MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX?; system, appendage closure, left atrial

Model Number	M635WU50310
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Abdominal Pain (1685); Chest Pain (1776); Encephalopathy (1833); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Muscle Weakness/Atrophy (1967); Paralysis (1997); Renal Failure (2041); Dizziness (2194); Numbness (2415); Spinal Cord Injury (2432); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451); Back pain (4895)
Date of Event	08/13/2026
Type of Reportable Event	Death
Event or Problem Description
Reported via literature article it was reported that death occurred.A 67-year-old man underwent successful transfemoral left atrial appendage occlusion (laao) with a 31mm watchman flx closure device with transesophageal echocardiography (tee) guidance.Multiple angles were used to evaluate the left atrial appendage (laa) dimensions, with the widest ostium measured at 22 mm.The implant satisfied manufacturer position, anchor, size, and seal (pass) criteria.Immediate post implant tee confirmed appropriate closure device position, stable anchoring, adequate seal, and closure device compression of 19 to 29 percent with no peri device leak on color doppler assessment.No procedural complications occurred, and the patient was observed overnight, as per institutional protocol.The patient was discharged on dual antiplatelet therapy and instructed to avoid strenuous activity for two (2) weeks.Eighteen days later, while shoveling snow, the patient developed sudden-onset chest and back pain followed by bilateral lower extremity paralysis.Computed tomography (ct) revealed complete mid abdominal aortic occlusion from embolization of the laao closure device.Using a non-boston scientific (bsc) grasping forceps, the embolized closure device was captured and successfully retrieved into the non-bsc sheath and removed.Postretrieval angiography demonstrated no aortic dissection or contrast extravasation, and there was successful restoration of arterial flow to the kidneys, viscera, and lower extremities.Despite emergent endovascular retrieval and restoration of aortic flow, the patient developed fatal distributive shock from severe ischemia-reperfusion injury.The patient died within 48 hours of presentation.
Additional Manufacturer Narrative
B2: estimated as 08/13/26 as the published date for the article is noted as august 13, 2026, and the death date is unknown.B3: estimated as 08/13/26 as the published date for the article is noted as august 13, 2026, and the event date is unknown.D4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Literature citation: mackey, r., miller, a., palatnic, l.Et al.(2026) delayed aortic embolization of a left atrial appendage occlusion device: implications for risk-stratified postprocedural management.J am coll cardiol case rep.Null2026, 0 (0).Https://doi.Org/10.1016/j.Jaccas.2026.109756.

• Brand Name: WATCHMAN FLX?
• 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: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50951585
• Report Number: 2124215-2026-52105
• Device Sequence Number: 15859081
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: (01)08714729860518
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: M635WU50310
• Device Catalogue Number: M635WU50310
• 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: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• 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: Hospitalization; Required Intervention; Death; Other
• Patient Age: 67 YR
• Patient Sex: Male