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); Claudication (2550)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

This is the same case as mdr numbers 3011632150-2019-00105 and 3011632150-2019-00107.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 numbers 3011632150-2019-00105 and 3011632150-2019-00107.The patient was treated as part of the (b)(6) post-market observational study on (b)(6) 2018.At index procedure (b)(6) 2018), the patient presented with a de-novo occlusion located in the middle third of the superficial femoral artery (sfa) to the proximal popliteal artery of the left leg.A 5.0 x 80 mm biomimics 3d stent, a 6.0 x 125mm biomimics 3d stent and a 6.0 x 80mm biomimics 3d stent were implanted.On (b)(6) 2019 an occlusion was reported to veryan with a date of onset of (b)(6) 2018.Angiography was reported as having been taken on (b)(6) 2018 and a pta was planned but the patient was treated with a surgical bypass of the common femoral to the distal third of the peroneal segment on (b)(6) 2018.On 25-september-2019 updated information was received updating the originally reported occlusion to "restenosis of the treated segment (target lesion)".The outcome of the event is that it has resolved and patient has recovered.

Manufacturer Narrative

The date of onset of the event was updated by the clinical site from (b)(6) 2018 to the (b)(6) 2018.As a result the date of event and the description of the event (sections b.3 and b.5) have been updated.

Event Description

This is the same case as mdr numbers 3011632150-2019-00105 and 3011632150-2019-00107.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 de-novo occlusion located in the middle third of the superficial femoral artery (sfa) to the proximal popliteal artery of the left leg.A 5.0 x 80 mm biomimics 3d stent, a 6.0 x 125mm biomimics 3d stent and a 6.0 x 80mm biomimics 3d stent were implanted.On (b)(6) 2019 an occlusion was reported to veryan with a date of onset of (b)(6) 2018.Angiography was reported as having been taken on (b)(6) 2018 and a pta was planned but the patient was treated with a surgical bypass of the common femoral to the distal third of the peroneal segment on (b)(6) 2018.On (b)(6) 2019 updated information was received updating the originally reported occlusion to "restenosis of the treated segment (target lesion)".The outcome of the event is that it has resolved and patient has recovered.

• 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
• MDR Report Key: 9203196
• MDR Text Key: 175060865
• Report Number: 3011632150-2019-00106
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 131816-14
• Device Lot Number: 412999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CALCIPARIN 12500; CLEXANE 0.2 ML; HEPARIN 5000 I.E.; MONOEMBOLEX S.C. 8000; MONOEMBOLEX S.C. 8000 I.E.; XARELTO; XARELTO; XARELTO/RIVAROXABAN
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 48