MAUDE Adverse Event Report: VERYAN MEDICAL LTD 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 Codes	Pain (1994); Restenosis (4576)
Date of Event	12/27/2022
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 the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent (a 6.0 x 80mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal segment in the left leg.A retrograde approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen in the clinic on 27-dec-22 for follow-up review.The patient reported that she had developed pain in her feet with very short distance claudication.It started first on the left leg and then shortly after similar symptoms followed in the right leg.Duplex ultrasound (dus) on the 27-dec-22 showed a 50-75% stenosis in inflow to the bm3d stent and >50% stenosis in the med segment of the bm3d stent.There was also 50-75% stenosis of the left middle popliteal segment.The left common femororal artery (cfa), proximal sfa and middle sfa showed <50% stenosis.The ankle brachial index (abi) on the left was measured at 0.33 and on the right it was measured at 0.48.A left leg angiogram on 03-jan-23 was used to treat the affected segments.Laser atherectomy and pta of the left sfa middle third to proximal popliteal segment.This was reported as a target lesion revascularisation (tlr)/target vessel revascularisation (tvr).There was also pta conducted on the left popliteal artery above the knee (a separate lesion from the thrombosed stent).Following pta, a small area of dissection was noted proximally.There was brisk flow of contrast reported through the treated areas including the stent.The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and 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 effects of restenosis leading to intervention and claudication are 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 the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen in the clinic on (b)(6) 2022 for follow-up review.The patient reported that she had developed pain in her feet with very short distance claudication.It started first on the left leg and then shortly after similar symptoms followed in the right leg.Duplex ultrasound (dus) on the (b)(6) 2022 showed a 50-75% stenosis in inflow to the bm3d stent and >50% stenosis in the med segment of the bm3d stent.There was also 50-75% stenosis of the left middle popliteal segment.The left common femororal artery (cfa), proximal sfa and middle sfa showed <50% stenosis.The ankle brachial index (abi) on the left was measured at 0.33 and on the right it was measured at 0.48.A left leg angiogram on 03-jan-23 was used to treat the affected segments.Laser atherectomy and pta of the left sfa middle third to proximal popliteal segment.This was reported as a target lesion revascularisation (tlr)/target vessel revascularisation (tvr).There was also pta conducted on the left popliteal artery above the knee (a separate lesion from the thrombosed stent).Following pta, a small area of dissection was noted proximally.There was brisk flow of contrast reported through the treated areas including the stent.The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and 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 effects of restenosis leading to intervention and claudication are 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.

• 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: 16264066
• Report Number: 3011632150-2023-00009
• Device Sequence Number: 19877230
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)230812(11)220111(10)0000128351
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/12/2023

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: 08/12/2023
• Device Model Number: 142122-06
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000128351
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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: 85 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White