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

Model Number	142122-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	11/15/2022
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 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
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 60mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third in the right leg.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon, cutting balloon and shockwave treatments.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen at clinic, reporting aching in her right foot intermittently while walking, but it was also bilaterally with the right leg worse than the left leg.Pain was not debilitating and did not interfere with activities of daily living.The patient had peripheral arterial disease rutherford class iv/v with rest pain/wound possibly of musculoskeletal etiology as the pain was exacerbated with pressure.There was a new wound on the lateral aspect of the patient's right hallux which was drained.The right foot was warm with intact motor function.The patient's previous imaging demonstrated multilevel flow-limiting disease with abnormal ankle brachial indexes (abis) and absent right toe pressures and severely limited left toe pressures.It was unlikely that the patient would heal appropriately due to her absent right toe pressures.A repeat revascularisation was recommended.The event of restenosis was reported as not related to the device and not related to the procedure but due to intercurrent intervention/worsening pre-existing condition.It was reported as target lesion related.The intervention on (b)(6) 2022 involved non bm3d stent placement, pta and laser atherectomy of the sfa middle third to distal popliteal.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The patient outcome was reported as continuing and the device remains implanted.This event was reviewed by veryan on 15-mar,2023 and considered possibly related to the device.
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/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
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 60mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third in the right leg.An antegrade approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon, cutting balloon and shockwave treatments.The treated segment was also post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen at the clinic, reporting aching in her right foot intermittently while walking, but it was also bilaterally with the right leg worse than the left leg.Pain was not debilitating and did not interfere with activities of daily living.The patient had peripheral arterial disease rutherford class iv/v with rest pain/wound possibly of musculoskeletal etiology as the pain was exacerbated with pressure.There was a new wound on the lateral aspect of the patient's right hallux which was drained.The right foot was warm with intact motor function.The patient's previous imaging demonstrated multilevel flow-limiting disease with abnormal ankle brachial indexes (abis) and absent right toe pressures and severely limited left toe pressures.It was unlikely that the patient would heal appropriately due to her absent right toe pressures.A repeat revascularisation was recommended.The event of restenosis was reported as not related to the device and not related to the procedure but due to intercurrent intervention/worsening pre-existing condition.It was reported as target lesion related.The intervention on (b)(6) 2022 involved non-bm3d stent placement, pta and laser atherectomy of the sfa middle third to distal popliteal.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.This event was reviewed by veryan on 15-mar-23 and considered possibly related to the device.The patient outcome update was received on 03-jan-24.

• 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: 16733122
• Report Number: 3011632150-2023-00050
• Device Sequence Number: 6862240
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)230605(11)211104(10)0000118074
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/31/2024

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: 06/05/2023
• Device Model Number: 142122-02
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000118074
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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: ATORVASTATIN; CILOSTAZOL (PLETAL)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American