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

Model Number 142122-06

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.The patient was implanted with one 6.0 x 80mm biomimics 3d stent (bm3d) on (b)(6) 2022 to treat a denovo lesion of the sfa distal third to proximal popliteal segment in the left leg.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, cutting balloon and atherectomy.The treated segment was post-dilated with pta.Veryan were made aware of a stent fracture of the implanted bm3d stent.It was reported that a re-intervention has been scheduled for (b)(6) 2023.The patient outcome was reported as unknown.Additional information has been requested.

Manufacturer Narrative

The investigation is in progress and additional information is being sought.Any additional information received will be reported in a mdr supplemental report.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system lot showed no issues that were deemed related to the complaint investigation in order to review the possibility of stent fracture in this case, angiographic images of the procedure were requested from the site.However, despite several requests being made, the angiographic images of the procedure were not made available to the investigation.Without visual information of the biomimics 3d device in situ, the presence of a stent fracture is unable to be determined.The investigation was closed and categorised as "insufficient information" with a cause category assigned as "insufficient information".Were updated.If additional information becomes available a supplemental report will be submitted.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On the 05-jul-22, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, cutting balloon and atherectomy.The treated segment was post-dilated with pta.A stent fracture was identified on 16-may-23, it was reported as definitely related to the device and not related to the procedure.It was target lesion related.The patient presented with pain of the left leg.Duplex ultrasound (dus) displayed occlusion of the stent (mdr report reference: 3011632150-2023-00109).A percutaneous intervention was attempted initially but the stented segment could not be crossed.On 11-jul-23, percutaneous intervention was attempted again and a non bm3d bare metal stent was deployed to maintain patency of the existing bm3d stent.Pta/standard balloon angioplasty was also performed.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The device remains implanted.

Manufacturer Narrative

The investigation is in progress and additional information is being sought.Any additional information received will be reported in a subsequent mdr supplemental report.Sections a.1., a.2., b.3., b.5., d.3., g.1., g.6., h.6., and h.10.Were updated.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On the 05-jul-22, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80mm stent which was used to treat a denovo lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, cutting balloon and atherectomy.The treated segment was post-dilated with pta.A stent fracture was identified on (b)(6) 2023, it was reported as definitely related to the device and not related to the procedure.It was target lesion related.The patient presented with pain of the left leg.Duplex ultrasound (dus) displayed occlusion of the stent (mdr report reference: (b)(6)).This occlusion was confirmed to be the same event that occurred on (b)(6) 2023.A percutaneous intervention was attempted initially but the stented segment could not be crossed.On (b)(6) 2023, percutaneous intervention was attempted again and a non bm3d bare metal stent was deployed to maintain patency of the existing bm3d stent.Pta/standard balloon angioplasty was also performed.The intervention was reported as a target lesion/vessel revascularisation (tlr/tvr).The device remains implanted.

Event Description

The patient was treated as part of the mimics 3d usa post-market observational study.On the (b)(6) 2022, the patient was implanted with one biomimics 3d (bm3d) stent in the left leg, a 6.0 x 80mm stent which was used to treat a restenotic lesion of the superficial femoral artery (sfa) distal third to proximal popliteal artery.A contralateral approach was used and the lesion was prepared using pre-dilation with a percutaneous transluminal angioplasty (pta) balloon, cutting balloon and atherectomy.The treated segment was post-dilated with pta.A stent fracture was identified on (b)(6) 2023, it was reported as definitely related to the device and not related to the procedure.It was target lesion related.The patient presented with pain of the left leg.Duplex ultrasound (dus) displayed occlusion of the stent (mdr report reference: (b)(4) ).A percutaneous intervention was attempted initially but the stented segment could not be crossed.On (b)(6) 2023, percutaneous intervention was attempted again and a non bm3d bare metal stent was deployed to maintain patency of the existing bm3d stent.Pta/standard balloon angioplasty was also performed.The intervention was performed on the sfa distal third to the posterior tibial proximal third segment.It was reported as a target lesion/vessel revascularisation (tlr/tvr).The device remains implanted.Updated information was received on (b)(6) 2023 on the lesion type treated at index, the patient outcome, and the intervention details.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system lot showed no issues that were deemed related to the complaint investigation.In order to review the possibility of stent fracture in this case, angiographic images of the procedure were requested from the site.However, despite several requests being made, the angiographic images of the procedure were not made available to the investigation.Without visual information of the biomimics 3d device in situ, the presence of a stent fracture is unable to be determined.The investigation was closed and categorised as "insufficient information" with a cause category assigned as "insufficient information".Sections b.5., g.6.And h.10.Were updated.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: 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: 17276861
• MDR Text Key: 318791930
• Report Number: 3011632150-2023-00085
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: 142122-06
• Device Catalogue Number: 142122-06
• Device Lot Number: 0000096641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/26/2023; 08/29/2023; 12/14/2023
• Supplement Dates FDA Received: 08/22/2023; 09/28/2023; 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Treatment: CLOPIDOGREL (PLAVIX)
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White