MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO®; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 00884450386521

Device Problem Migration (4003)

Patient Problem Stenosis (2263)

Event Date 12/20/2021

Event Type  Injury  

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.

Event Description

The account alleges that a graft was successfully implanted in (b)(6) 2021.On (b)(6) 2022, during follow up, it was discovered that the venous outflow component had migrated out of the right atrium and is causing stenosis.The entire graft needed to be explanted.

• Brand Name: HERO®
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 13636548
• MDR Text Key: 286361856
• Report Number: 1721504-2022-00023
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450386521
• UDI-Public: 00884450386521
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K172637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: 00884450386521
• Device Catalogue Number: HERO1001VOC/A
• Device Lot Number: H2257524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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; Hospitalization