SOLITAIRE¿ X
Received May 31, 2024 · Event occurred Apr 22, 2024
Report 19434189 · MDR key 19434189
Device
Generic name
Catheter, Thrombus Retriever
Manufacturer
Micro Therapeutics, Inc. Dba Ev3 Neurovascular.Model number
SFR4-6-40-10Catalog number
SFR4-6-40-10
Lot number
B592913
Patient
75 YR · Male
- Muscle Weakness/Atrophy
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Muscle Weakness/Atrophy
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT M1 OCCLUSION. DURING THE PROCEDURE, 2 STENTS WERE DEPLOYED, BUT THE SOLITAIRE STENT RETRIEVER BECAME STUCK ON THE CLOT, RESULTING IN A FRACTURE. AFTER THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE SIGNIFICANT LEFT-SIDED WEAKNESS. A CT ANGIOGRAM SHOWED THE RIGHT M1 OCCLUSION WITH A PERFUSION DEFECT. TENECTEPLASE (TNK) WAS GIVEN, BUT THE PATIENT STILL HAD SUBSTANTIAL LEFT-SIDED WEAKNESS, SO THE DECISION WAS MADE TO BRING HER FOR THROMBECTOMY.