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 10418 manufactured by Boston Scientific Corporation.
[187709956]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187709957]
(b)(6) study. It was reported that complete heart block and left bundle branch block occurred. Prior to the index procedure, heparin or other anticoagulant was given. The subject was on prior regimen of antiplatelet medication other than aspirin at the time of index procedure. A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty. No conduction disturbance was noted post balloon valvuloplasty. The aortic valve was treat with subsequent deployment of a 27 mm lotus edge valve. There was correct positioning of a single prosthetic heart valve into the proper anatomical location without the need for repositioning. Complete heart block and left bundle branch block were noted during index procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03265 |
| MDR Report Key | 9903421 |
| 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 |
| 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 LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY 9279 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | 9279 |
| 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 | 10418 |
| Catalog Number | 10418 |
| 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 | 2020-03-31 |