SOLO SMART ART21SMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00896208000467), received between Oct 28, 2016 and Sep 14, 2020 — classified as 1 death, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A SOLO SMART THAT WAS IMPLANTED ON (B)(6) 2016, WAS EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10532726 ↗
• InjurySep 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A SOLO SMART THAT WAS IMPLANTED ON (B)(6) 2016, WAS EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10532722 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS CASE REFERS TO A SOLO SMART VALVE SIZE 21, IMPLANTED ON (B)(6) 2015 IN AORTIC POSITION AND REPLACED WITH MITROFLOW VALVE DLA21 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 8317285 ↗
• InjuryFeb 1, 2019Gradient Increase; Gradient Increase

  ON (B)(6) 2018, A 65 YEARS OLD FEMALE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH SOLO SMART SIZE 21. DURING THE SAME PROCEDURE, 4 CABGS WERE ALSO PERFORMED. A WEEK LATER, THE PATIENT¿S GRADIENTS WERE UNUSUALLY HIGH: 60MMHG (MEAN) AND 90MMHG (PEAK). THE SURGEON REVIEWED THE ECHO AND DETERMINED THAT THE VALVE WAS OVERSIZED AS WELL AS IMPLANTED TOO HIGH ON ONE SIDE. ON (B)(6) 2019, THE VALVE WAS EXPLANTED AND A MAGNA EASE 19 WAS IMPLANTED INSTEAD. THE PATIENT'S MEAN GRADIENT WENT DOWN TO 16MMHG IMMEDIATELY AFTER THE REPLACEMENT OF THE DEVICE. THE PATIENT IS DOING WELL AFTER THE PROCEDURE. THERE WAS NO PERCEIVED ISSUE WITH THE EXPLANTED SOLO SMART.

  Patient problems: No Information

  MAUDE report 8298772 ↗
• DeathDec 7, 2017Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) REGISTRY: A SOLO SMART SIZE 21 WAS IMPLANTED ON (B)(6) 2016 VIA MEDIAN-STERNOTOMY. THE VALVE WAS IMPLANTED SUPRA-ANNULAR WITH NON-EVERTING SUTURE TECHNIQUE. ON (B)(6) 2017, THE PATIENT EXHIBITED NON STRUCTURAL DYSFUNCTION WHICH WAS REPORTED BY THE SITE AS DUE TO INAPPROPRIATE SIZING AND POSITIONING.

  Patient problems: Death; No Information

  MAUDE report 7098153 ↗
• InjuryJan 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON DECEMBER 19, 2016, THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING: ON (B)(6) 2016, A PATIENT UNDERWENT A MAZE PROCEDURE AND AN AVR. THE VALVE WAS VISUALLY CHECKED AFTER IMPLANTATION AND NO ANOMALY WAS OBSERVED. THE TEE WAS PERFORMED AND NO LEAK WAS CONFIRMED. THE PATIENT'S PRE-OPERATIVE PLATELET COUNT WAS 194,000 UNITS PER MICROLITER, THE POST-OPERATIVE PLATELET COUNT WAS 54,000 UNITS PER MICROLITER, THE 1ST POST-OPERATIVE DAY PLATELET COUNT WAS 46,000 UNITS PER MICROLITER, AND THE 2ND POST-OPERATIVE DAY PLATELET COUNT WAS 30,000 UNITS PER MICROLITER. THE PATIENT THEN RECEIVED A BLOOD TRANSFUSION AND THE PLATELET COUNT INCREASED TO 59,000 UNITS PER MICROLITER AND CONTINUED TO INCREASE GRADUALLY. THE THROMBOCYTOPENIA WAS NOT HIT.

  Patient problems: Hemolysis

  MAUDE report 6262530 ↗
• Oct 28, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  E-MAIL RECEIVED FROM PT (B)(6) ON 29 SEP 2016: RECEIVED A PATIENT REGISTRATION FORM (PRF) FOR PATIENT (C. M. FEMALE, DOB (B)(6)) WHO HAD A ART21SMT SN# (B)(4) EXPLANTED ON (B)(\6) 2016 AT (B)(6). HOSPITAL¿S ADDRESS IS (B)(6). NOV 3, 2016 UPDATE FROM USA SALES: THERE WAS NO ISSUE WITH THE VALVE. ONCE CHEST WAS OPEN AND SIZED THE DOCTOR DECIDED SOLO WAS NOT VALVE FOR THAT PATIENT AFTER THEY ALREADY OPENED IT. THIS WAS ALL THE INFORMATION THAT WAS ABLE TO BE OBTAINED.

  Patient problems: No Information

  MAUDE report 6065122 ↗