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 Reocclusion (1985); Thrombosis (2100); Claudication (2550)

Event Date 10/29/2018

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, thrombosis 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 european post-market observational study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with rutherford 5 symptoms and a de-novo occlusion located between the distal third of the superficial femoral artery (sfa) and the proximal popliteal of the left leg.The patient also presented with a non-healing wound on the target limb.The target lesion presented with a 6.0 mm (proximal) to 5.5 mm (distal) reference vessel diameter, 80 mm in length, and 100% stenosed.Pre-dilatation was performed using a 5.0 x 40 mm percutaneous transluminal angioplasty (pta) balloon.A 6.0 x 125 mm biomimics 3d stent was implanted.Post-dilatation was performed using a 6.0 x 120 mm drug-coated balloon (dcb).On (b)(6) 2018 the patient presented with thrombosis (treated segment) and on (b)(6) 2018 the patient was treated with thrombolytics and percutaneously via pta, thrombectomy and a dcb/deb.The event was resolved with sequelae on (b)(6) 2019.An occlusion of the treated segment had previously been treated on two occasions ((b)(6) 2018) with thrombolytics, thrombectomy, laser atherectomy and a bare metal stent.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, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: judy calt ; unit 11 galway technology park; parkmore; galway, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 8303039
• MDR Text Key: 134974501
• Report Number: 3011632150-2019-00029
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 131816-14
• Device Lot Number: 357667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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): Other
• Patient Age: 75 YR
• Patient Weight: 64