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

Model Number	9-ACP2-010-025
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/06/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was chosen for implant using a 14f amulet delivery system.The patient was reported to be stable prior to the procedure and in normal sinus rhythm.Transseptal puncture was performed at an inferior/mid-anterior location, after which a trivial baseline pericardial effusion was noted.The initial plan was to implant a 22 mm amplatzer amulet; however, after two recaptures the device demonstrated inadequate stability and compression, prompting an upsize to a 25 mm device.Anticoagulation during the case included heparin (act 250¿350 seconds), and protamine was administered.A single exchange to a torqvue 14f delivery system was performed over a versacross wire that had engaged the laa, with the sheath advanced to the mid left atrium and the laa engaged using a pigtail catheter.The 25 mm amulet was positioned successfully after one additional (partial) recapture due to a mitral shoulder; there was one partial recapture with the 25 mm device, one complete recapture into the delivery system, and the device was exchanged while the sheath was reused after a considerable backbleed.Because tee imaging was challenging, angiography was used in conjunction with tee to evaluate close, and the device was released.The pericardial effusion appeared relatively unchanged intra-procedurally and the case concluded at approximately 11:00 a.M.Left atrial pressure at the time of the procedure was 6 mmhg.The patient remained stable for several hours in recovery.At approximately 4:00 p.M., after returning from the restroom, the patient developed sudden chest discomfort followed by pulseless electrical activity; a code was initiated and life-saving measures were undertaken.Tte revealed an approximately 1 cm pericardial effusion; the effusion was later characterized as circumferential with the largest dimension of 2 cm, and the clinical team concluded cardiac tamponade was present.Bedside pericardiocentesis in the icu yielded 250 cc of fluid, but despite nearly an hour of resuscitative efforts, the patient did not respond and was pronounced deceased on (b)(6) 2026.The implanter believes that a pericardial effusion believed by the user to have been caused by an abbott device, ultimately led to pea and death.The cause of death was documented as pulseless electrical activity (pea).
Additional Manufacturer Narrative
The device remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of an implant patient-device incompatibility, angina, pericardial effusion, cardiac tamponade, cardiac arrest, and death was reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported patient-device incompatibility and pericardial effusion could not be determined.The reported angina, cardiac tamponade, and cardiac arrest are likely cascading effects from the event.The unexpected medical interventions were a result of case specific circumstances, as a pericardiocentesis and cpr were performed.The death is likely related to worsening of the pre-existing effusion; however, this cannot be determined.The reported improper or incorrect procedure or method is related to the same delivery system used for both plugs.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm amplatzer amulet was chosen for implant using a 14f amulet delivery system.The patient was reported to be stable prior to the procedure and in normal sinus rhythm.Transseptal puncture was performed at an inferior/mid-anterior location, after which a trivial baseline pericardial effusion was noted.The initial plan was to implant a 22 mm amplatzer amulet; however, after two recaptures the device demonstrated inadequate stability and compression, prompting an upsize to a 25 mm device.Anticoagulation during the case included heparin (act 250¿350 seconds), and protamine was administered.A single exchange to a torqvue 14f delivery system was performed over a versacross wire that had engaged the laa, with the sheath advanced to the mid left atrium and the laa engaged using a pigtail catheter.The 25 mm amulet was positioned successfully after one additional (partial) recapture due to a mitral shoulder; there was one partial recapture with the 25 mm device, one complete recapture into the delivery system, and the device was exchanged while the sheath was reused after a considerable backbleed.Because tee imaging was challenging, angiography was used in conjunction with tee to evaluate close, and the device was released.The pericardial effusion appeared relatively unchanged intra-procedurally and the case concluded at approximately 11:00 a.M.Left atrial pressure at the time of the procedure was 6 mmhg.The patient remained stable for several hours in recovery.At approximately 4:00 p.M., after returning from the restroom, the patient developed sudden chest discomfort followed by pulseless electrical activity; a code was initiated and life-saving measures were undertaken.Tte revealed an approximately 1 cm pericardial effusion; the effusion was later characterized as circumferential with a largest dimension of ~2 cm, and the clinical team concluded cardiac tamponade was present.Bedside pericardiocentesis in the icu yielded 250 cc of fluid, but despite nearly an hour of resuscitative efforts, the patient did not respond and was pronounced deceased on (b)(6) 2026.The implanter believes that a pericardial effusion believed by the user to have been caused by an abbott device, ultimately led to pea and death.The cause of death was documented as pulseless electrical activity (pea).

• 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: 24535930
• Report Number: 2135147-2026-01436
• Device Sequence Number: 10458392
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)300430(10)10878167
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 10878167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Death
• Patient Age: 78 YR
• Patient Sex: Male