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

Model Number	142122-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This relates to mdr number 3011632150-2022-00086.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with two biomimics 3d (bm3d) stents (one 7.0 x 60mm stent (this report) in the sfa proximal third and one 7.0 x 80mm bm3d stent in the sfa distal third) to treat denovo lesions in the right leg.A retrograde approach was used and the target lesion was prepared by pre-dilation of the target lesion with a standard balloon angioplasty and atherectomy.Post-dilation was conducted with percutaneous transluminal angioplasty (pta).On the (b)(6) 2022, an event of restenosis of treated segment (target lesion) was reported from the site.It was reported as "not related" to the device and "not related" to the procedure but due to a worsening pre-existing condition.It was also reported as target lesion related.It led to a percutaneous intervention and it involved a target lesion revascularisation on (b)(6) 2022 with bare metal stent placement, cutting balloon , laser atherectomy and thrombectomy.The devices remain implanted.The patient outcome is reported as "resolved/recovered".The event was reviewed on 22-aug-22 and considered possibly related to the device.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2022-00086.There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with 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 thrombosis leading to intervention is listed in the biomimics 3d instructions for use and is a known patient effect 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.
Additional Manufacturer Narrative
This is related to mdr number 3011632150-2022-00086.There was no reported device malfunction and the device was not returned for analysis.A review has been performed of the manufacturing certificate of conformance associated with this lot.There were no non-conformances or deviations which could be associated with 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 thrombosis leading to intervention is listed in the biomimics 3d instructions for use and is a known patient effect 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.Section b.5.Has been updated to reflect thrombosis of treated segment rather than restenosis.
Event or Problem Description
This relates to mdr number 3011632150-2022-00086.The patient was treated as part of the mimics 3d usa post-market observational study on 13-sept-2021.The subject was implanted with two biomimics 3d (bm3d) stents (one 7.0 x 60mm stent (this report) in the sfa proximal third and one 7.0 x 80mm bm3d stent in the sfa distal third) to treat denovo lesions in the right leg.A retrograde approach was used and the target lesion was prepared by pre-dilation of the target lesion with a standard balloon angioplasty and atherectomy.Post-dilation was conducted with percutaneous transluminal angioplasty (pta).On the 17-aug-2022, an event of thrombosis of treated segment was reported from the site.It was reported as "not related" to the device and "not related" to the procedure but due to a worsening pre-existing condition.It was also reported as target lesion related.It led to a percutaneous intervention and it involved a target lesion revascularisation on (b)(6) 2022 with bare metal stent placement, cutting balloon , laser atherectomy and thrombectomy.The devices remain implanted.The patient outcome is reported as "resolved/recovered".The event was reviewed on 22-aug-2022 and considered possibly related to the device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: 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 city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 15455701
• Report Number: 3011632150-2022-00085
• Device Sequence Number: 6897227
• Product Code: NIP
• UDI-Device Identifier: 05391526850404
• UDI-Public: (01)05391526850404(17)221007(11)210308(10)0000076761
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/07/2022
• Device Model Number: 142122-03
• Device Catalogue Number: 142122-03
• Device Lot Number: 0000076761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CLOPIDOGREL (PLAVIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White