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

Model Number	142122-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Restenosis (4576)
Date of Event	03/30/2022
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 effect of restenosis/claudication pain 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 (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent (5.0 x 80 mm stent) to treat a denovo lesion of the sfa distal third to proximal popliteal in the right leg.A contralateral approach was used and the target lesion was prepared by pre-dilation of the target lesion with a standard balloon percutaneous transluminal angioplasty and post dilated with pta.On the (b)(6) 2022, an event of restenosis of treated vessel (target vessel) was reported from the site.It was reported as "possibly related" to the device and "definitely related" to the procedure.It was also reported as target lesion related.It led to a percutaneous intervention and it involved a target lesion revascularisation and underwent uncomplicated angioplasty of right superficial artery with drug coated balloon and standard balloon angioplasty.The device remains implanted.The patient outcome is reported as "resolved/recovered".The event was reviewed on (b)(6) 2022 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 11-nov-2021.The subject was implanted with one biomimics 3d (bm3d) stent (5.0 x 80mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal in the right leg.A contralateral approach was used and the target lesion was prepared by pre-dilation of the target lesion with percutaneous transluminal angioplasty (pta) and post dilated with pta.On the (b)(6) 22, an event of restenosis of treated vessel (target vessel) was reported from the site with a date of onset of (b)(6) 22.It was reported as "possibly related" to the device and "definitely related" to the procedure.It was also reported as target lesion related.On (b)(6) 22, the patient was diagnosed with right extremity claudication (1/2 block).It led to a percutaneous intervention on (b)(6) 22, and it involved a drug coated balloon / drug eluting balloon (dcb/deb) and pta/standard balloon angioplasty of the sfa proximal third to distal third arterial segment.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The device remains implanted.The patient outcome is reported as "resolved/recovered".
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/claudication pain 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.Sections b.3., b.5.And d.10.Have been updated.
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, claudication/leg pain and hematoma 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) 2021.The patient was implanted with one biomimics 3d (bm3d) stent (5.0 x 80mm stent) to treat a denovo lesion of the sfa distal third to proximal popliteal in the right leg.A contralateral approach was used and the target lesion was prepared by pre-dilation with percutaneous transluminal angioplasty (pta) and post dilated with pta.On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was identified by the site.The patient's chart was reviewed by the site on (b)(6) 2022 and it showed that the patient had a target vessel revascularisation (tvr) at an external facility on (b)(6) 2022.They were diagnosed with claudication (1/2 block).It was reported as "possibly related" to the device and "definitely related" to the procedure.It was also reported as target lesion related.It led to a percutaneous intervention on (b)(6) 2022.On the sfa proximal third to distal third and it involved uncomplicated angioplasty with drug coated/eluting balloon (dcb/deb) and pta/standard balloon angioplasty.It was reported as a target lesion/vessel revascularisation (tlr/tvr).In the immediate post-operative period, a soft hematoma was noted in left groin and the patient was admitted overnight for monitoring.They were deemed medically stable for discharge on (b)(6) 2022.The device remains implanted.The patient outcome was reported as "resolved/recovered".The event was reviewed on (b)(6) 2022 and considered possibly related to the device.

• 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: 15460719
• Report Number: 3011632150-2022-00088
• Device Sequence Number: 17260370
• Product Code: NIP
• UDI-Device Identifier: 05391526850411
• UDI-Public: (01)05391526850411(17)220523(11)201022(10)0000056144
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/26/2023

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: 05/23/2022
• Device Model Number: 142122-05
• Device Catalogue Number: 142122-05
• Device Lot Number: 0000056144
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 11/18/2022; 06/27/2023
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 12/13/2022; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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: CLOPIDOGREL (PLAVIX); XARELTO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic