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

Model Number	144700-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Restenosis (4576)
Date of Event	12/15/2022
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 and claudication/leg pain leading to intervention 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 the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient returned to the clinic on(b)(6) 2022 for follow-up.They complained about aching in the achilles after walking for 15 minutes along with discomfort at the base of the left toes.An ultrasound showed stenosis in the distal portion of the left sfa stent (target leg).The ankle brachial indexes (abis) on the left dropped from 0.99 to 0.60.An angiogram on (b)(6) 2022 revealed a mid sfa stent which had an area of high grade stenosis of about 80% in the proximal portion and more distally there were several areas of moderate to severe stenosis.The intervention involved drug coated balloon / drug eluting balloon (dcb/deb), pta / standard balloon angioplasty and laser/atherectomy.Completion intravascular ultrasound (ivus) showed the entire stent to be widely patent with no evidence of residual stenosis.This was reported as a target lesion/vessel revascularisation (tlr/tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.
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 and claudication/leg pain leading to intervention 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.5., d.3., g.1., g.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 the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 150mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A contralateral approach was used and the lesion was prepared using predilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.The site identified a restenosis of treated segment (target lesion) on (b)(6) 2022.It was reported as possibly related to the device and not related to the procedure.It was target lesion related.The patient returned to the clinic on (b)(6) 2022 for follow-up.They complained about aching in the achilles after walking for 15 minutes along with discomfort at the base of the left toes.An ultrasound showed stenosis in the distal portion of the left sfa stent (target leg).The ankle brachial indexes (abis) on the left dropped from 0.99 to 0.60.An angiogram on (b)(6) 2022 revealed a mid sfa stent which had an area of high grade stenosis of about 80% in the proximal portion and more distally there were several areas of moderate to severe stenosis.The intervention involved drug coated balloon / drug eluting balloon (dcb/deb), pta / standard balloon angioplasty and laser/atherectomy of the sfa middle third to distal third.Completion intravascular ultrasound (ivus) showed the entire stent to be widely patent with no evidence of residual stenosis.This was reported as a target lesion/vessel revascularisation (tlr/tvr).The patient outcome was reported as resolved/recovered and 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: 17098144
• Report Number: 3011632150-2023-00068
• Device Sequence Number: 1983178
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)230916(11)220215(10)0000135054
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/11/2023

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: 09/16/2023
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000135054
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White