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

Catalog Number	SUPERHERO/EU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional 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®
• Common Device Name: 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
• Report Number: 1721504-2023-00088
• Device Sequence Number: 15290096
• Product Code: DSY
• UDI-Device Identifier: 00884450564325
• UDI-Public: 00884450564325
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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 Expiration Date: 01/31/2025
• Device Catalogue Number: SUPERHERO/EU
• Device Lot Number: H2740963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown