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 Pulmonary Embolism (1498); Death (1802); Embolus (1830); Thrombus (2101)

Event Date 06/26/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

The physician states that the hero device had clotted off and that a de-clotting procedure was necessary.The patient has had multiple thrombosed av fistulas in the past and was stable until the voc device was withdrawn about 5cm to reposition.At this stage, the patient had a massive pulmonary embolism.This was confirmed with transesophageal echo and angiogram.Physician suspects that the pulmonary embolus had collected outside the device and by pulling it back the thrombus detached and migrated.The patient was treated directly with thrombolysis while on the table through the voc without good response suggesting this was mature thrombus.Patient has since expired.The patient's cause of death was suspected to be a pulmonary embolism or a possible cardiac related event.

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 and device history record could not be performed 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: 6115137
• MDR Text Key: 60411730
• Report Number: 1721504-2016-00220
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

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: 10/19/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• 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): Death; Life Threatening; Other; Required Intervention