EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) 9300TFX (REF 9300TFX23A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00690103192070), received between Feb 5, 2021 and May 26, 2026 — classified as 1 death, 67 injuries.

The most frequently reported specific device problem is “Degraded” (29 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY THROUGH RECEIPT OF AN IMPLANT DATA CARD, APPROXIMATELY 9 YEARS AND 7 MONTHS POST TRANSFEMORAL TRANSCATHETER VALVE REPLACEMENT PROCEDURE WITH A 23 MM SAPIEN XT VALVE IN THE PULMONIC POSITION, THE PATIENT'S VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL VALVE. THE CAUSE OF THE EXPLANT IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25280507 ↗
• InjuryJan 19, 2026Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST IMPLANTATION OF A 23MM SAPIEN XT VALVE IN THE PULMONIC POSITION, A VALVE IN VALVE WITH A 23MM SAPIEN 3 VALVE WAS PERFORMED DUE TO CENTRAL PULMONIC REGURGITATION. PATIENT SYMPTOMS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24111412 ↗
• InjuryNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE, APPROXIMATELY 7 YEARS AND 3 MONTHS POST IMPLANTATION OF A 23MM SAPIEN XT VALVE IN THE PULMONIC POSITION, A VALVE IN VALVE WAS PERFORMED WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO MODERATE PULMONIC VALVE REGURGITATION, MEAN GRADIENT IS 20MMHG W/MILD PS. PATIENT SYMPTOMS: WORSENING RV DILATION VIA MRI.

  Patient problems: Insufficient Information

  MAUDE report 23469436 ↗
• DeathNov 4, 2025Malposition of Device; Device Stenosis; Malposition of Device; Device Stenosis

  AS REPORTED BY IMPLANT PATIENT REGISTRY, A PATIENT PASSED AWAY APPROXIMATELY 5 YEARS AND 9 MONTHS POST TAVR. MEDICAL RECORDS WERE RECEIVED FROM THE HOSPITAL. AFTER A REVIEW OF MEDICAL RECORDS PROVIDED, IT WAS CONFIRMED THAT THE PATIENT WAS AN 80-YEAR-OLD FEMALE WITH A PAST MEDICAL HISTORY OF AORTIC STENOSIS (AS), ACUTE ON CHRONIC DIASTOLIC HEART FAILURE, CORONARY ARTERY DISEASE (CAD), NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI), AND ACUTE HYPOXIC RESPIRATORY FAILURE, WHO UNDERWENT A SUCCESSFUL IMPLANTATION OF A 23MM EDWARDS XT VALVE IN THE AORTIC POSITION ON (B)(6) 2015. APPROXIMATELY 5 YEARS AND 9 MONTHS POST-IMPLANTATION, THE EDWARDS IMPLANT PATIENT REGISTRY RECEIVED NOTIFICATION OF THE PATIENT'S DEATH. RECORDS INDICATE THE PATIENT WAS ADMITTED ON (B)(6) 2025 WITH SHORTNESS OF BREATH AND TREATED WITH DIURETICS FOR ACUTE ON CHRONIC DIASTOLIC HEART FAILURE. ON (B)(6) 2025, THE PATIENT WAS FOUND UNRESPONSIVE WITHOUT A PULSE. ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED AND RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED AFTER APPROXIMATELY 6 MINUTES. THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE ICU. ON (B)(6) 2025, THE PATIENT EXPERIENCED BRADYCARDIA AND LATER A

  Patient problems: Cardiac Arrest

  MAUDE report 23468300 ↗
• InjurySep 16, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 7 YEARS POST TRANSFEMORAL TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR) PROCEDURE WITH A 23 MM SAPIEN XT VALVE, THE VALVE WAS FAILING DUE TO REGURGITATION AND MODERATE TO SEVERE STENOSIS. A CATHETERIZATION REVEALED A PRE-PROCEDURAL PRESSURE GRADIENT OF >35 MMHG. THE INITIAL BALLOON DILATIONS WERE PERFORMED USING A 24 MM X 4 CM NON-EDWARDS BALLOON, FOLLOWED BY A 26 MM X 4 CM NON-EDWARDS BALLOON, WHICH SHOWED A SMALL WAIST. THE SAPIEN XT VALVE WAS DESCRIBED AS ''NAPKIN RINGED.'' A VALVE-IN-VALVE PROCEDURE WAS PERFORMED USING A 26 MM SAPIEN 3 VALVE, IMPLANTED WITH AN OVERFILL OF +3CC. A VISUAL GAP BETWEEN THE VALVE FRAMES WAS NOTED, PROMPTING A POST-DILATION WITH AN ADDITIONAL +1CC, WHICH RESULTED IN MINIMAL IMPROVEMENT. THE PRESSURE GRADIENT DECREASED TO APPROXIMATELY 15 MMHG. A FINAL BALLOON INFLATION USING A 26 MM X 4 CM NON-EDWARDS BALLOON AT 12 ATM FURTHER REDUCED THE GRADIENT TO AROUND 10 MMHG. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CONFIRMED THAT THERE WAS NO RESIDUAL LEAK. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068579 ↗
• InjuryAug 27, 2025Calcified; Calcified

  AS LEARNED THROUGH EDWARDS IMPLANT PATIENT REGISTRY, A 23MM SAPIEN XT AORTIC VALVE IMPLANTED FOR 8 YEARS AND 2 MONTHS WAS EXPLANTED DUE TO CALCIFICATION. THE EXPLANT DIAGNOSIS IN THE MEDICAL RECORDS WAS NOTED AS MODERATE TO SEVERE VALVULAR AORTIC REGURGITATION, WHILE THE PATHOLOGY REPORT REVEALED THE EXPLANTED VALVE LEAFLETS WERE CALCIFIED. THE PATIENT ENDORSED SHORTNESS OF BREATH AND FATIGUE. A SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Dyspnea

  MAUDE report 22908958 ↗
• InjuryAug 25, 2025Degraded; Gradient Increase; Device Stenosis; Intravalvular regurgitation; Degraded; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  EDWARDS RECEIVED NOTIFICATION FROM A FIELD CLINICAL SPECIALIST THAT A PATIENT WITH A SAPIEN XT VALVE IMPLANTED IN THE AORTIC POSITION FOR 9 YEARS AND 10 MONTHS, UNDERWENT A VALVE IN VALVE PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO STENOSIS. THE PATIENT WAS SYMPTOMATIC WITH SHORTNESS OF BREATH AND FATIGUE. COMORBIDITIES INCLUDE HYPERTENSION, HYPERLIPIDEMIA, AND HEART FAILURE. THIS PATIENT WAS DISCHARGED AND IS IN STABLE CONDITION. PER THE MEDICAL RECORDS, THE PATIENT'S MOST RECENT ECHO REPORT PRIOR TO INTERVENTION SHOWED MILD JET OF AORTIC VALVE REGURGITATION AND AN AORTIC VALVE MEAN GRADIENT OF 30MMHG.

  Patient problems: Dyspnea

  MAUDE report 22891294 ↗
• InjuryJun 5, 2025Fluid/Blood Leak; Unspecified Valve Regurgitation; Fluid/Blood Leak; Unspecified Valve Regurgitation

  IT WAS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS) THAT APPROXIMATELY 10 YEARS, 3 MONTHS, AND 7 DAYS POST TRANSFEMORAL TAVR WITH A 23MM SAPIEN XT VALVE THE PATIENT HAD A VALVE IN VALVE USING A 20MM SAPIEN 3 ULTRA VALVE DUE TO REGURGITATION. THE VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22150869 ↗
• InjuryJan 31, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 9 YEARS AND 6 MONTHS AFTER A TRANSAPICAL TAVR PROCEDURE WITH A 23MM SAPIEN XT VALVE, THE VALVE WAS FAILING DUE TO INCREASED GRADIENTS AND STENOSIS. A VALVE IN VALVE PROCEDURE WAS PERFORMED AND A NEW 20 MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS IN STABLE CONDITION WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 21287441 ↗
• InjuryJan 29, 2025Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 9 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN XT VALVE, THE PATIENT PRESENTED WITH ACUTE HEART FAILURE. THE MECHANISM OF FAILURE WAS AN AORTIC INSUFFICIENCY FLAILED LEAFLET AND AORTIC STENOSIS. A VALVE-IN-VALVE PROCEDURE WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21263912 ↗
• InjuryJan 21, 2025Degraded; Perivalvular Leak; Device Stenosis; Degraded; Perivalvular Leak; Device Stenosis

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS AND 4 MONTHS POST-IMPLANT OF A 23 MM SAPIEN XT VALVE IN THE AORTIC POSITION, THE VALVE FAILED DUE TO STENOSIS. A VALVE IN VALVE WAS SUCCESSFULLY PERFORMED.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 21200669 ↗
• InjuryNov 15, 2024Device Stenosis; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 8 YEARS AND 9 MONTH POST TRANSFEMORAL TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WITH A 23MM SAPIEN XT VALVE, THE VALVE FAILED DUE TO STENOSIS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE IN VALVE PROCEDURE WITH A 20MM SAPIEN 3 ULTRA RESILIA VALVE. PER REPORT, THE PATIENT IS DOING FINE.

  Patient problems: Insufficient Information

  MAUDE report 20698814 ↗
• InjurySep 27, 2024Degraded; Degraded

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST, APPROXIMATELY 9 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN XT VALVE, THE VALVE IS FAILING DUE TO STENOSIS. THE CAUSE OF THE STENOSIS IS UNKNOWN AT THIS TIME. THE MEDICAL RECORDS RECEIVED SHOWED THE PATIENT PRESENTED WITH SHORTNESS OF BREATH DEPENDING ON EXERTION WITH ANGINA AND OCCASIONAL DIZZINESS. THE ECHO REPORT REVEALS SEVERE STENOSIS WITH A MEAN GRADIENT OF 42MMHG/PEAK GRADIENT 74MMHG, WITH A POSSIBILITY OF HYPO-ATTENUATING LEAFLET THICKENING (HALT). THE ECHO/CT RECOMMENDED A WORKUP FOR A POSSIBLE VALVE-IN-VALVE TAVR PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 20318826 ↗
• InjurySep 20, 2024Degraded; Device Stenosis; Degraded; Device Stenosis

  AS REPORTED BY THE FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN 3 VALVE, THE VALVE IS FAILING DUE TO AORTIC STENOSIS. NO TREATMENT DATE HAS BEEN SCHEDULED. PER FEEDBACK FROM THE FCS, THE PHYSICIAN PLANS TO START THE PATIENT ON ORAL ANTICOAGULATION X1 MONTH (COUMADIN). ATER TREATING THE PATIENT WITH COUMADIN FOR 3 MONTHS, THE PATIENT WILL BE RE-EVALUATED. THE MEDICAL RECORDS REVEALED, THE MEAN GRADIENT WAS 50MMHG (INCREASE FROM PREVIOUS 16MMHG IN 2021).

  Patient problems: Dyspnea

  MAUDE report 20267120 ↗
• InjurySep 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 9 YEARS AND 5 MONTHS POST-IMPLANT OF A 23 MM SAPIEN XT VALVE IN THE AORTIC POSITION, THE VALVE FAILED DUE TO SEVERE AORTIC STENOSIS (AS) WITH MODERATE AORTIC INSUFFICIENCY (AI). THE PATIENT PRESENTED WITH WORSENING DYSPNEA ON EXERTION AND OCCASIONALLY CHEST PAIN. THE PEAK GRADIENT OF 31 MMHG AND MEAN GRADIENT OF 18 MMHG. THE AORTIC VALVE AREA BY CONTINUITY EQUATION IS 1.0 CM2. THE PROSTHETIC VALVE APPEARS WELL-SEATED. THE VALVE LEAFLET MOTION IS NORMAL. THERE IS MODERATE TO SEVERE TRANSVALVULAR REGURGITATION. A NEW 23 MM SAPIEN 3 ULTRA RESILIA WAS IMPLANTED. AFTER REVIEW OF THE MEDICAL RECORDS PROVIDED, CENTRAL REGURGITATION WAS CONFIRMED. WHILE THE VALVE GRADIENTS WERE REPORTED AS ELEVATED, IT WAS SUSPECTED DUE TO THE HIGH FLOW RATE FROM THE CENTRAL LEAK. THE GRADIENTS WERE ALSO VERIFIED AS NORMAL FOR THIS TYPE OF VALVE. WHILE AORTIC STENOSIS WAS REPORTED AS UNABLE TO BE EXCLUDED, THE AVA WAS DOCUMENTED AS 1.0 CM2 WHICH PER THV COMPLAINT GUIDANCE IS WITHIN NORMAL RANGE FOR THIS VALVE. THE PATIENT REPORTED CHEST PAIN AND DYSPNEA AND A VIVIV WAS PERFORMED.

  Patient problems: Chest Pain

  MAUDE report 20257463 ↗
• InjuryAug 23, 2024Degraded; Device Stenosis; Degraded; Device Stenosis

  AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, A PATIENT WITH A 23MM SAPIEN XT AORTIC VALVE IMPLANTED FOR 8 YEARS AND 7 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. A 23MM SAPIEN 3 ULTRA VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Dyspnea; Insufficient Information; Peripheral Edema

  MAUDE report 20051731 ↗
• InjuryAug 9, 2024Degraded; Degraded

  AS REPORTED FROM BY AN FIELD CLINICAL SPECIALIST, APPROXIMATELY 6 YEARS AND 10 MONTHS POST TPVR WITH A 23MM SAPIEN XT VALVE, THE VALVE FAILED. PER CLINICAL REVIEW OF MEDICAL RECORDS, APPROXIMATELY 6 YEARS AND 10 MONTHS POST TAVR THE PATIENT PRESENTED WITH FATIGUE AND PROGRESSIVE PULMONARY STENOSIS AND SHORTNESS OF BREATH. PATIENT'S ECHO SHOWS MEAN GRADIENT ACROSS THE PULMONARY VALVE OF 35.9MMHG AND TRIVIAL INSUFFICIENCY. UNDER ANESTHESIA, THE PATIENT HAD A 26MM SAPIEN S3 IN THE PULMONIC POSITION VIA RIGHT FEMORAL VEIN APPROACH.

  Patient problems: Dyspnea

  MAUDE report 19950603 ↗
• InjuryJul 22, 2024Calcified; Calcified

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 6 YEARS AND 10 MONTHS POST TPVR WITH A 23MM SAPIEN XT IN NON-EDWARDS SURGICAL VALVE, THE SAPIEN XT FAILED DUE TO REGURGITATION AND STENOSIS. USED A NON-EDWARDS BALLOON TO FRACTURE ORIGINAL SURGICAL VALVE AND IMPLANTED A 26MM SAPIEN 3 ULTRA VALVE IN PULMONIC POSITION USING THE COMMANDER DS. GRADIENT OF 7MMHG, PATIENT IS STABLE. PER THE FCS, THE PATIENT HAD TROUBLE BREATHING PRIOR TO THE VIV PROCEDURE. THE GRADIENT PRIOR TO THE VIV WAS 35-55MMHG AND THERE WAS LEAFLET CALCIFICATION.

  Patient problems: Dyspnea

  MAUDE report 19794395 ↗
• InjuryJul 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY IMPLANT PATIENT REGISTRY, APPROXIMATELY 9 YEARS POST TRANSFEMORAL TAVR PROCEDURE WITH A 23 MM SAPIEN XT VALVE, A VALVE-IN-VALVE PROCEDURE WAS PERFORMED. THE CAUSE OF THE INTERVENTION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19793240 ↗
• InjuryJun 5, 2024Degraded; Degraded

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, A 23MM SAPIEN XT VALVE UNDERWENT A VALVE IN VALVE PROCEDURE APPROXIMATELY 9 YEARS AND 2 MONTHS POST IMPLANT. FAILURE MODE WAS STATED AS STENOSIS AND CENTRAL REGURGITATION.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 19472399 ↗
• InjuryApr 30, 2024Degraded; Degraded

  AS REPORTED BY A FIELD CLINICAL SPECIALIST (FCS), APPROXIMATELY 8 YEARS AND 7 MONTHS POST-IMPLANT OF A 23 MM SAPIEN XT VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH. THE VALVE FAILED DUE TO STENOSIS. THE BASELINE PEAK 100 MMHG AND MEAN 60 MMHG. THE CURRENT PEAK/MEAN GRADIENT IS 10 MMHG CATH GRADIENT. THE PATIENT WAS SYMPTOMATIC. THE TEAM DO NOT BELIEVE THE FAILURE TO BE EARLY AS VALVE WAS IMPLANTED 9 YEARS AGO. A VALVE IN VALVE WAS SUCCESSFULLY PERFORMED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 19215701 ↗
• InjuryApr 15, 2024Degraded; Degraded

  APPROXIMATELY 8 YEARS AND 7 MONTHS POST-TAVR IMPLANT USING A 23MM SAPIEN XT VALVE, THE PATIENT HAS SEVERE AORTIC STENOSIS AND MODERATE AORTIC INSUFFICIENCY. THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE USING A 23MM SAPIEN 3 ULTRA VALVE. PER REPORT, THE DIAGNOSIS WAS MADE AFTER THE PATIENT HAD A NON-SYNCOPAL FALL. PER MEDICAL RECORD REVIEW, THE 8-YEAR ECHO INDICATED THAT THE 23MM SAPIEN XT WITH SEVERE STENOSIS AND MODERATE REGURGITATION. THE MEAN GRADIENT WAS 50MMHG WITH AN AORTIC VALVE AREA (AVA) OF 0.5CM2. THE PATIENT IS HEMODYNAMICALLY STABLE.

  Patient problems: Balance Problems

  MAUDE report 19110511 ↗
• InjuryApr 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY AN EDWARDS LIFESCIENCE AFFILIATE, APPROXIMATELY 8 YEARS AND 9 MONTHS POST IMPLANTATION OF A 23MM SAPIEN XT VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WAS PERFORMED WITH A 23MM SAPIEN 3 ULTRA RESILIA VALVE DUE TO STENOSIS. THE VALVE WAS IMPLANTED IN A GOOD POSITION. PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLAINTS.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 19091139 ↗
• InjuryNov 22, 2023Fluid/Blood Leak; Difficult to Open or Close; Fluid/Blood Leak; Difficult to Open or Close

  AS REPORTED BY COMPASSION CLINICAL STUDY, POST TPVR PROCEDURE WITH A 23MM SAPIEN 3 XT VALVE, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN, AND ECHO REPORT REVEALED RIGHT HEART DYSFUNCTION ALONG WITH MODERATE STENOSIS AND INSUFFICIENCY. THE VALVE WAS EXPLANTED. PER REPORT, MODERATE RESIDUAL REGURGITATION WAS OBSERVED FOLLOWING PULMONARY VALVE INTERVENTION.

  Patient problems: Dyspnea

  MAUDE report 18195028 ↗
• InjuryOct 19, 2023Device Stenosis; Device Stenosis

  AS REPORTED BY AN EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST, APPROXIMATELY 8 YEARS AND 5 MONTHS POST-IMPLANT OF A 23MM SAPIEN XT VALVE IN THE AORTIC POSITION, A VALVE IN VALVE WAS DONE. A 23MM SAPIEN 3 ULTRA WAS PLACED INSIDE THE SAPIEN XT, AND THE VALVE IN VALVE WENT WELL. FAILURE MODE OF THE SAPIEN XT VALVE WAS REPORTED AS STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 17971150 ↗