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

Model Number 144700-19

Device Problems Fracture (1260); Material Separation (1562); Activation Failure (3270)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, during implantation of a biomimics 3d 7 x 150mm stent (bm3d), using a contralateral approach via a 65cm terumo sheath, the stent reportedly got stuck in the deployment shaft during deployment.About one centimetre (1 cm) of the stent broke off and remained in the vessel.The physician reports that the event is related to the device.The physician reported that there were no issues crossing the lesion and the bm3d system was prepared as per the instructions for use.The physician was able to continue the procedure by deploying another stent in the superficial femoral artery (sfa) and jailed the portion of stent that had remained from the first device.The patient was then discharged to home from the hospital.There was no patient impact reported.The device is being returned to veryan for evaluation.

Manufacturer Narrative

The complaint investigation is in progress.The device history record associated with this lot was reviewed and revealed no issues that were deemed related to the event reported.Once the investigation is concluded or if any additional information is made available a supplemental will be provided.Any blank fields in this report are fields which we have no information on at this present time.

Manufacturer Narrative

The investigation on this complaint has been finalised.A detailed review of all the lot history records relating to the relevant stent and delivery system lots identified no issues that were deemed related to the complaint investigation.The device was returned for evaluation.The reported separation of the outer braid to bifurcation hub was observed, and there was also kinking in the proximal end of the outer braid which was most likely due to the way the device was packaged for return.Close inspection of the proximal end of the outer braid and glue port on the bifurcation hub indicated that the device was manufactured as intended.The outer braid was measured and was within the range for the specification length for the catheter.There was 50mm of stroke length remaining in the delivery system of the returned device.The in-process test data for deployment force testing was reviewed and confirmed that this lot had passed and was considered manufactured as intended for stent deployment fractured stent struts were observed protruding from the distal end of the outer braid.The distal end of the device was also examined and a tear was noted in the radiopaque marker and outer braid.The complaints team attempted to deploy the stent, but the damaged stent crowns caused the guidewire lumen to kink.The whole stent was deployed with little resistance.During the case, it was reported that following the deployment attempt, the bifurcation hub to outer braid bond had been separated.This separation was confirmed in the returned device investigation.Separation of the outer braid to bifurcation hub bond suggests that a significantly high deployment force was present.Difficult anatomical conditions (including diseased vessel and occlusions) can create increased friction between the delivery system components, and between the delivery system and guide/introducer sheath during the stent deployment.It was reported that resistance was experienced upon initiation of deployment and continued deployment was attempted which resulted in roughly 1cm of the stent being released.The ifu states that "if unexpected resistance is felt at the start of the deployment, do not force the movement of the bifurcation luer; instead, carefully withdraw the sds without deploying the stent." it was reported that the target vessel had severe calcification, which is the most likely cause of the resistance noted during deployment in this case, which in turn resulted in elongation and separation of the outer braid to bifurcation hub bond.Angiographic images were not provided; without the angiographic images, the degree of vessel calcification cannot be fully established.The complaint was categorised as a "partial deployment" and a cause category of "user" was assigned.

Event Description

On the (b)(6) 2022, the physician attempted to deploy a 7.0 x 150mm biomimics 3d (bm3d) stent to treat a lesion in the mid superficial femoral artery (sfa).The lesion was described as severely calcified and there was diffuse disease throughout the leg.A contralateral approach was used with a 0.035" glide advantage guidewire, with a 6 french (fr) terumo access sheath.The target site was prepared using laser atherectomy and balloon angioplasty.The device was flushed in accordance with the instructions for use (ifu).There was no resistance reported during the advancement of the delivery system to the target site.During the physician's attempt to deploy the stent, resistance was experienced.The attempt at deployment was continued and 1cm of the stent was released from the outer braid.The physician noticed that the device began to curl under the tension of the deployment attempt, and the bifurcation hub reached the proximal luer but no additional stent had deployed.The physician then tried to deploy the stent by manipulating the device, however no further deployment could be achieved.The physician removed the device and while doing so discovered that the outer braid to bifurcation hub bond had separated.There was resistance experienced during removal of the device.The device removal resulted in fracture of the 1cm portion of the stent that had released from the outer braid during the deployment attempt.A second bm3d device was used and there was also resistance experienced during the initiation of deployment but the stent deployed successfully.The patient was then discharged to home from the hospital.There was no patient impact reported.

• 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, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16033433
• MDR Text Key: 306173412
• Report Number: 3011632150-2022-00129
• Device Sequence Number: 1
• Product Code: NIP
• 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: 03/01/2023

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: 09/01/2023
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000129505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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): Required Intervention