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 Problems Difficult to Flush (1251); Air/Gas in Device (4062)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported air within the device sheath and thrombosis occurred.A left atrial appendage (laa) closure procedure was performed using a 31mm watchman laa closure device with delivery system (wds).During introduction of the wds sheath, the physician did not see any back bleed, and aspirated through the wds sheath using a syringe.The physician noted it was difficult to aspirate and observed a few air bubbles within the sheath.The device was removed from the patient and flushed with a saline injection.The closure device was then pushed outside of the delivery sheath and traces of thrombus were seen on the closure device.The procedure was completed with a new wds.No patient complications were reported.

Event Description

It was reported air within the device sheath and thrombosis occurred.A left atrial appendage (laa) closure procedure was performed using a 31mm watchman laa closure device with delivery system (wds).During introduction of the wds sheath, the physician did not see any back bleed, and aspirated through the wds sheath using a syringe.The physician noted it was difficult to aspirate and observed a few air bubbles within the sheath.The device was removed from the patient and flushed with a saline injection.The closure device was then pushed outside of the delivery sheath and traces of thrombus were see on the closure device.The procedure was completed with a new wds.No patient complications were reported.

Manufacturer Narrative

Media evaluated by bsc quality engineer: the watchman flx laa closure, 31mm ce was disposed of by the facility therefore device analysis could not be performed.A photograph of the implant from the clinical procedure was provided to bsc and reviewed by a bsc quality engineer.The photograph depicts the implant with thrombus attached in 2 locations confirming the reported event of thrombosis.No additional media was provided.

Manufacturer Narrative

Device evaluated by mfr.: the watchman flx delivery system (wds) with no stopcock and no implant was returned for analysis.The device was visually and microscopically examined.Inspection of the device found numerous kinks in the sheath.Microscopic examination revealed the silicone valve was damaged.There was tip damage as the tri-cuts were flared and there were abrasions on the inside of the sheath tip.Functional testing was completed, and the device could not be flushed properly.The device was not able to backflush, and air could not be purged from the device.The reported information and confirmed damaged valve are consistent with hemostasis valve damage, which does not allow for proper flushing through the device and can prevent air from being completely purged from the device.It was considered likely that the observed damage was attributed to procedural factors as the most likely cause of the damage is due to the forces that are put upon the device during insertion, advancing, and manipulation.Media evaluated by bsc quality engineer: the 31mm watchman flx laa closure device was disposed of by the facility therefore device analysis could not be performed.A photograph of the implant from the clinical procedure was provided to bsc and reviewed by a bsc quality engineer.The photograph depicts the implant with thrombus attached in 2 locations confirming the reported event of thrombosis.No additional media was provided.

Event Description

It was reported air within the device sheath and thrombosis occurred.A left atrial appendage (laa) closure procedure was performed using a 31mm watchman laa closure device with delivery system (wds).During introduction of the wds sheath, the physician did not see any back bleed, and aspirated through the wds sheath using a syringe.The physician noted it was difficult to aspirate and observed a few air bubbles within the sheath.The device was removed from the patient and flushed with a saline injection.The closure device was then pushed outside of the delivery sheath and traces of thrombus were see on the closure device.The procedure was completed with a new wds.No patient complications were reported.

• 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: 18399388
• MDR Text Key: 331406819
• Report Number: 2124215-2023-73318
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0031283053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other