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 2020-03-30 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM manufactured by Boston Scientific Corporation.
[187709314]
Date of event: estimated based on the aware date of 09mar2020.
Patient Sequence No: 1, Text Type: N, H10
[187709315]
It was reported that thrombosis occurred. A left atrial appendage (laa) closure procedure was performed and a watchman closure device was implanted without issue. Post implant, the patient was put on lovenox and aspirin due to issues with noacs and warfarin with regard to bleeding. At the 45-day follow-up tee, clot was noted on the device. At this time, the patient was taken off of lovenox and placed on eliquis. A tee was scheduled for four weeks from that date to reassess the device. In that time, the patient developed a gi bleed because of the eliquis. They took the patient off of eliquis and the patient developed a deep vein thrombosis. When the patient returned for the 4-week evaluation tee, the clot on the device was gone. The patient was again placed on lovenox. The patient's condition right now was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03915 |
| MDR Report Key | 9900782 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| 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 | 2020-03-30 |