MITROFLOW LXA19Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00896208000092), received between Oct 28, 2016 and Oct 19, 2022 — classified as 4 deaths, 12 injuries.

The most frequently reported specific device problem is “Calcified” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2022Degraded; Degraded

  THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO HAD A MITROFLOW AORTIC PERICARDIAL VALVE LXA19 IMPLANTED ON (B)(6) 2013, DUE TO AORTIC ROOT ANEURYSM WITH AORTIC REGURGITATION WITH CONNECTIVE TISSUE DISORDER, DEVELOPED A PROGRESSIVE AORTIC STENOSIS AND MITRAL REGURGITATION. ON (B)(6) 2015, SHE UNDERWENT A RE-DO STERNOTOMY TO REPLACE THE MITROFLOW VALVE WITH A 19 MM MAGNA EASE. AS REPORTED, PATIENT DIED ON (B)(6) 2021 DUE TO SYSTOLIC HEART FAILURE DUE TO DIASTOLIC HEART FAILURE DUE TO VALVE (MAGNA EASE) DYSFUNCTION.

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

  MAUDE report 15633928 ↗
• InjuryJan 28, 2022Calcified; Calcified

  ON (B)(6) 2012, A PATIENT RECEIVED A MITROFLOW VALVE SIZE 19 AS PART OF AN AORTIC VALVE REPLACEMENT PROCEDURE. THE PATIENT¿S PREOPERATIVE DIAGNOSIS WAS OF NATIVE AORTIC VALVE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITIONS. THE ECHO PERFORMED IN (B)(6) 2012 SHOWED A MITROFLOW VALVE ADEQUATELY FUNCTIONING (MEAN/PEAK GRADIENTS 26/45MMHG, TRACE OF AORTIC VALVE REGURGITATION). MILD MITRAL REGURGITATION IS NOTED, WITH MILD-MODERATE MITRAL ANNULAR REGURGITATION. THE LEFT VENTRICULAR WALL THICKNESS IS MILDLY INCREASED (EF IS 55-60%). THE ECHO PERFORMED IN (B)(6) 2014 SHOWED A MITROFLOW VALVE WITH ELEVATED GRADIENTS. THE EF IS 55-60%. THE AORTIC VALVE IS WELL SEATED, WITH NO ROCKING MOTION AND NO PARAVALVULAR LEAKS. THE LEAFLETS APPEARED THINK AND FLEXIBLE. THE MEAN/PEAK GRADIENTS WERE 33/56MMHG. THE ECHO PERFORMED IN DEC 2016 REVEALED A LVEF OF 60-65%. THE MITROFLOW VALVE APPEARED WITH ELEVATED GRADIENTS (AV MEAN GRADIENT IS 37MMHG). THE PROSTHETIC VALVE LEAFLETS APPEARED THICKENED AND CALCIFIED. THERE IS POSSIBLE PROSTHETIC STENOSIS. THE ECHO PERFORMED IN (B)(6) 2017 CONFIRMED THE PRESENCE OF ELEVATED GRADIENTS IN THE AORTI

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 13385819 ↗
• InjuryJan 28, 2022Calcified; Calcified

  ON (B)(6) 2012, A PATIENT RECEIVED A MITROFLOW VALVE SIZE 19 AS PART OF AN AORTIC VALVE REPLACEMENT PROCEDURE. THE PATIENT¿S PREOPERATIVE DIAGNOSIS WAS OF NATIVE AORTIC VALVE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITIONS. THE ECHO PERFORMED IN (B)(6) 2012 SHOWED A MITROFLOW VALVE ADEQUATELY FUNCTIONING (MEAN/PEAK GRADIENTS 26/45MMHG, TRACE OF AORTIC VALVE REGURGITATION). MILD MITRAL REGURGITATION IS NOTED, WITH MILD-MODERATE MITRAL ANNULAR REGURGITATION. THE LEFT VENTRICULAR WALL THICKNESS IS MILDLY INCREASED (EF IS 55-60%). THE ECHO PERFORMED IN (B)(6) 2014 SHOWED A MITROFLOW VALVE WITH ELEVATED GRADIENTS. THE EF IS 55-60%. THE AORTIC VALVE IS WELL SEATED, WITH NO ROCKING MOTION AND NO PARAVALVULAR LEAKS. THE LEAFLETS APPEARED THINK AND FLEXIBLE. THE MEAN/PEAK GRADIENTS WERE 33/56MMHG. THE ECHO PERFORMED IN (B)(6) 2016 REVEALED A LVEF OF 60-65%. THE MITROFLOW VALVE APPEARED WITH ELEVATED GRADIENTS (AV MEAN GRADIENT IS 37MMHG). THE PROSTHETIC VALVE LEAFLETS APPEARED THICKENED AND CALCIFIED. THERE IS POSSIBLE PROSTHETIC STENOSIS. THE ECHO PERFORMED IN (B)(6) 2017 CONFIRMED THE PRESENCE OF ELEVATED GRADIENTS IN THE AO

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 13385805 ↗
• InjuryNov 20, 2019Degraded; Off-Label Use; Degraded; Off-Label Use

  RECEIVED INFORMATION FROM THE DEVICE TRACKING DEPARTMENT REGARDING A RECENT EXPLANT OF A MITROFLOW LXA19 IN SEPTEMBER 2019. THE DEVICE WAS IMPLANTED ON (B)(6) 2013 IN THE PULMONARY POSITION. THE INDICATIONS FOR THE RE-DO SURGERY WERE: PULMONARY VALVE INSUFFICIENCY AND RIGHT VENTRICULAR DILATION AFTER EARLIER REPAIR OF TETRALOGY OF FALLOT. AT TWO YEARS OLD, THE PATIENT HAD STRIKING RIGHT VENTRICULAR DILATION AND UNDERWENT PLACEMENT OF A 19 SORIN MITRAFLOW BIOPROSTHETIC VALVE (JAN 2013), WHICH HAS BECOME DYSFUNCTIONAL. THE TRICUSPID VALVE ALSO REQUIRED EARLIER REPAIR AND HAS AGAIN BECOME INSUFFICIENT. ON (B)(6) 2019, A RE-DO SURGERY WAS PERFORMED DUE TO PROSTHETIC PULMONARY VALVE INSUFFICIENCY AND STENOSIS, LEFT PULMONARY ARTERY STENOSIS WITH STENT AND TRICUSPID VALVE REGURGITATION. AFTER THE EXCISION OF THE OLD PULMONARY VALVE PROSTHESIS, A 22MM PULMONARY HOMOGRAFT VALVE WAS IMPLANTED. A GOOD POSTOPERATIVE OUTCOME IS REPORTED FOR THE PATIENT. A FURTHER VISIT WAS PERFORMED ON (B)(6) 2019, AND THE PATIENT WAS REPORTEDLY WELL, WITH NO CONCERNS.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 9351489 ↗
• InjuryNov 20, 2019Degraded; Off-Label Use; Degraded; Off-Label Use

  RECEIVED INFORMATION FROM THE DEVICE TRACKING DEPARTMENT REGARDING A RECENT EXPLANT OF A MITROFLOW LXA19. THE DEVICE WAS IMPLANTED ON (B)(6) 2013 AND WAS EXPLANTED ON (B)(6) 2019. THE EXPLANT OF THE DEVICE WAS DUE TO STENO-INSUFFICIENCY AND DYSFUNCTION OF THE DEVICE. A NEW VALVE FROM A DIFFERENT MANUFACTURER WAS IMPLANTED. NO OTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 9351485 ↗
• DeathJul 29, 2019Calcified; Degraded; Gradient Increase; Material Too Rigid or Stiff; Calcified; Degraded; Gradient Increase; Material Too Rigid or Stiff

  A PATIENT WAS IMPLANTED WITH A MITROFLOW LX19 (SN (B)(4)) ON (B)(6) 2013. THE PATIENT DEATH WAS REPORTED TO BE RELATED TO THE PREMATURE FAILURE OF THE MITROFLOW VALVE. MEDICAL RECORDS REPORTED FROM (B)(6) MEDICAL CENTER REPORTED THAT THE VALVE FAILURE WAS DUE SEVERE VALVE CALCIFICATION AND LEAFLETS FIXED. ON (B)(6) 2017 TOE REPORTED THAT ¿ THE AORTIC VALVE LEAFLETS ARE SEVERELY THICKENED WITH REDUCED SYSTOLIC EXCURSION. SEVERE AORTIC CALCIFICATION IS VISUALIZED. MEAN GRADIENT WAS REPORTED TO BE 97MMHG.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Calcium Deposits/Calcification; Death

  MAUDE report 8837280 ↗
• DeathJul 29, 2019Calcified; Gradient Increase; Material Too Rigid or Stiff; Calcified; Gradient Increase; Material Too Rigid or Stiff

  A PATIENT WAS IMPLANTED WITH A MITROFLOW LX19 (SN (B)(4)) ON (B)(6) 2013. THE PATIENT DEATH WAS REPORTED TO BE RELATED TO THE PREMATURE FAILURE OF THE MITROFLOW VALVE. MEDICAL RECORDS REPORTED FROM (B)(6) MEDICAL CENTER REPORTED THAT THE VALVE FAILURE WAS DUE SEVERE VALVE CALCIFICATION AND LEAFLETS FIXED. ON (B)(6) 2017 TOE REPORTED THAT ¿ THE AORTIC VALVE LEAFLETS ARE SEVERELY THICKENED WITH REDUCED SYSTOLIC EXCURSION. SEVERE AORTIC CALCIFICATION IS VISUALIZED. MEAN GRADIENT WAS REPORTED TO BE 97MMHG."

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Calcium Deposits/Calcification; Death

  MAUDE report 8834868 ↗
• DeathNov 27, 2018Gradient Increase; Gradient Increase

  THE MANUFACTURER WAS NOTIFIED OF THIS EVENT THROUGH THE (B)(6) REGISTRY. ON (B)(6) 2011, (B)(6) YEARS OLD FEMALE PATIENT RECEIVED A MITROFLOW LXA19 TO REPLACE HER NATIVE STENOTIC AORTIC VALVE. NO CONCOMITANT PROCEDURES WERE PERFORMED DURING THE SURGERY. UPON DISCHARGE, 6 DAYS LATER, THE PATIENT WAS IN ATRIAL FIBRILLATION. THE ECHO SHOWED A GOOD MEAN GRADIENT OF 12MMHG. ON (B)(6) 2016, THE PATIENT DIED DUE TO CARDIOVASCULAR MORTALITY REPORTED AS VALVE RELATED BY THE SITE. ON (B)(6) 2016, THE ECHO SHOWED A GRADE III SEVERE AORTIC INSUFFICIENCY (TRANS-VALVULAR MEAN GRADIENT WAS 77MMHG). NO CENTRAL/ PERIVALVULAR LEAKS WERE REPORTED. ON THE SAME DAY, A CORONAROGRAPHY WAS PERFORMED FOR A PRE-TAVI ASSESSMENT TO ACCURATELY VERIFY OPTIMAL VASCULAR ACCESS.

  Patient problems: Aortic Insufficiency; Death; Dyspnea; Multiple Organ Dysfunction Syndrome; Pulmonary Edema

  MAUDE report 8109155 ↗
• InjurySep 5, 2018Calcified; Calcified

  ON (B)(6) 2014 A MITROFLOW LXA19 WAS IMPLANTED AS PART OF THE SURE-AVR TRIAL. ON (B)(6) 2014 THE PATIENT HAD A SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD ACUTE RENAL FAILURE. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. ON (B)(6) 2014 THE PATIENT HAD A 2ND SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD ACUTE RESPIRATORY FAILURE. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. ON (B)(6) 2014 THE PATIENT HAD A 3RD SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT HAD CARDIAC ARRHYTHMIA, ATRIAL FIBRILLATION. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. THE SITE RECORDED FOLLOW-UP DATA FROM THE REFERRING PHYSICIAN ON (B)(6) 2016 WHICH INDICATED THE PATIENT HAD A RIGHT BUNDLE BRANCH BLOCK. THE PATIENTS NYHA CLASS WAS ELEVATED FROM I TO II. ON (B)(6) THE PATIENT HAD A 4TH SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-AVR CLINICAL REGISTRY. THE PATIENT WAS DIAGNOSED WITH BREAST CANCER AND RECEIVED RADIOTHERAPY AND CHEMOTHERAPY. THIS WAS DEEMED TO BE NOT VALVE RELATED BY THE SITE. ON (B)(6) 2016 THE PATIENT HAD A SERIOUS ADVERSE EVENT AS RECORDED BY THE SURE-A

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7849367 ↗
• InjuryApr 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITROFLOW LXA19 WAS IMPLANTED ON (B)(6) 2012. ON (B)(6) 2015, THE VALVE WAS EXPLANTED AND REPLACED WITH A CROWN CNA19 VALVE. NO FURTHER INFORMATION ABOUT THE EVENT WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7429822 ↗
• DeathMar 21, 2018Calcified; Material Too Rigid or Stiff; Folded; Material Deformation; Material Twisted/Bent; Insufficient Device Problem Information; Calcified; Material Too Rigid or Stiff; Folded; Material Deformation; Material Twisted/Bent; Insufficient Device Problem Information

  A MITROFLOW LXA19 WAS IMPLANTED ON (B)(6) 2011. A NOTIFICATION WAS RECEIVED BY A COMPANY REPRESENTATIVE STATING THAT THE PATIENT DIED IN MID - (B)(6) 2018.

  Patient problems: Aortic Valve Stenosis; Death

  MAUDE report 7359210 ↗
• InjuryMay 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MITROFLOW LXA19 WAS EXPLANTED FROM A PEDIATRIC PATIENT AFTER 3.9 YEARS DUE TO INEFFICIENCY (IMPLANT POSITION WAS PULMONARY - OFF LABEL USE) AND REPLACED BY A 25MM VALVE INSTEAD (MODEL AND BRAND ARE UNKNOWN). THE DEVICE WILL NOT BE RETURNED AND NO MORE INFORMATION WILL BE PROVIDED.

  Patient problems: No Information

  MAUDE report 6577317 ↗
• InjuryDec 21, 2016Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION THROUGH PATIENT TRACKING FORM ON 29 NOV 2016 : RECEIVED THE 2ND PATIENT REGISTRATION FORM FOR A PATIENT WITH FOLLOWING DETAILS: LXA19 SN # (B)(4) WAS IMPLANTED. THERE WAS NO IMPLANT DATE AVAILABLE, BUT INITIAL PATIENT REGISTRATION FORM WAS RECEIVED ON SEP 5, 2012. PVS21 SN # (B)(4) WAS IMPLANTED ON (B)(6) 2016 AT SAME AORTIC LOCATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 6197214 ↗
• InjuryDec 21, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING FORM ON (B)(6) 2016 ABOUT THE FOLLOWING: MITROFLOW LXA, SIZE 19, SN# (B)(4) WAS IMPLANTED ON (B)(6) 2012 AT (B)(6). MANUFACTURER RECEIVED ANOTHER PATIENT TRACKING FORM THAT MITROFLOW DLA, SIZE 21, SN# (B)(4) WAS IMPLANTED IN SAME AORTIC POSITION ON (B)(6) 2016.

  Patient problems: No Information

  MAUDE report 6197185 ↗
• InjuryDec 1, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER RECEIVED A PATIENT TRACKING FORM ON OCT 17, 2016 WITH INFORMATION THAT A PATIENT WHO WAS IMPLANTED WITH MITROFLOW LXA VALVE IN (B)(6) 2012 GOT IMPLANTED WITH MECHANICAL VALVE AT SAME AORTIC POSITION, AT SAME HOSPITAL. DETAILS RECEIVED ON THE PATIENT TRACKING FORM ARE AS FOLLOWS: DATE OF IMPLANT: DEVICE MODEL: SN: 1ST IMPLANT: (B)(6) 2012, LXA19, (B)(4); 2ND IMPLANT: (B)(6) 2016, R5-019, (B)(4).

  Patient problems: No Information

  MAUDE report 6139933 ↗
• InjuryOct 28, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED A 2ND PATIENT REGISTRATION FORM (PRF) FOR AORTIC POSITION FOR SAME PATIENT. DETAILS AS FOLLOWING: LXA19 SN# (B)(4) WAS IMPLANTED ON (B)(6) 2014 AT (B)(6) AT THE AORTIC POSITION. S5-021 SN# (B)(4) WAS IMPLANTED ON (B)(6) 2016 AT (B)(6) AT THE AORTIC POSITION FOR SAME PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 6064966 ↗