EXCELSIOR XT-27 STD STRAIGHT 150CM
Received Jul 1, 2026 · Event occurred Jun 10, 2026
Report 3008881809-2026-00417 · MDR key 25684894
Device
Generic name
Catheter, Percutaneous
Manufacturer
Stryker Neurovascular CorkCatalog number
M003XT2750810
Lot number
26061044
Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING OPHTHALMIC ARTERY OA SEGMENT ANEURYSM INTERVENTIONAL PROCEDURE, THE PHYSICIAN USED A FLOW DIVERTER FD STENT FOR THE PROCEDURE. AFTER DELIVERING THE SUBJECT MICROCATHETER TO THE TARGET POSITION, THE PHYSICIAN ADVANCED THE STENT TO THE TARGET POSITION SMOOTHLY. WHEN PULLING BACK THE SYSTEM TO RELEASE TENSION, THE ENTIRE STENT SYSTEM SLIPPED DISTALLY TO THE PROXIMAL SIDE OF THE ANEURYSM, AND THE STENT COULD NOT COVER THE ANEURYSM NECK. THE PHYSICIAN THEN RETRIEVED THE ENTIRE SYSTEM, RE-DELIVERED ANOTHER SECOND MICROCATHETER TO THE DISTAL M1 SEGMENT OF THE ANEURYSM, AND GUIDED THE STENT INTO THE SECOND MICROCATHETER THROUGH AN 8F INTRODUCING SHEATH. DURING ADVANCEMENT, THE STENT TIP ENCOUNTERED SIGNIFICANT RESISTANCE AT THE SUBJECT MICROCATHETER TIP, AND REPEATED ADJUSTMENT COULD NOT PASS IT. THE PHYSICIAN THEN RETRIEVED IT FOR INSPECTION AND FOUND THAT THE STENT HAD PUNCTURED THROUGH THE SIDE WALL OF THE FIRST SUBJECT MICROCATHETER TIP AND DEPLOYED, WITHOUT PASSING THROUGH THE TIP OF THE SUBJECT MICROCATHETER INTO THE SECOND MICROCATHETER. THE SUBJECT MICROCATHETER TIP WAS AT THE HUB OF SECOND MICROCATHETER WHEN THE STENT PUNCTURED THROUGH ITS SIDE WALL. THE PHYSICIAN THEN REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.