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

Catalog Number HERO1001

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Death (1802)

Event Date 12/22/2016

Event Type  Death  

Manufacturer Narrative

A search of the complaint data base was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exceptions documents were found.The complaint is unconfirmed.If the product happens to return a follow up will be submitted when the full evaluation is complete.

Event Description

The physician reports that a surfacer inside-out access device was used on the patient to get a wire across occlusions in the right brachiocephalic and internal jugular veins prior to attempting a hero venous outflow component implant procedure.The physician had a difficult time delivering the surfacer device and crossing the occlusion.Immediately after completion of the surfacer system deployment procedure and removal of the device, the patient showed hemodynamic instability and continued to do so throughout maneuvers to implant the hero device.A cardio-thoracic surgeon was consulted and an emergency sternotomy was performed.Despite a good surgical repair of a 2 cm linear tear in the svc junction to the innominate, the patient never regained spontaneous circulation and expired.The physician indicated his impression of the patient's death was caused by trauma to the central veins from the combination of the surfacer system delivery instrument and subsequent dilation of the tract created by the surfacer system delivery instrument.The physician noted that the patients body habitus (severe obesity) and venous tortuosity may also be contributing factors.No device malfunction was reported.

Manufacturer Narrative

No product has returned for investigation.Several requests have been made to obtain the autopsy report without success.No product malfunction is suspected for either device involved in the incident based on information obtained.If new information becomes available a follow up report will be submitted at that time.

• Brand Name: HERO VASCULAR 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: 6227317
• MDR Text Key: 64009050
• Report Number: 1721504-2017-00008
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 12/22/2016

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 Expiration Date: 03/23/2018
• Device Catalogue Number: HERO1001
• Device Lot Number: H16VC006
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2016
• 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): Death; Life Threatening; Required Intervention
• Patient Weight: 124