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 2019-05-23 for EXPRESS SD RENAL/BILIARY 20188 manufactured by Boston Scientific Corporation.
[145957976]
It was reported that the stent dislodged. The target lesion was located in a renal artery. A 7. 0mmx15mmx150cm express sd stent was advanced for treatment with a 6fr guide catheter. During procedure, the stent was unable to cross the lesion and the stent came off the balloon and landed in external iliac artery. The stent was deployed to 7. 5mm so it would be opposed to the vessel wall instead of trying to retrieve it. A 5mm balloon was used to pre-dilate the renal artery and another stent was successfully deployed in the target lesion with the used of a guide. No patient complications were reported and the patient was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-05729 |
| MDR Report Key | 8636959 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-05-10 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2019-05-23 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| 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 | EXPRESS SD RENAL/BILIARY |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | NIN |
| Date Received | 2019-05-23 |
| Model Number | 20188 |
| Catalog Number | 20188 |
| Lot Number | 0021504344 |
| 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. Other | 2019-05-23 |