MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24620 manufactured by Boston Scientific Corporation.
[183127159]
Age at time of event: subject was (b)(6) years old at time of enrollment.
Patient Sequence No: 1, Text Type: N, H10
[183127161]
(b)(6) clinical trial. It was reported that claudication and restenosis occurred. The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day. Target lesion #1 was in the right distal superficial femoral artery (sfa) with 80% stenosis and was 80mm long with a proximal reference vessel diameter of 6mm and distal vessel diameter of 6mm and was classified as tasc ii a lesion. Target lesion #1 was treated with pre-dilatation and placement of a 7mm x 120mm study stent. Following post-dilatation, residual stenosis was 0%. On (b)(6) 2016, subject was discharged on dual antiplatelet therapy. On (b)(6) 2019, subject presented with clinically significant symptoms relating to claudication in her left leg. On (b)(6) 2019, diagnostic test of angiography done on the left cfa revealed the need for intervention which was done using drug coated balloon by performing angioplasty and atherectomy. Per edc, there was no evidence of stent fracture or stent deformation. On same day, the event was considered to be resolved. On (b)(6) 2019, subject had presented to a hospital with clinically significant symptoms relating to bilateral claudication and had undergone angiography, which revealed diseased left common femoral artery (cfa) and right femoropopliteal restenosis. During that point of time, left limb was intervened which improved left claudication symptoms and treatment for right limb was planned at a later date. On (b)(6) 2019, subject visited the hospital for the scheduled treatment of right limb and had complained of increased discomfort in right leg even with minimal ambulation. Subsequently, the subject was hospitalized and right limb arteriography was performed which revealed complex ulcerated calcific changes in right cfa and profundus femoral artery; 90% stenosis in proximal right sfa with complete occlusion in mid, distal sfa stent extending into proximal popliteal artery (ppa) and 3 vessel run off was noted with flow in peroneal and posterior tibial artery. On (b)(6) 2019, 1261 days post index procedure, the stenosis noted in right femoropopliteal axis was treated initially by pre-dilation of proximal sfa followed by laser atherectomy of entire sfa extending to proximal popliteal artery. Due to the complexity of the lesion, stenting was done using one 6mm x 120mm drug eluting stent (des) and two 7mm x 120mm des from right ppa extending up to ostium of right sfa with excellent angiographic results. Per edc and source, there was no evidence of stent fracture or stent deformation. On (b)(6) 2019, the event was considered to be resolved. On (b)(6) 2019, the subject was discharged on dual antiplatelet therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02982 |
| MDR Report Key | 9823728 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-08-13 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2015-09-10 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-03-12 |
| Model Number | 24620 |
| Catalog Number | 24620 |
| Lot Number | 0018348448 |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |