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 2020-03-06 for EXPRESS SD RENAL/BILIARY 20188 manufactured by Boston Scientific Corporation.
[182388788]
It was reported that stent dislodgement occurred. The target lesion was located in the superior mesenteric artery. A 6. 0mmx18mmx90cm express sd stent was deployed far into the aorta. Subsequently, another 6. 0mmx18mmx90cm express sd stent was advanced to anchor with the already deployed stent. However, the stent came off the balloon as well as knocking the already deployed stent out of place. Both stents were snared and retrieved from the patient. The procedure was completed with a different device. No patient complications were reported and the patient's status was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02635 |
| MDR Report Key | 9799723 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-06 |
| 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 | EXPRESS SD RENAL/BILIARY |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | NIN |
| Date Received | 2020-03-06 |
| Model Number | 20188 |
| Catalog Number | 20188 |
| Lot Number | 0024263570 |
| 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 | 2020-03-06 |