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

Model Number 00884450386521

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

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.

Event Description

The account alleges that during an angiogam the hero graft appeared hazy with possible clot or cracking.During surgery the hero was confirmed to be cracked, and a revision of the hero graft was performed.The new graft is reported as working appropriately.No patient injury to report.

• 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: 10820161
• MDR Text Key: 216204255
• Report Number: 1721504-2020-00096
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450386521
• UDI-Public: 00884450386521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450386521
• Device Catalogue Number: HERO1001/C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• 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