MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HERO ARTERIAL GRAFT COMPONENT

Catalog Number HERO1002

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A review of the complaint database and device history record could not be performed since the lot number was not provided.

Event Description

The account alleges that the patient's hemodialysis graft has thrombosed.Serpiginous thrombi was noted to be collecting on the end of the venous outflow component and is showering the lungs with emboli.The physician stated that the thrombi could be seen swaying in the patient's right atrium during an echocardiogram.The device was removed from the patient.

• Brand Name: HERO ARTERIAL GRAFT COMPONENT
• Type of Device: ARTERIAL GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan 84095
• MDR Report Key: 6799594
• MDR Text Key: 82858596
• Report Number: 1721504-2017-00160
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HERO1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention