MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-06 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[182792625]
Device is combination product. Initial reporter address 1: (b)(6) hospital (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[182792626]
(b)(6) clinical study. It was reported that stenosis occurred. The subject underwent treatment with one study device on (b)(6) 2017 as part of the (b)(6) clinical trial. The target lesion was located in right distal superficial femoral artery (sfa) with 100% stenosis. The lesion was 40 mm long with a proximal and distal reference vessel diameter of 5 mm and was classified as a tasc ii a lesion. The target lesion was treated with pre-dilatation and placement of the 6 mm x 60 mm stent with 0% residual stenosis. Following post dilation, residual stenosis was 0%. The subject was treated as an outpatient on dual antiplatelet therapy (dapt). On (b)(6) 2017, the subject had symptoms of increasing calf claudication of the right side and numbness of the right foot. The calf claudication occurs after a walking distance of nearly 300 m. On (b)(6) 2017, the subject presented to the hospital with a worsening calf claudication. On examination, the temperature of the lower extremities were symmetrically warm, right foot cool compared to the left side. Recapitalization was delayed on the right with quiet, low frequency flow sounds in the inguinal regions bilaterally and high frequency quiet flow sounds at the proximal thigh on the right along with not palpable upper peripheral pulses on the right. On the same day, colour coded duplex ultrasound of the right arteries revealed a long segment of the hemodynamically relevant flow acceleration in the proximal region of the superficial femoral artery with still bi- to triphasic flow signal into the region of the distal popliteal artery and the stent placed in the region of distal sfa is open and shows perfusion without stenosis. However, the superficial femoral artery showed 50-75% of long stenosis. Since the general condition of the subject worsened and to prevent a probable occlusion, a revascularization of the right proximal sfa was planned on (b)(6) 2017. During this event, the subject was on dual antiplatelet therapy. On (b)(6) 2017, the 90% stenosis was treated successfully by percutaneous transluminal angioplasty (pta) with a drug coated 6 mm x 60 mm ranger balloon with 25% residual stenosis. During the same procedure, angioplasty was performed with one 3 mm x 150 mm ranger balloon and one 2. 5 mm x 150 mm ranger balloon for tibiofibularis and posterior tibial artery. On (b)(6) 2017, the event was considered resolved and was recommended to be on dual antiplatelet therapy. On (b)(6) 2017, core lab findings for distal sfa revealed non-patent inflow and outflow to the target distal sfa vessel with no thrombus or aneurysm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02634 |
| MDR Report Key | 9801091 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2016-05-10 |
| Date Added to Maude | 2020-03-06 |
| 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 | 2020-03-06 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0019370764 |
| Device Expiration Date | 2017-11-30 |
| 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 | 2020-03-06 |