MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS EMBOZENE MICROSPHERES; EMBOLIC DEVICE

Model Number UNK-EMBOZENE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

The injury was severe and initially considered life-threatening as described in the published case report.The injury is due to non-target embolization during uterine artery embolization in which a significant amount of microsphere inadvertently refluxed into the gluteal arteries causing significant full thickness skin necrosis requiring multiple surgeries to repair.This is an injury related to operator error and a rare but known potential complication of uterine artery embolization.This is not an injury due to device malfunction.

Event Description

Varian medical affairs conducted a literature search on (b)(6) 2022.Per the article titled "buttock necrosis following uterine artery embolization: a case report", the patient presented 12 days post-op from a uterine artery embolization with a lesion on the left buttock, associated with excruciating pain and generally becoming unwell.

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 9825 spectrum dr. bldg 2; austin TX 78717
• Manufacturer Contact: lisa schaller ; 9825 spectrum dr. bldg 2; austin, TX 78717 ; 5125181750
• MDR Report Key: 16099909
• MDR Text Key: 306680200
• Report Number: 3008262715-2023-00001
• Device Sequence Number: 1
• Product Code: NAJ
• UDI-Device Identifier: 00810563021318
• UDI-Public: 810563021318
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-EMBOZENE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female