MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Catalog Number 9-ACP2-010-031

Device Problems Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on 02 nov.2023, a 28mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implantation utilizing a 14f amulet delivery sheath.Before the amulet procedure, a mitraclip was placed successfully.The 28mm amulet was advanced to the laa, where transesophageal echocardiogram (tee) imaging showed that the device was undersized.The 28mm was removed and replaced with a 31mm amplatzer amulet laa occluder.The delivery system was not replaced as per instructions for use, to maintain access.Following the 31mm amulet partial deployment (ball position), a thrombus was suspected on tee.A small fiber-like filament was observed and seemed to be attached to the device (lobe) during the ball position step.The amulet device and the delivery system were then retrieved from the patient which removed the object.At that moment, patient's activated clotting time (act) was 309.The physician went ahead with a second amulet 31mm and replacement delivery system and the device was deployed and successfully released.The sheath was in the patient for a longer period due to device recaptures, repositioning and mis-sizing.The patient was given 100 units/kilogram heparin during the procedure and act was tested regularly.There was no clinically significant delay.The patient remained hemodynamically stable throughout the procedure and is recovering.

Manufacturer Narrative

An event of foreign body in patient and thrombus was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.Reported, the 28mm amplatzer amulet was removed due to undersized and replaced with a 31mm amplatzer amulet laa occluder using the same delivery system.Following the 31mm amulet partial deployment (ball position), a thrombus was suspected on tee.A small fiber-like filament was observed and seemed to be attached to the device (lobe) during the ball position step.The amulet device and the delivery system were then retrieved from the patient which removed the object.A new device was replaced.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

N/a.

• Brand Name: AMPLATZER AMULET
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18210907
• MDR Text Key: 329062952
• Report Number: 2135147-2023-05182
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: 00811806013510
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 6962843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMULET DELIVERY SHEATH
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 91 KG