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

Catalog Number 142122-02

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

Patient Problems Pain (1994); Restenosis (4576); Swelling/ Edema (4577)

Event Date 06/29/2023

Event Type  Injury  

Event Description

This is related to mdr number 3011632150-2023-00146.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents.A 5.0 x 125 mm bm3d stent and a 6.0 x 60 mm bm3d (the subject of this report) stent.They were used to treat a denovo lesion in the superficial femoral artery (sfa) middle third to sfa distal third artery in the left leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was post-dilated with pta.On the (b)(6) 2023, an event of restenosis of treated segment (target lesion) was identified.It was site reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient attended the office on (b)(6) 2023 complaining of significant swelling and pain in her left leg (target leg).She had a left leg extremity (lle) angiogram on (b)(6) 2023 which showed that the entire sfa that had previously been stented had significant stenosis throughout the entire region.The proximal popliteal segment also showed some evidence of the disease in the native segment but beyond this, the popliteal artery appeared otherwise normal.The common femoral artery also showed moderate stenosis and the distal common femoral artery, the entire stented region of the sfa and the proximal popliteal artery were treated with pta / standard balloon angioplasty.Completion arteriography showed an excellent result with brisk flow through all the treated sections.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The patient outcome was reported as resolved/recovered and the devices remain implanted.

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00146.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 effects of restenosis leading to intervention, leg/pain/claudication, swelling/oedema (as ischemia) are 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.

• 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: 18496827
• MDR Text Key: 332694957
• Report Number: 3011632150-2023-00147
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)221007(11)210308(10)0000076760
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000076760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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: ASPIRIN.; CILOSTAZOL (PLETAL).; CLOPIDOGREL (PLAVIX).
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White