MITROFLOW DLA19Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00896208000153), received between Nov 9, 2016 and Sep 8, 2021 — classified as 3 deaths, 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2014, A MITROFLOW VALVE DLA19 WAS IMPLANTED IN AORTIC POSITION. IN 2014 THE PATIENT HAD AORTIC VALVE FAILURE, CALCIFICATION AND SEVERE FATIGUE. AS REPORTED, THE PATIENT HAS BEEN IN HEART FAILURE 2 YEARS POST OP, AND WAS TAKEN TO HOSPITAL ON (B)(6) 2021 WITH TROUBLE BREATHING WHILE SEATED. THE VALVE WAS NOT EXPLANTED AS THERE WAS A VERY HIGH MORTALITY RATE. BASED ON THE ECHOCARDIOGRAM REPORTS PROVIDED ON (B)(6) 2016 AN ECHO SHOWED MODERATE ECCENTRIC AOR (PARAVALVULAR), THE PEAK GRADIENT WAS 60MMHG THE MEAN GRADIENT WAS 33MMHG. IT ALSO SHOWED SEVERE AORTIC BIOPROSTHESIS DYSFUNCTION WITH MODERATE PARAVALVULAR LEAK AND AT LEAST MODERATE AORTIC STENOSIS. IT WAS ALSO NOTED THAT THE PATIENT HAD MODERATE CENTRAL MR AND MODERATE PULMONARY HYPERTENSION WITH MODERATE TO SEVERE TRICUSPID REGURGITATION (TR). BASED ON THIS ECHO THERE WAS SIGNIFICANT WORSENING SINCE THE PREVIOUS STUDY. ON (B)(6) 2019 THE ECHO SHOWED EVIDENCE OF SEVERE STENOSIS OF THE AORTIC VALVE PROSTHESIS, MILD PARAVALVULAR AORTIC REGURGITATION, MEAN GRADIENT IS 31MMHG. IT WAS ALSO NOTED THAT THE PATIENT HAD MITRAL ANNULAR CALCIFICATION AND MODERATE MITRAL REGURGITATION. ON (B)(6) 2021 THE ECHO SHOWED THAT THE RCC IS

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 12438750 ↗
• InjurySep 7, 2021Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2014, A PATIENT WITH AORTIC VALVE FAILURE, CALCIFICATION AND FATIGUE UNDERWENT TO AORTIC VALVE REPLACEMENT. A MITROFLOW VALVE DLA19 (SIZE 19) WAS IMPLANTED. ON (B)(6) 2016, AN ECHO REPORTED MODERATE ECCENTRIC PARAVALVULAR LEAK, WITH PEAK GRADIENT OF 66 MMHG AND MEAN GRADIENT 33 MMHG. SEVERE AORTIC DYSFUNCTION WITH MODERATE REGURGITATION AND STENOSIS. MODERATE CENTRAL MITRAL REGURGITATION (MR), MODERATE PULMONARY HYPERTENSION, RV SIZE AND FUNCTION PRESERVED. RV PACEMAKER LEAD IN PLACE. MILD PULMONARY INSUFFICIENCY (IT IS REPORTED SIGNIFICANT WORSENING SINCE PREVIOUS STUDY). ON (B)(6) 2019 THE ECHO SHOWED EVIDENCE OF SEVERE STENOSIS OF THE AORTIC VALVE PROSTHESIS, MILD PARAVALVULAR AORTIC REGURGITATION, MEAN GRADIENT IS 31MMHG. IT WAS ALSO NOTED THAT THE PATIENT HAD MITRAL ANNULAR CALCIFICATION AND MODERATE MITRAL REGURGITATION. LEFT ATRIUM VOLUME IS MODERATELY INCREASED (IT IS REPORTED THAT; COMPARED WITH PREVIOUS, THE STUDY IS SIMILAR, HOWEVER WITH RIGHT VENTRICULAR SYSTOLIC PRESSURE IS LOWER). ON (B)(6) 2021 TEE WAS COMPLETED TO VERIFY POSSIBILITY FOR VIV; THE ECHO SHOWED THAT THE RCC IS IMMOBILE, GRADIENTS ARE ELEVATED ACROSS THE VALVE, MILD CENTRAL AI AND MODERATE PARA

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 12437009 ↗
• DeathDec 23, 2020Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. A PATIENT RECEIVED A MITROFLOW DLA19 ON (B)(6) 2014. ON (B)(6) 2020 THE DEVICE WAS EXPLANTED AND REPLACED WITH A CARBOSEAL VALSALVA CP-021. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 FOR NON STEMI. THE ECHO SHOWED SEVERE AORTIC STENOSIS WITH AN AORTIC VALVE AREA OF 0.6 CM2 AND A GRADIENT OF 47MMHG. THE PATIENT WAS REFERRED FOR A POSSIBLE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). HOWEVER, CONSIDERING THE PATIENT'S SITUATION WITH THE PREVIOUS LOW CORONARY ARTERIES AND SMALL PROSTHETIC, TAVR WAS NOT RECOMMENDED. THE BEST OPTION TO TREAT THE RESTENOSIS OF THE AORTIC VALVE WAS TO PROCEED WITH A RE-DO STERNOTOMY WITH AORTIC VALVE REPLACEMENT. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2020 FOR CHEST DISCOMFORT. THE PATIENT PRE-OPERATIVE DIAGNOSIS WAS OF SEVERE RECURRENT AORTIC STENOSIS WITH A MITROFLOW 19 AORTIC VALVE PROSTHESIS WITH UNDERLYING PREVIOUSLY STENTED CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, RECENT PNEUMONIA, HYPERTENSION AND HYPERLIPIDEMIA. AT THE TIME OF THE RE-INTERVENTION, IT WAS NOTED THAT THE AORTA WAS VERY SHORT AND CALCIFI

  Patient problems: Aortic Valve Stenosis

  MAUDE report 11068027 ↗
• DeathDec 23, 2020Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. A PATIENT RECEIVED A MITROFLOW DLA19 ON (B)(6) 2014. ON (B)(6) 2020 THE DEVICE WAS EXPLANTED AND REPLACED WITH A CARBOSEAL VALSALVA CP-021. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 FOR NON STEMI. THE ECHO SHOWED SEVERE AORTIC STENOSIS WITH AN AORTIC VALVE AREA OF 0.6 CM2 AND A GRADIENT OF 47MMHG. THE PATIENT WAS REFERRED FOR A POSSIBLE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). HOWEVER, CONSIDERING THE PATIENT'S SITUATION WITH THE PREVIOUS LOW CORONARY ARTERIES AND SMALL PROSTHETIC, TAVR WAS NOT RECOMMENDED. THE BEST OPTION TO TREAT THE RESTENOSIS OF THE AORTIC VALVE WAS TO PROCEED WITH A RE-DO STERNOTOMY WITH AORTIC VALVE REPLACEMENT. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2020 FOR CHEST DISCOMFORT. THE PATIENT PRE-OPERATIVE DIAGNOSIS WAS OF SEVERE RECURRENT AORTIC STENOSIS WITH A MITROFLOW 19 AORTIC VALVE PROSTHESIS WITH UNDERLYING PREVIOUSLY STENTED CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, RECENT PNEUMONIA, HYPERTENSION AND HYPERLIPIDEMIA. AT THE TIME OF THE RE-INTERVENTION, IT WAS NOTED THAT THE AORTA WAS VERY SHORT AND CALCIFI

  Patient problems: Aortic Valve Stenosis

  MAUDE report 11067774 ↗
• InjuryDec 23, 2019Degraded; Degraded

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON FEB. 25, 2020 IDENTIFYING THE FOLLOWING. THE PATIENT HAD AN INCREASE IN DYSPNEA AS WELL AS ANGIOGENIC PALPITATIONS. THE SVD WAS IDENTIFIED THROUGH AN INCREASING TRANSVALVULAR GRADIENT. IN 2015 10 MMHG, 2016 31 MMHG, 2017 39 MMHG, AND 2018 : 55 MMHG. NO DEVICE IMAGING IS AVAILABLE FOR ANALYSIS. THE PATIENT DEATH WAS SUDDEN AND A RESULT OF RESPIRATORY DISTRESS. TOMODENSITOMETRY IDENTIFIED A POSSIBLE PULMONARY INFECTION RATHER THAN PULMONARY EDEMA.

  Patient problems: Death

  MAUDE report 9514186 ↗
• DeathDec 23, 2019Degraded; Gradient Increase; Degraded; Gradient Increase

  THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON (B)(6)2020 IDENTIFYING THE FOLLOWING. THE PATIENT HAD AN INCREASE IN DYSPNEA AS WELL AS ANGIOGENIC PALPITATIONS. THE SVD WAS IDENTIFIED THROUGH AN INCREASING TRANSVALVULAR GRADIENT. IN 2015 10 MMHG, 2016 31 MMHG, 2017 39 MMHG, AND 2018 : 55 MMHG. NO DEVICE IMAGING IS AVAILABLE FOR ANALYSIS. THE PATIENT DEATH WAS SUDDEN AND A RESULT OF RESPIRATORY DISTRESS. TOMODENSITOMETRY IDENTIFIED A POSSIBLE PULMONARY INFECTION RATHER THAN PULMONARY EDEMA.

  Patient problems: Death

  MAUDE report 9514180 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA19 AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED VIA THE PATIENT TRACKING SYSTEM THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A PERCEVAL PVS21 SUTURELESS AORTIC HEART VALVE IMPLANT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9349536 ↗
• InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA19 AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED VIA THE PATIENT TRACKING SYSTEM THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A PERCEVAL PVS21 SUTURELESS AORTIC HEART VALVE IMPLANT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9349479 ↗
• InjuryDec 18, 2018Calcified; Appropriate Device Problem Term/Code Not Available; Calcified; Appropriate Device Problem Term/Code Not Available

  IN 2013 (EXACT DATE UNKNOWN), THE PATIENT RECEIVED A MITROFLOW IN THE AORTIC POSITION. ON (B)(6) 2018, THE PATIENT WAS RE-OPERATED TO HAVE THE MITROFLOW EXPLANTED AND REPLACED WITH A ST.JUDE 19MM. TWO OTHER CONCOMITANT PROCEDURES WERE PERFORMED ON THE SAME DAY: MITRAL VALVE REPLACEMENT WITH A 27MM ST.JUDE AND TRICUSPID REPAIR WITH AN EDWARDS RING 30MM. NO OTHER INFORMATION IS AVAILABLE TO DATE.

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

  MAUDE report 8177275 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016 A MITROFLOW DLA19 AORTIC HEART VALVE PROSTHESIS WAS IMPLANTED. THE MANUFACTURER WAS NOTIFIED OF AN IMPLANT OF A PERCEVAL PVS21 AT THE SAME LOCATION ON (B)(6) 2018. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 7615144 ↗
• InjuryApr 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MITROFLOW VALVE DLA19 WAS IMPLANTED ON (B)(6) 2015. PATIENT CONTRACTED LATE ENDOCARDITIS. THE VALVE WAS EXPLANTED AFTER 1.5 YEARS AND REPLACED BY CNA21 CROWN. MITROFLOW WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS. PATIENT WAS DISCHARGED.

  Patient problems: Endocarditis

  MAUDE report 6531895 ↗
• InjuryNov 9, 2016Gradient Increase; Gradient Increase

  THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 THAT A PATIENT WITH MITROFLOW VALVE (DLA19, S/N (B)(4) PRESENTED TO THE EMERGENCY ROOM WITH WORSENING SHORTNESS OF BREATH AND ORTHOPNEA, UPON EXAMINATION IT WAS FOUND THAT THE PATIENT HAD SEVERE AORTIC STENOSIS WITH A PEAK GRADIENT OF 71MMHG. A NEW PERCEVAL VALVE WAS IMPLANTED SIZE SMALL AND POST PROCEDURE SHOWED NO PERIVALVULAR LEAKS OR CENTRAL LEAKS AND SHOWED A PEAK GRADIENT OF 14MMHG AND MEAN OF 4MMHG.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 6091437 ↗