MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-12 for BIOMIMICS 3D VASCULAR STENT SYSTEM 131816-01 manufactured by Veryan Medical.
[185976826]
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 restenosis/occlusion 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.
Patient Sequence No: 1, Text Type: N, H10
[185976827]
The patient was treated as part of the (b)(6) post-market observational study on (b)(6) 2018. At index procedure ((b)(6) 2018), the patient presented with a restenotic occlusion of the segment involving the ostial sfa to distal third of the sfa in the right leg. One 5. 0 x 60mm biomimics stent was implanted. On (b)(6) 2020 an event of occlusion was identified. This relationship to the device was described as "not assessible/unknown" and the relationship to the procedure was described as "not related". The occlusion required a graft/bypass of the occluded segment between the ostial sfa and popliteal proximal. The segment included the target lesion. The event is described as "continuing" and the device remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011632150-2020-00019 |
| MDR Report Key | 9826688 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2017-06-23 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR ALAN MCDONAGH |
| Manufacturer Street | UNIT 11 GALWAY TECHNOLOGY PARK PARKMORE |
| Manufacturer City | GALWAY, GALWAY H91 VE0H |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 VE0H |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMIMICS 3D VASCULAR STENT SYSTEM |
| Generic Name | BIOMIMICS 3D VASCULAR STENT SYSTEM |
| Product Code | NIP |
| Date Received | 2020-03-12 |
| Catalog Number | 131816-01 |
| Lot Number | 407479 |
| Device Expiration Date | 2018-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERYAN MEDICAL |
| Manufacturer Address | UNIT 11 GALWAY TECHNOLOGY PARK PARKMORE ROAD GALWAY CITY, GALWAY H91 VE0H EI H91 VE0H |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |