MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC HERO VENOUS OUTFLOW COMPONENT

Catalog Number HERO1001

Device Problem Occlusion Within Device (1423)

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Pulmonary Infarction (2021); Right Ventricular Dysfunction (2054)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint data base could not be reviewed since the lot number was not provided.

Event Description

The physician alleged that the patient presented with a pulmonary embolism caused by the hero device.The physician stated that the pulmonary embolism was considered life threatening and may have caused permanent damage to the patients body function or impairment of the patient's body structure.Iv heparin and coumadin drips were started during the procedure for anticoagulation.The physician states that the pulmonary embolism was large enough to cause pulmonary infarction, arrhythmia, pulmonary hypertension and right heart failure.A temporary dialysis catheter was placed following the venous outflow component removal.The physician states that the patient required prolongation of hospitalization and currently suffers from end stage renal disease.The hero device was implanted in (b)(6) 2016 and was explanted in (b)(6) 2017.The patient has clinically improved as of today.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Type of Device: HERO
• 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: casey hughes ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6335914
• MDR Text Key: 67579405
• Report Number: 1721504-2017-00035
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• 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: 01/25/2017

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
• Device Operator: Physician
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/16/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention