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

Model Number	142122-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Skin Discoloration (2074); Obstruction/Occlusion (2422)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is related to mdr reports 3011632150-2023-00059 and 3011632150-2023-00060.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 restenosis/occlusion leading to intervention, leg pain/claudication and ischemia 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 or Problem Description
This report is related to mdr reports 3011632150-2023-00059 and 3011632150-2023-00060.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021 the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 100mm stent (the subject of this report) which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.Two additional bm3d stents, a 6.0 x 150mm stent and a 6.0 x 60mm stent were placed in this patient on (b)(6) 2022 to treat a restenosis of the treated vessel.They were used to treat a denovo lesion in the proximal sfa and overlapped with the first bm3d stent implanted on (b)(6) 2021.The site reported that on (b)(6) 2023, an occlusion was identified.It was reported as definitely related to the device and not related to the procedure.It was reported as target lesion related.The patient returned for follow-up duplex ultrasound (dus) and ankle brachial index (abi) on (b)(6) 2023.The dus showed severe stenosis of proximal sfa stents and occlusion of the distal sfa and popliteal stent.This event of occlusion led to limb ischemia which was reported as possibly related to the device.The patient also had foot discolouration and pain at rest.Ankle brachial index (abi) was unable to doppler a pulse in the left lower extremity.The intervention occurred on (b)(6) 2023 where angiogram showed occlusion from the mid sfa to the distal popliteal artery with sluggish flow distally.Rotarex atherectomy and thrombectomy were performed throughout sfa and proximal popliteal.A thrombolytic catheter with tissue plasminogen activator (tpa) was placed in the proximal sfa and left overnight.On (b)(6) 2023, a repeat angiogram was performed and the tpa thrombolytic catheter was removed.The left extremity was patent but showed significant stenosis in the mid popliteal and proximal sfa.Rotarex atherectomy and thrombectomy was performed throughout the sfa and popliteal artery, followed by a ranger drug coated balloon (dcb).Plain old balloon angioplasty (poba) was used in the anterior tibial artery (ata).There was an excellent result reported with brisk flow into the ata.The patient outcome was reported as resolved/recovered and the devices remain implanted.
Additional Manufacturer Narrative
This is related to mdr reports 3011632150-2023-00059 and 3011632150-2023-00060.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 restenosis/occlusion leading to intervention, leg pain/claudication and ischemia 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 or Problem Description
This report is related to mdr reports 3011632150-2023-00059 and 3011632150-2023-00060.The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 100mm stent (the subject of this report) which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.Two additional bm3d stents, a 6.0 x 150mm stent and a 6.0 x 60mm stent were placed in this patient on (b)(6) 2022 to treat a restenosis of the treated vessel.They were used to treat a denovo lesion in the proximal sfa and overlapped with the first bm3d stent implanted on (b)(6) 2021.The site reported that on (b)(6) 2023, an occlusion was identified.It was reported as definitely related to the device and not related to the procedure.It was reported as target lesion related.The patient returned for follow-up duplex ultrasound (dus) and ankle brachial index (abi) on (b)(6) 2023.The dus showed severe stenosis of proximal sfa stents and occlusion of the distal sfa and popliteal stent in the left leg.This event of occlusion led to limb ischemia which was reported as possibly related to the device.The patient also had foot discolouration and pain at rest.Ankle brachial index (abi) was unable to doppler a pulse in the left lower extremity.The intervention occurred on (b)(6) 2023 where an angiogram showed occlusion from the mid sfa to the distal popliteal artery with sluggish flow distally.Laser/atherectomy (rotarex atherectomy), thrombectomy and thrombolysis were performed throughout the sfa proximal third to proximal popliteal.A thrombolytic catheter with tissue plasminogen activator (tpa) was placed in the proximal sfa and left overnight.On (b)(6) 2023, a repeat angiogram was performed and the tpa thrombolytic catheter was removed.The left extremity was patent but showed significant stenosis in the mid popliteal and proximal sfa.Laser/atherectomy (rotarex atherectomy) and thrombectomy were performed throughout the sfa and popliteal artery, followed by a ranger drug coated/eluting balloon (dcb/deb).Plain old balloon angioplasty (poba)/pta/standard balloon angioplasty was used in the anterior tibial artery (ata) proximal third.Both interventions on the (b)(6) 2023 were reported as target lesion/vessel revascularisations (tlr/tvr).There was an excellent result reported with brisk flow into the ata.The patient outcome was reported as resolved/recovered and the devices remain implanted.
Event or Problem Description
This report is related to mdr reports 3011632150-2023-00059 and 3011632150-2023-00060.The patient was treated as part of the (b)(6) study.On the (b)(6) 2021, the patient was implanted with one biomimics 3d (bm3d) stent, a 6.0 x 100mm stent (the subject of this report) which was used to treat a restenotic lesion of the superficial femoral artery (sfa) middle third in the left leg.A retrograde approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) balloon and atherectomy.The treated segment was also post-dilated with pta.Two additional bm3d stents, a 6.0 x 150mm stent and a 6.0 x 60mm stent were placed in this patient on (b)(6) 2022 to treat a restenosis of the treated vessel.They were used to treat a denovo lesion in the proximal sfa and overlapped with the first bm3d stent implanted on (b)(6) 2021.The site reported that on (b)(6) 2023, an occlusion was identified.It was reported as definitely related to the device and not related to the procedure.It was reported as target lesion related.The patient returned for follow-up duplex ultrasound (dus) and ankle brachial index (abi) on (b)(6) 2023.The dus showed severe stenosis of proximal sfa stents and occlusion of the distal sfa and popliteal stent in the left leg.This event of occlusion led to limb ischemia which was reported as possibly related to the device.The patient also had foot discolouration and pain at rest.Ankle brachial index (abi) was unable to doppler a pulse in the left lower extremity.The intervention occurred on (b)(6) 23 where an angiogram showed occlusion from the mid sfa to the distal popliteal artery with sluggish flow distally.Laser/atherectomy (rotarex atherectomy), thrombectomy and thrombolysis were performed throughout the sfa proximal third to proximal popliteal.A thrombolytic catheter with tissue plasminogen activator (tpa) was placed in the proximal sfa and left overnight.On (b)(6) 2023, a repeat angiogram was performed and the tpa thrombolytic catheter was removed.The left extremity was patent but showed significant stenosis in the mid popliteal and proximal sfa.Laser/atherectomy (rotarex atherectomy) and thrombectomy were performed throughout the sfa and popliteal artery, followed by a ranger drug coated/eluting balloon (dcb/deb).Plain old balloon angioplasty (poba)/pta/standard balloon angioplasty was used in the anterior tibial artery (ata) proximal third.Both interventions on the (b)(6) 2023 were reported as target lesion/vessel revascularisations (tlr/tvr).There was an excellent result reported with brisk flow into the ata.The patient outcome was reported as resolved/recovered and the devices remain implanted.The clinical events committee (cec) adjudicated that this event was not related to the study device and this adjudication was reviewed by veryan on 06-feb-24.The non-study devices implanted are captured on mdr 3011632150-2023-00059 and 3011632150-2023-00060.
Additional Manufacturer Narrative
This is related to mdr reports 3011632150-2023-00059 and 3011632150-2023-00060.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 restenosis/occlusion leading to intervention, leg pain/claudication and ischemia 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.The cec adjudicated that this event was not related to the study device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Common Device Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 16916428
• Report Number: 3011632150-2023-00058
• Device Sequence Number: 12492783
• Product Code: NIP
• UDI-Device Identifier: 05391526850459
• UDI-Public: (01)05391526850459(17)220715(11)201214(10)0000063198
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 03/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: 142122-10
• Device Catalogue Number: 142122-10
• Device Lot Number: 0000063198
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 02/06/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 11/27/2023; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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: ASPIRIN; CLOPIDOGREL (PLAVIX); ELIQUIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White