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

Catalog Number	142122-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994); Skin Discoloration (2074); Discomfort (2330); Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Date of Event	05/03/2022
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 occlusion leading to intervention, leg pain/claudication, ischemia are 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
The patient was treated as part of the mimics 3d usa post-market observational study.On 26-may-21, the patient was implanted with one 6.0 x 60 mm biomimics 3d (bm3d) stent, which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal in the left leg.A retrograde approach was used and the lesion was prepared using predilation with drug coated/eluting balloon pre-stent placement and atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta).On 03-may-22, an occlusion was identified by the site.It was reported as definitely related to the device and not related to the procedure.It was target lesion related.At the patient's 12-month duplex ultrasound (dus) on 03-may-22, it showed moderate in-stent stenosis of proximal left sfa and severe in-stent stenosis of distal left sfa.The patient routinely experienced discoloration, swelling, itching and discomfort that can also be related to her venous issues and had a history of deep vein thrombosis (dvt) in this leg.The patient's claudication increased from rutherford 1 to 3 between 03-may-22 and 08-may-23.Of note, the patient was diagnosed with acute myeloid leukemia in december 2023 and began treatment, which resulted in severe thrombocytopenia.Due to this, dual antiplatelet therapy (dapt) was paused at the beginning in february 2023.Dus on 20-jun-23 found that the left mid sfa and distal sfa were occluded.The percutaneous intervention was delayed many times due to inability to restart dapt.The intervention was performed on 04-jun-24.At that time the entire sfa was found to be occluded.Laser atherectomy, thrombectomy and drug coated/eluting balloon (dcb/deb) were performed throughout sfa proximal third to sfa distal third leaving no residual stenosis.It was reported as a target lesion/vessel revascularisation (tlr/tvr).At the time of the patient's study exit on 20-jun-24, dapt still has not been resumed.The outcome was reported as resolved/recovered.The device remains implanted.The date of awareness of this event was the 24-aug-23, but additional details received by veryan on 20-jun-24 made this event reportable.

• 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: 19770301
• Report Number: 3011632150-2024-00038
• Device Sequence Number: 15634682
• 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: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

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: 07/15/2022
• 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: 06/20/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; BRILINTA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White