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 LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.
[184162267]
It was reported a patient death occurred. A left atrial appendage (laa) closure procedure was performed. A 27mm watchman laa closure device was successfully implanted. The duration of the procedure was less than 30 minutes and based on the transesophageal echocardiogram (tee), no thrombus or other issue was noted. The patient was discharged the following day without complication. Two days post procedure, the patient presented to the emergency room with heart failure, ventricular fibrillation,and respiratory failure. The emergency team gave the patient cardiopulmonary resuscitation (cpr) until he showed some pulse and was placed on an artificial respiratory machine. Five days post procedure, the patient died from brain damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03597 |
| MDR Report Key | 9856553 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-03-08 |
| 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 | 0 |
| 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 | 2020-03-19 |
| Model Number | 10371 |
| Catalog Number | 10371 |
| Lot Number | 0023457073 |
| 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. Death | 2020-03-19 |