MAUDE Adverse Event Report: VERYAN MEDICAL BIOMIMICS 3D VASCULAR STENT SYSTEM

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A biomimics 3d (bm3d) stent would not fully deploy after the outer sheath was completely retracted.This is the third time the same physician has experienced this since using the bm3d system.The device details and details of the event have not yet been provided.Mdr reports 3011632150-2024-00010 and 3011632150-2024-00012 are related to these two previous occurrences.

Manufacturer Narrative

The investigation is in progress.Any additional information will be provided in a follow-up supplemental.

Manufacturer Narrative

The investigation is in progress.Any additional information will be provided in a follow-up supplemental.Section b.5.Was updated with additional information received.Section g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and the reason and section h.11.Was updated to reflect the sections changed in this report.

Event Description

A biomimics 3d (bm3d) stent would not fully deploy after the outer sheath was completely retracted.The device details and details of the event have not yet been provided.The physician has been using the bm3d device for the last three years.This is the third time the same physician has experienced this since using the bm3d system.Additional information was received on 28-mar-24 and it was confirmed that this partial deployment event was a separate occurrence to the events reported on 21-feb-24 related to mdr reports 3011632150-2024-00010 and 3011632150-2024-00012.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 18912277
• MDR Text Key: 337763640
• Report Number: 3011632150-2024-00011
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other