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

Model Number	144700-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Restenosis (4576)
Date of Event	12/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00014.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, ischemia and claudication pain are listed in the biomimics 3d instructions for use and are 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 or Problem Description
This mdr report is related to mdr number 3011632150-2023-00014.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 150mm stent - the subject of this report and a 5.0 x 60mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) proximal third to middle third segment and middle third to distal third segments in the right leg.An antegrade approach was used and the lesion was 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 in the emergency department (ed) on (b)(6) 2022 for right foot pain which began the previous day and there was no pulse in the right foot and ankle.It was diagnosed as acute on chronic ischemia of the right foot.The patient was started on heparin and transferred to a different hospital ((b)(6) hospital).The patient was admitted between the (b)(6) 2022 and the (b)(6) 2022.The event was treated successfully with medication, a non bm3d bare metal stent, drug coated balloon / drug eluting balloon (dcb/deb), pta / standard balloon angioplasty and laser atherectomy of the sfa proximal third to proximal popliteal segment on (b)(6) 2022.The patient also received one unit of packed red blood cells (prbc) for acute blood loss anemia.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as not related to the device and not related to the procedure but was due to a worsening of the patient's condition.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the devices remain implanted.The event was reviewed by veryan on (b)(6) 2023 and considered possibly related to the device.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00014.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, ischemia and claudication 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.
Event or Problem Description
This mdr report is related to mdr number 3011632150-2023-00014.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 150mm stent - the subject of this report) to treat a restenotic lesion of the superficial femoral artery (sfa) proximal third to middle third segment in the right leg and a (5.0 x 60 mm stent) to treat a restenotic lesion of the sfa middle third to distal third segment in the right leg.An antegrade approach was used and the lesions were pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were post-dilated with pta.The site reported that on 18-dec-22, a restenosis of treated segment (target lesion) was identified.The patient was seen in the emergency department (ed) on (b)(6) 22 for right foot pain which began the previous day and there was no pulse in the right foot and ankle.It was diagnosed as acute on chronic ischemia of the right foot.The patient was started on heparin and transferred to a different hospital.The patient was admitted between the (b)(6) 2022.On the (b)(6) 2022, the patient had a selective arteriogram of the right lower extremity (rle).The sfa was occluded 6 cm beyond its origin.The previously placed stents in the mid to distal sfa and proximal popliteal arteries were nearly completely occluded except for some minimal flow within the proximal 4 cm of the stent as well as the distal 6 cm portion of the stent where there was marked intimal hyperplasia.Laser atherectomy was utilised followed by balloon dilatation of the sfa and popliteal arteries utilising a drug coated balloon / drug eluting balloon (dcb/deb) 4 mm x 220 mm in length and pta / standard balloon angioplasty.There was a focal high-grade residual stenosis in the proximal to mid sfa above the previously placed stents.A non bm3d self-expanding bare metal stent 6 x 60 mm was placed across the stenotic lesion with a good result.The event was treated successfully.The patient also received one unit of packed red blood cells (prbc) for acute blood loss anemia.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as not related to the device and not related to the procedure but was due to a worsening of the patient's condition.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the devices remain implanted.The event was reviewed by veryan on 09-jan-23 and considered possibly related to the device.
Event or Problem Description
This mdr report is related to mdr number 3011632150-2023-00014.The patient was treated as part of the (b)(6) study.On the (b)(6) 2021, the patient was implanted with two biomimics 3d (bm3d) stents (a 5.0 x 150mm stent - the subject of this report) to treat a restenotic lesion of the superficial femoral artery (sfa) proximal third to middle third segment in the right leg and a (5.0 x 60 mm stent) to treat a restenotic lesion of the sfa middle third to distal third segment in the right leg.An antegrade approach was used and the lesions were pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were 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 in the emergency department (ed) on 19-dec-22 for right foot pain which began the previous day and there was no pulse in the right foot and ankle.It was diagnosed as acute on chronic ischemia of the right foot.The patient was started on heparin and transferred to a different hospital.The patient was admitted between the 19-dec-22 and the 23-dec-22.On the 20-dec-22, the patient had a selective arteriogram of the right lower extremity (rle).The sfa was occluded 6 cm beyond its origin.The previously placed stents in the mid to distal sfa and proximal popliteal arteries were nearly completely occluded except for some minimal flow within the proximal 4 cm of the stent as well as the distal 6 cm portion of the stent where there was marked intimal hyperplasia.Laser atherectomy was utilised followed by balloon dilatation of the sfa and popliteal arteries utilising a drug coated balloon / drug eluting balloon (dcb/deb) 4 mm x 220 mm in length and pta / standard balloon angioplasty.There was a focal high-grade residual stenosis in the proximal to mid sfa above the previously placed stents.A non bm3d self-expanding bare metal stent 6 x 60 mm was placed across the stenotic lesion with a good result.The event was treated successfully.The patient also received one unit of packed red blood cells (prbc) for acute blood loss anemia.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as not related to the device and not related to the procedure but was due to a worsening of the patient's condition.It was reported as target lesion related.The patient outcome was reported as resolved/recovered and the devices remain implanted.The event was reviewed by veryan on 09-jan-23 and considered possibly related to the device.Veryan received additional information on this event on 02-feb-24 where the site corrected a date they had reported in the narrative they had provided.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00014.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, ischemia and claudication 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.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2023-00014.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, ischemia and claudication 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.Section b.5.Was updated with additional information, sections g.6.And h.2.Were updated with the type of report (follow-up 03) and the reason and section h.11.Was updated to reflect the changed sections in this report.
Event or Problem Description
This mdr report is related to mdr number 3011632150-2023-00014.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 150mm stent - the subject of this report) to treat a restenotic lesion of the superficial femoral artery (sfa) proximal third to middle third segment in the right leg and a (5.0 x 60 mm stent) to treat a restenotic lesion of the sfa middle third to distal third segment in the right leg.An antegrade approach was used and the lesions were pre-dilated with percutaneous transluminal angioplasty (pta).The treated segments were 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 in the emergency department (ed) on (b)(6) 2022 for right foot pain which began the previous day and there was no pulse in the right foot and ankle.It was diagnosed as acute on chronic ischemia of the right foot.The patient was started on heparin and transferred to a different hospital.The patient was admitted between the (b)(6) 2022 and the (b)(6) 2022.On (b)(6) 2022, the patient had a selective arteriogram of the right lower extremity (rle).The sfa was occluded 6 cm beyond its origin.The previously placed stents in the mid to distal sfa and proximal popliteal arteries were nearly completely occluded except for some minimal flow within the proximal 4 cm of the stent as well as the distal 6 cm portion of the stent where there was marked intimal hyperplasia.Laser atherectomy was utilised followed by balloon dilatation of the sfa and popliteal arteries utilising a drug coated balloon / drug-eluting balloon (dcb/deb) 4 mm x 220 mm in length and pta / standard balloon angioplasty.There was a focal high-grade residual stenosis in the proximal to mid sfa above the previously placed stents.A non-bm3d self-expanding bare metal stent 6 x 60 mm was placed across the stenotic lesion with a good result.The event was treated successfully.The patient also received one unit of packed red blood cells (prbc) for acute blood loss anemia.It was reported as a target lesion revascularisation (tlr) / target vessel revascularisation (tvr).The event of restenosis was reported as not related to the device and not related to the procedure but was due to a worsening of the patient's condition.It was reported as target lesion-related.The patient outcome was reported as resolved/recovered and the devices remain implanted.The event was reviewed by veryan on 09-jan-23 and considered possibly related to the device.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 3011632150-2022-00090 and 3011632150-2022-00091.

• 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: 16264105
• Report Number: 3011632150-2023-00013
• Device Sequence Number: 17186967
• Product Code: NIP
• UDI-Device Identifier: 05391526850503
• UDI-Public: (01)05391526850503(17)221113(11)210414(10)0000082298
• 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,Followup
• Report Date (Section B): 05/14/2024

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: 11/13/2022
• Device Model Number: 144700-05
• Device Catalogue Number: 144700-05
• Device Lot Number: 0000082298
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 02/02/2024; 04/15/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 11/10/2023; 03/01/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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: APIXABAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White