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

Model Number 144700-12

Device Problems Deformation Due to Compressive Stress (2889); No Apparent Adverse Event (3189); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record revealed no issues associated with the lot that were deemed related to the issue under investigation.The investigation is in progress and any additional information received will be submitted as an mdr supplemental report.

Event Description

On (b)(6) 2023, a biomimics 3d (bm3d) 6.0 x 150mm device was being used during a superficial femoral artery (sfa) to popliteal (pop) artery intervention via the right anterior tibial artery.A 6 french (6f) terumo slender access sheath was used and the sfa/pop segment was treated with a 1.5 classic crown cardiovascular systems inc.(csi) atherectomy.The lesion was dilated with a 5 x 200 mm percutaneous transluminal angioplasty (pta) balloon.The bm3d device was advanced without difficulty to target deployment area over a.014" guidewire.Upon finishing the stent deployment, the physician noted that the stent had foreshortened by 20 to 30 mm.The stent covered the dissection that needed to be treated, so no additional steps were required.There was no patient impact.The device remains implanted.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots showed no issues that were deemed related to the complaint investigation.Angiographic imaging was provided.The images showed the patient's anatomy included high-grade disease throughout the sfa and popliteal arteries.The sfa before dilation with balloon angioplasty and after dilation was reviewed.The high-grade disease in the proximal sfa did not receive preparation with balloon angioplasty.It was noted that while the balloon angioplasty was at full pressure, there was not full expansion in the vessel which was a result of the severe calcification present in the vessel.There were images of the bm3d stent post deployment.Residual disease was observed above the stent, within the stent and below the stent.The distal end crown of the stent was prevented from fully expanding due to the residual disease in the vessel.The angiographic images were reviewed to allow a determination of any stent foreshortening.It was considered that the known length of the 5 x 200 mm pta balloon could be used as a comparison against the deployed length of the complaint bm3d stent to allow an estimation of any stent foreshortening.Two of the images were selected as they represented the same region of the sfa to allow an accurate estimated comparison of the deployed stent length.The deployed stent was estimated to have a length of 114 mm.The typical deployed length of a 150 mm bm3d stent can be within the range of 143 - 152 mm.In this case, the angiographic images reviewed suggested that the bm3d stent was not within the expected range of deployed length for 150 mm long stents.Therefore, the investigation concluded that stent foreshortening occurred in this case.There were no angiographic images provided of the stent deployment during the procedure, therefore it was not possible to determine if any other factors may have contributed to the observed foreshortening.The site clarified that the proximal pin luer was held in a fixed position during deployment and that excess slack was removed from the system before initiation of deployment, therefore a cause for the foreshortening in this case cannot be established.The complaint was categorised as "stent compression" with an "unknown" cause category assigned.Sections b.5., g.3.,g.6., h.2., h.6., and h.10 have been updated.

Event Description

On (b)(6) 2023, a physician attempted to treat chronic total occlusion in the superficial femoral artery (sfa) and popliteal arteries in the right leg with a 6 x 150 mm biomimics 3d (bm3d) device.A pedal approach was taken.The target vessel was described as significantly calcified, with total occlusion present in the sfa.Prior to implantation, the vessel was treated using atherectomy and balloon angioplasty.The delivery system was flushed in accordance with the instructions for use (ifu), and then it was introduced into the patient.The device was advanced to the target site without difficulty using a 6f terumo slender access sheath and a 0.014" command guidewire.When in position at the target site, the physician removed slack from the delivery system and then initiated deployment.There were no issues with deployment of the stent or removal of the delivery system.It was initially reported that the proximal pin luer of the delivery system was moved forward during the deployment of the stent but was subsequently confirmed by the reporter that the proximal pin luer was held in a fixed position during deployment.Post-dilation was performed following implantation.After the stent had been deployed, the physician identified potential stent foreshortening, noting the device had foreshortened by approximately 20 - 30mm.Despite the foreshortening the stent still covered the target lesion, so no further action was required.There was no patient impact.The device remains implanted.

• 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
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 16538782
• MDR Text Key: 311255350
• Report Number: 3011632150-2023-00035
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)240113(11)220614(10)0000154240
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000154240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Female