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

Catalog Number HERO1001

Device Problem Material Integrity Problem (2978)

Patient Problem Thrombus (2101)

Event Date 01/22/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return.A follow up will be submitted when the evaluation is complete.

Event Description

The physician alleges that during a follow up appointment the patient presented with a thrombosed hero device.X-rays suggested the venous outflow component was prone to kinking with arm adduction, but open with abduction.In the operating room, the physician removed the venous outflow component and over-sewed the arterial graft inflow.A temporary dialysis catheter was then placed.The physician states that when the explanted venous outflow component was examined, structural wire damage was observed causing it to be prone to kinking during adduction.A new venous outflow component will be placed at a later date.

Manufacturer Narrative

One device was returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was most likely due to the positioning of the venous outflow component within the patients anatomy.A review of the device history and complaint data base could not be reviewed since the lot number was not provided.

• 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: casey hughes ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6335908
• MDR Text Key: 67579821
• Report Number: 1721504-2017-00049
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K134039
• 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,Followup
• Report Date: 01/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention