SPIDER FX
Received Jul 17, 2026 · Event occurred Jun 22, 2026
Report 2183870-2026-00323 · MDR key 25852765
Device
Generic name
Temporary Carotid Catheter For Embolic Capture
Manufacturer
CovidienCatalog number
SPD2-US-060-320
Lot number
C184542
Product problems
- Peeled/Delaminated
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A LEG VASCULAR ATHERECTOMY PROCEDURE USING THE SPIDER FX EMBOLIC PROTECTION DEVICE, THE FILTERWIRE COATING PEELED. THE INSTRUCTIONS FOR USE WERE REPORTED TO HAVE BEEN FOLLOWED DURING PREPARATION, THE PROCEDURE, AND POST-PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.