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

Catalog Number 131816-13

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This is related to mdr numbers 3011632150-2020-00009, 3011632150-2020-00010 and 3011632150-2020-000.The investigation is ongoing.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.As soon as further information regarding this event becomes available a follow-up supplemental form will be provided within 30 days of awareness of this information.

Event Description

This is related to mdr numbers 3011632150-2020-00009,3011632150-2020-00010 and 3011632150-2020-00011.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 of the segment involving the ostial of the sfa to the distal popliteal artery of the right leg.Four biomimics 3d devices were implanted : two 6.0 x125mm stents, one 5.0 x 125mm stent and one 6.0 x 80mm stent.On the (b)(6) 2020 at the patient's 24 month follow-up clinic visit a suspected type ii stent fracture was identified on x-rays taken.There has been no clinical effects or adverse events reported associated with the suspected fracture or the target lesion.The devices remain implanted.

Manufacturer Narrative

This mdr supplemental report relates to the following mdr numbers: 3011632150-2020-00009,3011632150-2020-00010,3011632150-2020-00011,3011632150-2020-00012 and mdr supplemental numbers: 3011632150-2020-00009_01,3011632150-2020-00010_01,3011632150-2020-00011_01.As part of the complaint investigation the following was conducted: a review of all lot history records pertaining to the relevant device lots.A review of all information available to veryan relating to the index procedure and any follow-up procedures or interventions including a detailed review of all relevant angiographic evidence.The analysis of the information gathered during the investigation provided the following conclusions: the detailed lot history review revealed no issues that were deemed related to the suspected type ii stent fracture.The index procedure relating to the individual patient took place on (b)(6) 2018 where four biomimics 3d devices were implanted.Percutaneous transluminal angioplasty/standard balloon angioplasty was used pre and post stent deployment and drug coated/drug eluting balloon treatment was used pre-stent placement only.The site indicated this was a paclitaxel drug coated balloon.On (b)(6) 2018 the onset of a non serious aneurysm of the sfa in the right leg was recorded and reported to veryan.Drug coated balloon/drug eluting balloon treatment coated with paclitaxel have been associated development of aneurysms in the sfa.From information received from the site indicating that this aneurysm was "definitely related" to the procedure , it is likely that the formation was a product of the procedures used prior to the biomimics stent deployment.X-ray and angiographs were obtained at the subject's 24-month follow-up.The rutherford score and velocities obtained at this follow-up indicate the stent was patent.Angiographic review identified a distorted stent pattern coinciding with an aneurysm just proximal and at the junction of the overlapped sections of two 6.0 x 125mm stents.More detailed imaging of this region shows separation of stent struts and the presence of a fracture.As there is no clear separation of the stent this is considered a type ii stent fracture as described in the literature [jaff 2007].Summary: four biomimics 3d stents were implanted to treat a 300mm restenotic occlusion.A paclitaxel drug coated/drug eluting balloon was used at index prior to the biomimics 3d stent placement.A non serious aneurysm was identified on the (b)(6) 2018.Evidence from the literature indicates a connection between paclitaxel dcb/deb and focal aneurysm development.A possible type ii stent fracture was identified at the patients 24-month follow up clinic visit.Review of angiographs obtained confirm the presence of a stent fracture at the same site as the focal aneurysm.It is likely that the sudden change in vessel diameter due to the aneurysm caused the stent to be focally unsupported, leading to uncharacteristic focal deformations and the type ii stent fracture.The type ii stent fracture relates to a 6.0 x 125mm stent.As there were two 6.0 x 125 mm stents implanted (mdr ref: 3011632150-2020-00009 and supplemental report mdr no 3011632150-2020-00009_01 and mdr no.3011632150-2020-00010 and mdr supplemental 3011632150-2020-00010_01).The device to which this supplemental report relates is a 6.0 x 80mm and is related to mdr report no.: 3011632150-2020-00012.It was not affected by any device malfunction and was not related to any adverse event.This has been corrected via the updated device problem description and the update to the fda codes via this supplemental.As part of the investigation it was determined that the devices were implanted within their intended location for use and each device was within their ideal functional region.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

This is related to mdr numbers 3011632150-2020-00009,3011632150-2020-00010 and 3011632150-2020-00011.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 of the segment involving the ostial of the sfa to the distal popliteal artery of the right leg.Four biomimics 3d devices were implanted: two 6.0 x125mm stents, one 5.0 x 125mm stent and one 6.0 x 80mm stent.On the (b)(6) 2020 at the patient's 24 month follow-up clinic visit a suspected type ii stent fracture was identified on x-rays taken.There has been no clinical effects or adverse events reported associated with the suspected fracture or the target lesion.The devices remain implanted.Following completion of the investigation, the results determined that the 6.0 x 80mm stent to which the supplemental report and mdr report 3011632150-2020-00012 relates was not related to any adverse event or device malfunction.

• 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 road,; galway city, H91 V E0H; EI H91 VE0H
• MDR Report Key: 9726407
• MDR Text Key: 206733544
• Report Number: 3011632150-2020-00012
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 131816-13
• Device Lot Number: 411359
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); ELIQUIS; ELIQUIS; HEPARIN 5000 I.E.; HEPARIN 5000 I.U.; MONOEMBOLEX S.C. 3000 I.U.
• Patient Age: 76 YR
• Patient Weight: 69