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

Model Number 9-ACP2-010-031

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, a 31mm amplatzer amulet left atrial appendage occluder was chosen for implant.Air bubbles were observed while attempting to implant the amulet device.The device was retracted into the loader and de-aired.The device was attempted to implant again.When it was deployed in the left atrial appendage (laa), stringy materials were seen that were suspected to have come from the inside of the delivery sheath.The stringy materials were then wrapped around the device, and they were removed from the patient with the device.The procedure was aborted.The patient was discharged the next day.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of strands being observed on an amulet device was reported.A returned device assessment could not be performed as the device and the substance 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 form the field indicated the device was fully retracted into the amplatzer steerable sheath that was used again to deploy the amulet.Based on the information received, the use of the same sheath after full retraction to eliminate air bubbles observed in the sheath could have lead to the inner lining of the sheath being transferred onto the occluder thus causing the reported incident.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note per the instructions for use: ¿ if the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced.Failure to replace both the device and the sheath may result in sheath and/or device malfunction.

Event Description

Subsequent to the initially filed report, the following information was received that the patient was under general anesthesia during the procedure.A continuous flush was attached to the device.The user was advised to flush forward while advancing the device to the end of the sheath.It was unsure if that was done.No contrast was being injected.No additional information was provided.Related manufacturer reference number: 2135147-2022-02623-00.

• 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: 15997216
• MDR Text Key: 305785698
• Report Number: 2135147-2022-02621
• 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,Followup
• Report Date: 02/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ACP2-010-031
• Device Catalogue Number: 9-ACP2-010-031
• Device Lot Number: 8534660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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