MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HERO SUPER HERO; VASCULAR GRAFT

Catalog Number HERO1000

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

Patient Problem Bacterial Infection (1735)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.

Event Description

The account reports the hero graft was infected resulting in bacterial sepsis with vegetation around the catheter.The patient had the hero placed (b)(6) 2017.During a follow up visit the patient presented with signs of infection.The patient was treated with antibiotics and the hero was explanted on (b)(6) 2017.

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 was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: HERO SUPER HERO
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 94095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 94095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 94095 ; 8012531600
• MDR Report Key: 6835721
• MDR Text Key: 84269709
• Report Number: 1721504-2017-00164
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: HERO1000
• Device Lot Number: H1028856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• 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): Life Threatening; Required Intervention