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 LD ILIAC / BILIARY 20226 manufactured by Boston Scientific Corporation.
[182388671]
It was reported that balloon rupture, stent inadequate apposition, and vessel dissection occurred. The target lesion was located in the left common iliac vessel. Following pre-dilatation with an 8x40 balloon, a 10. 0x30x75cm express ld iliac / biliary stent was advanced for treatment. However, upon inflating the balloon inside the stent, the balloon ruptured. The balloon was pulled out. The stent was noted to be dog-boned, which could not fully inflate the stent. Another non-bsc balloon was used to post dilate the stent. There was a slight dissection noted from the common iliac towards the aorta and the physician post dilated it again with the non-bsc balloon. No further patient complications were reported and the patient did good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02700 |
| MDR Report Key | 9799961 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2017-08-16 |
| 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 | 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 | EXPRESS LD ILIAC / BILIARY |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 20226 |
| Catalog Number | 20226 |
| Lot Number | 0021015198 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |