MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number UNK AMPLATZER OCCLUDER

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date, an unknown size device was implanted in the patient using an unknown delivery system.On 45 day follow up transesophageal echocardiogram (tee) reveled a clot on the disc.

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided 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, an unknown size amplatzer amulet was chosen for a left atrial appendage occlusion (laao) procedure using an unknown delivery system.Patient was on 2.5mg eliquis prior to laao.The amulet was implanted.Patient discharged on plavix 75mg and asa 81mg.On (b)(6) 2023, 45 day follow up transesophageal echocardiogram (tee) reveled a layered thrombus.The patient reinitiated on xarelto 20 x 3 months.On (b)(6) 2023, repeat tee was performed, no thrombus was noted.

Manufacturer Narrative

An event of patient device interaction problem and thrombus was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, a root cause of the reported incident could not be conclusively determined.Thrombus is a potential adverse events associated with the device or implant procedure per the amplatzer amulet instructions for use.Furthermore, this complaint was reviewed by abbott representative.The reviewer stated that, "patient was on eliquis 2.5mg prior to laao, discharged on plavix 75mg and asa 81mg event date: 09/20/2023 tee layered thrombus ¿ reinitiated on xarelto 20 x 3 months 45 day follow up imaging review- sequence 7 demonstrates at least moderate mitral regurgitation.Sequence 8 shows a bi-plane tee image across the amulet device.A 2.5mm thick layer of either tissue or thrombus is noted across the entire disc into the pulmonary vein ridge.The disc also appears to be under the ridge at approximately a 90 degree angle to the ridge.Sequence 10 is a biplane view of the laa now with color.Significant mr noted in this image.There does not appear to be any leaks.Thickening across the disc is also noted.Sequence 12 demonstrates again the thickness across the entire disc into the pulmonary vein ridge.Sequence 13 is a 3d of the disc.Difficult to assess thrombus in this image but does appear to have a textured look to the disc with more globular looking tissue.6 month follow up imaging review- sequence 7 is a biplane tee image across the amulet device.A thinner layer of tissue appears across the entire disc.Imaging may be more suggestive of endothelization vs.Thrombus.Thickness does appear slightly less than at the 45 day follow up after resuming xarelto.Sequence 9 is another biplane view, again it appears to have a thinner look to the tissue covering the amulet disc.In summary-findings suggestive of grade 1 hat after referencing article nielsen-kudsk drt-jaccci-2023 article per dr.Delaughter." (reference pre-investigation task (pit-005111) cine reviews within the complaint record)h6 health effect - clinical code: code 4582 removed.H6 health effect - impact code: code 4614 removed.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: 18454875
• MDR Text Key: 332199897
• Report Number: 2135147-2024-00096
• Device Sequence Number: 1
• Product Code: MLV
• 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: 02/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male