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

Catalog Number 131816-05

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

Patient Problems Ischemia (1942); Reocclusion (1985); Pain (1994); Swelling (2091); Claudication (2550)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

This report is related to mdr numbers: 3011632150-2020-00035 and 3011632150-2020-00036.During preparation of mdr id # 3011632150-2019-00036 it was identified that the biomimics 3d vascular stent system used during the index procedure on (b)(6) 2018 was expired (expiry date 31-march-2018, catalog no.131816-10, and lot no.353284).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 effect of occlusion/restenosis,ischemia, pain and claudication are all 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 report is related to mdr numbers: 3011632150-2020-00035 and 3011632150-2020-00036.The patient was treated as part of the (b)(6) study on (b)(6) 2018.At index procedure ((b)(6) 2018 ), the patient presented with a de-novo occlusion of the proximal third of the sfa to proximal popliteal artery in the right leg.Three biomimics 3d devices were implanted.A 5.0 x 80 mm, a 6.0 x 125 mm and 6.0 x 100 mm stent.On (b)(6) 2020 the patient presented with foot pain in the right leg which had lasted two weeks (date of onset of restenosis provided as (b)(6) 2020).The foot was swollen and red with no signs of fever or nausea/vomiting.Walking was very poor.Ct scan showed occlusion of the right sfa.On (b)(6) 2020 a target lesion revascularisation took place on the segment of common femoral artery to the proximal popliteal artery.The intervention included drug coated balloon/drug eluting balloon and percutaneous transluminal angioplasty / standard balloon angioplasty, and thrombectomy.The outcome of the event is that it is resolved and the patient has recovered.The biomimics 3d devices remain implanted.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road,; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 10220689
• MDR Text Key: 201271248
• Report Number: 3011632150-2020-00034
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 131816-05
• Device Lot Number: 418351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 70