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

Catalog Number 131816-14

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

Patient Problems Ischemia (1942); Occlusion (1984); Thrombus (2101)

Event Date 12/06/2019

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 ischemia, occlusion and thrombosis 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 Description

The patient was treated as part of the mimics-3d european post-market observational study on (b)(6) 2018.At index procedure (((b)(6) 2018), the patient presented with a de-novo occlusion of the segment involving the middle third of the superficial femoral artery (sfa) and the distal third of the sfa of the left leg.One 6.0 x 125mm biomimics stent was implanted.On (b)(6) 2019 an event of ischemia was reported.This event was not related to the device or the procedure but was described as an intercurrent intervention.Percutaneous intervention took place on the (b)(6) 2019 and involved bare metal stent, drug coated balloon / drug eluting balloon and percutaneous transluminal angioplasty /standard balloon angioplasty and thrombolysis of the segment between the middle third of the sfa and distal popliteal artery.The outcome of the event is that it has resolved and patient has recovered.The device remains implanted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; unit 11 galway technology park; parkmore; co. galway, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway techology park; parkmore; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 9670714
• MDR Text Key: 186525934
• Report Number: 3011632150-2020-00002
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 131816-14
• Device Lot Number: 364194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 66