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

Model Number 00884450320563

Device Problems Material Fragmentation (1261); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

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 hemodialysis reliable outflow graft de-clot procedure on (b)(6) 2021 , the physician noted that a distal part of the voc placed within this patient in 2017 had detached.According to radiology images received from the account, approximately 5cm of the distal voc is free floating within the patient's right ventricle.Intervention will be required for foreign body removal.Patient was admitted and asymptomatic.

Manufacturer Narrative

The suspect device was not returned for evaluation.A photograph was provided by the account but the location of the break or detachment is unclear.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
• 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
• MDR Report Key: 11734906
• MDR Text Key: 251725921
• Report Number: 1721504-2021-00025
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450320563
• UDI-Public: 00884450320563
• Combination Product (y/n): N
• PMA/PMN Number: K172637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450320563
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention