MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number 10371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

Summary reporting exemption approval number - e2017028.This summary report represents 4 patient death events.

Event Description

Boston scientific received events as part of the laao/ncdr registry for the watchman left atrial appendage (laa) closure devices, falling under the left atrial appendage occlusion (laao) registry of the american college of cardiology's national cardiovascular data registry (ncdr).Registry.This manufacturer report is being sent as a requirement under summary reporting exemption approval number - e2017028 for product code ngv.The data was downloaded 11 january 2019, due 11 may 2019.

Manufacturer Narrative

Summary reporting exemption approval number - e2017028.This supplemental report is being filed as requested by fda to include codes in the marker 3500a.This report summarizes 4 patient deaths.The submission was requested on 07 november 2019.Date of event: unknown.

Event Description

Boston scientific received events as part of the laao/ncdr registry for the watchman left atrial appendage (laa) closure devices, falling under the left atrial appendage occlusion (laao) registry of the american college of cardiology's national cardiovascular data registry (ncdr).This manufacturer report is being sent as a requirement under summary reporting exemption approval number - e2017028 for product code ngv.The data was downloaded 11 january 2019.Please see spreadsheet due 11 may 2019.

Event Description

Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes
10976112,,D,386;457,WATCHMAN LAA Closure Device & Delivery System,WU2706,2993
10976063,,D,664,WATCHMAN LAA Closure Device & Delivery System,WU2406,2993
10976572,,D,662,WATCHMAN LAA Closure Device & Delivery System,WU3006,2993
10975978,,D,Unk,WATCHMAN LAA Closure Device & Delivery System,WU2706,2993

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8579555
• MDR Text Key: 144089300
• Report Number: 2134265-2019-04850
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death