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

Model Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This mdr report is related to mdr number 3011632150-2022-00096.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2022.The subject was implanted with two biomimics 3d (bm3d) stents (one 6.0 x 60mm stent and one 6 x 100mm stent) to treat a denovo lesion of the sfa proximal third to middle third and sfa middle third to distal third artery in the right leg.A retrograde approach was used and pre- and post-dilatation was conducted with percutaneous transluminal angioplasty (pta) and the lesion was prepared using atherectomy.On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was reported from the site.It was reported as "possibly related" to the device and "not related" to the procedure.It was also reported as target lesion related.The patient attended for an office visit, complaining of recurrent claudication symptoms in her right leg.An ultrasound showed concern for recurrent stenosis within the distal right superficial femoral artery.On (b)(6) 2022, the patient had an angiogram which revealed two areas of critical stenosis at the proximal end of the proximal right sfa stent as well as at the distal end of the distal sfa stent and a critical stenosis in the mid popliteal artery.There was soft thrombus lining the previously placed stents as well as the mid popliteal artery.Laser atherectomy and standard balloon percutaneous transluminal angioplasty (pta) was done on all critical stenoses with good results.Completion imaging revealed wide patency of the sfa and popliteal arteries.The intervention was reported as a target lesion revascularisation.The devices remain implanted.The patient outcome is reported as "resolved/recovered".
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2022-00096.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 claudication/pain and restenosis leading to intervention 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.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2022-00096.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 claudication/pain and restenosis leading to intervention 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.Section b.5.Was updated, section d.10.Was updated to include aspirin, sections d.3.And g.1.Were updated with veryan's site address, sections g.6.And h.2.Were updated with the type of report (follow-up 01) and the reason and section h.11.Reflects the sections changed in this report.
Event or Problem Description
This mdr report is related to mdr number 3011632150-2022-00096.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2022.The subject was implanted with two biomimics 3d (bm3d) stents one 6.0 x 60 mm stent and one 6 x 100 mm stent (the subject of this report) to treat denovo lesions of the sfa proximal third to middle third and sfa middle third to distal third arterial segments in the right leg.A retrograde approach was used and pre- and post-dilation was conducted with percutaneous transluminal angioplasty (pta) and the lesions were prepared using atherectomy.On (b)(6) 2022 a restenosis of treated segment (target lesion) was identified by the site.It was reported as "possibly related" to the device and "not related" to the procedure.It was also reported as target lesion related.The patient attended for an office visit, complaining of recurrent claudication symptoms in her right leg.An ultrasound showed concern for recurrent stenosis within the distal right sfa.On (b)(6) 2022, the patient had an angiogram which revealed two areas of critical stenosis at the proximal end of the proximal right sfa stent as well as at the distal end of the distal sfa stent and a critical stenosis in the mid popliteal artery.There was soft thrombus lining the previously placed stents as well as the mid popliteal artery.Laser atherectomy and standard balloon percutaneous transluminal angioplasty (pta) were done on all critical stenoses with good results.Completion imaging revealed wide patency of the sfa and popliteal arteries.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The devices remain implanted.The patient outcome was reported as "resolved/recovered".Additional information was provided by the site updating the concomitant medication to include aspirin which was started on (b)(6) 2022 and was ongoing at the time of the event.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; 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: 15778233
• Report Number: 3011632150-2022-00097
• Device Sequence Number: 4873712
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)230702(11)211201(10)0000123388
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000123388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White