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

Catalog Number HERO1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Embolism (1829)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.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 post-hemodialysis access graft implant, the patient suffered from a pulmonary embolism [pe].The patient presented to a hospital located in (b)(6) with a clotted graft and a tunneled dialysis catheter already in place.The patient was experiencing pulmonary embolism [pe] symptoms that led to cardiac arrest and successful revival during hospitalization.The patient is stable and doing well.The course of action that was taken was to remove the tunneled dialysis catheter.The physician believes that the pe was caused by the hemodialysis access graft.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Type of Device: HERO GRAFT
• 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: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8531368
• MDR Text Key: 142483760
• Report Number: 1721504-2019-00025
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/19/2019
• 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