SYNCHRO2-14 STANDARD STRAIGHT 200CM
Received Jul 17, 2026 · Event occurred Jun 10, 2026
Report 3012931345-2026-00114 · MDR key 25854901
Device
Generic name
Wire, Guide, Catheter
Manufacturer
Stryker Neurovascular-utah-salt Lake CityCatalog number
M00326410
Lot number
0001144825
Product problems
- Fracture
Patient
NA · Female
- Paralysis
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A MCA STENOSIS TREATMENT, WHEN THE PHYSICIAN DEPLOYED A NON-STRYKER STENT AT THE TREATMENT SITE, IT WAS NOT APPOSING TO THE VESSEL WALLS. THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO TRY TO OPEN THE STENT. DURING THE MANIPULATION, THE GUIDEWIRE TIP FRACTURED AT THE PROXIMAL END OF THE STENT. THE TIP OF THE GUIDEWIRE REMAINED LODGED INSIDE THE STENT AND WAS NOT RETRIEVED. THERE WAS A SURGICAL DELAY OF 1 HOUR. POSTOPERATIVELY, THE PATIENT DEVELOPED CONTRALATERAL LIMB HEMIPLEGIA. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.