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

Model Number	142122-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/22/2022
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-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 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 the (b)(6) 2021, the patient was implanted with one 5.0 x 100mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal segment in the right leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening of the pre-existing condition.It was reported as target lesion related.There was an in-stent restenosis and short segment occlusions throughout the entire length of the stent.On (b)(6) 2022, the sfa proximal third to the proximal popliteal segment was treated with pta/standard balloon angioplasty and laser atherectomy and the patient underwent an angiogram of the right leg extremity (rle), laser atherectomy of the sfa, angioplasty of the sfa and iliac arteries, as well as stent placement in the rle iliac artery followed by intravascular ultrasound (ivus) of the rle arterial vessels.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.The event was reviewed by veryan on 23-jan-2023 and considered possibly related to the device.
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 5.0 x 100mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal segment in the right leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on 22-apr-22, a restenosis of treated segment (target lesion) was identified.It was reported as not related to the device and not related to the procedure but due to a worsening of the pre-existing condition.It was reported as target lesion-related.There was an in-stent restenosis and short segment occlusions throughout the entire length of the stent.On 13-may-22, the sfa distal third to the proximal popliteal segment was treated with pta/standard balloon angioplasty and laser atherectomy and the patient underwent an angiogram of the right leg extremity (rle), laser atherectomy of the sfa, angioplasty of the sfa and iliac arteries, as well as stent placement in the rle iliac artery followed by intravascular ultrasound (ivus) of the rle arterial vessels.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.The event was reviewed by veryan on 23-jan-23 and considered possibly related to the device.Additional updates provided by the site on 27-feb-24 updated the date of onset from 13-may-22 to 22-apr-22 and the proximal segment treated at the intervention was updated to reflect the sfa distal third.
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.3.Was updated with the date of onset, b.5.Was updated with the date of onset and proximal segment treated, section b.7.Was updated to reflect an updated medical history including cva/tia and coronary artery disease provided by the site, d.3.And g.1.Were updated with veryan's address, section g.6.And h.2.Were updated to reflect the report type (follow-up 01) and reason, and section h.11.Was updated to reflect the sections of the report that were updated.

• 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 ; unit 11 galway technology park; parkmore road; galway, H91VE-0H ; EI H91VE0H
• MDR Report Key: 16403677
• Report Number: 3011632150-2023-00023
• Device Sequence Number: 20178200
• Product Code: NIP
• UDI-Device Identifier: 05391526850442
• UDI-Public: (01)05391526850442(17)220516(11)201015(10)0000054850
• 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): 03/26/2024

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: 05/16/2022
• Device Model Number: 142122-09
• Device Catalogue Number: 142122-09
• Device Lot Number: 0000054850
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 140 KG
• Patient Ethnicity: Hispanic