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

Catalog Number HERO1001VOC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

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 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.

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.
• Type of Device: PROSTHESIS, VASCULAR GRAFT,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11852454
• MDR Text Key: 251727070
• Report Number: 1721504-2021-00031
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450329559
• UDI-Public: 884450329559
• Combination Product (y/n): N
• PMA/PMN Number: K172637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HERO1001VOC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention