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

Model Number 144700-12

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/12/2022

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 thrombosis 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 subject was implanted with one biomimics-3d stent (a 6.0 x 150mm ) to treat a denovo lesion of the sfa middle third artery in the left leg.A retrograde approach was used and pre-dilatation and post-dilatation of the target lesion was conducted with percutaneous transluminal angioplasty.Atherectomy was also performed pre stent placement and thrombectomy performed also pre-stent placement.On (b)(6) 2022, an event of thrombosis of treated segment was reported from the site.It was reported as "not related" to the device or procedure but to worsening pre-existing condition.It was also reported as target lesion related.The patient outcome is reported as "resolved/recovered".On review of the event by veryan on (b)(6) 2022, it was determined to be possibly related to the device as it led to a graft bypass of the treated segment.This intervention took place on (b)(6) 2022.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 effect of thrombosis 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.Section b.5.Was updated to reflect the details provided by the site, section b.7.Was corrected to update stent placement to stent graft, sections d.3.And g.1.Were updated to reflect the change in veryan's address since the initial report was submitted.Section d.10.Was updated to reflect only aspirin, section e.1.The reporter address details were updated.Sections g.6.And h.2.Reflects the type of the report (follow-up 1) and the reasons for the report.Section h.11.Reflects the updates made in this follow-up report.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 subject was implanted with one biomimics-3d stent (a 6.0 x 150mm stent) to treat a denovo lesion of the superficial femoral artery (sfa) middle third artery in the left leg.A retrograde approach was used and pre-dilation and post-dilation of the target lesion was conducted with percutaneous transluminal angioplasty (pta).Atherectomy was also performed pre-stent placement and thrombectomy was performed also pre-stent placement.On the 12-jan-22, an event of thrombosis of treated segment was identified by the site.It was reported as not related to the device or procedure but due to a worsening pre-existing condition.It was also reported as target lesion-related.On review of the event by veryan on 02-june-22, it was determined to be possibly related to the device as it led to a graft bypass of the treated segment.The sfa ostial to the anterior tibial middle third segment was bypassed.It was reported as a target lesion/vessel revascularisation (tlr/tvr).This intervention took place on (b)(6) 2022.The patient outcome was reported as resolved/recovered.The device remains implanted.Additional information was provided via the site on 27-feb-24 to confirm that this event was target lesion-related and the segment bypassed during the intervention was the sfa ostial to anterior tibial middle third and the fact that the intervention was a tlr were updated on (b)(6) 2024.

• 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: 14884814
• MDR Text Key: 295119842
• Report Number: 3011632150-2022-00043
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850510
• UDI-Public: (01)05391526850510(17)220617(11)201116(10)0000058641
• 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
• Report Date: 03/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 144700-12
• Device Catalogue Number: 144700-12
• Device Lot Number: 0000058641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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; ASPIRIN; BRILINTA (TICAGRELOR); XARELTO (RIVAROXABAN)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 161 KG
• Patient Ethnicity: Hispanic