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

Model Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional 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-conformance's 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 restenosis 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 or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent ( 7.0 x 60mm stent) to treat a denovo lesion of the sfa ostial to sfa proximal third artery in the left leg.A contralateral approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta), and atherectomy.On the (b)(6) 2022, an event of restenosis of treated segment target lesion) was reported from the site.It was reported as "not related" to the device and "not related" to the procedure but due to worsening pre-existing condition.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered".It led to a percutaneous intervention on (b)(6) 2022 and it involved balloon angioplasty and laser atherectomy and two stent placements.The device remains implanted.This was reviewed by veryan on (b)(6) 2022 and considered to be possibly related to the device as it led to a target lesion revascularisation.
Additional 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 effects of restenosis leading to intervention and claudication/pain 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.Sections have been updated.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on 29-nov-2021.The patient was implanted with one biomimics 3d (bm3d) stent (7.0 x 60mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) ostial to sfa proximal third artery in the left leg.A contralateral approach was used and the lesion was prepared using percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with pta.On the 10-jun-22, an event of restenosis of treated segment (target lesion) was identified by the site.It was reported as "not related" to the device or procedure but was due to a worsening pre-existing condition.The patient had severe left leg extremity (lle) claudication.An angiogram was performed with bilateral runoff.Intravascular ultrasound (ivus) was conducted and the restenosis of the left sfa was treated on 17-jun-22 with laser atherectomy, pta/standard balloon angioplasty and additional stenting with two non bm3d bare metal stents.The intervention was a target lesion/vessel revascularisation (tlr/tvr).It was also reported as target lesion related.The patient outcome was reported as "resolved/recovered".The device remains implanted.This was reviewed by veryan on 27-jun-22 and considered to be possibly related to the device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: 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: 15108666
• Report Number: 3011632150-2022-00062
• Device Sequence Number: 14500875
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)230312(11)210811(10)0000100307
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/26/2023

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: 03/12/2023
• Device Model Number: 142122-03
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000100307
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic