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

Catalog Number 131816-11

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

Patient Problems Reocclusion (1985); Pain (1994); Claudication (2550); Restenosis (4576)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

This is the same case as mdr number 3011632150-2019-00103.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 number 3011632150-2019-00103.The patient was treated as part of the (b)(6) study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a restenotic occlusion located in the proximal to distal third of the superficial femoral artery (sfa) of the right leg.A 6.0 x 80 mm biomimics 3d stent and biomimics 3d a 7.0 x 100mm stent were implanted.On (b)(6) 2019 a restenosis of the treated segment (target lesion) was reported.On (b)(6) 2019 the patient had a percutaneous intervention on the treated segment.This included a drug eluting stent, drug coated balloon/drug eluting balloon.The outcome of the event is that it has resolved and patient has recovered.The device remains implanted.

Manufacturer Narrative

This mdr number is related to mdr 3011632150-2019-00103.Following an update on the adverse event information made by site 24, the details of adverse event 24-005_ae1 were consolidated into 24-005_ae4.As a result the patient identifier has been updated to 24-005_ae4, date of event has been updated to (b)(6) 2018, and the event description details have been updated also to reflect this date of onset.The udi number has been included.The coding has also been updated to restenosis and pain for health effect clinical codes and serious injury/illness/impairment for health effect impact codes following harmonisation of fda reporting terms with the imdrf coding nomenclature.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.This supplemental report was scheduled to be submitted by 10-september-2020.The delay in reporting has been identified and is being addressed as part of capa-064.This delay in reporting this supplemental has no effect on safety or performance associated with the biomimics 3d device.

Event Description

This is the same case as mdr number 3011632150-2019-00103.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 a restenotic occlusion located in the proximal to distal third of the superficial femoral artery (sfa) of the right leg.A 6.0 x 80 mm biomimics 3d stent and biomimics 3d a 7.0 x 100mm stent were implanted.On (b)(6) 2018 a restenosis of the treated segment (target lesion) was identified and reported to veryan on (b)(6) 2019.It was described as definitely related to the device.The patient also had claudication pain due to the restenosis and percutaneous transluminal angioplasty was planned.On (b)(6) 2019 the patient had a percutaneous intervention on the treated segment.This included a drug eluting stent, drug coated balloon/drug eluting balloon.The outcome of the event is that it has resolved and patient has recovered.The devices remain 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 city, H91 V E0H; EI H91 VE0H
• MDR Report Key: 9203183
• MDR Text Key: 175061529
• Report Number: 3011632150-2019-00104
• 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: 09/11/2020

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: 131816-11
• Device Lot Number: 411364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN 5000; HEPARIN 5000 I.U.; MONOEMBOLEX 3000 S.C.; MONOEMBOLEX S.C. 3000 I.U.
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Weight: 95