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

Model Number 144700-12

Device Problems Difficult or Delayed Activation (2577); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint investigation is ongoing.The device is returning for evaluation.Any additional information which veryan become aware of will be provided in a supplemental follow-up report.

Event Description

On 02-jun-2022 a company representative was made aware that during a procedure to implant a biomimics device, following pre-treatment of the target lesion with laser atherectomy and plain old balloon angioplasty (poba) the biomimics 3d device was advanced using a pedal access approach.The physician reported that there were no difficulties during advancement of the delivery system to the target site.The physician reported that the device was difficult to deploy and he felt like he was forcing it.As per the directions in the ifu the device was removed and another one was used in its place.The second device deployed successfully and the physician was impressed with the results but he felt that the first stent shouldn't have been as difficult to deploy.The device is returning for evaluation as part of the complaint investigation which is ongoing.

Event Description

On (b)(6) 2022 a company representative was made aware that during a procedure to implant a biomimics 3d (bm3d) device, following pre-treatment of the target lesion in the mid superficial femoral artery (sfa) with laser atherectomy and plain old balloon angioplasty (poba) the bm3d device was advanced using a pedal access approach.A 0.014" guidewire with a 6 fr access sheath despite information provided by the veryan representative that a 0.035" guidewire is indicated for use with bm3d.There was mild disease in the anterior tibial artery through which the device was advanced on approach to the target site.The physician reported that there were no difficulties during advancement of the delivery system to the target site.The physician reported that the device was difficult to deploy and he felt like he was forcing it.The complaint device was removed when resistance was experienced by the physician which is in accordance with the instructions for use (ifu).Following additional vessel preparation after removal of the complaint device, a second bm3d device was deployed successfully using the same access sheath and guidewire but with less resistance at initiation of deployment reported compared to the first device.The investigation has now been completed.

Manufacturer Narrative

The complaint investigation has been completed a summary of the investigation is provided.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.Additional information was received from the reporter and section b.5 has been updated.Following removal of the complaint device, the physician deployed the stent on a benchtop.The stent deployed without issue.The returned complaint delivery system was evaluated by the complaints investigation team.It had very little cast and the deployed stent was also returned confirming the benchtop deployment reported by the physician.There was no damage to the system.A kink in the proximal end aligned with the support shaft and was probably due to the way the device was packaged for return at the site.There were no issues of friction noted by the investigation team.There was no outer braid elongation.The bonds were intact.There was no damage observed to the device or to the deployed stent.The device tested satisfactorily and is not considered to be the root cause of the event.The investigation determined that the degree of vessel preparation used prior to insertion of the first bm3d system may have contributed to the resistance that the physician experienced during the attempted deployment.The anterior tibial artery was reported as having mild disease which may also have contributed to the resistance possibly causing friction between delivery system components as well as between the system and the guidewire/access sheath.However, without the angiographic images of the case, the vessel conditions cannot be confirmed.The complaint was categorised as "unable to deploy" with a cause category assigned as "unknown" and "vessel preparation".Sections b.5., d.9, and h.6.Have been aligned with the conclusions of the investigation.

• 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 city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 14877485
• MDR Text Key: 302778282
• Report Number: 3011632150-2022-00039
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)230224(11)210726(10)0000099528
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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: 02/24/2023
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000099528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• 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