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

Catalog Number SUPERHERO/EU

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/20/2023

Event Type  Injury  

Event Description

The account alleges that during a venous outflow component (voc) graft placement on (b)(6) 2023, the graft was inserted into the patient's internal jugular [ij] vein.The clinical team failed to acquire hemostasis following insertion, so the voc was removed.Both physicians involved [ir physician and surgeon] are indeed experienced in voc insertion procedures.General anesthesia was used for this procedure.Balloon dilatation was used prior to sheath placement, and prior to the excessive blood loss event.Excessive bleeding was noted around the sheath area following placement.The interventional radiologist and surgeon both attempted to minimize the blood loss for approximately 3-4 hours.Additional ballooning techniques to control the blood loss were attempted under fluoroscopy.The patient was temporarily stable for a time but, further surgical intervention was necessary as the patient continued to hemorrhage.A head and neck surgeon was consulted and assisted with blood loss techniques.Blood transfusions were started during the procedure and continued post-procedure.On tue (b)(6) 2023, the patient required further cardiothoracic surgical intervention.The patient expired in the evening of (b)(6) 2023.The actual cause of death is unknown.There is no product malfunction alleged with relation to this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

• 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: 18212394
• MDR Text Key: 329044420
• Report Number: 1721504-2023-00088
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450564325
• UDI-Public: 00884450564325
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K213845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: SUPERHERO/EU
• Device Lot Number: H2740963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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