INTERGARD WOVEN
Received May 22, 2026 · Event occurred May 2, 2026
Report 1640201-2026-0000029 · MDR key 25255758
Device
Generic name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Manufacturer
Intervascular SasModel number
IGW1206Catalog number
IGW1206
Lot number
22G14
Product problems
- Material Frayed
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 22G14. (3331/3233) A REVIEW OF THE DEVICE HISTORY RECORDS IS ONGOING, RESULTS ARE PENDING. (10/3233) THE PRODUCT IS AVAILABLE FOR INVESTIGATION AND WAS RETURNED TO INTERVASCULAR ON 12 MAY 2026 FOR EXAMINATION. THE RESULTS ARE PENDING ANALYSIS BY QUALITY ASSURANCE TEAM. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED TO INTERVASCULAR THAT DURING THE ROUTINE PRE-OP CHECK, A MINOR SURFACE IRREGULARITY (SLIGHT FRAYING) WAS NOTED ON THE PRODUCT. AS A PRECAUTION, THEY SWITCHED TO ANOTHER UNIT AVAILABLE ON-SITE. THE PROCEDURE PROCEEDED AS PLANNED WITH NO IMPACT ON THE PATIENT OR SURGERY SCHEDULE. THE ORIGINAL UNIT IS KEPT FOR COLLECTION. COMPLAINT # (B)(4)