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

Model Number	142122-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This mdr is related to 3011632150-2022-00029.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with two biomimics-3d stents (a 7.0 x 150mm and a 7.0 x 125mm) to treat a denovo lesion of the sfa proximal third to sfa middle third of the right leg.A retrograde approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty.Atherectomy was also performed pre-stent placement.On (b)(6) 2022, an event of occlusion was reported from the site.It was reported as "not related" to the device or procedure but to a worsening of the pre-existing condition.It was reported as target lesion related.It was identified at 12-month ultrasound but an angiogram on (b)(6) 2022 showed occlusion of the proximal to middle segment of the biomimics stent.The site is considering surgical versus percutaneous intervention.The event is reported as serious.The patient outcome is described as "continuing".The device remains implanted.On review of the event by veryan, it was determined to be possibly related to the device due to the target lesion relationship.
Additional Manufacturer Narrative
This mdr is related to 3011632150-2022-00029.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 is 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.
Additional Manufacturer Narrative
This mdr is related to 3011632150-2022-00029.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 occlusion is 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
This mdr is related to 3011632150-2022-00029.The patient was treated as part of the mimics 3d usa post-market observational study.The patient was implanted with two biomimics-3d stents (a 7.0 x 150mm and a 7.0 x 125mm (the subject of this report)) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to sfa middle third of the right leg.A retrograde approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta) balloon.Atherectomy was also performed pre-stent placement to prepare the target site.On (b)(6) 2022, an event of occlusion was reported from the site.It was reported as "not related" to the device or procedure but to a worsening of the pre-existing condition.It was reported as target lesion related.It was identified at 12-month duplex ultrasound (dus) but an angiogram on (b)(6) 2022 showed occlusion of the proximal to middle sfa segment of the biomimics stent.The site evaluated the patient for femoropopliteal bypass on (b)(6) 2022 but they were not considered a good candidate.As of the (b)(6) 2023, the patient was being managed medically and was considered stable.The event is reported as not serious.The patient outcome is described as "continuing".The device remains implanted.On review of the event by veryan initially, it was determined to be possibly related to the device due to the target lesion relationship.
Additional Manufacturer Narrative
This mdr is related to 3011632150-2022-00029.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 occlusion is 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.Section b.5.Was updated with the additional information received from the site, d.3 was updated to reflect the block 5 address, d.10.Was updated to remove aspirin as the patient was not taking this at the time of the event., g.1.Was updated to reflect the block 5 address, g.6.And h.11.Have been updated to reflect the type of report (follow-up 02) and the sections updated via this report.
Event or Problem Description
This mdr is related to 3011632150-2022-00029.The patient was treated as part of the mimics 3d usa post-market observational study.The patient was implanted with two biomimics-3d stents (a 7.0 x 150mm and a 7.0 x 125mm (the subject of this report)) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to sfa middle third of the right leg.A retrograde approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty (pta) balloon.Atherectomy was also performed pre-stent placement to prepare the target site.On (b)(6) 2022, an event of occlusion was reported from the site.It was reported as "not related" to the device or procedure but to a worsening of the pre-existing condition.It was reported as target lesion related.It was identified at 12-month duplex ultrasound (dus) but an angiogram on (b)(6) 2022 showed occlusion of the proximal to middle sfa segment of the biomimics stent.The site evaluated the patient for femoropopliteal bypass on (b)(6) 2022 but they were not considered a good candidate.As of the (b)(6) 2023, the patient was being managed medically and was considered stable.At the patient's 36-month follow-up on (b)(6) 2024, no further evaluation was performed.The patient's symptoms are stable and they do not wish to proceed with any further interventions at this time.The event is reported as not serious.The patient outcome is described as "continuing".The device remains implanted.On review of the event by veryan initially, it was determined to be possibly related to the device due to the target lesion relationship.Veryan received additional information on this event on 05-feb-24.The site provided the additional information that the patient's symptoms remain stable following the patient's 36-month follow-up.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIIMICS 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: 14562384
• Report Number: 3011632150-2022-00030
• Device Sequence Number: 20104262
• Product Code: NIP
• UDI-Device Identifier: 05391526850497
• UDI-Public: (01)05391526850497(17)220417(11)200916(10)0000052115
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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: 04/17/2022
• Device Model Number: 142122-15
• Device Catalogue Number: 142122-15
• Device Lot Number: 0000052115
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 02/10/2023; 02/05/2024
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 03/10/2023; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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); CLOPIDOGREL (PLAVIX); ELIQUIS; HEPARIN IV; HEPARIN IV; XARELTO; XARELTO; XARELTO
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 187 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White