inforMED
MalfunctionPOL

MEDTRONIC SOLITAIRE X REVASCULARIZATION DEVICE 4MM X 40MM /STENT

Received Jan 30, 2020 · Event occurred Jan 20, 2020

Report MW5092657 · MDR key 9653617

Device

Generic name

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Lot number

A861719

Product problems

  • Material Separation

Patient

88 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

SOLITAIRE STENT RETRIEVER BEING USED FOR A MECHANICAL THROMBECTOMY PROCEDURE BECAME SEPARATED FROM ITS DELIVERY WIRE. IT WAS DEPLOYED IN THE PT'S CAROTID ARTERY. SOLITAIR DELIVERY WIRE DETACHED FROM STENT RETRIEVER DEVICE AT CAROTID SIPHON (LOCATION OF INTRACRANIAL STENOSIS) DURING RETRIEVAL; STENT LEFT IN PLACE AT LEVEL OF STENOSIS. DELIVERY WIRE FRAGMENT RETRIEVED WITH SNARE. FDA SAFETY REPORT ID# (B)(4).