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

Model Number 10371

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  Injury  

Event Description

It was reported that a device embolization occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The closure device was deployed in the laa of the patient.The physician checked the release criteria of the device and after successfully meeting all criteria the device was released.Upon release, the position of the device changed in such a way that it needed to be removed as it was not safe to leave in the patient.The was exchanged for a 20fr sheath across the septum and multiple attempts were made to snare the device into the sheath.The device was dislodged from the appendage, travelled down into the left ventricle and through the aortic valve.The physician had earlier obtained access in the right femoral artery.The watchman access sheath was inserted into the femoral artery to reach the device in the descending aorta.The device was successfully removed from the descending aorta and removed from the patient.The patient was checked and monitored and no trauma had been inflicted on the patient throughout the process.The patient remained stable throughout the entire procedure and there was no signs of pericardial effusion or other complications.

Event Description

It was reported that a device embolization occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The closure device was deployed in the laa of the patient.The physician checked the release criteria of the device and after successfully meeting all criteria the device was released.Upon release, the position of the device changed in such a way that it needed to be removed as it was not safe to leave in the patient.The was was exchanged for a 20fr sheath across the septum and multiple attempts were made to snare the device into the sheath.The device was dislodged from the appendage, travelled down into the left ventricle and through the aortic valve.The physician had earlier obtained access in the right femoral artery.The watchman access sheath was inserted into the femoral artery to reach the device in the descending aorta.The device was successfully removed from the descending aorta and removed from the patient.The patient was checked and monitored and no trauma had been inflicted on the patient throughout the process.The patient remained stable throughout the entire procedure and there was no signs of pericardial effusion or other complications.It was further reported that there were no further attempts to complete the procedure that day.The patient was discharged home the next day.

Manufacturer Narrative

Date of event corrected from (b)(6) 2019 to (b)(6) 2019.Implant date corrected from (b)(6) 2019 to (b)(6) 2019.Explant date corrected from (b)(6) 2019 to (b)(6) 2019.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9477219
• MDR Text Key: 171647236
• Report Number: 2134265-2019-15425
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024072434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention