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

Model Number	142122-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated as part of the (b)(6) study on (b)(6) 2021 to treat a restenotic lesion in the sfa proximal third of the right leg.An event of restenosis of the treated segment (target lesion) was identified on (b)(6) 2021.It was reported as not related to the device or procedure but due to a worsening of the patient condition.Doppler ultrasound on (b)(6) 2021 showed severe stenosis of right sfa stents.A target lesion revascularisation (tlr) was conducted on the (b)(6) 2021 and involved bare metal stent, drug coated balloon/drug eluting balloon (dcb/deb) and laser atherectomy.The stent was placed in mid sfa (outside of target lesion).The outcome of the event is reported as resolved/recovered.The device remains implanted.
Additional Manufacturer Narrative
There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 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
There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 is listed in the biomimics 3d instructions for use and are known patient effects of peripheral stenting procedures.Section b.5.Has been updated with additional information received.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 to treat a restenotic lesion in the sfa proximal third of the right leg.A retrograde approach was used and the lesion was prepared using standard balloon angioplasty and atherectomy.The lesion was post dilated with a drug coated balloon.An event of restenosis of the treated segment (target lesion) was identified on (b)(6) 2021.It was reported as "not related" to the device or procedure but due to a worsening of the patient condition.The device relationship was later updated to "possibly related" to the device on (b)(6) 2022.Doppler ultrasound on (b)(6) 2121 showed severe stenosis of right sfa stents.A target lesion revascularisation (tlr) was conducted on (b)(6) 2021 and involved bare metal stent, drug coated balloon/drug eluting balloon (dcb/deb) and laser atherectomy.The stent was placed in mid sfa (outside of target lesion).The outcome of the event is reported as resolved/recovered.The device remains implanted.
Additional Manufacturer Narrative
There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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.Sections b.3., b.5, b.7., d.3., d.4., d.10, e.1., g.1., g.6., h.6.And h.10.Have been updated.
Event or Problem Description
The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.A 6.0 x 125 mm biomimics 3d stent (bm3d) was used to treat a restenotic lesion in the superficial femoral artery (sfa) proximal third of the right leg.A retrograde approach was used and the lesion was prepared using percutaneous transluminal angioplasty (pta) balloon and atherectomy.The lesion was post-dilated with a drug coated/eluting balloon (dcb/deb).An event of restenosis of the treated segment (target lesion) was identified on (b)(6) 2021.It was reported as "possibly related" to the device and not related to the procedure.It was target lesion related duplex ultrasound (dus) on (b)(6) 2021 showed severe stenosis in the right proximal sfa.The patient was experiencing rutherford class (rc) 3 symptoms.Angiographic findings included severe stenosis in the right proximal sfa stent, and mild restenosis of the mid/distal sfa stent.Between the two stents was severe diffuse stenosis.The popliteal artery had moderate stenosis.An intervention was performed on (b)(6) 2021.Laser atherectomy was performed throughout the sfa and popliteal artery.Dcb/deb of the sfa performed, followed by stenting of the mid sfa with 6.0 x 80 mm bare metal non bm3d stent.The stent was post-dilated with plain old balloon catheter (pobc)/pta/standard balloon angioplasty.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The outcome was reported as resolved/recovered.The device remains implanted.

• 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: 14561083
• Report Number: 3011632150-2022-00025
• Device Sequence Number: 17663651
• Product Code: NIP
• UDI-Device Identifier: 05391526850480
• UDI-Public: (01)05391526850480(17)220329(11)200828(10)0000050212
• 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): 09/22/2023

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: 03/29/2022
• Device Model Number: 142122-14
• Device Catalogue Number: 142122-14
• Device Lot Number: 0000050212
• 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: 08/30/2022; 08/25/2023
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 09/27/2022; 09/22/2023
• Date Device Manufactured: 08/28/2020
• 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; BRILLINTA; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN IV; HEPARIN IV; HEPARIN IV
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White