FDA Adverse Event Death Summary report: N

TRUFILL N-BCA

MDR report key: 21899073 · Received April 24, 2025

Report

Report Number
MW5169480
Event Type
Death
Date Received
April 24, 2025
Date of Event
April 2, 2025
Report Date
April 14, 2025
Manufacturer
CERENOVUS, INC.
Product Code
KGG
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

ON (B)(6) 2025, PT ADMITTED TO IR FOR COILING AND GLUE PLACEMENT FOR ENDOLEAK. FOLLOWING THE PROCEDURE, THE PATIENT HAD DISCHARGE ORDERS BUT STARTED TO EXPERIENCE ACUTE ABDOMINAL PAIN AND LOST THE PULSE IN HIS LEFT FOOT. PT WAS ADMITTED TO CCU AND CT ANGIOGRAM PERFORMED AND SHOWED HIGH-DENSITY MATERIAL IN THE RIGHT HEPATIC, DISTAL SPLENIC ARTERIES, AND DISTAL SMA. PATIENT WAS TAKEN TO OR EMERGENTLY FOR AORTOGRAM, SMA STENT, LEFT POPLITEAL CUTDOWN AND TIBIAL THROMBECTOMY, LEFT LOWER EXTREMITY ANGIOGRAM, LEFT DORSALIS PEDIS CUT DOWN AND TIBIAL PEDAL THROMBECTOMY. ON (B)(6), PATIENT ALSO HAD AN EXPLORATORY LAP WITH RIGHT HEMICOLECTOMY - FINDINGS INCLUDE ISCHEMIC ILEUM WITH A WELL PERFUSED JEJUNUM AND COLON. ON (B)(6), HE RETURNED TO THE OPERATING ROOM FOR A SECOND LOOK, WHICH INDICATED THAT THE MAJORITY OF THE SMALL BOWEL IS NONVIABLE AND THE GALLBLADDER IS NECROTIC. THERE IS LESS THAN 40CM OF VIABLE BOWEL AND EVEN THESE AREAS HAVE SMALL PATCHES OF ISCHEMIA. IT WAS THE UNDERSTANDING OF NURSING THAT THE GLUE TRAVELED THROUGH THE VASCULAR SYSTEM AND CAUSED THE ISCHEMIC LEG AND NECROTIC BOWEL. WHEN PHYSICIAN SPOKE WITH THE FAMILY, HE MENTIONED THAT HE WAS UNSURE HOW THIS COULD HAVE HAPPENED. PALLIATIVE WAS CONSULTED AND THE FAMILY DECIDED TO TRANSITION TO COMFORT CARE. THE PATIENT PASSED AWAY (B)(6) 2025.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
591376 TRUFILL N-BCA TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS KGG CERENOVUS, INC. 631-400

Patients

Seq Age Sex Outcome Treatment
1 55 YR Male Death