MAUDE Adverse Event Report: MERIT MEDICAL, INC - ROISSY EMBOGOLD®; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number S210EG/A

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

Patient Problem Loss of Vision (2139)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a cerebral angio with embolization procedure, the patient suffered single-eye blindness.The middle meningeal artery was embolized but complicated by retinal artery embolization.Patient received hyperbaric oxygen therapy and ct scans and experienced subtle improvement in vision.Patient discharged with plans to follow-up with additional ct scan.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: EMBOGOLD®
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MERIT MEDICAL, INC - ROISSY; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer (Section G): MERIT MEDICAL, INC; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15008292
• MDR Text Key: 295857278
• Report Number: 9615728-2022-00001
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: S210EG/A
• Device Lot Number: X1824130R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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): Disability
• Patient Age: 52 YR
• Patient Sex: Female