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

Model Number WS6040

Device Problem Difficult to Open or Close (2921)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Speech Disorder (4415); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Heal-laa study with patient identifier (b)(6).It was reported that a device failure to seal occurred.Prior to the index procedure, heparin was administered.In (b)(6) 2023, a left atrial appendage (laa) closure procedure was performed using a 40mm watchman flx pro laa closure device (wds) with a complete laa seal and deployed device diameter of 36 mm.The patient was discharged with aspirin and apixaban.In december 2023, during a routine 45-day follow-up examination, transesophageal echocardiogram (tee) identified the closure device was positioned at the laa ostium with the maximum diameter plane of the closure device within 2mm of the desired ostial plane.Additionally, a peri-device leak measuring 4mm was observed.The patient was instructed to discontinue apixaban and begin clopidogrel.

Event Description

Heal-laa study with patient identifier (b)(6).It was reported that a device failure to seal occurred.Prior to the index procedure, heparin was administered.In october 2023, a left atrial appendage (laa) closure procedure was performed using a 40mm watchman flx pro laa closure device (wds) with a complete laa seal and deployed device diameter of 36 mm.The patient was discharged with aspirin and apixaban.In december 2023, during a routine 45-day follow-up examination, transesophageal echocardiogram (tee) identified the closure device was positioned at the laa ostium with the maximum diameter plane of the closure device within 2mm of the desired ostial plane.Additionally, a peri-device leak measuring 4mm was observed.The patient was instructed to discontinue apixaban and begin clopidogrel.It was further reported in (b)(6) 2024 the patient present to the emergency department with right sided weakness and aphasia.The patient was given a dose of tenecteplase (tnk).At the time of the event, the patient withheld on eliquis medication for two months.The patient was admitted to the hospital and underwent brain computed tomography (ct), laboratory tests, and radiographs.An ischemic stroke was diagnosed, medication was administered, and angiography without revascularization was performed.The patient was transferred to another hospital for thrombectomy procedure.Five (5) days post admittance to the hospital the patient recovered and was discharged with aspirin and clopidogrel.

• Brand Name: WATCHMAN FLX PRO LAA 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: 18566797
• MDR Text Key: 333516342
• Report Number: 2124215-2024-01220
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WS6040
• Device Catalogue Number: WS6040
• Device Lot Number: 0032255230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White