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

Catalog Number	9-ACP2-007-016
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) - catalyst ide, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 16mm amplatzer amulet left atrial appendage occluder was chosen for implant with a 12f amplatzer amulet delivery sheath.At the start of procedure, the patient's atrial rhythm was at atrial flutter.The patient's left atrial appendage (laa) dimensions were as follows: laa depth = 16mm, laa orifice = 13mm, landing zone = 11-13mm, and la pressure = 9mmhg).The patient's most recent international normalized ratio (inr) was 1.0 on (b)(6) 2024.During procedure, heparin was administered and the patient's activated clotting time (act) levels ranged 212-289 seconds.During procedure, there were 3 partial recaptures before the 16mm amplatzer amulet was completely recaptured prior to release from the delivery cable and removed from the patient.It was then decided to attempt an implant with an 18mm amplatzer amulet but it was also unsuccessful due "spontaneous dislocation and over-compression because of sized mis-match" and was subsequently recaptured prior to release from the delivery cable and replaced.A decision was made to reuse the first 16mm amplatzer amulet but during device preparation, it was noted that the loader was broken and the device was not aspirating properly.It was observed that there was resistance, air was lost from the catheter, and there was an air leak in the loader sheath.The 16mm amplatzer amulet was then replaced with a second 16mm amplatzer amulet.There were 2 partial recaptures before the device was successfully implanted.It was reported the same 12f amplatzer amulet delivery sheath was reused for all three amulet devices and remained in the patient for 54min during the procedure.It was then reported on 29 august 2024, a follow-up transesophageal echocardiography (tee) noted a large thrombus on the device.The thrombus was noted "pedunculated" and "round" in shape, not fiber-like in shape, and located on the surface of amulet disc, measuring 10x13mm.The patient was started on anticoagulation.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of thrombus was reported.A returned device assessment could not be performed as the device remains implanted and 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported unexpected medical intervention was related to administration of medication (anticoagulant).There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER AMULET
• Common Device Name: 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: 20278663
• Report Number: 2135147-2024-04662
• Device Sequence Number: 7564302
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)271130(10)8798976
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8798976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER AMULET DS, DS-TV45X45-12F-080
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 90 KG