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

Model Number	142122-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Restenosis (4576)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00017.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 and claudication/leg pain 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 report is related to mdr number 3011632150-2023-00017.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents (a 5.0 x 125mm stent and a 6.0 x 60mm stent - the subject of this report) to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third segment in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen for her 12-month follow-up and complained of recurrent claudication in the left lower extremity.Her duplex ultrasound (dus) showed occlusion of the stent with an ankle brachial index (abi) of 0.24.She had an angiogram done on (b)(6) 2023 which showed chronic appearing thrombus throughout the length of the stent.A pta / standard balloon angioplasty was done on the external iliac and common femoral arteries as well as the entirety of the sfa including both stented segments on (b)(6) 2023.There was a dissection in the unstented segment of the sfa and a 6.0 x 80mm self expanding bare metal non bm3d stent was placed.Following the procedure, angiography showed flow through all treated segments of the left leg.It was reported as a target lesion revascularization (tlr) / target vessel revascularization (tvr).The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the devices remain implanted.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00017.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 and claudication/leg pain 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 additional information received, sections d.3.And g.1.Were updated to reflect veryan's address details, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 01) and the reason and section h.11.Was updated to reflect the sections of this report that were changed.
Event or Problem Description
This mdr report is related to mdr number 3011632150-2023-00017.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents, a 5.0 x 125 mm stent and a 6.0 x 60mm stent (the subject of this report) to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third segment in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen for her 12-month follow-up and complained of recurrent claudication in the left lower extremity.Her duplex ultrasound (dus) showed occlusion of the stent with an ankle brachial index (abi) of 0.24.She had an angiogram done on (b)(6) 2023 which showed chronic appearing thrombus throughout the length of the stent.A pta / standard balloon angioplasty was done on the external iliac and common femoral arteries as well as the entirety of the sfa including both stented segments on (b)(6) 2023.There was a dissection in the unstented segment of the sfa and a 6.0 x 80mm self-expanding bare metal non-bm3d stent was placed.Following the procedure, angiography showed flow through all treated segments of the left leg.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion-related.The patient outcome was reported as resolved/recovered and the devices remain implanted.Additional information reviewed on 15-apr-24 included the clinical events committee (cec) determination that this event of restenosis was not related to the devices implanted.This event was the second restenosis that had occurred and required a tlr intervention and as a result, this event was determined to be due to the progression of the patient's underlying disease.The first restenosis event was reported in mdr 3011632150-2023-00002 and 3011632150-2023-00003.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00017.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 and claudication/leg pain 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 additional information received, sections d.3.And g.1.Were updated to reflect the manufacturer name as veryan medical limited, sections g.6.And h.2.Were updated to reflect the type of report (follow-up 02) and the reason for the report and section h.11.Was updated to reflect the sections of this report that were changed.
Event or Problem Description
This mdr report is related to mdr number 3011632150-2023-00017.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents, a 5.0 x 125 mm stent and a 6.0 x 60mm stent (the subject of this report) to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third segment in the left leg.A contralateral approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The treated segment was post-dilated with pta.The site reported that on (b)(6) 2022, a restenosis of treated segment (target lesion) was identified.The patient was seen for her 12-month follow-up and complained of recurrent claudication in the left lower extremity.Her duplex ultrasound (dus) showed occlusion of the stent with an ankle brachial index (abi) of 0.24.She had an angiogram done on (b)(6) 2023 which showed chronic appearing thrombus throughout the length of the stent.A pta/standard balloon angioplasty was done on the external iliac and common femoral arteries as well as the entirety of the sfa including both stented segments to the anterior tibial (at) proximal third on (b)(6) 2023.There was a dissection in the unstented segment of the sfa and a 6.0 x 80 mm self-expanding bare metal non-bm3d stent was placed.Following the procedure, angiography showed flow through all treated segments of the left leg.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as possibly related to the device and not related to the procedure.It was reported as target lesion-related.The patient outcome was reported as resolved/recovered and the devices remain implanted.The clinical events committee (cec) determined that this event of restenosis was not related to the devices implanted.This event was the second restenosis that had occurred and required a tlr intervention and as a result, this event was determined to be due to the progression of the patient's underlying disease.The first restenosis event was reported in mdr 3011632150-2023-00002 and 3011632150-2023-00003.Additional information provided by the site on (b)(6) 2024, updated the distal segment treated during the intervention on (b)(6) 2023 from the proximal popliteal segment to include the at proximal third and the outcome of the fracture updated to resolved with sequelae (refer to report mdr 3011632150-2023-00017).

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LIMITED; 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: 16239840
• Report Number: 3011632150-2023-00018
• Device Sequence Number: 20409848
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)221007(11)210308(10)0000076760
• 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: 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): 12/18/2024

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: 10/07/2022
• Device Model Number: 142122-02
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000076760
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 04/15/2024; 12/03/2024
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/14/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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.; CILOSTAZOL (PLETAL).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White