SOLO SMART ART23SMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00896208000474), received between Jun 30, 2016 and Jun 11, 2021 — classified as 2 deaths, 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A SOLO SMART VALVE SIZE 23 WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WILL UNDERGO A VALVE-IN-VALVE PROCEDURE (DATE STILL UNKNOWN). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL, PRE-OPERATIVELY, THE ECHO SHOWED A SEVERE AORTIC VALVE INSUFFICIENCY. AS SUCH, AN EMERGENCY TAVR VALVE-IN-VALVE WAS PERFORMED FOR CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED ON (B)(6) 2021. A 26 MM SAPIENS 3 VALVE IN VALVE WAS PLACED FROM PERCUTANEOUS FEMORAL APPROACH WITH NO COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11982139 ↗
• InjuryJun 8, 2021Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A SOLO SMART VALVE SIZE 23 WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WILL UNDERGO A VALVE-IN-VALVE PROCEDURE (DATE STILL UNKNOWN). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL, PRE-OPERATIVELY, THE ECHO SHOWED A SEVERE AORTIC VALVE INSUFFICIENCY. AS SUCH, AN EMERGENCY TAVR VALVE-IN-VALVE WAS PERFORMED FOR CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED ON (B)(6) 2021. A 26 MM SAPIENS 3 VALVE IN VALVE WAS PLACED FROM PERCUTANEOUS FEMORAL APPROACH WITH NO COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiogenic Shock; Insufficient Information

  MAUDE report 11962738 ↗
• InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT VIA THE SURE-AVR PATIENT REGISTRY: A SOLO SMART SIZE 23 WAS IMPLANTED ON (B)(6) 2016. AT THE TIME OF OPERATION, A MEAN GRADIENT OF 11 MMHG AND PARAVALVULAR LEAK 1+ WERE REPORTED. THE PATIENT EXPERIENCED THROMBOCYTOPENIA ON (B)(6) 2016. THE VALVE WAS FUNCTIONING WELL AT FOLLOW UP IN (B)(6) 2017, WITH A MEAN GRADIENT OF 12 MMHG AND NO CENTRAL OR PARAVALVULAR LEAK. THE TOTAL CROSS-CLAMP TIME WAS 59 MINUTES AND THE TOTAL PUMP TIME WAS 72 MINUTES. THE PHYSICIAN REPORTED THAT THE THROMBOCYTOPENIA WAS BELIEVED TO BE ATTRIBUTABLE TO THE SOLO VALVE. ASSAY FOR HEPARIN-INDUCED THROMBOCYTOPENIA WAS NEGATIVE. THE PATIENT WAS NOT TRANSFUSED.

  Patient problems: No Code Available

  MAUDE report 7904091 ↗
• InjuryAug 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, A SOLO SMART SIZE 23 WAS IMPLANTED AND EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7764881 ↗
• DeathFeb 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A SOLO SMART 23 WAS IMPLANTED WITHOUT SUCCESS. UPON RELEASING THE CROSS-CLAMP, THE PATIENT BECAME TACHYCARDIC, REQUIRING MULTIPLE DEFIBRILLATIONS, WITH THE RIGHT VENTRICLE NOT EJECTING. INTRA-OPERATIVE TEE SHOWED THE LEAFLETS DID NOT OPEN CORRECTLY. THE SOLO SMART 23 WAS EXPLANTED AND A SOLO SMART 21 WAS IMPLANTED. THE RIGHT VENTRICLE REGAINED ITS OWN RHYTHM, HOWEVER THE LEFT VENTRICLE WAS COMPLETELY NON-FUNCTIONAL. THE PATIENT REMAINED ON BYPASS AND WAS EVENTUALLY SWITCHED TO ECMO AND TRANSFERRED TO BAYLOR FOR EMERGENT L-VAD, HOWEVER EXPIRED SHORTLY AFTER ARRIVING.

  Patient problems: Death; Tachycardia

  MAUDE report 7236142 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) CLINICAL REGISTRY: A SOLO SMART SIZE 23 WAS IMPLANTED ON (B)(6) 2016 VIA MINI- STERNOTOMY. THE VALVE WAS IMPLANTED SUPRA-ANNULAR. ON (B)(6) 2017, THE PATIENT EXHIBITED STROKE AND IT WAS REPORTED BY THE SITE AS UNKNOWN FOR DEVICE RELATION.

  Patient problems: Stroke/CVA

  MAUDE report 7100507 ↗
• InjuryAug 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(4) THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF A SOLO SMART SIZE 23 DEVICE THAT WAS 'WASTED' ON (B)(6). A CROWN PRT PERICARDIAL HEART VALVE SIZE 21 WAS IMPLANTED ON THE SAME DAY.

  Patient problems: No Information

  MAUDE report 6799067 ↗
• InjuryNov 10, 2016Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS NOTIFIED ON (B)(4) 2016 OF THE FOLLOWING: A SOLO SMART SIZE 23MM WAS IMPLANTED IN THE PATIENT AND IN THE INTRA-OPERATIVE TEE, A MILD AI WAS DETECTED. THE SOLO SMART VALVE WAS EXPLANTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 6094151 ↗
• DeathJun 30, 2016Incomplete Coaptation; Difficult to Open or Close; Incomplete Coaptation; Difficult to Open or Close

  THE MANUFACTURER WAS NOTIFIED ON 02 JUN 2016: [SUMMARY]: FOLLOWING THE OCCURRENCE AND AGGRAVATION OF AORTIC REGURGITATION (AR) AFTER IMPLANTATION OF SOLO SMART ART23SMT, ANOTHER AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED. WITHIN ONE MONTH LATER FROM THE REOPERATION, THE PATIENT DIED FOR AN UNKNOWN CAUSE. SUMMARY OF THE EVENT AS FOLLOWS: (B)(6) 2016 IN AN AVR PROCEDURE, THE SOLO SMART ART23SMT WAS IMPLANTED IN A MALE PATIENT IN HIS EARLY 70S. THE PATIENT'S PULMONARY CONDITION WAS BAD. THE ANESTHESIOLOGIST COULD NOT SMOOTHLY DELIVER AIR TO THE PATIENT'S LUNGS AND DIFFICULTY WAS ENCOUNTERED IN PULMONARY CONTROL WHEN STARTING THE OPERATION. THE MODEL ART23SMT WAS SELECTED BASED ON THE DIAMETER OF THE AORTIC ANNULUS MEASURED WITH THE SIZER SET (ICV1237). SINCE THE DIAMETER OF THE ST JUNCTION HAD ENLARGED TO 28 MM, BANDING WAS PERFORMED AROUND THE JUNCTION TO PREVENT FURTHER ENLARGEMENT (DETAILS OF HOW THIS PROCESS WAS DONE ARE UNKNOWN). THE PROCEDURE WAS COMPLETED WITH THE SOLO SMART IMPLANTED. ON POST-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), NO TRANSVALVULAR LEAK WAS SHOWN. AFTER THE PROCEDURE, THE PATIENT RECEIVED WARFARIN WITH AN INR OF AROUND 2.0. THE PATIENT RECOVERED TO

  Patient problems: Aortic Regurgitation; Death; Thrombus; Vascular Dissection

  MAUDE report 5763846 ↗