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

Model Number 144700-19

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

On the (b)(6) 2022, veryan received a report of a procedure where a biomimics 3d (bm3d) stent 7 x 150mm was deployed in a patient's right superficial femoral artery (sfa) via the anterior tibial artery access.The stent deployed successfully however the physician reported that the stent appeared to have a shorter /compressed deployed length identified on post dilating the stent with a 150mm plain old balloon angioplasty (poba) where the balloon extended past the shoulders of the stent.It is reported that the physician may have pushed/pulled the delivery system during initial deployment rather than keeping the proximal luer hub in a fixed position however this still needs to be confirmed.The physician reported that the lesion appeared to be covered and no further action was necessary.The physician was curious to know if foreshortening occurs and as per the ifu a stent of this length has a typical deployment length within the reference vessel diameter of between 143 and 152 mm.However, the length of the deployed stent in the vessel is not known.The complaint investigation is in progress and any additional information received will be provided on an mdr supplemental follow-up report.

Manufacturer Narrative

The complaint investigation is in progress.Any additional information received will be provided in an mdr supplemental/follow-up report.

Event Description

On the (b)(6) 2022, veryan received a report of a procedure where a biomimics 3d (bm3d) stent 7 x 150mm was deployed in a patient's right superficial femoral artery (sfa) via the anterior tibial artery access.The stent deployed successfully however the physician reported that the stent appeared to have a shorter /compressed deployed length identified on post dilating the stent with a 150mm plain old balloon angioplasty (poba) where the balloon extended past the shoulders of the stent.It is reported that the physician may have pushed/pulled the delivery system during initial deployment rather than keeping the proximal luer hub in a fixed position however this still needs to be confirmed.The physician reported that the lesion appeared to be covered and no further action was necessary.The physician was curious to know if foreshortening occurs and as per the ifu a stent of this length has a typical deployment length within the reference vessel diameter of between 143 and 152 mm.However, the length of the deployed stent in the vessel is not known.There was no impact to the patient and 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.The complaint investigation consisted of : 1) communication/interviews: information obtained by the investigation team identified the following additional details: on the (b)(6) 2022, the physician attempted to treat a lesion in the right sfa with a 7x150 mm biomimics 3d (bm3d) stent.Pedal access was used, and the condition of the target vessel was described as without vessel occlusion.Vessel preparation was done using rotablator atherectomy and angioplasty.A 0.014" command guidewire was used.The delivery system was flushed in accordance with the ifu.There were no complications when advancing the 7x150 mm bm3d stent to the target site.Notable resistance was felt during deployment of the stent, but ultimately the stent was deployed successfully without issue.Upon completing the deployment of the bm3d device, the physician elected to post dilate the stent using a 6x150 mm medtronic balloon angioplasty device.It was noticed that the 6x150 mm balloon extended past both ends of the 7x150 mm bm3d stent.It was at this point the physician came to his perception that the bm3d stent had been foreshortened during deployment.However, the lesion appeared to be fully covered and no further actions were deemed necessary.There was no impact on the patient as a result of this complaint.The device was not returned for this investigation and the original angiographic images were not made available as the procedure was done using ivus.2) review of imaging received: the image received by the investigation team were not the procedural angiographic image files but was taken via smartphone and provided for investigation.Based on the review of the images provided by the site, it can be seen that the bm3d stent had deployed successfully, however it could not be determined if the stent had experienced stent foreshortening.3) review of in process data: a review of the in-process functional test data for the deployment length testing of this lot was carried out and revealed that the data show that the lot deployed length was within the range as outlined in the ifu.4) determinations/conclusions: the investigation determined that although there was notable resistance experienced during the attempted deployment, the physician continued with the deployment despite the information in the ifu which highlights that the delivery system should be carefully withdrawn without deploying the stent in such cases.Based on the review of the complaint image, the length of the stent in the deployed state could not be confirmed and the presence of stent foreshortening could also not be confirmed.The ifu states in table 2 that the typical deployed length of a 150 mm bm3d stent can be within the range of 143 - 152 mm.The feedback from the physician noted that the 6x150 mm balloon extended past both ends of the 7x150 mm bm3d stent.Based on the 143 - 152 mm range of anticipated 150 mm length bm3d stent deployment, a 150 mm length balloon extending past both ends of the device does not indicate the presence of foreshortening.Therefore, stent foreshortening cannot be confirmed as present in this complaint case based on the balloon angioplasty device length.Information provided during the investigation indicates that the physician may have moved the proximal pin luer during deployment.The intended technique would be to "initiate stent deployment by holding the luer hub of the inner shaft in a fixed position and retract the outer sheath over the inner shaft".Figure 5 of the ifu is provided to the physician as instruction.Veryan is aware that an unfixed pin luer during deployment can potentially lead to stent foreshortening, as the pin and pull device is not designed to accommodate movement during deployment.The complaint was categorised as unknown- no issues found, with an unknown cause category assigned.If any additional information is made 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 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: 14987679
• MDR Text Key: 304612816
• Report Number: 3011632150-2022-00050
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850527
• UDI-Public: (01)05391526850527(17)221230(11)210531(10)0000091472
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2022
• Device Model Number: 144700-19
• Device Catalogue Number: 144700-19
• Device Lot Number: 0000091472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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