MITROFLOW DLA23Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00896208000177), received between Jun 14, 2016 and Oct 11, 2024 — classified as 7 deaths, 34 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (17 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 44 reports, in the reporter's own words as published by the FDA.

• DeathOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURE WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT IMPLANT FORM, A DLA23 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2016. REPORTEDLY, PATIENT DECEASED ON (B)(6) 2016. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20434057 ↗
• DeathOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURE WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT IMPLANT FORM, A DLA23 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2016. REPORTEDLY, PATIENT DECEASED ON (B)(6) 2016. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20433708 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12424993 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12424014 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021 , AN EVENT OF SVD ON A MITROFLOW DLA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12423800 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12423691 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422736 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 16TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422612 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 12TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422482 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422449 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 6TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12421990 ↗
• InjurySep 2, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 6TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12416270 ↗
• InjurySep 1, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 16TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411691 ↗
• InjurySep 1, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 12TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411660 ↗
• MalfunctionDec 9, 2020Calcified; Calcified

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR REGISTRY. ON (B)(6) 2013, A PATIENT RECEIVED A MITROFLOW DLA23 IN AORTIC POSITION. THE SITE REPORTS THAT STRUCTURAL VALVE DETERIORATION/LEAFLET STIFFENED (CALCIFIED) WAS DETECTED ON (B)(6) 2018. THE CLINICAL STATUS AND CONSEQUENCES ARE REPORTEDLY UNKNOWN. THE ECHO PERFORMED ON THIS DATE SHOWED A MEAN GRADIENT OF 50MMHG, EOA OF 1 CM2, AND EJECTION FRACTION OF 65%. THE DEVICE FUNCTIONALITY WAS CHECKED AGAIN ON 23 SEP 2019 AND A MEAN GRADIENT OF 70MMHG WAS DETECTED, WITH A EOA 0.4 CM2 AND EJECTION FRACTION OF 70%. THERE IS NO EVIDENCE OF DEVICE EXPLANT ON THE STUDY DATABASE. PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THE MITROFLOW VALVE REMAINS IMPLANTED IN THE PATIENT. THIS PROSTHESIS PRESENTS A DEGENERATION OF A TIGHT STENOSIS TYPE WITH AN AVERAGE GRADIENT AT 84MMHG, VMAX AT 5.6M / S AND A SURFACE AREA OF 0.36CM2. THE PROSTHESIS ALSO PRESENTS A 2/4 AORTIC REGURGITATION. DUE TO THE PATIENT'S ADVANCED AGE, A NEW SURGICAL REPLACEMENT IS NOT CONSIDERED. MOREOVER, BECAUSE OF AN UNFAVORABLE CORONARY ANATOMY, THE PATIENT DOES NOT QUALIFY FOR A TAVI.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10980546 ↗
• MalfunctionDec 8, 2020Degraded; Degraded

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR REGISTRY. ON (B)(6) 2013, A PATIENT RECEIVED A MITROFLOW DLA23 IN AORTIC POSITION. THE SITE REPORTS THAT STRUCTURAL VALVE DETERIORATION OF THE DEVICE WAS DETECTED ON (B)(6) 2018. THE CLINICAL STATUS AND CONSEQUENCES ARE REPORTEDLY UNKNOWN. THE ECHO PERFORMED ON THIS DATE SHOWED A MEAN GRADIENT OF 38MMHG, PERIVALVULAR LEAK 1+, EOA OF 0.93 CM2, AND EJECTION FRACTION OF 50%. THE DEVICE FUNCTIONALITY WAS CHECKED AGAIN ON (B)(6) 2019 AND A MEAN GRADIENT OF 50MMHG WAS DETECTED, WITH A CENTRAL LEAK 1+, EOA 0.7 CM2 AND EJECTION FRACTION OF 65%. THERE IS NO EVIDENCE OF DEVICE EXPLANT ON THE STUDY DATABASE. THE MANUFACTURER RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE HOSPITAL: THE PATIENT DID NOT HAVE A REOPERATION AND THE DEVICE IS STILL IN PLACE. THE STENOSIS DEGENERATION WAS STABLE AT THE LAST ULTRASOUND CHECK ON (B)(6) 2020. IT IS FOUND A MAXIMUM GRADIENT AT 74MMHG AND MEAN AT 57MMHG AND A VALVULAR SURFACE AT 0.8CM2. THE PATIENT SUFFERS FROM SHORTNESS OF BREATH BUT IS NOT VERY TROUBLESOME FOR HER ACTIVITIES. DUE TO THE SMALL GENE, THE STABILITY OF THE DEGENERATION AND THE AGE OF THE PATIENT (90 YEARS), VALVE REPL

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10971123 ↗
• DeathFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE (B)(4) REGISTRY. ON (B)(6) 2016, A PATIENT RECEIVED A MITROFLOW DLA23 IN AORTIC POSITION. A DISCHARGE FROM THE HOSPITAL, A GOOD DEVICE FUNCTIONALITY WAS RECORDED. THE MANUFACTURER WAS INFORMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2019 DUE TO CARDIOVASCULAR MORTALITY / ALL VALVE-RELATED DEATHS / ENDOCARDITIS. DATA ON THE DEVICE FUNCTIONALITY IS AVAILABLE ON THE DATABASE WITH THE FOLLOWING DETAILS: (B)(6) 2018 MEAN GRADIENT 17.4 MMHG, NO LEAKS; (B)(6) 2017 10.6 MMHG, NO LEAKS. FOLLOW UP INFORMATION FROM THE SITE CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death; Endocarditis

  MAUDE report 9758069 ↗
• DeathFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE AVR REGISTRY. ON (B)(6) 2016, A PATIENT RECEIVED A MITROFLOW DLA23 IN AORTIC POSITION. A DISCHARGE FROM THE HOSPITAL, A GOOD DEVICE FUNCTIONALITY WAS RECORDED. THE MANUFACTURER WAS INFORMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2019 DUE TO CARDIOVASCULAR MORTALITY / ALL VALVE-RELATED DEATHS / ENDOCARDITIS. DATA ON THE DEVICE FUNCTIONALITY IS AVAILABLE ON THE DATABASE WITH THE FOLLOWING DETAILS: (B)(6) 2018 MEAN GRADIENT 17.4MMHG, NO LEAKS; (B)(6) 2017 10.6MMHG, NO LEAKS. FOLLOW UP INFORMATION FROM THE SITE CONFIRMED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death; Endocarditis

  MAUDE report 9753821 ↗
• InjurySep 20, 2019Degraded; Material Too Rigid or Stiff; Degraded; Material Too Rigid or Stiff

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA23 AORTIC HEART VALVE IMPLANT AS PART OF THE SURE-AVR TRIAL. THE MANUFACTURER WAS NOTIFIED OF A SERIOUS ADVERSE EVENT: STRUCTURAL VALVE DETERIORATION, LEAFLET STIFFENING (CALCIFICED), STENOSIS, PATIENT SYMPTOMATIC, WHICH OCCURRED ON (B)(6) 2019. PER REVIEW OF THE FOLLOW-UP WHICH OCCURRED ON (B)(6) 2019 THE PATIENT HAD A MEAN GRADIENT OF 35 MMHG, CENTRAL LEAK 1+, WAS NYHA CLASS III, AND HAS NOT HAD ANY RE-OPERATION.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 9101077 ↗
• InjurySep 20, 2019Degraded; Material Too Rigid or Stiff; Degraded; Material Too Rigid or Stiff

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA23 AORTIC HEART VALVE IMPLANT AS PART OF THE SURE-AVR TRIAL. THE MANUFACTURER WAS NOTIFIED OF A SERIOUS ADVERSE EVENT: STRUCTURAL VALVE DETERIORATION, LEAFLET STIFFENING (CALCIFIED), STENOSIS, PATIENT SYMPTOMATIC, WHICH OCCURRED ON (B)(6) 2019. PER REVIEW OF THE FOLLOW-UP WHICH OCCURRED ON (B)(6) 2019 THE PATIENT HAD A MEAN GRADIENT OF 35 MMHG, CENTRAL LEAK 1+, WAS NYHA CLASS III, AND HAS NOT HAD ANY RE-OPERATION.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 9101044 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA23 AORTIC HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT ON MAR. 29, 2019 THE VALVE WAS EXPLANTED DUE TO THROMBUS. NO NEW IMPLANT INFORMATION WAS PROVIDED. THE EVENT OCCURRED AT WVU RUBY MEMORIAL HOSPITAL AND INVOLVED DR. (B)(6). THE MANUFACTURER RECEIVED IDENTIFICATION THAT THIS WAS AN EVENT OF EARLY EXPLANT DUE TO SVD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombus

  MAUDE report 8824739 ↗
• InjuryJul 24, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA23 AORTIC HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT ON MAR. 29, 2019 THE VALVE WAS EXPLANTED DUE TO THROMBUS. NO NEW IMPLANT INFORMATION WAS PROVIDED. THE EVENT OCCURRED AT (B)(6) HOSPITAL AND INVOLVED DR. (B)(6). THE MANUFACTURER RECEIVED IDENTIFICATION THAT THIS WAS AN EVENT OF EARLY EXPLANT DUE TO SVD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombus

  MAUDE report 8824727 ↗
• InjuryJun 26, 2019Degraded; Perivalvular Leak; Degraded; Perivalvular Leak

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA23 AORTIC HEART VALVE IMPLANT AS PART OF THE (B)(6) STUDY. THE MANUFACTURER WAS NOTIFIED OF A VALVE RELATED ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2019. THE EVENT WAS RECORDED AS NON-STRUCTURAL DYSFUNCTION - PARAVALVULAR LEAK 2+. UPON REVIEW OF THE REGISTRY DATA THE PATIENT HAD A MEAN GRADIENT OF 18.9 MMHG WITH EOA OF 5.8 CM^2, EF% OF 65, AND WAS NYHA CLASS II AT THEIR FIRST FOLLOW-UP ON (B)(6) 2017. THE PATIENTS SECOND FOLLOW UP WAS ON (B)(6) 2018. THE PATIENT HAD A MEAN GRADIENT OF 27MMHG, EOA OF 1.19 CM^2 AND AN EF% OF 75 WITH A 1+ CENTRAL LEAK. THEY WERE STILL NYHA CLASS II. NO FURTHER FOLLOW-UPS HAVE BEEN CONDUCTED SINCE THE REPORTED ADVERSE EVENT OCCURRED.

  Patient problems: Aortic Regurgitation

  MAUDE report 8736297 ↗
• InjuryMar 19, 2019Gradient Increase; Material Deformation; Gradient Increase; Material Deformation

  ON (B)(6) 2014 A PATIENT RECEIVED A MITROFLOW DLA23. ON (B)(6) 2019 THE PATIENT HAD A RE-OPERATION DUE TO SEVERE AI. THE MITROFLOW WAS DETERMINED ON INTER-OP TEE TO HAVE SEVER AI AND A MEAN GRADIENT OF 20MMHG. THE OPERATION WENT FORWARD WITH THE MITROFLOW BEING REMOVED AND A PERCEVAL, PVS21 (SN: (B)(4)) BEING IMPLANTED. THE OPERATION WENT SMOOTHLY WITH A MEAN GRADIENT ACROSS THE VALVE OF 5MMHG AT THE END OF THE CASE. THE PHYSICIAN NOTED THE CAUSE OF THE FAILURE WAS NOT CALCIFICATION BUT A TORN LEAFLET NEAR ONE OF THE POSTS. THE LOCATION OF THE TEAR RELATIVE TO THE PATIENTS ANATOMY IS UNKNOWN.

  Patient problems: Aortic Insufficiency

  MAUDE report 8434219 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A MITROFLOW VALVE DLA23 IMPLANTED ON (B)(6) 2015. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS TOP HAT MECHANICAL HEART VALVE S5-021 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED. THIS CASE IS BEING REPORTED TO FDA IN A CONSERVATIVE MANNER.

  Patient problems: No Information

  MAUDE report 8318328 ↗