MAUDE Adverse Event Report: VERYAN MEDICAL LTD. BIOMIMICS 3D VASCULAR STENT SYSTEM; BIOMIMICS3D VASCULAR STENT SYSTEM

Catalog Number 142122-03

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

Patient Problems Claudication (2550); Patient Problem/Medical Problem (2688)

Event Date 01/21/2019

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 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 is the same case as mdr id 3011632150-2019-00041.The patient was treated as part of the (b)(6) study on (b)(6) 2015.At index procedure ((b)(6) 2015), the patient presented with a de-novo occlusion located in the distal superficial femoral artery (sfa) of the left leg.Two biomimics 3d stents were implanted.On (b)(6) 2019 restenosis of the left distal sfa was reported.Patient had office visit (b)(6) 2019 where he was given an option for conservative medical management with exercise therapy and repeat duplex doppler study, but patient elected to undergo angiography intervention directly.The patient has recovered.The device remains implanted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD.; blk 11 galway technology park; parkmore; galway, ireland H91VE 0H; EI H91VE0H
• Manufacturer (Section G): VERYAN MEDICAL; blk 11 galway technology park; parkmore; galway, galway H91 V E0H; EI H91 VE0H
• Manufacturer Contact: william bachinsky ; harrisburg hospital; 111 south front st.; 7177310101
• MDR Report Key: 8394457
• MDR Text Key: 137949688
• Report Number: 3011632150-2019-00042
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 142122-03
• Device Lot Number: 287381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG; CLOPIDOGREL 75MG
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 83