FDA Adverse Event Injury Summary report: N

ADVANTA V12 COVERED STENT SYSTEM

MDR report key: 9639205 · Received January 28, 2020

Report

Report Number: 3011175548-2020-00182
Event Type: Injury
Date Received: January 28, 2020
Report Date: January 28, 2020
Manufacturer: ATRIUM MEDICAL CORPORATION
Product Code: NIO
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER OR SAMPLE WAS PROVIDED. THE ARTICLE CONCLUDED SUBSTANTIAL DISTAL MIGRATION OF THE ENDOGRAFT AND POSITIONAL CHANGES OF THE CH-SGS IN THE JUXTARENAL AORTIC NECK WERE OBSERVED AT 1 YEAR OF FOLLOW-UP. CAREFUL FOLLOW-UP AFTER CH-EVAS IS ADVISED BECAUSE CHANGES ARE OFTEN SUBTLE. [(B)(4)]. DEVICE NOT RETURNED.

Description of Event or Problem · 1

RECEIVED AN ARTICLE TITLED ASSESSMENT OF CHANGES IN STENT GRAFT GEOMETRY AFTER CHIMNEY ENDOVASCULAR ANEURYSM SEALING. PURPOSE: THE AIM OF THE PRESENT STUDY WAS TO QUANTIFY THE (NON) APPOSITION OF THE ENDOBAGS IN THE PROXIMAL AORTIC NECK, MIGRATION OF THE ENDOGRAFT STENT FRAMES, AND CHANGES IN GEOMETRY OF THE CH-SGS DURING THE FOLLOW-UP PERIOD. METHOD: THE PROSPECTIVE DATA FROM 20 PATIENTS UNDERGOING ELECTIVE CH-EVAS WERE RETROSPECTIVELY REVIEWED. THE AORTIC ANATOMY WAS ANALYZED ON PREOPERATIVE AND POSTOPERATIVE COMPUTED TOMOGRAPHY SCANS. PER THE ARTICLE ADVERSE EVENTS INCLUDED: BLEEDING, OCCLUSION AND KIDNEY INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
99722	ADVANTA V12 COVERED STENT SYSTEM	STENT, ILIAC	NIO	ATRIUM MEDICAL CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention