WALLSTENT? ENTERAL ENDOPROSTHESIS
Received Jul 1, 2026 · Event occurred Jan 1, 2023
Report 3005099803-2026-02644 · MDR key 25686133
Device
Generic name
Stent, Colonic, Metallic, Expandable
Manufacturer
Boston Scientific CorporationModel number
M00565650Catalog number
M00565650
Lot number
0026451101
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL UNCOVERED STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY ONE YEAR AFTER THE DEVICE IMPLANTATION. A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT'S DEATH HAS NOT BEEN ESTABLISHED.
Additional Manufacturer Narrative
BLOCK B2 (DATE OF DEATH) AND B3 (DATE OF EVENT): APPROXIMATED BASED ON THE YEAR PROVIDED IN THE EVENT. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF THE PATIENT DEATH.