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

Model Number	142122-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00044.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/leg pain 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
This is related to mdr report number 3011632150-2023-00044.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 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third segment in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2023, a restenosis of treated segment (target lesion) was identified.The patient attended clinic complaining of recurrent claudication symptoms in the left leg.An ultrasound revealed that the stent had critical stenoses in several areas with slow flow.The patient returned for an angiogram of the left leg on (b)(6) 2023.The examination showed multiple areas of high grade in-stent restenosis of 80% to 90% in the proximal segment of the sfa stent.The midportion of the stent appeared widely patent.The segment of the stent in the above-the-knee popliteal artery showed severe in-stent restenosis.The stenotic areas including the sfa middle third to proximal popliteal segment were treated with laser atherectomy and low pressure pta/standard balloon angioplasty was with a prolonged inflation of a 6.0 x 240mm.The arteriogram showed brisk flow through the entire treated area with no evidence of residual stenoses and nicely preserved distal outflow.The entire stented area appeared patent with no significant flow limiting lesions or other complications.It was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The treated segment related to this event included a second 6.0 x 125mm bm3d stent (the subject of this report) placed as part of an earlier restenosis treatment on (b)(6) 2022 in the sfa middle third to proximal popliteal segment.The patient outcome was reported as resolved/recovered and the devices remain implanted.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00044.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/leg pain 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
This is related to mdr report number 3011632150-2023-00044.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022 the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third segment in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The patient was also implanted with a non-study 6.0 x 125 mm bm3d stent (the subject of this report) placed as part of an earlier restenosis treatment on (b)(6) 2022 in the sfa middle third to proximal popliteal segment.The site reported that on (b)(6) 2023 a restenosis of treated segment (target lesion) was identified.The patient attended clinic complaining of recurrent claudication symptoms in the left leg.An ultrasound revealed that the stent had critical stenoses in several areas with slow flow.The patient returned for an angiogram of the left leg on (b)(6) 2023.The examination showed multiple areas of high-grade in-stent restenosis of 80% to 90% in the proximal segment of the sfa stent.The midportion of the stent appeared widely patent.The segment of the stent in the above-the-knee popliteal artery showed severe in-stent restenosis.The stenotic areas including the sfa middle third to proximal popliteal segment were treated with laser atherectomy and low-pressure pta/standard balloon angioplasty was with a prolonged inflation of a 6.0 x 240mm.The arteriogram showed brisk flow through the entire treated area with no evidence of residual stenoses and nicely preserved distal outflow.The entire stented area appeared patent with no significant flow limiting lesions or other complications.It was reported as possibly related to the device and not related to the procedure.It was reported as target lesion-related.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as resolved/recovered and the devices remain implanted.Additional information reviewed on 15-apr-24 included the clinical events committee (cec) determination that this event of restenosis was not related to the study device implanted.This event was the second restenosis that had occurred in that stent and required a tlr intervention and as a result, this event was determined to be due to the progression of the patient's underlying disease.The first restenosis event in the study stent was reported in mdr 3011632150-2022-00116.This was the first restenosis of the non-study stent and the event was still considered possibly related to this device.

• 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: 16644583
• Report Number: 3011632150-2023-00045
• Device Sequence Number: 17693119
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)230929(11)220228(10)0000136622
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: 142122-14
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000136622
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White