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

Catalog Number 145276-05

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

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 10/10/2018

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 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

The patient was treated as part of the mimics-3d (b)(6) study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a de-novo occlusion of the distal third of the superficial femoral artery (sfa) of the right leg.A 5.0 x 150 mm biomimics 3d stent was implanted.On (b)(6) 2018 a restenosis of the treated segment (target lesion) was seen at the patient's 12 month follow-up clinic visit.At this time the target lesion was 70% stenosed but no treatment was required.On (b)(6) 2019 veryan were provided with further information from the hospital site stating that percutaneous intervention was now clinically indicated.The intervention took place on (b)(6) 2019 this included bare metal stent,cutting balloon, drug coated balloon/drug eluting balloon, percutaneous transluminal angioplasty/standard balloon angiplasty and intra-arterial spasmolysis.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; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: judy calt ; unit11, galway technology park; parkmore,; co.galway, H91 V-EOH ; EI H91 VEOH
• MDR Report Key: 9294538
• MDR Text Key: 165607218
• Report Number: 3011632150-2019-00109
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 145276-05
• Device Lot Number: 390156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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); ENOXAPARIN-NATRIUM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70