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 Problem Sepsis (2067)

Event Date 11/29/2018

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 information provided by physician, the most likely cause for the reported patient effects is progression of existing critical limb ischemia leading to arterial ischemic ulcers resulting in amputation of the limb.Tissue necrosis, and amputation are known adverse events associated with peripheral stenting procedures and are listed in the biomimics 3d vascular stent system instructions for use.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 3011632150-2019-00043.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 restenotic occlusion located in the ostial to distal third of the superficial femoral artery (sfa) of the left leg with a rutherford of 5.At the time of the index procedure the indication was critical limb ischemia.Two 6.0 x 125 mm biomimics 3d stents were implanted.On (b)(6) 2018 an infected peripheral wound of the left sfa with sepsis was reported due to progression of critical limb ischemia (rutherford 6).The investigator confirmed that the stent was occluded.The progression of arterial ischemic ulcers led to the unplanned trans-femoral amputation on the index leg.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; blk 11 galway technology park; parkmore; galway, galway H91 V E0H; EI H91 VE0H
• Manufacturer (Section G): VERYAN MEDICAL LTD.; blk 11 galway technology park; parkmore; galway, ireland H91VE 0H; EI H91VE0H
• Manufacturer Contact: judy calt ; blk 11 galway technology park; parkmore; galway, galway H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 8417588
• MDR Text Key: 138716949
• Report Number: 3011632150-2019-00044
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 131816-14
• Device Lot Number: 431799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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: RIVAROXABAN; TICAGRELOR; WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR