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

Catalog Number 131816-05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

There was no reported device malfunction and the device was not returned for analysis.The investigation is ongoing.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of aneurysm is listed in the biomimics 3d instructions for use and are known patient effects of peripheral stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture or labelling of the device.If further information regarding this event becomes available, a follow-up report will be submitted.

Event Description

On the (b)(6) 2022 a veryan representative was made aware of a patient who experienced an aneurysm at the stented segment following implantation with a biomimics 3d stent in the sfa distal to proximal popliteal artery.The index procedure involved treatment of a total occlusion that required subintimal crossing.The date of the index procedure and the duration of time between the index procedure and the aneurysm event has not yet been provided.The investigation into this is ongoing.Any new or updated information will be provided in a follow-up report.The device remains implanted.The patient outcome is unknown at this time.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system could not be performed as the lot details were not provided by the reporting clinical site despite repeated requests (3) from the complaints investigation team.The investigation included communication/interviews with the veryan representative who originally reported the information, and repeated requests made to the clinical site for additional information on the reported complaint.There were no angiographic images provided.To date no additional information has been received.A root cause of the reported aneurysm cannot be determined as there is insufficient information available.It is not possible to establish if the aneurysm event is related to the implanted stent based on the information available.The complaint was categorised as "unknown, insufficient information" and a root cause category of "unknown" was assigned.It could not be established if the complaint is related to a deficiency of the device.Any additional information provided will be provided in a follow-up report.Section h.6.Adverse event coding has been updated to reflect the findings and conclusion of the investigation.

Event Description

On 02-mar-22 a veryan representative in germany was made aware of a patient who was implanted with three biomimics 3d (bm3d) stents in the left leg (two 5.0 x 80mm stents and one 5.0 x 150mm stent) on (b)(6) 2021 using a contralateral approach.The patient was treated for a long chronic total occlusion (cto) of the superficial femoral artery (sfa) and high grade restenosis of the popliteal artery and tractus tibiofibularis in the left leg.Several different guide catheters and wires were used during the procedure.The treated segment was pre-dilated with a 2,0 - 6,0mm plain old balloon angioplasty (poba).One of the bm3d 5.0 x 80mm stents was placed in the proximal sfa and the other 5.0 x 80mm stent was placed in the proximal popliteal.There was also a 5.0 x 150mm stent placed in the distal sfa.Drug eluting balloon (deb) treatment was used in between the stented segments as well as the tractus vessel.A cutting balloon treatment was also conducted on the sfa ostial segment.The procedure involved sub-intimal crossing at the proximal sfa of the occlusion with an outback device in order to facilitate re-entry from the subintimal space back into the true lumen.The physician reported a good result.There was no evidence of infection or aneurysm prior to the bm3d stents deployment.On (b)(6) 2021, the day after the implantation procedure, the patient is reported as having presented to the hospital, where an aneurysm in the popliteal stented segment around the 5.0 x 80mm device (which this mdr report relates) was identified via duplex ultrasound.The patient outcome is described as good and has no symptoms.No treatment was required as there are no symptoms and the patient is observed every 3 months.There is no reported device malfunction or deficiency associated with the devices implanted and they remain implanted.

Manufacturer Narrative

A detailed review of the device history record associated with this lot revealed no issues that were deemed related to this reported event.There has been additional detailed provided on the event from the physician including the details of the device that were implanted.Any additional information received will be provided in a follow-up supplemental report.

Manufacturer Narrative

Following submission of mdr supplemental report 3011632150-2022-00014_02 a review of the imaging provided by the hospital site was made.The images were taken during the ultrasound examination on (b)(6) 2021 and show the popliteal vessel.The images highlight the presence of the reported aneurysm and the biomimics 3d stent (bm3d) is no longer opposing the vessel wall.The stent is patent as blood flow can be observed through this stented region.Veryan's chief medical officer commented that the aneurysm that developed was detected a day after the procedure, meaning that it is not due to the stent or drug coated balloon (dcb) but almost certainly due to the subintimal recanalization used during the procedure on (b)(6) 2021.Aneurysm formation has been associated with subintimal recanalization in the sfa [1].Taking these findings from literature and input from veryan's chief medical officer, the most likely root cause of the aneurysm formation is the subintimal crossing method used during the procedure.The complaint was categorised as "aneurysm" with a root cause assigned of "subintimal recanalisation".Reference [1] : l.M.Palena et al.,feasibility and 1-year outcomes of subintimal revascularization with supera ® stenting of long femoropopliteal occlusions in critical limb ischemia: the "supersub study', catheter.Cardiovasc.Interv., vol.89, no.5, pp.910-920, apr.2017, doi: 10.1002/ccd.26863.

• 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: 13892483
• MDR Text Key: 287848289
• Report Number: 3011632150-2022-00014
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850039
• UDI-Public: (01)05391526850039(17)230123(11)210624(10)0000095199
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 131816-05
• Device Lot Number: 0000095199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Female