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 2020-03-30 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24620 manufactured by Boston Scientific Corporation.
[187709004]
This is a combination device. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187709005]
(b)(6) study. It was reported that 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 located in right mid superficial femoral artery (sfa) with 70% stenosis and was 120 mm long with a proximal reference vessel diameter of 6. 0 mm and distal vessel diameter of 6. 0 mm and was classified as tasc ii b lesion. Target lesion #1 was treated with pre-dilatation and placement of a 7. 0 mm x 150 mm study stent. Following post dilation residual stenosis was 0%. On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel. On (b)(6) 2020, the subject presented to hospital as a regular visit with complaint of continued claudication symptoms of the lower extremity. Subsequently, catheter test was performed (of note, the onset date of the event is reported as (b)(6) 2019 and site has been queried for the correct onset date and for catheter test report findings). Based on the above symptoms, no action was taken at that point of time and the subject was planned for the treatment on later date. On (b)(6) 2020, the subject was admitted to the hospital for planned catheter treatment to find out if there was a lesion. On (b)(6) 2020, angiography of the lower extremities was performed which revealed:right limb: in-stent restenosis in sfa; severe stenosis noted in the popliteal artery. On the same day, 1303 days post index procedure, 90% instent restenosis (isr) noted in right sfa was treated by performing catheter directed dilatation with 3. 5 x 15 mm cutting balloon followed by drug coated ballooning with inpact 6mm x 150 mm balloon. Post procedure the final residual stenosis was found to be 25%. (of note site has been queried if cutting balloon 3. 5 x 15 mm was used to revascularize right sfa prior dilating the lesion with dcb). On the same day, 90% stenosis noted in right popliteal artery was treated by performing drug coated balloon angioplasty using inpact 5. 0mm x 60mm balloon. Post procedure the final residual stenosis was found to be 25%. On (b)(6) 2020, the subject was discharged from the hospital. At the time of reporting, the outcome of the both events were resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03997 |
| MDR Report Key | 9897724 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | 24620 |
| Catalog Number | 24620 |
| Lot Number | 0018822225 |
| Device Expiration Date | 2017-01-31 |
| 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 | 2020-03-30 |