MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number 9-TV45X45-14F-080

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/09/2024

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 08 february 2024, a 28mm amplatzer amulet left atrial appendage occluder was selected for implant using a 14f amplatzer torqvue 45x45 delivery sheath.The sizing of the appendage was 21mm x 34mm for the orifice, 20mm x 23mm for the landing zone, and 24mm for the depth.The patient's activated clotting time (act) levels was over 250 seconds, and heparin was administered.During the procedure, the device was too big to close the appendage despite the measurements obtained during baseline.The physician decided to re-size to a 25mm amplatzer amulet left atrial appendage occluder and used the same 14f amplatzer torqvue 45x45 delivery sheath.As it was more suitable for patient's anatomy.After meeting close criteria and deployment, the patient's blood pressure dropped, and transesophageal echocardiography (tee) noticed an effusion near the left atrial appendage.The pericardial effusion lead to cardiac tamponade.The effusion was drained.The cause of the pericardial effusion was believed to be due to the 25mm amplatzer amulet occluder and the 14f amplatzer torqvue 45x45 delivery sheath.Patient was reported as stable.No further intervention was performed.

Manufacturer Narrative

An event of pericardial effusion lead to cardiac temponade during implant was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.There are multiple risk factors for pericardial effusion after a left atrial appendage closure procedure, including anticoagulation status of the patient, maneuvering of the guidewire or sheaths within the heart, the trans-septal puncture, or the stabilizing wires on the amulet puncturing the laa.The patient's act was over 250 seconds.Information from the field indicated that device was too big to close the appendage so to decided to re-size the occluder which may have contributed to the reported event.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 available information, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18838713
• MDR Text Key: 336958506
• Report Number: 2135147-2024-00998
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 05415067025906
• UDI-Public: (01)05415067025906(17)260630(10)9132467
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163000
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-TV45X45-14F-080
• Device Lot Number: 9132467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2023
• 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: AMPLATZER AMULET LAA OCCLUDER, 9-ACP2-010-025; AMPLATZER TORQVUE 45X45 DS, 9-TV45X45-14F-080
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male