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

Catalog Number 9-ACP2-010-025

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 11/21/2023

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 25mm amplatzer amulet left atrial appendage occluder was chosen for a left auricle closure procedure using a 12f amplatzer torqvue 45x45 delivery sheath.During the procedure, after the transseptal puncture heparin was administrated.The amulet was successfully implanted.One day after the procedure, on the recovery room, the tension of the patient got decreased and transesophageal echocardiogram (tee) showed a cardiac tamponade.The patient had a circumferential effusion and was transferred to the operating room for drainage.The implanter mentioned the stabilizing wires caused the pericardial effusion and cardiac tamponade.A wound was also noted in the pulmonary artery.The patient was reported stable after that.The amulet remain implanted.The patient required prolonged hospitalization.

Manufacturer Narrative

An event of pericardial effusion 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.Reportedly, the amulet was successfully implanted.One day after the procedure, the patient's blood pressure decreased, and transesophageal echocardiogram (tee) showed a cardiac tamponade.The patient had a circumferential pericardial effusion and was transferred to the operating room for drainage.The implanter mentioned the stabilizing wires caused the pericardial effusion and cardiac tamponade.A wound was also noted in the pulmonary artery.The patient was reported stable after that.The amulet remained implanted.Based on the information received, the cause of the reported incident appears to be related to procedural conditions.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18323272
• MDR Text Key: 330428739
• Report Number: 2135147-2023-05508
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)271231(10)8824250
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 8824250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening