MITROFLOW DLA21Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00896208000160), received between Jun 16, 2016 and Jan 11, 2022 — classified as 5 deaths, 36 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2022Calcified; Calcified

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE MITROFLOW DLA21 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2017 AND EXPLANTED DUE TO STENOSIS ON (B)(6) 2021 . ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS A HISTORY OF COPD, HISTORY OF TOBACCO ABUSE, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, OBESITY, CHRONIC DIASTOLIC DISEASE. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT, MITRAL VALVE REPLACEMENT, 4 VESSEL BYPASS, MAZE PROCEDURE IN (B)(6) 2017. BASED ON THE OPERATIONAL REPORT PROVIDED, EVALUATION AND THE ECHOCARDIOGRAPHY OF THE PATIENT DEMONSTRATED AORTIC INSUFFICIENCY, AS WELL AS SOME DEGREE OF AORTIC STENOSIS. THE MITRAL VALVE ALSO HAD MILD STENOSIS AND THE MITRAL PROSTHESIS WAS OBSTRUCTING THE LEFT VENTRICULAR OUTFLOW TRACT. THUS, THE PATIENT PRESENTED FOR THE SURGICAL CORRECTION. THE PATIENT WAS STABLE DURING THE PROCEDURE AND THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS. PATIENT DISCHARGED 10 DAYS POST-OP WITH STABLE CONDITION.

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

  MAUDE report 13232080 ↗
• InjuryJan 11, 2022Calcified; Calcified

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE MITROFLOW DLA21 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2017 AND EXPLANTED DUE TO STENOSIS ON (B)(6) 2021 . ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS A HISTORY OF COPD, HISTORY OF TOBACCO ABUSE, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, OBESITY, CHRONIC DIASTOLIC DISEASE. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT, MITRAL VALVE REPLACEMENT, 4 VESSEL BYPASS, MAZE PROCEDURE IN (B)(6) OF 2017. BASED ON THE OPERATIONAL REPORT PROVIDED, EVALUATION AND THE ECHOCARDIOGRAPHY OF THE PATIENT DEMONSTRATED AORTIC INSUFFICIENCY, AS WELL AS SOME DEGREE OF AORTIC STENOSIS. THE MITRAL VALVE ALSO HAD MILD STENOSIS AND THE MITRAL PROSTHESIS WAS OBSTRUCTING THE LEFT VENTRICULAR OUTFLOW TRACT. THUS, THE PATIENT PRESENTED FOR THE SURGICAL CORRECTION. THE PATIENT WAS STABLE DURING THE PROCEDURE AND THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS. PATIENT DISCHARGED 10 DAYS POST-OP WITH STABLE CONDITION.

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

  MAUDE report 13231941 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA21 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12423830 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE MODEL DLA21 WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12423025 ↗
• InjuryMay 6, 2021Degraded; Degraded

  A PATIENT RECEIVED A MITROFLOW DLA21 IN 2013. THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD DEVELOPED ENDOCARDITIS AND WAS SUBJECTED TO ANTIBIOTIC THERAPY FOR SEVERAL WEEKS. TO DATE, THE PET IS NEGATIVE. THE ENDOCARDITIS WAS DIAGNOSED ON (B)(6) 2020. THE VALVE APPEARED DEGENERATED WITH STENO-INSUFFICIENCY. THE PATHOGEN WAS IDENTIFIED AS ENTEROCOCCUS CASSELIFLAVUS. AS REPORTED, THE ENDOCARDITIS RESOLVED AFTER THE ANTIBIOTIC TREATMENT PROVIDED. THE PATIENT IS IN EXCELLENT CLINICAL CONDITIONS, APYRETIC AND ASYMPTOMATIC. THE DEVICE WAS NOT EXPLANTED. THE PATIENT RECEIVED A PACEMAKER IN 2018. THE REPORTED POSSIBLE CAUSE IS PERHAPS DUE TO TEMPORARY CATHETER (HYPOTHESIS). THE STENO INSUFFICIENCY IS MODERATE, AND IT IS NOT KNOWN WHETHER IT WAS PRESENT PRIOR TO THE DIAGNOSIS OF ENDOCARDITIS.

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

  MAUDE report 11786709 ↗
• InjuryMay 6, 2021Degraded; Degraded

  A PATIENT RECEIVED A MITROFLOW DLA21 IN 2013. THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD DEVELOPED ENDOCARDITIS AND WAS SUBJECTED TO ANTIBIOTIC THERAPY FOR SEVERAL WEEKS. TO DATE, THE PET IS NEGATIVE. THE ENDOCARDITIS WAS DIAGNOSED ON (B)(6) 2020. THE VALVE APPEARED DEGENERATED WITH STENO-INSUFFICIENCY. THE PATHOGEN WAS IDENTIFIED AS ENTEROCOCCUS CASSELIFLAVUS. AS REPORTED, THE ENDOCARDITIS RESOLVED AFTER THE ANTIBIOTIC TREATMENT PROVIDED. THE PATIENT IS IN EXCELLENT CLINICAL CONDITIONS, APYRETIC AND ASYMPTOMATIC. THE DEVICE WAS NOT EXPLANTED. THE PATIENT RECEIVED A PACEMAKER IN 2018. THE REPORTED POSSIBLE CAUSE IS PERHAPS DUE TO TEMPORARY CATHETER (HYPOTHESIS). THE STENO INSUFFICIENCY IS MODERATE, AND IT IS NOT KNOWN WHETHER IT WAS PRESENT PRIOR TO THE DIAGNOSIS OF ENDOCARDITIS.

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

  MAUDE report 11786623 ↗
• InjuryMay 26, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON MARCH 25, 2020 AND REPLACED WITH A CARBOMEDICS S5-025 MECHANICAL HEART VALVE PROSTHESIS. THE MANUFACTURER RECEIVED THE OPERATION REPORT IDENTIFYING THE FOLLOWING. PRE-OPERATIVE DIAGNOSIS WAS FOR CRITICAL AORTIC STENOSIS, SEVERELY REDUCED LEFT VENTRICULAR EJECTION FRACTION (15%), BIOPROSTHETIC VALVE DEGENERATION, INFLUENZA TYPE A INFECTION. THE SITE PERFORMED A 3RD TIME REDO STERNOTOMY WITH AN AORTIC ROOT RE-REPLACEMENT USING COMPOSITE MECHANICAL VALVED CONDUIT (25MM CARBOMEDICS TOP-HAT +28MM GELWEAVE VALSALVA). THE POST-OPERATIVE GRADIENT WAS 15MMHG VIA TEE AND THE PATIENT WAS TRANSPORTED BACK TO THORACIC INTENSIVE CARE IN A STABLE BUT CRITICAL CONDITION.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 10090022 ↗
• May 26, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2016 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A CARBOMEDICS S5-025 MECHANICAL HEART VALVE PROSTHESIS. THE MANUFACTURER RECEIVED THE OPERATION REPORT IDENTIFYING THE FOLLOWING. PRE-OPERATIVE DIAGNOSIS WAS FOR CRITICAL AORTIC STENOSIS, SEVERELY REDUCED LEFT VENTRICULAR EJECTION FRACTION (15%), BIOPROSTHETIC VALVE DEGENERATION, INFLUENZA TYPE A INFECTION. THE SITE PERFORMED A 3RD TIME REDO STERNOTOMY WITH AN AORTIC ROOT RE-REPLACEMENT USING COMPOSITE MECHANICAL VALVED CONDUIT (25MM CARBOMEDICS TOP-HAT +28MM GELWEAVE VALSALVA). THE POST-OPERATIVE GRADIENT WAS 15MMHG VIA TEE AND THE PATIENT WAS TRANSPORTED BACK TO THORACIC INTENSIVE CARE IN A STABLE BUT CRITICAL CONDITION.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 10090013 ↗
• InjuryNov 27, 2019Degraded; Degraded

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR REGISTRY. ON (B)(6) 2014, A PATIENT RECEIVED A MITROFLOW DLA21 IN AORTIC POSITION. THE PRE-OPERATIVE DIAGNOSIS WAS AORTIC STENOSIS (CALCIFICATION). THE PREOPERATIVE MEAN/PEAK GRADIENTS WERE 59/85 MMHG. AT DISCHARGE, THE ECHO SHOWED A MEAN GRADIENT OF 17MMHG. THE MANUFACTURER RECEIVED A NOTIFICATION OF AN ADVERSE EVENT: ON (B)(6) 2019, A RE-DO SURGERY WAS PERFORMED TO EXPLANT THE DEVICE. STRUCTURAL VALVE DETERIORATION WAS IDENTIFIED. THE DEVICE WAS REPLACED WITH A NON-LIVANOVA DEVICE. YEARLY DATA ON THE DEVICE FUNCTIONALITY IS AVAILABLE ON THE DATABASE: THE MEAN GRADIENT WAS 17MMHG, 10MMHG, 18MMHG, 39MMHG IN 2015, 2016, 2017 AND 2018, RESPECTIVELY. THE REGURGITATION IS NOT RECORDED ON THE DATABASE. ADDITIONAL INFORMATION RECEIVED FROM THE SITE CONFIRMED THAT NO EXAMINATION WAS PERFORMED ON THE EXPLANTED VALVE. THE PATIENT IS REPORTEDLY ALIVE AFTER THE RE-DO SURGERY.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 9385822 ↗
• InjuryNov 27, 2019Degraded; Degraded

  HOLD FOR REVIEW - DPM 6.16.2023

  Patient problems: Aortic Valve Stenosis

  MAUDE report 9385588 ↗
• InjuryOct 7, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2016, A FEMALE PATIENT RECEIVED A DLA21 IN AORTIC POSITION. THE DLA21 WAS EXPLANTED ON (B)(6) 2019. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 9164295 ↗
• InjuryOct 7, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2016, A FEMALE PATIENT RECEIVED A DLA21 IN AORTIC POSITION. THE DLA21 WAS EXPLANTED ON (B)(6) 2019. THE DEVICE WAS EXPLANTED DUE TO SEVERE PROSTHESIS STENOSIS. THE EXPLANTED DEVICE WAS REPLACED WITH A MEDTRONIC FREESTYLE ROOT. A GOOD POSTOPERATIVE OUTCOME IS REPORTED FOR THIS PATIENT, WHO HAD A FULL RECOVERY. THE PATIENT HAS A HISTORY OF CALCIFIC AORTIC STENOSIS, BUT NO PARTICULAR RISK FACTORS WERE IDENTIFIED.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 9164284 ↗
• InjurySep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015 A PATIENT RECEIVED A MITROFLOW DLA21 AS PART OF THE (B)(6) TRIAL. THE MANUFACTURER WAS NOTIFIED OF A SERIOUS ADVERSE EVENT, CARDIOVASCULAR MORTALITY - ENDOCARDITIS, WHICH OCCURRED ON (B)(6) 2018. THE PATIENT HAD THREE FOLLOW-UPS PRIOR TO THE REPORTED ADVERSE EVENT. FU 1: (B)(6) 2016, RHYTHM SINUS, NYHA CLASS I, MEAN GRADIENT 7 MMHG, GOOD VALVE FUNCTIONALITY. FU 2: (B)(6) 2017, A-FIB, NYHA CLASS I, MEAN GRADIENT 15 MMHG, GOOD VALVE FUNCTIONALITY. FU 3: (B)(6) 2018, A-FIB, NYHA CLASS II, MEAN GRADIENT 29 MMHG. NO FURTHER INFORMATION REGARDING THE PATIENT OR THE EVENT WAS RECORDED OR RECEIVED.

  Patient problems: Death; Endocarditis

  MAUDE report 9079969 ↗
• DeathSep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015 A PATIENT RECEIVED A MITROFLOW DLA21 AS PART OF THE (B)(6) TRIAL. THE MANUFACTURER WAS NOTIFIED OF A SERIOUS ADVERSE EVENT, CARDIOVASCULAR MORTALITY - ENDOCARDITIS, WHICH OCCURRED ON (B)(6) 2018. THE PATIENT HAD THREE FOLLOW-UPS PRIOR TO THE REPORTED ADVERSE EVENT. FU 1: (B)(6) 2016, RHYTHM SINUS, NYHA CLASS I, MEAN GRADIENT 7 MMHG, GOOD VALVE FUNCTIONALITY. FU 2: (B)(6) 2017, A-FIB, NYHA CLASS I, MEAN GRADIENT 15 MMHG, GOOD VALVE FUNCTIONALITY. FU 3: (B)(6) 2018, A-FIB, NYHA CLASS II, MEAN GRADIENT 29 MMHG. NO FURTHER INFORMATION REGARDING THE PATIENT OR THE EVENT WAS RECORDED OR RECEIVED.

  Patient problems: Death; Endocarditis

  MAUDE report 9079946 ↗
• InjuryJul 25, 2019Calcified; Degraded; Insufficient Device Problem Information; Calcified; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2018 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT AS PART OF A AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2019 THE DEVICE WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS TOP HAT S5-023 MECHANICAL HEART VALVE. ADDITIONAL INFORMATION RECEIVED ON AUG. 07, 2019 IDENTIFYING THE FOLLOWING INFORMATION. THE DEVICE WAS EXPLANTED DUE TO LEAFLET CALCIFICATION. THE PATIENT OUTCOME WAS A SUCCESSFUL CARBOMEDICS TOP HAT IMPLANTATION. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Calcium Deposits/Calcification; No Information

  MAUDE report 8827617 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT AS PART OF A AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT ON APR. 30, 2019 THE DEVICE WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS TOP HAT S5-023 MECHANICAL HEART VALVE. ADDITIONAL INFORMATION RECEIVED ON AUG. 07, 2019 IDENTIFYING THE FOLLOWING INFORMATION. THE DEVICE WAS EXPLANTED DUE TO LEAFLET CALCIFICATION. THE PATIENT OUTCOME WAS A SUCCESSFUL CARBOMEDICS TOP HAT IMPLANTATION. THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Information

  MAUDE report 8827547 ↗
• InjuryJul 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT. THE MANUFACTURER WAS NOTIFIED 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 8770026 ↗
• InjuryJul 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015 A PATIENT RECEIVED A MITROFLOW DLA21 AORTIC HEART VALVE IMPLANT. THE MANUFACTURER WAS NOTIFIED 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 8770017 ↗
• InjuryFeb 7, 2019Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  A MITROFLOW DLA23 WAS IMPLANTED ON (B)(6) 2016 VIA MEDIAN STERNOTOMY. HOWEVER, IT WAS REPORTED THAT THE VALVE CAUSED OBSTRUCTION OF THE CORONARY OSTIUM. THE VALVE WAS EXPLANTED AND REPLACED WITH A SMALLER MITROFLOW DLA21. THE NEW IMPLANTED DEVICE WAS FUNCTIONING WELL UPON DISCHARGE AND DURING THE 2 FOLLOW-UP VISITS IN 2017 AND 2018.

  Patient problems: No Information; Occlusion

  MAUDE report 8318656 ↗
• InjuryJan 14, 2019Calcified; Gradient Increase; Perivalvular Leak; Calcified; Gradient Increase; Perivalvular Leak

  ON (B)(6) 2016, A 67 YEARS OLD FEMALE PATIENT RECEIVED A MITROFLOW DLA21. THE PROCEDURE WAS PERFORMED IN MEDIAN STERNOTOMY, AND A LEFT ATRIAL APPENDAGE EXCLUSION WAS PERFORMED AS WELL DURING THE SURGERY. ON (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH FINDINGS OF HEART FAILURE. SHE REPORTED THAT SINCE LATE (B)(6) 2018 SHE HAS HAD PROGRESSIVELY WORSENING EXERTIONAL SHORTNESS OF BREATH. A STRUCTURAL VALVE DETERIORATION OF THE MITROFLOW DLA21 WAS IDENTIFIED, RESULTING IN VALVE STENOSIS AND REGURGITATION, AS CONFIRMED THROUGH THE ECHO PERFORMED (AORTIC GRADIENTS PEAK/MEAN 115/66MMHG). MITRAL REGURGITATION WAS CONFIRMED THROUGH THE ECHO AS WELL. CONSEQUENTLY, THE PATIENT WAS RE-OPERATED ON (B)(6) 2018. THE MITROFLOW DLA21 WAS EXPLANTED AND A 21MM EDWARDS MAGNA PERICARDIAL VALVE WAS IMPLANTED INSTEAD. AN AORTIC ROOT ENLARGEMENT WAS PERFORMED, AS WELL AS A MITRAL VALVE REPAIR. THE EXPLANTED DLA21 WAS FOUND TO BE HEAVILY CALCIFIED WITH PANNUS INGROWTH. THE PATIENT TOLERATED THE PROCEDURE WELL AND SHE HAD EXCELLENT CARDIAC HEMODYNAMICS WHEN WEANED OFF THE CARDIOPULMONARY BYPASS. SHE WAS TRANSFERRED TO THE ICU IN STABLE CONDITIONS, WITH NO PERIVALVULAR AORTIC INSUFFICIENCY. SHE

  Patient problems: Aortic Regurgitation; Aortic Valve Stenosis; Heart Failure

  MAUDE report 8246171 ↗
• InjuryDec 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITROFLOW DLA WAS IMPLANTED ON (B)(6), 2014 AT THE AORTIC POSITION. ON (B)(6), 2018, THE VALVE WAS EXPLANTED AND REPLACED WITH A SOLO SMART SIZE 21 VALVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8156894 ↗
• InjurySep 24, 2018Calcified; Gradient Increase; Material Too Rigid or Stiff; Material Deformation; Calcified; Gradient Increase; Material Too Rigid or Stiff; Material Deformation

  ON (B)(6) 2014, A PATIENT RECEIVED A MITROFLOW VALVE TO REPLACE HIS NATIVE AORTIC VALVE WHICH HAS BECOME STENOTIC. ON (B)(6) 2016, STRUCTURAL VALVE DETERIORATION WITH LEAFLET CALCIFICATION WAS IDENTIFIED. THIS EVENT LEAD TO RE-OPERATION OF THE PATIENT ON (B)(6) 2016, DURING WHICH THE MITROFLOW VALVE WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. IT WAS REPORTED THAT CALCIFICATION WAS IDENTIFIED ON 3 CUSPS OF THE VALVE AND THERE WAS A SHRINKING EFFECT. THE VALVE WAS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7904185 ↗
• InjuryJul 24, 2018Material Deformation; Material Deformation

  A MITROFLOW DLA21 WAS IMPLANTED ON (B)(6) 2015. THREE YEARS POST-IMPLANT, THE PATIENT IS BEING REFERRED FOR TAVR, DUE TO STRUCTURAL VALVE DETERIORATION. NO OTHER INFORMATION IS AVAILABLE. THE PATIENT'S CLINICAL HISTORY REMAINS UNKNOWN.

  Patient problems: No Information

  MAUDE report 7715127 ↗
• InjuryFeb 23, 2018Material Deformation; Material Deformation

  THE MANUFACTURER WAS NOTIFIED THAT A MITROFLOW DLA WAS EXPLANTED ON (B)(6) 2018. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Pannus; No Information

  MAUDE report 7293052 ↗
• InjuryFeb 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  I MITROFLOW DLA21 WAS IMPLANTED ON (B)(6) 2015. THE VALVE WAS EXPLANTED ON (B)(6) 2017, AND REPLACED WITH A CROWN (B)(4).

  Patient problems: No Information

  MAUDE report 7236443 ↗