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

Model Number 142122-06

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

Patient Problems Localized Skin Lesion (4542); Restenosis (4576)

Event Date 11/09/2021

Event Type  Injury  

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 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

The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was treated with one 6.0 x 80mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.An antegrade approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The lesion was also post-dilated with pta.The site reported that on (b)(6) 2021, a restenosis of the treated segment (target lesion) was identified.A severe right middle sfa in-stent restenosis was treated with laser atherectomy and angioplasty.An occluded right popliteal and tibioperoneal trunk (tpt)/peroneal was also treated with laser atherectomy and angioplasty.The restenosis event was reported as not related to the device or procedure but due to a worsening of the patient's pre-existing condition.It was reported as target lesion related.It was reviewed by veryan on 28-nov-22 and considered possibly related to the device.The device remains implanted and the event is reported as resolved/recovered.

Manufacturer Narrative

This mdr supplemental provides an update to section b.5.And also updates the initial reporter address in section e.1.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was treated with one 6.0 x 80mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.An antegrade approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The lesion was also post-dilated with pta.The site reported that on (b)(6) 2021, a restenosis of the treated segment (target lesion) was identified.A severe in-stent restenosis of the right middle third sfa was treated with laser atherectomy and pta/standard balloon angioplasty on (b)(6) 2021.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).An occluded right popliteal and tibioperoneal trunk (tpt)/peroneal was also treated with laser atherectomy and angioplasty.The restenosis event was reported as not related to the device or procedure but due to a worsening of the patient's pre-existing condition.It was reported as target lesion related.The device remains implanted and the event outcome is reported as resolved/recovered.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On (b)(6) 2021, the patient was treated with one 6.0 x 80mm biomimics 3d (bm3d) stent to treat a denovo lesion of the superficial femoral artery (sfa) middle third to distal third in the right leg.An antegrade approach was used and the lesion was prepared using atherectomy and pre-dilated with percutaneous transluminal angioplasty (pta).The lesion was also post-dilated with pta.The site reported that on (b)(6) 2021, a restenosis of the treated segment (target lesion) was identified.The patient had a lesion on the third toe of the right foot which was non healing.A severe right middle sfa in-stent restenosis was treated laser atherectomy and pta/standard balloon angioplasty of the sfa middle third on (b)(6) 2021.It was reported as a target lesion revascularisation (tlr) and target vessel revascularisation (tvr).The restenosis event was reported as not related to the device or procedure but due to a worsening of the patient's pre-existing condition.It was reported as target lesion related.It was reviewed by veryan on 28-nov-2022 and considered possibly related to the device.The device remains implanted and the event is reported as resolved/recovered.

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 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.

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 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.7., d.3., g.1., g.6.And h.10.Were 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: 15978862
• MDR Text Key: 305491739
• Report Number: 3011632150-2022-00118
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850428
• UDI-Public: (01)05391526850428(17)220401(11)200831(10)0000050210
• 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,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 142122-06
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000050210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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; CLOPIDOGREL (PLAVIX)
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White