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

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

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Heart Failure (2206); Injury (2348)

Event Date 02/06/2019

Event Type  Injury  

Event Description

Reporter called to report on behalf of her son.Reporter stated her son had a hero graft placed on (b)(6) 2019, and during placement the device punched a hole in his heart.Reporter said her son ended up coding and requiring open heart surgery.Reporter stated that her son has remained in heart failure since the procedure and is now unable to receive a kidney transplant because of the damage to his heart.Reporter stated that anytime he goes under anesthesia his pressure drops.Reporter also said that her son is currently now experiencing hypertension.

• Brand Name: HERO GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREAT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 9934346
• MDR Text Key: 187066813
• Report Number: MW5094075
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR