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

Model Number 10390

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

Patient Problems Bacterial Infection (1735); Endocarditis (1834)

Event Date 04/19/2023

Event Type  Injury  

Event Description

It was reported that infection occurred.A left atrial appendage (laa) closure procedure was performed and a 35mm watchman flx closure device was implanted.Approximately two (2) months post-implant at a routine follow-up, transesophageal echocardiogram (tee) was performed revealing filamentous strands.The patient was diagnosed with staph bacteremia.The physician is not certain what the cause is as the patient also has a valve replacement and pacemaker.

Event Description

It was reported that infection occurred.A left atrial appendage (laa) closure procedure was performed and a 35mm watchman flx closure device was implanted.Approximately two (2) months post-implant at a routine follow-up, transesophageal echocardiogram (tee) was performed revealing filamentous strands.The patient was diagnosed with staph bacteremia.The physician is not certain what the cause is as the patient also has a valve replacement and pacemaker.It was further reported that the patient underwent a lead extraction of the existing pacemaker and further review of the watchman closure device showed no more vegetation.There had been no shift or seal compromise of the watchman closure device.

Manufacturer Narrative

B5: additional information added.

Manufacturer Narrative

B3: updated from 4/29/2023 to 4/19/2023 to align with date of new information.B5: additional information added.H6: patient code added and evaluation conclusion code added.

Event Description

It was reported that infection occurred.A left atrial appendage (laa) closure procedure was performed and a 35mm watchman flx closure device was implanted.Approximately two (2) months post-implant at a routine follow-up, transesophageal echocardiogram (tee) was performed revealing filamentous strands.The patient was diagnosed with staph bacteremia.The physician is not certain what the cause is as the patient also has a valve replacement and pacemaker.It was further reported that the patient underwent a lead extraction of the existing pacemaker and further review of the watchman closure device showed no more vegetation.There had been no shift or seal compromise of the watchman closure device.It was further reported that the patient had endocarditis on (b)(6) 2023, 10 days prior to the routine follow up where the patient was diagnosed with staph bacteremia.

• Brand Name: WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16904415
• MDR Text Key: 314929364
• Report Number: 2124215-2023-21535
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: 08714729860525
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0027718912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 92 KG