MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-21 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180585243]
Initial reporter state: (b)(6). Device is a combination product.
Patient Sequence No: 1, Text Type: N, H10
[180585244]
It was reported that the stent shortened. The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa). Ipsilateral antegrade approach was performed with a non-bsc 6f introducer sheath. The lesion was pre-dilated. A 6x80x130 eluvia drug-eluting vascular stent system was advanced; however, resistance was felt when delivering the stent from the side hole to the placement point. The shaft of the delivery device was stuck with the stent and the stent shortened after full deployment. A second stent was selected. The 6x40x130 eluvia drug-eluting vascular stent system was deployed approximately 3cm then became difficult to deploy with the pull grip; therefore the whole system was pulled to fully deploy the stent. There were no patient complications reported and the patient's status is good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01857 |
| MDR Report Key | 9740825 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-02-28 |
| Date Added to Maude | 2020-02-21 |
| 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 | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| 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 | 2020-02-21 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0023560290 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-21 |