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

Model Number 10371

Device Problems Leak/Splash (1354); Migration (4003)

Patient Problem Transient Ischemic Attack (2109)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated based on the tia occurring in (b)(6) 2021.

Event Description

It was reported that a transient ischemic attack (tia) had occurred.A left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted.In (b)(6) 2020, the patient had their 45-day follow-up at which point the device was noted to still look great and the patient stopped the use of blood thinners.In (b)(6) 2021, the patient had a tia.At that point, the device was checked and was sitting noticeably different.It was deeper and canted with a large gutter down the limbus.No surgical intervention was required, however, the patient would resume the use of blood thinners.The patient made a full recovery.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12895451
• MDR Text Key: 281421344
• Report Number: 2134265-2021-15036
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White