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

Device Problem Difficult or Delayed Activation (2577)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation was completed on 09-sept-22.It involved the following: communication/interviews: multiple attempts (3) were made to obtain additional information from the complaint site but to date, no response has been received.The date of the initial deployment, information on the biomimics 3d device, procedural information, and patient information are unknown.Summary/investigation determination: the complaint description states a physician found a biomimics 3d device stiff to deploy.It also states there were no adverse events and no patient injury as a result of the stiff deployment.Following the investigation, no further information could be obtained from the complaint site.Therefore, it cannot be established if the complaint is related to the device.The complaint was categorised as "unknown, insufficient information" and a cause category of "unknown" was assigned.If any additional information becomes available a mdr supplemental follow-up will be submitted.

Event Description

On 22-jul-22 a veryan sales representative was notified via veryan's uk distributor that a physician from pinderfields hospital made a comment that he found the biomimics 3d device stiff to deploy in general.The comments were general and were not related to any device failure.There was no patient impact reported and no devices were returned for evaluation.There were no device specific details provided in the course of the investigation.There was no patient impact reported and no consequences to the patient or user based on the information received.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 15556164
• MDR Text Key: 306702218
• Report Number: 3011632150-2022-00093
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• 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: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other