MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? PRO; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU60400
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature citation: gianni c, et al., (2025).Percutaneous aspiration thrombectomy in patients with persistent left atrial appendage thrombus.Jacc: clinical electrophysiology, vol.11, no.11.Http://doi.Org/10.1016/j.Jacep.2025.06.018.B3: event date not reported in the article.Event date estimated based on date of article publication.D6a: implant date not reported in the article.Implant date estimated based on date of article publication.E1: facility name: (b)(6).Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the complete unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported via literature that transient ischemic attack and device did not seal occurred.This literature article discusses 22 cases of percutaneous aspiration thrombectomy (at) in patients with persistent left atrial appendage (laa) thrombus with subsequent laa closure.Aspiration thrombectomy was performed either manually, with a syringe, or mechanically with the aid of an aspiration pump.After at, laa closure was performed with either a watchman flx, watchman flx pro, or non-boston scientific laa occluder.Laa closure was successful in all cases.One patient who was discharged with half-dose apixaban after implantation of a 40mm watchman flx pro device experienced a transient ischemic attack 3 weeks post-implant.The patient's apixaban dose was increased to 5mg twice daily.The patient's 6-week transesophageal echocardiogram revealed the presence of a peri-device leak.The leak was subsequently closed at 2 months.
Event or Problem Description
It was reported via literature that transient ischemic attack and device did not seal occurred.This literature article discusses 22 cases of percutaneous aspiration thrombectomy (at) in patients with persistent left atrial appendage (laa) thrombus with subsequent laa closure.Aspiration thrombectomy was performed either manually, with a syringe, or mechanically with the aid of an aspiration pump.After at, laa closure was performed with either a watchman flx, watchman flx pro, or non-boston scientific laa occluder.Laa closure was successful in all cases.One patient who was discharged with half-dose apixaban after implantation of a 40mm watchman flx pro device experienced a transient ischemic attack 3 weeks post-implant.The patient's apixaban dose was increased to 5mg twice daily.The patient's 6-week transesophageal echocardiogram revealed the presence of a peri-device leak.The leak was subsequently closed at 2 months.
Additional Manufacturer Narrative
Literature citation: gianni c, et al., (2025).Percutaneous aspiration thrombectomy in patients with persistent left atrial appendage thrombus.Jacc: clinical electrophysiology, vol.11, no.11.Http://doi.Org/10.1016/j.Jacep.2025.06.018 detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the complete unique identifier (udi) # and other specific product information.With all the available information, boston scientific (bsc) concludes: device history record review: the batch number of the watchman flx pro closure device was not provided.Boston scientific's manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, and there is no evidence that this product did not meet specification prior to distribution.Device technical analysis: the watchman flx pro closure device remains implanted, therefore returned device analysis could not be completed.The attached literature article contains medical media which was already reviewed by authors of the publication.No further review was performed by boston scientific.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.The ifu lists "implant did not seal", and "transient ischemic attack (tia)" (medication required) as potential adverse events.Risk review: a risk review was completed and confirmed that the events of implant did not seal and tia were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: bsc has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: WATCHMAN FLX? PRO
• Common Device Name: 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: 24475228
• Report Number: 2124215-2026-11178
• Device Sequence Number: 18545708
• Product Code: NGV
• UDI-Device Identifier: 00191506004637
• UDI-Public: (01)00191506004637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60400
• Device Catalogue Number: M635WU60400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown