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

Model Number	00884450386521
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Heart Failure/Congestive Heart Failure (4446)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
Upon conducting a maude database query, the following event was discovered: a reporter stated that during a graft placement the device migrated.The reporter alleges that the migration caused cardiac tissue damage, resuscitation, and additional surgery.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: HERO
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11364875
• Report Number: 1721504-2021-00013
• Device Sequence Number: 2660663
• Product Code: DSY
• UDI-Device Identifier: 00884450386521
• UDI-Public: 00884450386521
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 00884450386521
• Device Catalogue Number: HERO1001VOC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention