MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO; PROSTHESIS, VASCULAR GRAFT

Model Number 00884450385685

Device Problems Material Separation (1562); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

Event Description

The account reports that the dialysis graft was successfully placed on (b)(6) 2019; in (b)(6) 2021, they found that the device tore and migrated to the ivc, and is lodged in the hip/pelvis area.Removal of the device is pending.

• Brand Name: HERO
• Type of Device: PROSTHESIS, VASCULAR 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: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12747436
• MDR Text Key: 280008665
• Report Number: 1721504-2021-00079
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450385685
• UDI-Public: 00884450385685
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450385685
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HERO 1003