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

Catalog Number 144700-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 05/04/2023

Event Type  Injury  

Event Description

This report is related to mdr report 3011632150-2023-00127.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 6.0 x 150mm biomimics 3d (bm3d) stent in the sfa distal third to proximal popliteal segment and one 6.0 x 150mm bm3d stent in the sfa middle third to sfa distal third to treat restenotic lesions in the right leg.A contralateral approach was used and the lesions were prepared using standard percutaneous transluminal angioplasty (pta) and atherectomy.The treated segments were also post-dilated with pta.On (b)(6) 2022, the patient had an angiogram of the left lower extremity (lle) for worsening claudication symptoms.Atherectomy, angioplasty and stenting were performed of multiple high-grade stenoses of the left sfa.The patient was implanted with two additional bm3d stents (the subjects of this report) to treat an arterial stenosis of the sfa in the non-study left leg.The details of these stents were not reported.On the (b)(6) 2023, the site identified a restenosis in the non-study leg.The patient attended the clinic for follow-up and ultrasound showed worsening stenosis of the left common femoral artery (cfa) to sfa stent as well as critical stenosis in the left popliteal artery.An angiogram performed on the (b)(6) 2023 which showed high-grade heavily calcified stenosis in the popliteal artery and high-grade stenosis of the cfa and proximal sfa stent.The rest of the sfa was patent and there was a distal sfa that was also patent.The popliteal stenosis was treated with cardiovascular systems inc.(csi) atherectomy and balloon angioplasty.The proximal sfa in-stent stenosis was treated with balloon angioplasty.Completion arteriogram showed good flow through the treated areas with residual stenosis of 30% which did not appear flow limiting.The procedure was completed and the patient was discharged in good condition.The event outcome was reported as resolved/recovered.The event was reviewed by veryan and considered possibly related to the devices on (b)(6) 2023.The devices remain implanted.

Manufacturer Narrative

This report is related to mdr 3011632150-2023-00127.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 is listed in the biomimics 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.

Manufacturer Narrative

This report is related to mdr 3011632150-2023-00127.There was no reported device malfunction and the device was not returned for analysis.The lot details were not reported.Based on the case information, 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 biomimics 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 Description

This report is related to mdr report 3011632150-2023-00127.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 6.0 x 150mm biomimics 3d (bm3d) stent in the sfa distal third to proximal popliteal segment and one 6.0 x 150mm bm3d stent in the sfa middle third to sfa distal third to treat restenotic lesions in the right leg.A contralateral approach was used and the lesions were prepared using standard percutaneous transluminal angioplasty (pta) and atherectomy.The treated segments were also post-dilated with pta.On (b)(6) 2022, the patient had an angiogram of the left lower extremity (lle) for worsening claudication symptoms.Atherectomy, angioplasty and stenting were performed on multiple high-grade stenoses of the left sfa.The patient was implanted with two additional stents to treat an arterial stenosis of the sfa in the non-study left leg.Intravascular ultrasound (ivus) showed areas of persistent stenosis at hunter's canal of about 70% and areas of high-grade residual stenosis in the proximal sfa just below its origin.One of the stents (the subject of this report) was reported to be a veryan medical device deployed across the distal lesion.A second stent was deployed proximally ending right at the origin of the sfa.The details have not been provided on this stent.On the (b)(6) 2023, the site identified a restenosis in the non-study leg.The patient attended the clinic for follow-up and ultrasound showed worsening stenosis of the left common femoral artery (cfa) to sfa stent as well as critical stenosis in the left popliteal artery.An angiogram was performed on the (b)(6) 2023 which showed high-grade heavily calcified stenosis in the popliteal artery and high-grade stenosis of the cfa and proximal sfa stent.The rest of the sfa was patent and there was a distal sfa stent that was also patent.The popliteal stenosis was treated with cardiovascular systems inc.(csi) atherectomy and balloon angioplasty.The proximal sfa in-stent stenosis was treated with balloon angioplasty.Completion arteriogram showed good flow through the treated areas with residual stenosis of 30% which did not appear flow limiting.The procedure was completed and the patient was discharged in good condition.The event outcome was reported as resolved/recovered.The event was reviewed by veryan and considered possibly related to the devices on (b)(6) 2023.The devices remain implanted.

Event Description

This report is related to mdr report 3011632150-2023-00127.The patient was treated as part of the (b)(6) study.On the (b)(6) 2022, the patient was implanted with one 6.0 x 150mm biomimics 3d (bm3d) stent in the sfa distal third to proximal popliteal segment and one 6.0 x 150mm bm3d stent in the sfa middle third to sfa distal third to treat restenotic lesions in the right leg.A contralateral approach was used and the lesions were prepared using standard percutaneous transluminal angioplasty (pta) and atherectomy.The treated segments were also post-dilated with pta.On (b)(6) 2022, the patient had an angiogram of the left lower extremity (lle) for worsening claudication symptoms.Atherectomy, angioplasty and stenting were performed on multiple high-grade stenoses of the left sfa.The patient was implanted with two additional stents to treat an arterial stenosis of the sfa in the non-study left leg.Intravascular ultrasound (ivus) showed areas of persistent stenosis at hunter's canal of about 70% and areas of high-grade residual stenosis in the proximal sfa just below its origin.One of the stents (the subject of this report) was reported to be a 6.0 x 150 mm veryan medical device deployed across the distal lesion.A second stent was deployed proximally ending right at the origin of the sfa.The details have not been provided on this stent.On the (b)(6) 2023, the site identified a restenosis in the non-study leg.The patient attended the clinic for follow-up and ultrasound showed worsening stenosis of the left common femoral artery (cfa) to sfa stent as well as critical stenosis in the left popliteal artery.An angiogram was performed on the (b)(6) 2023 which showed high-grade heavily calcified stenosis in the popliteal artery and high-grade stenosis of the cfa and proximal sfa stent.The rest of the sfa was patent and there was a distal sfa stent that was also patent.The popliteal stenosis was treated with cardiovascular systems inc.(csi) atherectomy and balloon angioplasty.The proximal sfa in-stent stenosis was treated with balloon angioplasty.Completion arteriogram showed good flow through the treated areas with residual stenosis of 30% which did not appear flow limiting.The procedure was completed and the patient was discharged in good condition.The event outcome was reported as resolved/recovered.The event was reviewed by veryan and considered possibly related to the devices on 13-sep-23.The devices remain implanted.Veryan received additional information on this event on 02-feb-24 which clarified the size of the stent related to this report.

Manufacturer Narrative

This report is related to mdr 3011632150-2023-00127.There was no reported device malfunction and the device was not returned for analysis.The lot details were not reported.Based on the case information, 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 biomimics 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.Sections b.5.And d.4.Were updated to reflect the 6.0 x 150 mm stent size for one of the stents, and h.11.Was updated.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: 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: 17922939
• MDR Text Key: 325520066
• Report Number: 3011632150-2023-00126
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 144700-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/13/2023; 02/02/2024
• Supplement Dates FDA Received: 11/10/2023; 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CLOPIDOGREL (PLAVIX)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 235 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White