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 2020-02-20 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.
[180414203]
Age at time of event- age at time of event: 18 years or older. Initial reporter state: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[180414204]
It was reported that the patient experienced a dissection. Vascular access was obtained via the left upper arm. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa). After passing with a non-bsc 0. 014" guidewire and inflating a non-bsc 6x80 balloon, a dissection occurred. The guidewire was changed to a 0. 035" guidewire and a 6x80, 130cm eluvia drug-eluting vascular stent system was implanted. After placement of the eluvia stent, the dissection spread to the distal side of the stent. A 6x120, 130cm eluvia drug-eluting vascular stent system was implanted. The thumbwheel spins as the stent was deployed approximately one third. The pull grip was pulled out, but the stent did not deploy any more. The physician disassembled the handle and tried to deploy the stent, but could not deploy it. After an attempt was made to pull the eluvia into the non-bsc 6fr introducer sheath with the whole system together, but the stent broke. One third of the stent was implanted in the vessel, it stretched a few centimeters and broke. Several struts of the stent on the shaft side were protruding from the shaft, and the stent could not be pulled into the sheath. The physician pulled it slowly to the puncture site as it was, then the puncture site was cut open by a vascular surgeon to remove the entire system. After that, an eluvia 6x120 was placed in the broken stent. Good blood flow was confirmed by angio and the procedure was completed. There were no further patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-01722 |
| MDR Report Key | 9732441 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-01-09 |
| Date Added to Maude | 2020-02-20 |
| 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 | 2020-02-20 |
| Model Number | 24653 |
| Catalog Number | 24653 |
| Lot Number | 0023235505 |
| 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 | 2020-02-20 |