FDA Adverse Event
Death
Summary report: N
WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM
MDR report key: 6061925
·
Received October 27, 2016
Report
- Report Number
- 2134265-2016-09454
- Event Type
- Death
- Date Received
- October 27, 2016
- Date of Event
- September 29, 2016
- Report Date
- September 30, 2016
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NGV
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. IN (B)(6) 2016, A 24MM WATCHMAN ® LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED DURING A LAA CLOSURE PROCEDURE. IN (B)(6) 2016, THE PATIENT WENT INTO FULL CARDIAC ARREST AND EXPIRED. THE CAUSE OF DEATH WAS NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713515 | WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC - MAPLE GROVE | M635WU24060 | 0019297353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |