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

Model Number 144700-05

Device Problems Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577); Malposition of Device (2616); Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

This report is related to mdr number: 3011632150-2021-00031.The device was not returned for evaluation.The complaint investigation is ongoing.When further information regarding this event becomes available, or the investigation is concluded a follow-up/supplemental report will be submitted.

Event Description

This mdr report is related to mdr number 3011632150-2021-00031.The procedure in question involved the implantation of two 150mm biomimics 3d stents to treat a long target lesion from the distal superficial femoral artery (sfa) to popliteal artery.Following stent delivery system (sds) preparation, the sds was tracked over the iliac bifurcation to the proximal popliteal artery using a 6fr x 45cm flexor ansel 1 curve ancillary sheath over a 0.014" guidewire.There was severe vessel tortuosity and a tight bifurcation angle.A cross-over approach was used, and it was reported that no resistance was felt during the approach of the device to the target site.Upon initiation of deployment, the physician experienced resistance and at first was unable to retract the outer braid.The sds was slightly retracted to remove slack and the tuohy borst was unlocked.The physician made several attempts to continue the deployment, and used significant force throughout the deployment procedure to get the stent to release.The physician also needed to pause and reposition the device at the target site between deployment attempts.The first stent implanted (a 5 x 150mm stent) was positioned slightly more proximal to the intended position.The second stent (6 x 150mm stent) was then deployed with a slight overlap proximally to the first stent and resistance was also reported but successful deployment was achieved after a small number of attempts.There is no reported patient impact and both stents remain implanted.

Manufacturer Narrative

This mdr number is related to 3011632150-2021-00031.The device history review was completed.There were no issues identified that could have contributed to the reported complaint.The lot met the relevant in-process monitoring acceptance criteria.The coding has also been updated to reflect completion of this investigation.There were no devices returned for evaluation and no angiographic imaging returned despite multiple requests made by veryan's complaint investigators.The conclusions are based on the information provided in the initially reported complaint as well as descriptions provided by the veryan representative which included his suggestions to the implanting physician during the procedure and the results of the complaint investigation.Although the physician reported significant resistance during the deployment of both stents, the complaint investigation concluded that this is likely to be related to the severely tortuous patient anatomy and a tight bifurcation angle.These types of anatomical conditions can lead to higher deployment forces due to the likelihood of friction created between components of the biomimics 3d delivery system (e.G.Outer braid and inner assembly) as well as between the ancillary devices used with the biomimics 3d system (e.G.Guidewire/introducer sheath).The updated information still highlights that a number of attempts to complete deployment were required which included repositioning the device at the target site.The veryan sales representative confirmed that there was no distortion/misalignment/foreshortening of the first stent.It was implanted slightly proximal to what was intended.There is no indication of a product quality issue with respect to the design, manufacture or labelling of the device.If further information regarding this event becomes available, a follow-up report will be submitted.

• 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, H91 V E0H; EI H91 VE0H
• MDR Report Key: 12180823
• MDR Text Key: 261948839
• Report Number: 3011632150-2021-00030
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850503
• UDI-Public: (01)05391526850503(17)220424(11)200923(10)0000052818
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/24/2022
• Device Model Number: 144700-05
• Device Catalogue Number: 144700-05
• Device Lot Number: 0000052818
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other