InjuryMAL
HEMASHIELD BIFURCATED GRAFT
Received Apr 7, 2021 · Event occurred Apr 5, 2021
Report MW5100640 · MDR key 11633735
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Getinge / Intervascular, SasCatalog number
M002020851480
Lot number
19B27
Product problems
- Leak/Splash
Patient
50 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT SCHEDULED FOR AORTA BIFEMORAL BYPASS. SYNTHETIC GRAFT WAS OPENED TO FIELD. ONCE GRAFT WAS SEWN TO AORTA, IT WAS DISCOVERED THERE WAS A LEAK AT THE INFERIOR SEAM WHERE THE GRAFT SPLIT INTO THE BIFURCATION. MD REPAIRED GRAFT WITH PROLENE SUTURE. CASE CONTINUED AND NO LEAKS WERE NOTED. SIZE 40 X 14 X 8. FDA SAFETY REPORT ID # (B)(4).