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

Catalog Number 142122-06

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of occlusion leading to intervention is listed in the biomimics 3d instructions for use and is a known patient effect 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

The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon, atherectomy and cutting balloon.The treated segment was post-dilated with pta.The site identified an occlusion on (b)(6) 2023.It was reported as possibly related to the device and possibly related to the procedure.It was target lesion related.Duplex ultrasound (dus) was performed (b)(6) 2023 and an angiogram was performed on (b)(6) 2023.The outcome was reported as continuing but the occlusion was subsequently treated on (b)(6) 2023 with a non bm3d bare metal stent and pta/standard balloon angioplasty were used.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022 the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, atherectomy and cutting balloon.The treated segment was post-dilated with pta.The site identified an occlusion on (b)(6) 2023.It was reported as possibly related to the device and possibly related to the procedure.It was target lesion related.Duplex ultrasound (dus) was performed on (b)(6) 2023 and an angiogram was performed on (b)(6) 2023.The occlusion was subsequently treated on (b)(6) 2023 where a non-bm3d bare metal stent and pta/standard balloon angioplasty were used to treat the sfa distal third to the posterior tibial proximal third segment.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.Updated information was received on 14-dec-23 on the the lesion type treated at index, the patient outcome, and the intervention details.

Manufacturer Narrative

There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of occlusion leading to intervention is listed in the biomimics 3d instructions for use and is a known patient effect 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.Sections b.5., g.6.And h.10.Have been updated.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, atherectomy and cutting balloon.The treated segment was post-dilated with pta.The site identified an occlusion on (b)(6) 2023.It was reported as possibly related to the device and not related to the procedure.It was target lesion related.Duplex ultrasound (dus) was performed on (b)(6) 2023 and an angiogram was performed on (b)(6) 2023.The occlusion was subsequently treated on (b)(6) 2023 where a non-bm3d bare metal stent and pta/standard balloon angioplasty were used to treat the sfa distal third to the posterior tibial proximal third segment.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.Updated information was received on 21-mar-24 where the site updated the procedure relationship from possibly related to not related.

Manufacturer Narrative

There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of occlusion leading to intervention is listed in the biomimics 3d instructions for use and is a known patient effect 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.Section b.5.Reflects the additional information received, g.6.And h.2.Reflect the type of report submitted (follow-up 02) and the reason and section h.11.Reflects the sections of the report updated.

• 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: 17594298
• MDR Text Key: 321623980
• Report Number: 3011632150-2023-00109
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05291526850428
• UDI-Public: (01)05291526850428(17)230211(11)210713(10)0000096641
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000096641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 03/21/2024
• Supplement Dates FDA Received: 01/11/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Treatment: CLOPIDOGREL (PLAVIX)
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White