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 2020-03-19 for WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM 10390 manufactured by Boston Scientific Corporation.
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(b)(6) study. It was reported thrombus on the device occurred. On (b)(6) 2019, a left atrial appendage (laa) closure procedure was performed. A 27mm watchman flx laa closure device was successfully implanted with a complete laa seal and deployed device diameter of 21. 0 mm. There was no evidence of thrombus. One day post procedure, the patient was started with 75 mg of aspirin and clopidogrel. On (b)(6) 2020, the patient presented for their follow up transesophageal echocardiogram (tee). It was noted there was a complete laa seal with pedunculated mobile thrombus with maximum area of 1. 0 cm2 on the atrial facing surface of the watchman device. The patient's medication was adjusted and the thrombus has since resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03442 |
| MDR Report Key | 9856720 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-03-19 |
| 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 FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM |
| Generic Name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Product Code | NGV |
| Date Received | 2020-03-19 |
| Model Number | 10390 |
| Catalog Number | 10390 |
| Lot Number | 0023964852 |
| 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 | 2020-03-19 |