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

Catalog Number	HERO1001VOC
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device will not be returning for an evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.
Event or Problem Description
The account alleges that a female patient was experiencing clotting issues within a venous outflow component [voc] device implanted approximately 3 years ago.During a thrombectomy procedure within the voc, under fluoroscopy, a split was identified under fluoroscopy when the device was torqued at a certain angle within the patient's anatomy.The de-clot procedure was successful however, the physician was concerned that the damaged voc was no longer viable for use.The device could no longer perform it essential function or provide the necessary therapy for the patient.It is unknown as to what caused the damage to the voc.A new device was placed for this patient.The device is not returning for investigation.
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 review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: HERO.VENOUS OUTFLOW COMPONENT.
• Common Device Name: PROSTHESIS, VASCULAR GRAFT,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11852454
• Report Number: 1721504-2021-00031
• Device Sequence Number: 14383601
• Product Code: DSY
• UDI-Device Identifier: 00884450329559
• UDI-Public: 884450329559
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: HERO1001VOC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention