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

Catalog Number 9-ACP2-010-028

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)

Patient Problems Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 01/16/2024

Event Type  Death  

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 16 january 2024, a 28mm amplatzer amulet left atrial appendage occluder was chosen for a left atrial appendage occlusion (laao) procedure using a 14f amplatzer amulet delivery sheath.The patient had a challenging anatomy with a landing zone of 27.2 x 17.2 mm on computed tomography (ct) and the shape of the appendage was broccoli.For device selection, the team used ct, transesophageal echocardiogram (tee) and fluoroscopy imaging.During procedure, after some tries and different possible device position, the physician decided to release the device.The physician confirmed the close criteria was fulfilled and tension test was performed, and the device was delivered and the device compression was in the flat tire shape.Some minutes after the delivery, tee showed the device was moving and the physician decided to recapture the amulet via a non-abbott catheter, but the device embolized.The amulet went from the auricle to the ventricle.There was partial obstruction of blood flow between auricula and ventricle.The physician believes the cause of embolization was device failure and/or sizing and anatomy.After hours of trying to recapture the device with the amulet delivery sheath, non-abbott catheters, snares, and wires, the attempts were unsuccessful, so the patient went to open-heart surgery.The retrieval of the embolized device was considered an emergency procedure.The device was extracted, but the mitral valve was damaged.The surgeon replaced the mitral valve.On (b)(6) 2024, 10 hours after the surgery, the patient passed away.

Manufacturer Narrative

An event of device embolization from the auricle to the ventricle, partial obstruction of blood flow between auricula and ventricle and patient death was reported.It was reported that the patient had a challenging anatomy and the shape of the appendage was broccoli.It was confirmed that the close criteria was fulfilled and tension test was performed, and the device was delivered in flat tire shape compression after attempts and different possible device positions during procedure.Information from field indicated that after hours of trying to recapture the device the attempts were unsuccessful, the patient went to open-heart surgery.The device was extracted, but the mitral valve was damaged.It was reported that the mitral valve was replaced and the patient expired ten hours after the surgery.A returned device assessment 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.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.The provided imaging from field showed that the proposed landing zone had 9.6 mm of depth in the 136-degree tee view, less than the 12 mm required for the 28 mm device attempted.Please note that per the instructions for use, "identify and measure the left atrial appendage at the landing zone (defined as about 10 mm-12 mm from the orifice) for the device lobe (shown as v in table t2) to determine the appropriate device size to occlude the left atrial appendage.".

• 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: 18655377
• MDR Text Key: 334705403
• Report Number: 2135147-2024-00546
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)270831(10)8677719
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 04/03/2024

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 Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 8677719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Female