MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for WALLSTENT ENDOPROSTHESIS 26280 manufactured by Boston Scientific Corporation.
[184674751]
It was reported that stent migration occurred and required additional intervention. On (b)(6) 2020, the more than 75% stenosed target lesion, measuring 15mm in healthy vessel, was located in the right subclavian vein and noted via ivus. During the procedure, a 16mm x 60mm x 75cm wallstent endoprosthesis stent was deployed. The stent was pre and post dilated with charger balloon dilatation catheters 8mm x 40mm and 10 mm x 40mm. The physician was pleased with the results and the patient outcome was optimal. On (b)(6) 2020, it was noted that the wallstent had migrated to the superior vena cava, past the initial stenosis and placement by at least 2-3 cm. A 16mm x 60mm vici venous stent was placed at the lesion. Post dilatation was completed with a balloon catheter. There were no patient complications nor injuries reported and the patient was stable and doing well post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03743 |
| MDR Report Key | 9871793 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-03-27 |
| Date Added to Maude | 2020-03-24 |
| 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 | WALLSTENT ENDOPROSTHESIS |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | MAF |
| Date Received | 2020-03-24 |
| Model Number | 26280 |
| Catalog Number | 26280 |
| Lot Number | 0023550585 |
| 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 | 12 | 1. Required No Informationntervention | 2020-03-24 |