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 2020-03-11 for ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM 24620 manufactured by Boston Scientific Corporation.
[183003644]
Device is a combination product.
Patient Sequence No: 1, Text Type: N, H10
[183003645]
It was reported that stent thrombosis 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 was in the left proximal superficial femoral artery (sfa) extending to mid sfa with 100% stenosis and was 190 mm long with a proximal reference vessel diameter of 5. 5 mm and distal vessel diameter of 5. 2 mm and was classified as tasc ii c lesion. The target lesion was treated with pre-dilatation and placement of two 6 mm x 150 mm and 6 mm x 100 mm study stents respectively. Following post-dilatation, residual stenosis was 0%. On (b)(6) 2016, the subject was discharged on aspirin and clopidogrel. On (b)(6) 2020, the subject visited the hospital as an outpatient and subsequently vascular ultrasound of both lower extremity arteries was performed which revealed a right limb: stenosis in iliac area; mild stenosis was noted in common femoral artery (cfa) and sfa to popliteal artery. The left limb was moderate to severe stenosis in cia; moderate stenosis in cfa; occlusion of stent noted from proximal to distal sfa. Based upon above findings, no action was taken at that point of time and the subject was scheduled for endovascular treatment on (b)(6) 2020. On (b)(6) 2020, the subject was hospitalized for scheduled treatment. On the same day, 1162 days post procedure, 100% in stent occlusion noted in left sfa was treated by performing percutaneous intervention where the target lesion was initially predilated with a 4. 0 x 150 mm non-bsc study stent followed by additional dilation with a 5. 0 x 150 mm non-bsc study stent. Post dilatation, the poor site of dilation in the stent was treated by performing hyperbaric dilation added with a 5. 0 x 20 mm cutting balloon. Finally, long time dilation was performed twice with a 6. 0 x 150 mm non-bsc drug coated balloon with 0% residual stenosis (tvr). On (b)(6) 2020, the event was considered resolved and the subject was discharged on the same day. No further information is available at this point of time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02914 |
| MDR Report Key | 9818792 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2020-03-11 |
| 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 SCIMED, INC |
| 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 | ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-03-11 |
| Model Number | 24620 |
| Catalog Number | 24620 |
| Lot Number | 0018779191 |
| Device Expiration Date | 2016-12-31 |
| 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 | 2020-03-11 |