Solitaire™ SFR3-4-20-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536029279), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PASS WAS ATTEMPTED WITH REPORTED SOLITAIRE 4X20 STENT BUT DID NOT RE-VASCULARIZED THE VESSEL. ATTEMPTED A PASS WITH ANOTHER MEDTRONIC STENT BUT STILL DID NOT RE-VASCULARIZED THE VESSEL. THEN THE PHYSICIANS STENTED THE LESION WITH A NON-MEDTRONIC STENT. AFTER DEPLOYMENT, THE NON-MEDTRONIC STENT CLOTTED OFF. THE PHYSICIAN THE ATTEMPTED TO USE SOLITAIRE 4X20 TO OPEN THE BLOCKED STENT BY OPENING IT WITH THE EXISTING STENT, BUT NOT PULLING OR PUSHING THE SOLITAIRE UPON DEPLOYMENT. THE SOLITAIRE BECAME ENTANGLED IN THE NON-MEDTRONIC STENT AND COULD NOT BE RECAPTURE OR REMOVED. THE SOLITAIRE STENT WAS THEN DEPLOYED, AND THE DELIVERY WIRE WAS DELIBERATELY TORQUED UNTIL IT FRACTURED AT THE PROXIMAL MARKER LEAVING THE SOLITAIRE IMPLANTED IN THE NON-MEDTRONIC STENT. THE PATIENT UNDERWENT THROMBECTOMY TREATMENT FOR ISCHEMIC STROKE IN RIGHT M1. THE CHARACTERISTICS OF THE CLOT WAS ATHEROSCLEROTIC. THE VESSEL WAS SEVERELY TORTUOUS. INTEGRELIN WAS GIVEN TO THE PATIENT. REGARDING PATIENT CURRENT MEDICAL CONDITION NOT SURE MADE AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8848679 ↗