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

Model Number	142122-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
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 100mm stent) to treat a restenotic lesion of the sfa distal third to proximal popliteal 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 "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 underwent routine duplex ultrasound (dus) on (b)(6) 2021 with follow-up on (b)(6) 2021.He was experiencing recurrent claudication (rutherford grade 4).Dus showed severe in stent restenosis within proximal sfa.Although the patient had stents from proximal to distal sfa prior to enrollment in mimics 3d usa.Diagnostic angio on (b)(6) 2021 showed "multiple high grade stenoses >90%.The p1 segment [portion of target lesion] showed >80% restenosis.It led to a percutaneous intervention on (b)(6) 2021 and it involved a target lesion revascularisation with pta balloon angioplasty, stent placement, cutting balloon, drug coated balloon and laser atherectomy.The device remains implanted.The patient outcome is reported as "resolved/recovered".It was reviewed on (b)(6) 2022 by veryan and considered possibly device related.
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 effects of claudication/pain and restenosis leading to intervention is listed in the biomimics 3d instructions for use and are 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 100mm stent) to treat a restenotic lesion of the sfa distal third to proximal popliteal 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 22, 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.This information was subsequently updated by the site on (b)(6) to "possibly related" to the device.It was also reported as target lesion related.The patient underwent routine duplex ultrasound (dus) on (b)(6) 2021 with follow-up on (b)(6) 2021.He was experiencing recurrent claudication (rutherford grade 4).Dus showed severe in stent restenosis within proximal sfa.Although the patient had stents from proximal to distal sfa prior to enrollment in mimics 3d usa.Diagnostic angio on (b)(6) 2021 showed "multiple high grade stenoses >90%.The p1 segment [portion of target lesion] showed >80% restenosis.It led to a percutaneous intervention on (b)(6) 2021 and it involved a target lesion revascularisation with pta balloon angioplasty, stent placement, cutting balloon, drug coated balloon and laser atherectomy.The device remains implanted.The patient outcome is reported as "resolved/recovered".It was reviewed on (b)(6) 2022 by veryan and considered possibly device related.
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 claudication/pain and restenosis leading to intervention is listed in the biomimics 3d instructions for use and are 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.Section b.5.Has been updated due to additional information received.If further information regarding this event becomes available, a follow-up report will be submitted.
Additional Manufacturer Narrative
This supplemental is to correct the date of the report from 25-aug-22 to the 10-aug-22 in section b.4.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: 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: 15196912
• Report Number: 3011632150-2022-00075
• Device Sequence Number: 16700641
• Product Code: NIP
• UDI-Device Identifier: 05391526850466
• UDI-Public: (01)05391526850466(17)220409(11)200809(10)0000051493
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 09/27/2022

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: 04/09/2022
• Device Model Number: 142122-11
• Device Catalogue Number: 142122-11
• Device Lot Number: 0000051493
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 08/30/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/11/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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); ELIQUIS; HEPARIN IV; HEPARIN IV; HEPARIN IV; HEPARIN IV; HEPARIN IV; HEPARIN IV; XARELTO
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White