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

Model Number	142122-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	01/27/2022
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 of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 worsening claudication and restenosis leading to intervention is 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.
Event or Problem Description
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021 to treat a denovo occlusion in the sfa distal third of the left leg.An event of restenosis of treated segment (target lesion) was originally reported to veryan on 25 feb 2022 as "definitely related" to the device.It was reported as target lesion related.It was identified on (b)(6) 2022 when the patient presented for an ultrasound due to experiencing worsening claudication.The outcome of the event is reported as resolved/recovered.The device remains implanted.
Additional Manufacturer Narrative
This related to mdr number 3011632150-2022-00012.Section d4 is being corrected to updated the udi number from (b)(4) to (b)(4).
Additional Manufacturer Narrative
On 12 april 2022, the site updated the device relationship from "definitely related" to "not related" and was reported as related to a worsening of pre-existing condition.Section b.5.Has been updated to reflect this information.
Event or Problem Description
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021 to treat a denovo occlusion in the sfa distal third of the left leg.An event of restenosis of treated segment (target lesion) was originally reported to veryan as "not related" to the device but related to a worsening of the patient's pre-existing condition.It was reported as target lesion related.It was identified on (b)(6) 2022 when the patient presented for an ultrasound due to experiencing worsening claudication.The outcome of the event is reported as resolved/recovered.The device remains implanted.
Additional Manufacturer Narrative
Section b.3.The date of onset for this event was the 27-jan-22 and it has been corrected from the previously reported 27-feb-22.The description in section b.5.Has been updated to correct the leg treated which was the right leg.The details of the intervention have also been added to section b.5.Section b.7.Has been updated to include history of hypertension.
Event or Problem Description
There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on 24-may-21 to treat a denovo lesion in the sfa distal third of the right leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilation with percutaneous transluminal angioplasty (pta) balloon.The treated segment was also post-dilated with pta.An event of restenosis of treated segment (target lesion) was reported to veryan as "not related" to the device or procedure but related to a worsening of the patient's pre-existing condition.It was reported as target lesion related.It was identified on 27-jan-22 when the patient presented for an ultrasound due to experiencing worsening claudication.The angiogram was conducted on the 15-feb-22 and the restenosis was treated with pta/standard balloon angioplasty of the sfa proximal third to distal third segment.It was reported as a target lesion revascularisation/target vessel revascularisation (tlr/tvr).The outcome of the event is reported as resolved/recovered.The device remains implanted.

• 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: 13868033
• Report Number: 3011632150-2022-00012
• Device Sequence Number: 4666136
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)220715(11)201214(10)0000063196
• 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,Followup,Followup
• Report Date (Section B): 02/15/2023

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: 07/15/2022
• Device Model Number: 142122-02
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000063196
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 03/25/2022; 04/13/2022; 02/07/2023
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/28/2022; 05/12/2022; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White