AXIOS¿
Received Mar 5, 2026 · Event occurred Feb 19, 2026
Report 24518776 · MDR key 24518776
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553650Catalog 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.