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); Embolus (1830); Thrombus (2101)

Event Date 10/19/2016

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 states that the patients hero device has occluded multiple times in the past with intermittent hypotension.The hero device was removed from the patient and the patient started having pes.The physician states that the patients explant was easy, only 10ml of lidocaine was needed for this patient.The hero device slid out of the patient with very little effort and soft fresh thrombus was pulled from the lumen of the outflow device.The patient has had avf/grafts that have clotted as well in the past.The physician is convinced that the clotted hero device is the source of this patients pulmonary embolisms.The physician states that a clotted hero device could be life threatening.Multiple attempts to de-clot the hero device has been made.Pe's were confirmed with ct pulmonary angiography [ctpa].A new hero device was not placed in this patient.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and no defects could be identified.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: 6115130
• MDR Text Key: 60413167
• Report Number: 1721504-2016-00221
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• 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?: 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): Life Threatening; Required Intervention