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

Catalog Number 9-ACP2-010-031

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/25/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 31mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implant, utilizing 14f amplatzer torqvue 45x45 delivery sheath.Prior to the amulet procedure, a small effusion was observed anteriorly on transesophageal echocardiogram (tee).During the procedure, after the third device recapture, the patient¿s blood pressure was noted to drop.Pericardial effusion was observed in the inferior left ventricle via tee, causing cardiac tamponade.It was believed that the distal end screw got caught in the distal pectinate muscle of the heart, causing the perforation.The device was removed and pericardiocentesis was performed.The procedure was completed with a non-abbott device implanted.The patient is reported to be stable.

Manufacturer Narrative

An event of low blood pressure/hypotension, perforation, and pericardial effusion led to cardiac tamponade was reported.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.Information obtained from the field indicated that prior to the amulet procedure, a small effusion was observed anteriorly on transesophageal echocardiogram (tee).During the procedure, after the third device recapture, the patient¿s blood pressure was noted to drop.Pericardial effusion was observed in the inferior left ventricle via tee, causing cardiac tamponade.It was believed that the distal end screw got caught in the distal pectinate muscle of the heart, causing the perforation.The device was removed and pericardiocentesis was performed.The procedure was completed with a non-abbott device implanted.The patient is reported to be stable.Based on the information received, the cause of the reported event of pericardial effusion could not be conclusively determined.

• 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: 18133030
• MDR Text Key: 328071380
• Report Number: 2135147-2023-05008
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013510
• UDI-Public: 00811806013510
• 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
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8723212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2022
• 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): Required Intervention; Life Threatening
• Patient Age: 89 YR
• Patient Sex: Female