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

Lot Number 0026194046

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

Patient Problems Anemia (1706); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 03/21/2021

Event Type  Injury  

Event Description

(b)(6) study.It was reported that a hematoma with blood loss occurred.On (b)(6) 2021, a left atrial appendage (laa) closure procedure was performed.Prior to the procedure, 75 mg aspirin was administered.A watchman truseal access system (was) was positioned and a 31mm watchman flx laa closure device & delivery system (wds) were used.The closure device was successfully implanted with a complete laa seal and deployed device diameter of 26.0 mm.On (b)(6) 2021, 2 days post implant procedure, the patient was noted with vast right-sided inguinal hematoma, which was painful on palpation, with anemia of 1.5 points.The suspected cause was due to puncture of collateral small arterial vessel.It was difficult to assess the presence of an actively bleeding hematoma since the patient was obese with extensive thigh edema.An urgent right femoral computer tomography (ct) angiography was recommended.On (b)(6) 2021, re-evaluation of the ct angiogram of the right lower limb revealed evidence of diffused blood suffusion in the right thigh, femoral artery bifurcation normally patent, no signs of pseudoaneurysm caused by spreading of the large arterial vessels.A small spot of contrast agent was present, possibly due to rupture of a thin peripheral collateral branch minimally fed in the late phase.The patients thigh was soft with no major pain and no signs of tension.An inguinal compression bandage was applied and was kept in place 24-48 hours.Complete blood count (cbc) monitoring and discontinuation of anticoagulant therapy was recommended.On (b)(6) 2021, ct scan of complete abdomen with and without contrast agent revealed extensive suffusion of high-density fluid, hematic in nature, in the right inguinal area that is present in the subcutaneous adipose tissue at the top of the thigh, an area at least 5 mm deep, descending along the lower right abdominal wall and along the medial aspect of the thigh itself.In the context of this suffusion, in the arterial contrasting phase, a thin spread of contrast medium was seen, from active bleeding probably originating from a thin collateral branch of the right femoral artery.Spreading increases minimally in the subsequent contrast phases.In the right inguinal area, multiple enlarged lymph node formations, possibly were reactive in appearance.Colonic diverticulosis and marked thinning of the renal cortical thickness due to chronic renal insufficiency (cri) were reported.On (b)(6) 2021, a blood transfusion was performed in response to the event.On (b)(6) 2021, the event was considered to be resolved.It was noted that this event was considered related to anticoagulant/antiplatelet medication (aspirin and antiplatelets).

Event Description

Ice-laa study: it was reported that a hematoma with blood loss occurred.On (b)(6) 2021, a left atrial appendage (laa) closure procedure was performed.Prior to the procedure, 75 mg aspirin was administered.A watchman truseal access system (was) was positioned and a 31mm watchman flx laa closure device & delivery system (wds) were used.The closure device was successfully implanted with a complete laa seal and deployed device diameter of 26.0 mm.On (b)(6) 2021, 2 days post implant procedure, the patient was noted with vast right-sided inguinal hematoma, which was painful on palpation, with anemia of 1.5 points.The suspected cause was due to puncture of collateral small arterial vessel.It was difficult to assess the presence of an actively bleeding hematoma since the patient was obese with extensive thigh edema.An urgent right femoral computer tomography (ct) angiography was recommended.On (b)(6) 2021, re-evaluation of the ct angiogram of the right lower limb revealed evidence of diffused blood suffusion in the right thigh, femoral artery bifurcation normally patent, no signs of pseudoaneurysm caused by spreading of the large arterial vessels.A small spot of contrast agent was present, possibly due to rupture of a thin peripheral collateral branch minimally fed in the late phase.The patients thigh was soft with no major pain and no signs of tension.An inguinal compression bandage was applied and was kept in place 24-48 hours.Complete blood count (cbc) monitoring and discontinuation of anticoagulant therapy was recommended.On (b)(6) 2021, ct scan of complete abdomen with and without contrast agent revealed extensive suffusion of high-density fluid, hematic in nature, in the right inguinal area that is present in the subcutaneous adipose tissue at the top of the thigh, an area at least 5 mm deep, descending along the lower right abdominal wall and along the medial aspect of the thigh itself.In the context of this suffusion, in the arterial contrasting phase, a thin spread of contrast medium was seen, from active bleeding probably originating from a thin collateral branch of the right femoral artery.Spreading increases minimally in the subsequent contrast phases.In the right inguinal area, multiple enlarged lymph node formations, possibly were reactive in appearance.Colonic diverticulosis and marked thinning of the renal cortical thickness due to chronic renal insufficiency (cri) were reported.On (b)(6) 2021, a blood transfusion was performed in response to the event.On (b)(6) 2021, the event was considered to be resolved.It was noted that this event was considered related to anticoagulant/antiplatelet medication (aspirin and antiplatelets).It was further reported that 100 mg of aspirin was administered prior to the procedure.Hemoglobin was noted to be 9.9 grams per liter on (b)(6) 2021.On (b)(6) 2021, three liters of blood was transfused and administered with intravenous iron therapy during the stay.

• 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
• MDR Report Key: 11780380
• MDR Text Key: 249236402
• Report Number: 2134265-2021-05023
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

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: 10/15/2023
• Device Lot Number: 0026194046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR