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

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant date was reported as (b)(6) 2020.
Event or Problem Description
It was reported that the patient experienced a cerebral vascular accident.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman flx laa closure device & delivery system (wds) were used.The procedure went as planned and the closure device was successfully implanted in the laa of the patient.There were no patient complications that were reported to have occurred.6 weeks post procedure the patient had a follow up procedure.There were no device leaks or a device related thrombus.The patient was taken off of their anticoagulation medication.8 weeks post procedure the patient presented to the hospital with a cerebral vascular accident.Imaging tests showed that there was no device related thrombus or any device leaks.A thrombus was noted behind the closure device.5 months post procedure the patient had a transesophageal echocardiogram procedure.The imaging showed no device related thrombus or leaks.The imaging still showed the thrombus behind the closure device.7 months post procedure the patient presented with a syncopal episode.No device related thrombus or leak was noted.The area affected by the cerebral vascular accident in the left parietal lobe from 8 weeks post procedure could still be seen with no change.
Event or Problem Description
It was reported that the patient experienced a cerebral vascular accident.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.The procedure went as planned and the closure device was successfully implanted in the laa of the patient.There were no patient complications that were reported to have occurred.6 weeks post procedure the patient had a follow up procedure.There were no device leaks or a device related thrombus.The patient was taken off of their anticoagulation medication.8 weeks post procedure the patient presented to the hospital with a cerebral vascular accident.Imaging tests showed that there was no device related thrombus or any device leaks.A thrombus was noted behind the closure device.5 months post procedure the patient had a transesophageal echocardiogram procedure.The imaging showed no device related thrombus or leaks.The imaging still showed the thrombus behind the closure device.7 months post procedure the patient presented with a syncopal episode.No device related thrombus or leak was noted.The area affected by the cerebral vascular accident in the left parietal lobe from 8 weeks post procedure could still be seen with no change.It was further reported that the patient was started on plavix along with a statin following the cerebral vascular accident.The patient had mild grip weakness of the right hand and some dexterity issues along with slurred speech and confusion at times post cerebral vascular accident.The patient was planned to receive pt/ot and be discharged to a skilled facility however family declined the transfer to the skilled facility.At 6 weeks post procedure the patient had a minimal peri-device leak and there was a thrombus noted to be behind the closure device.At 8 weeks post procedure the patient presented to the hospital with increase in weakness and slurred speech.The patient was found to have a stroke on the left frontal parental area with no bleed.At 5 months post procedure the imaging showed that there was a 2mm device leak.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13957464
• Report Number: 2134265-2022-03685
• Device Sequence Number: 4350450
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024800723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown