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

Model Number 142122-03

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.If any additional information becomes avaialble a mdr supplemental report will be submitted.

Event Description

On (b)(6) 2023, a biomimics 3d 7.0 x 60mm stent (bm3d) was implanted in the right distal superficial femoral artery (sfa) using a 300cm.014" grand slam guide wire.The lesion was pre-dilated with a 7.0 x 60mm shockwave balloon and a 7.0 x 60mm lutonix drug coated balloon (dcb).The bm3d stent deployed without issue.The stent was post-dilated with 7.0 x 60mm ultraverse balloon, and it was reported that the bm3d stent fractured at both the proximal and distal ends.The physician had difficulty recrossing the fractured stent and used a.035" j-shaped guide wire to get through the damaged stent in order to deploy a 7.0 x 80mm bm3d stent which was implanted to tack down the fractured stent.There was no impact to the patient.

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.A review of the angiographic images confirmed the level of calcification and 99% stenosis of the target lesion.The images taken post-deployment showed that the bm3d stent pattern appeared in good condition and a clear stent fracture could not be identified.The images taken post-dilation of the bm3d stent showed multiple expansions using the 7 x 60 mm bard ultraverse pta balloon, with an expansion in the distal portion of the stent and further balloon expansion being done in the proximal portion of the stent.A stent pattern distortion was seen in the angiographic images following the balloon angioplasty but the presence of a stent fracture was not observed, due to lack of image resolution.In order to get a clear understanding of the difference in pattern orientation between these points, an image comparison was carried out.This review noted that the stent location had moved downward, and the orientation of both end crowns had been significantly changed as a result of the balloon angioplasty performed by the physician.The review of the angiographic images in this case has determined that the bm3d stent pattern was in good condition upon deployment but became distorted in the 8 minutes in which the physician performed post-dilation following stent deployment.The investigation did note slight downward distortion of the biomimics 3d stent pattern which potentially was the result of movement of a post-dilation balloon while at full expansion.The investigation has determined that this stent pattern distortion occurred during the post-dilation performed by the user, and thus the user is the potential root cause of the complaint.However, the manner in which the stent pattern distortion was caused by the user cannot be fully established.Therefore, the investigation also considers the 7x60 mm bard ultraverse pta balloon a potential root cause of the complaint although the pta balloon size aligns with the guidance given in the ifu.There was difficulty reported while crossing the deployed bm3d stent.The ifu states "caution: use caution when crossing a deployed stent with any ancillary device." a 0.014" asahi grandslam guidewire was used and was the same wire which was used in stent deployment.The ifu states "the biomimics 3d stent is mounted on a 6f over-the-wire stent delivery system (sds) for use with a 0.035" guidewire" and this is also reflected in table 1 'patient preparation and stent system selection'.The use of a 0.014" sized guidewire potentially caused the difficulty noted in crossing the complaint stent following its deployment, as once a 0.035" j-shaped wire was used the stent was crossed without issue.The complaint investigation was categorised as "distorted stent pattern" with cause categories of "user" and "ancillary device" assigned.The reported complaint was not related to a deficiency of the device.

Event Description

On (b)(6) 2023, a physician intended to treat the right distal superficial femoral artery (sfa) of a patient using 7 x 60mm biomimics 3d (bm3d) device.The patient's vessel anatomy was described as having moderate calcification and a 99% stenotic lesion at the target site.A contralateral approach was taken, using a 65cm 6 fr terumo destination guidewire and a 0.014" asahi grandslam guidewire.The target vessel was prepared with balloon angioplasty via a 7 x 60 mm shockwave device, and drug coated balloon (dcb) via 7 x 60 mm and 7 x 40 mm lutonix devices.The device was flushed as per the instruction for use (ifu), and then introduced into the patient and advanced to the target site.The physician removed any slack from the system and deployment of the stent was initiated while holding the proximal pin luer in a fixed position.There were no issues while the stent was being deployed.The physician elected to post-dilate the stent, however there was difficulty in crossing the 7 x 60 mm complaint stent.The physician switched guidewires from a 0.014" guidewire to a 0.035" j-shaped guidewire.The stent was crossed with a 7 x 60mm bard ultraverse percutaneous transluminal angioplasty (pta) balloon.Multiple balloon expansions were performed, after which the physician identified a potential stent fracture at both the distal and proximal ends of the stent.It was clarified that no movement of the balloon device occurred at any point while at full expansion, and no ancillary devices contacted the stent in a manner that could have caused damage.It was reported that a type 2 stent fracture had occurred, which implied multiple single strut fractures.The physician then deployed a 7 x 80 mm bm3d device into the confines of the complaint stent.No issues were reported in the deployment of the additional stent.Post-dilation was performed with a 7 x 80 mm bard ultraverse pta balloon.The impact on the patient in this case was a prolonged procedure.Feedback was given that the patient had brisk flow across the target site upon completing the procedure, and no adverse impacts occurred due to the events of the procedure.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; 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: 17115801
• MDR Text Key: 317759994
• Report Number: 3011632150-2023-00070
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)240511(11)221011(10)0000177221
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: 142122-03
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000177221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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