inforMED
InjuryPCU

AXIOS¿

Received Mar 5, 2026 · Event occurred Feb 19, 2026

Report 24518776 · MDR key 24518776

Device

Generic name

Pancreatic Stent, Covered, Metallic, Removable

Model number

M00553650

Catalog number

REF M00553650

Lot number

37401290

Patient

43 YR · Male

  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

PATIENT UNDERGOING EGD [ESOPHAGOGASTRODUODENOSCOPY] WITH STENT PLACEMENT FOR DRAINAGE OF A PSEUDOCYST EXPERIENCED UNEXPECTED BLEEDING AND WAS EMERGENTLY TRANSFERRED TO IR [INTERVENTIONAL RADIOLOGY]. THE PROCEDURE BEGAN AS PLANNED, WITH NO INITIAL CONCERNS ASIDE FROM THE TIGHT ANGLE BETWEEN THE ENDOSCOPE AND THE PATIENT¿S ANATOMY DUE TO A LARGE PSEUDOCYST. UPON STENT DEPLOYMENT, THE PATIENT DEVELOPED A LARGE-VOLUME BLEED. THE MD PROMPTLY DEPLOYED THREE HEMOCLIPS TO ACHIEVE HEMOSTASIS. THE TEAM DREW EMERGENCY LABS FOR TYPE AND SCREEN AND SECURED UN-CROSSMATCHED PRBCS [PACKED RED BLOOD CELLS], FFP [FRESH FROZEN PLASMA], AND PLATELETS. THE TEAM COORDINATED WITH [REDACTED] IR TO PREPARE THE OR FOR AN EMERGENT CASE TO ENSURE THE BLEEDING WAS STOPPED. THE PATIENT WAS RAPIDLY TRANSFERRED TO IR FOR BLEEDING CONTROL.