MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Lot Number 0027774632

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: (b)(6).

Event Description

(b)(6) study.It was reported that femoral puncture site bleeding occurred.The patient was enrolled into the champion-af clinical study on (b)(6) 2022, and the procedure was performed ten days later.A 24mm watchman flx left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 18.0mm.On the same day post index procedure, bleeding was noted through the femoral puncture site.No hematoma was seen and the bleeding was noted from the superficial subcutaneous cellular tissue.Three stitches were applied to the femoral puncture site in order to stop the bleeding and a swab compression with low pressure was given.Swab compression was removed four hours later without signs of bleeding.The patient was discharged home the following day on aspirin and edoxaban.

Event Description

Champion-af study.It was reported that femoral puncture site bleeding occurred.The patient was enrolled into the champion-af clinical study on (b)(6) 2022, and the procedure was performed ten days later.A 24mm watchman flx left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 18.0mm.On the same day post index procedure, bleeding was noted through the femoral puncture site.No hematoma was seen and the bleeding was noted from the superficial subcutaneous cellular tissue.Three stitches were applied to the femoral puncture site in order to stop the bleeding and a swab compression with low pressure was given.Swab compression was removed four hours later without signs of bleeding.The patient was discharged home the following day on aspirin and edoxaban.It was further reported that transthoracic echocardiography (tte) one day post procedure revealed the left ventricle (lv) was of normal size and thickness.Preserved systolic function was seen with no contractility disorders.The right ventricle (rv) was of normal size and function.The left atrium (la) was moderately dilated with intact interatrial septum (ias).The aortic valve was noted with 3 leaflets, with mild central leak.The mitral valve was noted with mild mitral insufficiency with no significant mitral stenosis (mean gradient < 3 mmhg) and tricuspid insufficiency.No pericardial effusion and pleural effusion.Noted.Twelve (12) days post procedure, the groin stiches were removed and dehiscence of the wound was noted.The patient was on aspirin (100mg) and edoxaban (30mg) at the time of this event.The patient treated this wound at home and the dehiscence was resolved ten days later.

Manufacturer Narrative

Describe event or problem - updated with new information.Other relevant history - updated with corrected baseline tee date.E1: initial reporter address 1 - (b)(6).

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Type of Device: 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: 13602094
• MDR Text Key: 286150975
• Report Number: 2134265-2022-02058
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2024
• Device Lot Number: 0027774632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White