FDA Adverse Event Injury Summary report: N

WATCHMAN FLX? PRO

MDR report key: 22849353 · Received August 20, 2025

Report

Report Number
2124215-2025-57873
Event Type
Injury
Date Received
August 20, 2025
Date of Event
July 25, 2025
Report Date
August 20, 2025
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
NGV
UDI-DI
00191506004590
PMA / PMN Number
P130013
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
AZ, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. POST-PROCEDURE AS THE PATIENT WAS COMING BACK FROM THE POST-ANESTHESIA CARE UNIT, THE NURSE NOTICED THE PATIENT HAD DIFFICULTY FINDING THEIR LEFT HAND, SLURRED SPEECH, AND LEFT ARM TINGLING. DURING CONSULTATION WITH THE NEUROLOGIST, THE PHYSICIAN NOTICED WHEN THE PATIENT WAS TRANSFERRING AN OBJECT FROM RIGHT HAND, THEY HAD TROUBLE PLACING IN THEIR LEFT HAND. HEAD COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. THE CT RESULTS READ, "NO ACUTE INTRACRANIAL ABNORMALITY IS DEMONSTRATED. MODERATE TO SEVERE PATCHY AND CONFLUENT HYPOATTENUATION OF THE SUPRATENTORIAL WHITE MATTER IS NON-SPECIFIC BUT MOST LIKELY REPRESENTS THE SEQUEL OF CHRONIC MICROVASCULAR ISCHEMIC DISEASE. THERE IS A SUPRASELLAR MASS LESION WITH MARGINAL CALCIFICATIONS MEASURING UP TO 1.8 CM. THIS APPEARS TO DISTINCT FROM THE PITUITARY GLAND. THIS IS NON-SPECIFIC BUT MAY REPRESENT A MENINGIOMA." A FOLLOW UP MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. THE MRI RESULTS READ, "SUPRASELLAR MASS, MENINGIOMA VERSUS HEMATOMA WOULD BE MOST LIKELY IN THE DDX. L CEREBELLUM PERIPHERAL SMALL LESS THAN 5 MM ACUTE INFARCT." THE FINAL DIAGNOSIS WAS TIA AND ACUTE 5 MM INFARCT OF CEREBELLUM. THE SUSPECTED CAUSE OF THE TIA WAS EMBOLIC TIA SETTING OF RECENT PROCEDURE VS. POSITIONAL IN SETTING OF C-SPINE ISSUES. THE PATIENT IS SCHEDULED FOR CERVICAL EPIDURAL HEMATOMA SURGERY WITH LAMINECTOMY OF C3-C6 IN (B)(6) 2025 FOR THEIR UNDERLYING SPINE ISSUES. ORAL ANTITHROMBOTIC WAS ADMINISTERED IN RESPONSE TO THE TIA EVENT AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1316128 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60240 0036466716 00191506004590

Patients

Seq Age Sex Outcome Treatment
1 82 YR Female Other