MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO®; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 00884450386514

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that a patient diagnosed with central venous stenosis died in the icu post procedure.The procedure was the implantation of a prosthetic vascular graft.During insertion, the device was became stuck when inserting in the peel-away sheath.A new peel-away sheath was tested and the graft was stuck again and could not be released.The patient's blood pressure started to fall.Resuscitation was required, the patient's heartbeat returned after an electric shock, and the operation was stopped.The patient was transferred to icu and received a blood transfusion.Cause of death is unknown.

Manufacturer Narrative

The suspect medical 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.Should the device be returned later, the investigation will be reopened.

• Brand Name: HERO®
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: 17205222
• MDR Text Key: 317899049
• Report Number: 1721504-2023-00058
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450386514
• UDI-Public: 00884450386514
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K172637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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: Health Professional
• Device Expiration Date: 12/21/2023
• Device Model Number: 00884450386514
• Device Catalogue Number: HERO1000/C
• Device Lot Number: H2293069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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
• Patient Age: 41 YR
• Patient Sex: Male