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

Catalog Number 131816-03

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

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

This is related to mdr numbers 3011632150-2019-00087 and 3011632150-2019-00089.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 claudication and occlusion/restenosis 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

This report is related to mdr numbers : 3011632150-2019-00087 and 3011632150-2019-00089.The patient was treated as part of the mimics-3d european post-market observational study on (b)(6) 2017.At index procedure (b)(6) 2017), the patient presented with a de-novo occlusion located between the proximal third of the sfa and the distal third of the sfa in the left leg.Three biomimics 3d stents were implanted.On (b)(6) 2018 restenosis of the treated segment (target lesion) was identified.On (b)(6) 2018 percutaneous intervention was performed (cutting balloon,drug coated balloon/drug eluting balloon, percutaneous transluminal angioplasty/ standard balloon angioplasty).The event has resolved.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; galway city, H01 V E0H; EI H01 VE0H
• Manufacturer Contact: judy calt ; unit 11,galway technology park; parkmore; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 9079133
• MDR Text Key: 162971284
• Report Number: 3011632150-2019-00088
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 131816-03
• Device Lot Number: 325057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 87