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 2020-03-18 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.
[183955947]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183955948]
It was reported that thrombus occurred. On (b)(6) 2019, a left atrial appendage (laa) closure procedure was successfully performed and a 27mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 23 mm. Prior to the procedure, aspirin was not administered. One day post procedure, the patient was discharged on aspirin and clopidogrel. On (b)(6) 2020, a transesophageal echocardiogram (tee) evaluation revealed a thrombus on the watchman device. The tee revealed a complete laa seal, with 1 cm thrombus on the atrial facing surface of the watchman device. It was noted that the patient stopped taking their medication and this could be the cause. The patient was started on eliquis to treat the thrombus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03358 |
| MDR Report Key | 9849545 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2018-09-23 |
| Date Added to Maude | 2020-03-18 |
| 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 | WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM |
| Generic Name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Product Code | NGV |
| Date Received | 2020-03-18 |
| Model Number | 10371 |
| Catalog Number | 10371 |
| Lot Number | 0022692941 |
| 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 | 2020-03-18 |