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	03/07/2022
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 leading to intervention is listed in the biommics 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 (6.0 x 80mm stent) to treat a denovo lesion of the sfa middle third 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 atherectomy.On the (b)(6) 2022, an event of restenosis of treated vessel (target vessel) was reported from the site.It was reported as "not related" to the device and "not related" to the procedure but due to a worsening pre-existing condition.It was also reported as not target lesion related.On (b)(6) 2022 the site provided an update to the event that highlighted the event led to a percutaneous intervention and it involved a target lesion revascularisation on (b)(6) 2022 with laser atherectomy.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.
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-conformance's 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 bionomics 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 (b)(6) 2021.The subject was implanted with one biomimics 3d (bm3d) stent (6.0 x 80mm stent) to treat a denovo lesion of the sfa middle third in the right leg.A contralateral approach was used and the target lesion was prepared by pre-dilation of the target lesion with a percutaneous transluminal angioplasty/standard balloon angioplasty and atherectomy.An event of restenosis of treated vessel (target vessel) was identified by the site on (b)(6) 2022.It was reported as "not related" to the device and "not related" to the procedure but due to a worsening pre-existing condition.It was also reported as target lesion related.The patient experienced claudication in the right leg extremity (rle) and presented for ultrasound and an angiogram was performed.The event led to a percutaneous intervention and it involved a target lesion revascularisation on (b)(6) 2022 with laser atherectomy and pta/standard balloon angioplasty on the sfa middle third.The device remains implanted.The patient outcome is reported as "resolved/recovered".The event was reviewed on 22-aug-2022 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 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 (b)(6) 2021.The subject was implanted with one 6.0 x 80 mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) middle third in the right leg.A contralateral approach was used and the target lesion was prepared by pre-dilation of the target lesion with a percutaneous transluminal angioplasty (pta) balloon and atherectomy.An event of restenosis of treated segment (target lesion) was identified by the site on 07-mar-22.It was reported as "not related" to the device and "not related" to the procedure but due to a worsening pre-existing condition.It was also reported as target lesion related.The patient experienced claudication in the right leg extremity (rle) and presented for ultrasound and an angiogram was performed.The event led to a percutaneous intervention and it involved a target vessel/lesion revascularisation (tlr/tvr) on 01-apr-22 with laser atherectomy and pta/standard balloon angioplasty on the sfa middle third.The device remains implanted.The patient outcome is reported as "resolved/recovered".The event was reviewed on 22-aug-22 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: 15460707
• Report Number: 3011632150-2022-00087
• Device Sequence Number: 19950405
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)220409(11)200908(10)0000051495
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/13/2023

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: 04/09/2022
• Device Model Number: 142122-06
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000051495
• 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: 06/16/2023; 08/15/2023
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 07/14/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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.; ASPIRIN.; CLOPIDOGREL (PLAVIX).; CLOPIDOGREL (PLAVIX).; HEPARIN.; HEPARIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White