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

Catalog Number 142122-10

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

There was no reported device malfunction and the device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to 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 occlusion and emergency or non-emergency arterial bypass surgery 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.This report was originally submitted on 26-oct-21 and has been resubmitted to enable submission of a mdr supplemental 3011632150-2021-00042_01.The mdr number referenced on the initial report was 3011362150-2021-00042 and it should have referenced 3011632150-2021-00042.

Event Description

There is no evidence to suggest that the device caused or contributed to this event.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with a 6.0 x 100mm biomimics 3d stent on (b)(6) 2021 to treat a restenotic occlusion (100% stenosis) with a target lesion length of 80mm of the sfa distal third to proximal popliteal segment of the left leg.A contralateral approach was used, and pre-dilatation of the target lesion was conducted with standard balloon angioplasty/percutaneous transluminal angioplasty.Atherectomy was also performed pre stent placement.An occlusion, early (7 - 30 days treated vessel) was reported to veryan on (b)(6) 2021.The event was reported as follows: "during procedure on rle on (b)(6) 2021, a left angiogram was performed which showed the sfa is widely patent but the popliteal occludes above the knee and reconstitutes below knee.Bypass left femoral-below knee popliteal performed on (b)(6) 2021." it was reported as "not related" to the device and "not related" to the procedure by the clinical site.It was also reported as target lesion related.The intervention was reported as being a target vessel revascularisation (tvr).The event is resolved, and patient has recovered.The device remains implanted.

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 occlusion and emergency or non-emergency arterial bypass surgery 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., e.1., g.6.And h.10.Have been updated.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 21, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 100 mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery 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.On the (b)(6) 21, an event of occlusion, early (7 - 30 days treated vessel) was identified by the site.It was reported as not related to the device or procedure but due to a worsening of the patient's pre-existing condition.It was target lesion related.It required surgical intervention.During a procedure on the right leg extremity (rle) on (b)(6) 21, a left angiogram was performed which showed the sfa was widely patent but the popliteal occluded above the knee and reconstituted below knee.A bypass of the left femoral-below knee popliteal was performed on (b)(6) 21.The graft/bypass involved the segment between the sfa distal third and proximal popliteal artery.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The patient outcome was reported as resolved/recovered and the device remains implanted.The event was originally reviewed by veryan on (b)(6) 21 and considered possibly related to the device.

• 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: 18007742
• MDR Text Key: 326554842
• Report Number: 3011632150-2021-00042
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)220715(11)201214(10)0000063198
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000063198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White