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 2020-03-31 for LOTUS EDGE VALVE SYSTEM 10394 manufactured by Boston Scientific Corporation.
[187709599]
Patient identifier: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187709600]
(b)(6) study. It was reported that left bundle branch block(lbbb) and 1st degree atrioventricular(av) block occurred. Procedure summary: prior to the index procedure, heparin or another anticoagulant was given and the subject was on a prior regiment of aspirin and other antiplatelet medications at the time of index procedure. A lotus introducer sheath was placed, and the native aortic valve was treated with balloon valvuloplasty according to the directions for use. No conduction disturbances were noted post balloon valvuloplasty. The aortic valve was then treated with deployment of a 27 mm lotus edge valve which was implanted successfully into the proper anatomical location. On the same day of the index procedure, during the procedure, the subject was noted to have left bundle branch block and first-degree av block. No diagnostic procedure was performed for the event. The event led to prolongation of hospitalization. At the time of reporting the event was considered recovering. The patient was discharged home on aspirin and other antiplatelets the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03838 |
| MDR Report Key | 9903721 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-10-04 |
| Date Added to Maude | 2020-03-31 |
| 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 IRELAND LIMITED |
| 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 | LOTUS EDGE VALVE SYSTEM |
| Generic Name | LOTUS EDGE TM VALVE SYSTEM |
| Product Code | NPT |
| Date Received | 2020-03-31 |
| Model Number | 10394 |
| Catalog Number | 10394 |
| Lot Number | 0024544467 |
| 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. Hospitalization | 2020-03-31 |