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

Catalog Number 145276-12

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.As the stent was deployed successfully, the delivery system has been returned and will be evaluated.As soon as further information regarding this event becomes available a follow-up supplemental form will be provided within 30 days of awareness of this information.

Event Description

On the (b)(6) 2019 a patient was being implanted with a biomimics 3d vascular stent system.The stent deployed successfully however during pullback the outer sheath remained on the handle and the inner sheath remained in the vessel.The implanting physician was able to remove the inner sheath and the patient was unharmed.There was a clinically significant extension in the procedure time.

Manufacturer Narrative

As part of the investigation into this adverse event veryan conducted : 1) analysis of the returned delivery system which included visual assessment,measurements, in process lot release test data review 2) angiography review 3) follow-up communication with reporting physician, dr (b)(6) at (b)(6).The conclusions of the investigation were : 1) that the stent deployed as expected without any issues, 2) the inner peek liner to the inner shaft bond on the delivery system has a design specification of 5n which has been confirmed as appropriate through design verification and validation testing.In-process control testing for this lot confirmed that the units tested exceeded the 5n specification.3) there was elongation of the inner peek liner which occurred during the procedure, which indicates that a tensile event of greater than 5n occurred, to separate the peek liner from the inner shaft.It is possible that such a tensile event and associated elongation of the inner peek liner could have occurred when retracting the delivery system post deployment of the stent.4) the reporting physician reported minimal resistance felt during delivery system pullback following stent placement.The source of the resistance which resulted in the inner peek liner detachment from the rest of the delivery system is unknown.It is possible that the tip of the delivery system may have snagged on the stent during retraction from the vessel post deployment.This could have contributed to the resistance experienced by the physician during retraction.It is also possible that the guide-wire used during deployment of the stent may have lost its lubricity.The terumo guide-wire used has a hydrophilic coating and can loose lubricity and become sticky, creating friction with the inner peek liner, which could also be a reason for the resistance felt by the physician and detachment of the inner peek liner from the delivery system.5) the physician stated he was not concerned about this case although it was a little tricky there was no harm to the patient.Following the investigation the complaint was categorised as "detachment of peek inner liner" and the root cause is defined as unknown.It could not be established if the complaint is related to a deficiency of the device.All manufacturing history for this device show that it was manufactured as intended with no issues relevant to this complaint.In addition there have been no other complaints of this nature from sales of over 8000 biomimics 3d vascular stent systems sold to date.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; unit 11 galway technology park; parkmore; galway city, H91 V E0H; EI H91 VE0H
• MDR Report Key: 9320375
• MDR Text Key: 216348777
• Report Number: 3011632150-2019-00111
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 145276-12
• Device Lot Number: 0000007240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention