBSEQUENTLY DIED.

  Patient problems: Death; No Information

  MAUDE report 10064009 ↗
• InjurySep 14, 2019Gradient Increase; Difficult to Open or Close; Gradient Increase; Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT WHICH TOOK PLACE AT FORTIS ESCORTS HEART INSTITUTE, (B)(6). A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT USING CROWN PRT 19MM VALVE ON (B)(6) 2019. ON ROUTINE PREDISCHARGE ECHO DONE ON (B)(6) 2019, SHE WAS FOUND TO HAVE HIGH TRANSVALVULAR GRADIENT (65MMHG), VALVE AREA OF 0.6 CM WITH HIGH LVEDP. ONLY TWO LEAFLETS OF THE VALVE WERE MOVING, THIRD LEAFLET COULD NOT BE VISUALIZED. CARDIAC MRI WAS THEREFORE DONE ON (B)(6) 2019 WHICH ALSO CONFIRMED THAT ONLY TWO LEAFLETS WERE MOVING. IN VIEW OF ECHO AND CARDIAC MRI FINDINGS, SHE WAS RE-EXPLORED ON (B)(6) 2019. INTRAOPERATIVELY, ONE OF THE LEAFLETS WAS NOT MOBILE AND THE EDGES OF THIS LEAFLET GOING BEYOND THE EDGES OF OTHER TWO LEAFLETS. THE VALVE WAS EXPLANTED AND REPLACED WITH SIMILAR SIZE VALVE. INTRAOPERATIVE ECHO SHOWED NORMAL VALVE FUNCTIONING VALVE.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 9056671 ↗
• InjurySep 13, 2019Gradient Increase; Difficult to Open or Close; Gradient Increase; Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT WHICH TOOK PLACE AT FORTIS (B)(6). A PATIENT UNDERWENT AORTIC VALVE REPLACEMENT USING CROWN PRT 19MM VALVE ON (B)(6) 2019. ON ROUTINE PREDISCHARGE ECHO DONE ON (B)(6) 2019, SHE WAS FOUND TO HAVE HIGH TRANSVALVULAR GRADIENT (65MMHG), VALVE AREA OF 0.6 CM WITH HIGH LVEDP. ONLY TWO LEAFLETS OF THE VALVE WERE MOVING, THIRD LEAFLET COULD NOT BE VISUALIZED. CARDIAC MRI WAS THEREFORE DONE ON (B)(6) 2019 WHICH ALSO CONFIRMED THAT ONLY TWO LEAFLETS WERE MOVING. IN VIEW OF ECHO AND CARDIAC MRI FINDINGS, SHE WAS RE-EXPLORED ON (B)(6) 2019. INTRAOPERATIVELY, ONE OF THE LEAFLETS WAS NOT MOBILE AND THE EDGES OF THIS LEAFLET GOING BEYOND THE EDGES OF OTHER TWO LEAFLETS. THE VALVE WAS EXPLANTED AND REPLACED WITH SIMILAR SIZE VALVE. INTRAOPERATIVE ECHO SHOWED NORMAL VALVE FUNCTIONING VALVE.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 9050377 ↗
• InjuryNov 26, 2018Gradient Increase; Material Too Rigid or Stiff; Gradient Increase; Material Too Rigid or Stiff

  A CROWN PRT 19 MM VALVE WAS IMPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT DURING SURGERY ONE LEAFLET OF THE VALVE APPEARED RIGID AND WAS NOT CLOSING PROPERLY. THE PHYSICIAN FORCED THE LEAFLET CLOSED MANUALLY, BUT THERE WAS A GAP BETWEEN THE LEAFLETS. THE PHYSICIAN DID NOT EXPLANT THE VALVE AND CLOSED THE AORTA. POST-PROCEDURE TEE SHOWED NO REGURGITATION AND THE MEAN GRADIENT WAS 15 MMHG (MAX 25 MMHG). HOWEVER, AT DISCHARGE, THE PATIENT'S GRADIENT WAS 35 MMHG. THE PATIENT IS BEING MONITORED, BUT THERE IS A CHANCE THAT THE DEVICE WILL BE EXPLANTED AND REPLACED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 8103982 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A CROWN PRT PERICARDIAL HEART VALVE WAS IMPLANTED ON (B)(6) 2015. DEVICE WAS EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION ON (B)(6) 2018 AND WAS REPLACED BY PERCEVAL S.

  Patient problems: No Information

  MAUDE report 7252362 ↗
• InjuryJul 17, 2017Material Too Rigid or Stiff; Incomplete Coaptation; Material Too Rigid or Stiff; Incomplete Coaptation

  ON (B)(6) 2017 A CROWN PRT SIZE 19 WAS IMPLANTED. AFTER DECLAMPING, THE VALVE'S OPENING-CLOSING MOVEMENT WAS CHECKED WITH ECHOCARDIOGRAPHY; A LEAK FROM THE LEAFLET COAPTATION WAS CONFIRMED. THE PHYSICIAN COMMENTED THAT THE MOVEMENT OF MARKED LEAFLET APPEARED POOR AND STIFF COMPARED TO OTHERS. THE VOLUME OF THE LEAK WAS NOT AT AN ACCEPTABLE LEVEL AND THE VALVE WAS EXPLANTED AND A NEW CROWN PRT SIZE 19 WAS IMPLANTED. NORMAL MOVEMENT WAS OBSERVED WITH NO LEAK. THE PATIENT IS IN GOOD CONDITION AFTER THE OPERATION.

  Patient problems: Aortic Insufficiency; Aortic Regurgitation; No Information

  MAUDE report 6717256 ↗
• InjuryDec 16, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 THAT A CROWN VALVE IMPLANTED ON (B)(6) 2016 WAS EXPLANTED AFTER 1 MONTH DUE TO ENDOCARDITIS. THE EVENT AS FOLLOW: ON (B)(6) 2016 - CROWN PRT WAS IMPLANTED IN THE PATIENT. THE PATIENT DISCHARGED 2 WEEKS AFTER THE IMPLANTATION. AROUND MID-NOVEMBER - THE PATIENT VISITED THE HOSPITAL DUE TO HAVING FEVER. INFECTIOUS ENDOCARDITIS WAS CONFIRMED, AND INFECTIOUS BACTERIUM IDENTIFIED BY THE INSTITUTE WAS STAPHYLOCOCCUS. ON (B)(6) 2016 - THE VALVE REPLACEMENT WAS PERFORMED WITH REINFORCING THE VALVE RING WITH A PATCH. THIS CROWN PRT VALVE WAS EXPLANTED AND VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED.

  Patient problems: Endocarditis

  MAUDE report 6182977 ↗
• InjuryOct 28, 2016Occlusion Within Device; Retraction Problem; Folded; Occlusion Within Device; Retraction Problem; Folded

  ADDITIONAL INFO RECEIVED FEB 15, 2017: THE CAUSE OF THE REINTERVENTION AFTER THE THROMBOSIS SOLUTION WAS THE EARLY DEGENERATION OF THE BIOLOGICAL PROSTHESIS WHICH PRESENTED DOUBLE AORTIC LESION WITH SEVERE STENOSIS AND MODERATE INSUFFICIENCY. AFTER THE FIRST INTERVENTION THE PATIENT WASN´T ANTI-COAGULATED. THE SURGEON¿S PROTOCOL IN CASE OF BIOLOGICAL AORTIC PROSTHESES IN PRESERVED SINUS RHYTHM AND LVEF IS THE ANTI-AGGREGATION WITH ASPIRIN 100 MG / 24 H. THE ANTICOAGULATION WAS INITIATED AFTER THE DIAGNOSIS OF PROSTHETIC THROMBOSIS. THE STENT DEFORMATION WAS OBSERVED INTRAOPERATIVE, IMMEDIATELY BEFORE THE EXPLANT. PATIENT'S (B)(6).

  Patient problems: Aortic Insufficiency; Heart Failure; Thrombosis; Thrombus

  MAUDE report 6064965 ↗
• InjuryJul 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS NOTIFIED ON 19 JUNE 2016 THAT CROWN PRT CNA19 WAS EXPLANTED DUE TO INFECTIOUS ENDOCARDITIS. THE CROWN PRT, CNA 19 WAS IMPLANTED ON (B)(6) 2016 WHICH WAS PERFORMED ALONG WITH MITRAL VALVE REPLACEMENT AND TRICUSPID ANNULOPLASTY. THE BACTERIUM IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS.

  Patient problems: Endocarditis

  MAUDE report 5800663 ↗
• DeathJul 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS NOTIFIED ON 01 JULY 2016 ABOUT THE DEATH OF PATIENT WHO UNDERWENT RE-OPERATION TO IMPLANT CROWN PRT, SIZE 19MM. CROWN SIZE 19MM WAS IMPLANTED AND THE IMPLANT WAS OK AT POST OPERATIVE ECHO. PATIENT WAS FINE WHEN SHE WENT TO ICU BUT THEN HAD A MULTIORGAN FAILURE. THE SURGEON SAID THE PATIENT DIED PROBABLY DUE TO ABDOMINAL ISCHEMIA. BACKGROUND INFORMATION: 1ST OPERATION: (B)(6) 2016. PATIENT AFFECTED BY AORTIC STENOSIS WHO WAS REPORTED TO BE A FRAGILE WOMAN WITH INTESTINAL PROBLEMS (DIVERTICULA). AORTIC VALVE REPLACEMENT WAS PERFORMED BY MINITHORACOTOMY 2ND SPACE WHERE CROWN PRT, SIZE 21MM WAS IMPLANTED WITH 3 SEMI-CONTINUOUS SUTURES IN PROLENE. AT 2ND DAY AFTER SURGERY, THE ECHO SHOWED A MILD INTRAPROSTHETIC INSUFFICIENCY AND PATIENT HAD PLEURAL EFFUSION. AFTER 20 DAYS, PATIENT HAD A HEART FAILURE, WENT TO ICU AND TRANS THORACIC ECHO SHOWED A SEVERE INTRA PROSTHETIC INSUFFICIENCY. PATIENT WAS SENT TO OR TO GET VALVE EVALUATED. DURING 2ND OPERATION: PERFORMED IN TOTAL STERNOTOMY, THE VALVE SEEMED TO BE NORMAL AT FIRST VISUAL EXAM, NO PROSTHETIC DETACHMENT AND NO STITCHES RUPTURE WERE FOUND. THE VALVE WAS EXPLANTED AND THEN THE SURGEONS NOTICED THAT ONE OF THE CUSP

  Patient problems: Death

  MAUDE report 5797129 ↗