MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER STEERABLE DS; CATHETER, PERCUTANEOUS

Model Number	ASDS-14F-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using an amplatzer steerable delivery sheath.After the defect was sized via transesophageal echocardiogram (tee), the physician planned to use either a 25mm or 28mm amulet device.A non-abbott guidewire was introduced, and the steerable sheath was tracked over the guidewire.The dilator was then removed from the sheath, a pigtail catheter was advanced over the guidewire, and the guidewire was removed.At this time contrast was injected into the appendage and the patient's blood pressure dropped.The procedure was paused to monitor the patient's blood pressure.The patient's blood was recycled the patient's blood pressure returned to a safe reading.No pericardial effusion was noticed at this time.The procedure was continued.Fluoroscopy images were then taken, and the physician decided to use the 28mm amulet device.The 28mm device was advanced into the appendage and deployed.Before the device was released, the patient's blood pressure dropped to 68/38.The physician observed via tee that a large pericardial effusion occurred in the pericardial space.The device was released from the delivery cable shortly after the pericardial effusion was noticed.The pericardial effusion progressed to cardiac tamponade.A pericardiocentesis was performed and fluid was removed from around the heart.Protamine was administered to reverse the heparin and increase the patient's clotting time.Approximately 10-15 minutes later, the patient's blood pressure improved to 148/67 and the patient became stable.The patient remained in the hospital overnight and improved.The patient was discharged the following day.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of hypotension was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, but the reported effusion may have contributed to the hypotension.

• Brand Name: AMPLATZER STEERABLE DS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16381053
• Report Number: 2135147-2023-00531
• Device Sequence Number: 12297634
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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 Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female