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.
[187709787]
Patient identifier: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187709788]
(b)(6) study. It was reported that arrhythmia occurred. Prior to the index procedure, heparin or other anticoagulant was given and the subject was not on a prior regimen of aspirin or antiplatelet at the time of index procedure. The subject received a loading dose of 300 mg of aspirin. A lotus introducer was placed, and aortic annulus was treated with balloon aortic valvuloplasty (bav) and subsequent deployment of a 23 mm lotus edge valve. Successful repositioning of the lotus valve system involved partial re-sheathing into the delivery catheter and deployment into a more accurate position within the aortic annulus, in accordance with the directions for use. On the same day, post index procedure, the subject developed left bundle branch block (lbbb), 1st degree atrioventricular (av) block and 3rd degree av block. Of note, no conduction disturbance was noted post bav. No action was taken to treat the events. One (1) day post index procedure, a new permanent pacemaker was successfully implanted. Three (3) days post index procedure, the arrhythmias were considered resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03831 |
| MDR Report Key | 9905117 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-09-28 |
| 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 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 | 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 | 0024507888 |
| 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 | 2020-03-31 |