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

Catalog Number HERO1001

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/02/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The user reported that during a scheduled follow-up appointment, the venous outflow component was found to have sheard off a few inches from the connecting hub.The physician retrieved the component with a snare through the patient's femoral vein.A new device was not placed.

Manufacturer Narrative

One device has been returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause was undetermined.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.

Event Description

Additional information received alleged that the venous outflow component [voc] had migrated to the patient's heart a few days after implantation.All other information remains consistent per the original mdr.

Manufacturer Narrative

Additional information received identified the lot number of the suspect device and a concomitant device.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Type of Device: HERO GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6281428
• MDR Text Key: 65895540
• Report Number: 1721504-2017-00030
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 01/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HERO1001
• Device Lot Number: HL4VC52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• 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