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

Catalog Number 9-ACP2-007-022

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/19/2023

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 (b)(6) 2023, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During the procedure, the patient's activated clotting time (act) was 250s and heparin was administrated and patient was under general anesthesia.The physician felt some difficulty to implanting the device.During implant, the end screw of the amulet device perforated the posterior base of left atrial appendage (laa) was perforated, resulting in pericardial effusion.Due to pericardial effusion patient became tachycardic and hypotensive with the pericardial effusion until it was drained with pericardiocentesis.The pericardial effusion lead to cardiac tamponade.Patient need for an emergency open heart surgery to repair the perforation in the laa.The torqvue 45x45 sheath and the amulet device were in the laa when the perforation was noticed.The surgery was successful and the perforation was closed.The patient required extended hospital stay.The patient remained stable after post surgery.

Manufacturer Narrative

An event of difficulty implanting the device due to complex and trabeculated anatomy was reported.It was also reported that the end screw of the amulet device perforated the posterior base of laa during implant, resulting in pericardial effusion that led to cardiac tamponade.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, however, patient's complex anatomy and implanting difficulties may have contributed to the reported perforation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2023, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During the procedure, the patient's activated clotting time (act) was >250s and heparin was administrated and patient was under general anesthesia.The physician felt some difficulty to implanting the device due to complex and trabeculated anatomy during implant, the end screw of the amulet device perforated the posterior base of left atrial appendage (laa) was perforated, resulting in pericardial effusion.Due to pericardial effusion patient became tachycardic and hypotensive with the pericardial effusion until it was drained with pericardiocentesis.The pericardial effusion lead to cardiac tamponade.Patient need for an emergency open heart surgery to repair the perforation in the laa.The torqvue 45x45 sheath and the amulet device were in the laa when the perforation was noticed.The surgery was successful and the perforation was closed.The patient required extended hospital stay.The patient remained stable after post surgery.

• 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: 18119523
• MDR Text Key: 327928615
• Report Number: 2135147-2023-04972
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013480
• UDI-Public: 00811806013480
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-007-022
• Device Lot Number: 8849726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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: UNKNOWN SIZE AMPLATZER TORQVUE 45X45 DELIVERY SHEA
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention