SOLOPATH STFI-1935Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852381004272), received between Feb 1, 2017 and Apr 24, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2018Break; Break

  THE USER FACILITY REPORTED INTRODUCING THE SHEATH WAS POSSIBLE AS USUAL. UNFOLDING THE SHEATH WITH 20 ATM. APPROX 5CM PROXIMAL TO THE FEMORAL APPROACH WAS HEAVY CALCIFICATION. THIS COULD NOT BE OPENED BY UNFOLDING. PROSTHESIS FOR TAVI COULD NOT GO BEYOND THIS BOTTLENECK. RE-INFLATION WITH 23 ATM HAD NO SUCCESS TO OPEN THE BOTTLENECK. ATTEMPT OF THE LOCK REMOVAL 5CM POSSIBLE WITH THE CALCIFICATION THAT THE SHEATH WAS "STUCK IN THE MIDDLE". THEY TRIED TO REMOVE THE LOCK SEVERAL TIMES AND ENDED UP RIPPING IT OFF. ACCORDING TO THE INFORMATION OF THE DOCTOR, THEY DID NOT USE MORE POWER THAN USUAL AND THAT THE SHEATH WAS VERY POROUS. THE ATTEMPT TO RECOVER THE SHEATH AFTER SUCCESSFUL TAVI FAILED. THE REMOVAL OF THE REMAINING SHEATH WAS MADE THE DAY AFTER ON (B)(6) 2018 BY THE HEART SURGEON. ADDITIONAL INFORMATION WAS RECEIVED ON 4/5/2018: VASCULAR SURGEON TRIED TO WITHDRAW THE SOLOPATH WITHOUT SUCCESS, EVEN WITH A CUT DOWN. THE NEXT DAY A TAVI TRANSAORTAL WAS PERFORMED SUCCESSFULLY AND THE VASCULAR SURGEON WAS ABLE TO WITHDRAW THE SOLOPATH ABDOMINALLY. ALL REMAINING PIECES WERE REMOVED SUCCESSFULLY. THE PATIENT IS IN GOOD CONDITION, THERE WAS NO MAJOR BLOOD LOSS AND WAS TRANSFERRED TO TH

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque; Lead(s), Burn(s) From

  MAUDE report 7456523 ↗
• InjuryFeb 1, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE VALVE OF THE SOLOPATH DISCONNECTED FROM THE SHEATH. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING A FEM POP SURGERY AN EDWARDS SAPIEN 3 23 VALVE WAS INSERTED INTO THE SOLOPATH SHEATH; THE VALVE THEN BECAME STUCK PROXIMAL TO MID SHEATH; IT WAS STATED THAT THE SOLOPATH WAS OBSERVED ON X-RAY FULLY EXPANDING; THE ILIAC WAS REPORTED TO BE HEAVILY CALCIFIED AND TO HAVE A SIGNIFICANT LESION; ONCE THE VALVE WAS STUCK, IT WAS DECIDED TO REMOVE EVERYTHING, SHEATH INCLUDED; THE SHEATH WAS THEN STUCK AS WELL; AFTER PULLING ON THE SHEATH, THE VALVE OF THE SOLOPATH BECAME DISCONNECTED FROM THE SHEATH; A CUT DOWN WAS PERFORMED AND THE SOLOPATH ALONG WITH THE EDWARDS VALVE WAS REMOVED THE REST OF THE WAY CAUSING A COMPLETE EVULSION OF THE ARTERY; A VASCULAR BYPASS WAS PERFORMED FOR REPAIR; THE INITIAL PROCEDURE WAS ABORTED; BLOOD LOSS WAS LESS THAN 250 CC; AND THE PATIENT WAS REPORTED AS IN STABLE CONDITION.

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 6292873 ↗