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

Model Number 142122-13

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Restenosis (4576)

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00018.The investigation in relation to the stent fracture is progressing.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 the event of restenosis reported.A device history review for this lot is pending as part of the investigation.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.If further information regarding this event becomes available, a follow-up report will be submitted.

Event Description

This mdr report is related to mdr number 3011632150-2023-00018.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 - the subject of this report and a 6.0 x 60mm stent) 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 22-dec-22, 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.During the procedure it was noted that the bm3d stent (the 5.0 x 125mm stent) located in the distal sfa was possibly fractured.

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00018.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 the event of restenosis reported.A device history review for this lot revealed no issues that could be related to the complaint issue investigated.A review of the angiographic imaging from the reintervention procedure on the (b)(6) 2023, showed multiple images were taken of the distal 5.0 x 125mm biomimics 3d (bm3d) stent, which allowed for investigation through multiple angles of view.Based on the review of the angiographic images, a stent fracture could not be identified.The images displayed a slight increased gap between adjoining stent crowns in the distal portion of the stent.However, stent struts are visible within this gap which suggested a connection was still present, and a type 3 stent fracture has not occurred.A single strut stent fracture (type 1) could not be identified either.The complaint was categorised as "no fracture confirmed" and a cause category of "no issues found" was assigned.Sections b.1., b.4., b.5., g.3., g.6., h.6., and h.10 have been updated.

Event Description

This mdr report is related to mdr number 3011632150-2023-00018.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 - the subject of this report and a 6.0 x 60mm stent) 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.During the procedure it was noted that the bm3d stent (the 5.0 x 125mm stent) located in the distal sfa was possibly fractured.A review of the angiographic images from the intervention procedure where the possible fracture was identified was performed as part of the investigation.A stent fracture could not be identified.

Event Description

This mdr report is related to mdr number 3011632150-2023-00018.The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2022, the patient was implanted with two biomimics 3d (bm3d) stents, a 5.0 x 125 mm stent (the subject of this report) and a 6.0 x 60 mm stent 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 a 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 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 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.During the procedure, it was noted that the bm3d stent (the 5.0 x 125mm stent) located in the distal sfa was possibly fractured.A review of the angiographic images from the intervention procedure where the possible fracture was identified was performed as part of the investigation.A stent fracture could not be identified.Additional information reviewed on (b)(6) 2024 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.

Manufacturer Narrative

This is related to mdr number 3011632150-2023-00018.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 the event of restenosis reported.A device history review for this lot revealed no issues that could be related to the complaint issue investigated.A review of the angiographic imaging from the reintervention procedure on (b)(6) 2023, showed multiple images were taken of the distal 5.0 x 125mm biomimics 3d (bm3d) stent, which allowed for investigation through multiple angles of view.Based on the review of the angiographic images, a stent fracture could not be identified.The images displayed a slight increased gap between adjoining stent crowns in the distal portion of the stent.However, stent struts are visible within this gap which suggested a connection was still present, and a type 3 stent fracture has not occurred.A single strut stent fracture (type 1) could not be identified either.The complaint was categorised as "no fracture confirmed" and a cause category of "no issues found" was assigned.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; 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: 16239802
• MDR Text Key: 309305466
• Report Number: 3011632150-2023-00017
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850473
• UDI-Public: (01)05391526850473(17)220617(11)201116(10)0000058439
• 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: 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 142122-13
• Device Catalogue Number: 142122-13
• Device Lot Number: 0000058439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/23/2023; 04/15/2024
• Supplement Dates FDA Received: 03/23/2023; 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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; CILOSTAZOL (PLETAL)
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White