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 06/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician alleges that the patient had a clotted hero venous outflow component [voc].The graft had been implanted over a year ago.After taking the first few angiograms of the hero graft, the physician realized that the venous outflow component had detached from the connector and was sitting in the patient's inferior vena cava [ivc] with the proximal end in the patient's right atrium [ra].The voc was successfully removed with a vascular snare device.The patients graft was found to be patent and still viable.The physician is planning on implanting a new voc device this thursday, (b)(6) 2017.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint is unconfirmed 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, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6660066
• MDR Text Key: 78174561
• Report Number: 1721504-2017-00137
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• 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