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

Model Number	142122-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	09/23/2022
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 patient was implanted with one 6.0 x 80mm biomimics 3d (bm3d) stent.This was used to treat a de novo lesion of the superficial femoral artery (sfa) middle third in the left leg.A contralateral approach was used and the lesion was prepared using standard percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was also post-dilated with pta.It was reported that on (b)(6) 2022, the patient had a duplex ultrasound (dus) which showed a left sfa stent occlusion.A left leg lower extremity (lle) angiogram was performed and laser atherectomy and pta was conducted on (b)(6) 2022 on sfa ostial and sfa distal third in the left leg.It is reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The event outcome was reported as resolved/recovered.The event was reported as "not related" to the bm3d device and "not related" to the study procedure due to a worsening of the patient's pre-existing condition and target lesion related.The event was reviewed by veryan and considered possibly related to the device on (b)(6) 2022.The device remains implanted.
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 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 patient was implanted with one 6.0 x 80mm biomimics 3d (bm3d) stent.This was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third in the left leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was also post-dilated with pta.It was reported that on (b)(6) 2022, the patient had a duplex ultrasound (dus) which showed a left sfa stent occlusion.A left lower extremity (lle) angiogram was performed and laser atherectomy, drug coated balloon/drug eluting balloon (dcb/deb) and pta were conducted on (b)(6) 2022 on sfa ostial and sfa distal third in the left leg.It is reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The event outcome was reported as resolved/recovered.The event was reported as "not related" to the bm3d device and "not related" to the study procedure but due to a worsening of the patient's pre-existing condition and target lesion related.The event was reviewed by veryan and considered possibly related to the device on (b)(6) 2022.The device remains implanted.Additional information was reviewed on 15-apr-24 that included the clinical events committee (cec) adjudication of this event which determined it was not related to the study device as there had been a previous restenosis of the target lesion treated with a tlr which would have manipulated the vessel and therefore this was considered a result of progression of the underlying disease.The previous restenosis was reported in mdr 3011632150-2022-00111.The target lesion was also updated from the sfa middle third to sfa distal third following an update from the site.
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 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.Section b.5.Was updated with additional information, section b.7.Was updated to include that the patient is a current smoker, section e.1.Updated the site address, sections d.3.And g.1.Were updated to reflect veryan's new address, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and reasons and section h.11.Was updated to reflect the sections of this report that have changed.

• 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: 15932837
• Report Number: 3011632150-2022-00110
• Device Sequence Number: 15087030
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)220401(11)200831(10)0000050210
• 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): 05/14/2024

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
• Device Expiration Date: 04/01/2022
• Device Model Number: 142122-06
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000050210
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 185 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White