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

Model Number	9-ACP2-010-028
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a 28mm amplatzer amulet was chosen for implant using an unknown delivery system.Initially a 25mm amplatzer amulet device was attempted initially but it did not pass the tension test and therefore it was removed and a 28mm amplatzer amulet was implanted and noted that it met the close criteria.It was also noted that this was implanted during a concomitant procedure and it was reported that this was a challenging case dure to heavy pectinate anatomy and pre-procedure was attempted initially.On (b)(6) 2025, a post-discharge chest x-ray (dc cxr) was performed later demonstrated that the device had embolized.This finding was not identified at the time, of the imaging review.Subsequent evaluation determined that the device had migrated to the descending aorta.Review of the implant-day transesophageal echocardiogram (tee) images showed the device appeared seated; however, one imaging view suggested a possible lack of posterior apposition, though this may have been attributable to the imaging angle.The ep lab staff notified on a later date that an embolized device was present.Retrieval of the embolized device and explant were performed on (b)(6) 2025.The device was successfully retrieved without complications.Following retrieval, an laa closure was completed using a non-abbott device.The patient remained stable throughout the retrieval procedure, exhibited no symptoms related to the embolized device, and was discharged without complications.
Additional Manufacturer Narrative
An event of device embolization was reported.A returned device assessment could not be performed as the device 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported device embolization is likely related to the patient's anatomy and procedural conditions, however this could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as the device was removed via snare.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) 2025, a 28mm amplatzer amulet was chosen for implant using a 14f amplatzer torqvue delivery sheath.Initially a 25mm amplatzer amulet device was attempted initially but it did not pass the tension test and therefore it was removed and a 28mm amplatzer amulet was implanted and noted that it met the close criteria.It was also noted that this was implanted during a concomitant procedure and it was reported that this was a challenging case dure to heavy pectinate anatomy and pre-procedure was attempted initially.Landing zone measurements used for sizing were obtained by transesophageal echocardiography (tee) and included the following: at 0°¿ostium 30mm, landing zone 21mm, depth 28mm; at 45°¿ostium 29mm, landing zone 19mm, depth 27mm; at 90°¿ostium 30mm, landing zone 21mm, depth 26mm; at 135°¿ostium 30mm, landing zone 23mm (depth not available).Device sizing was determined using these tee measurements, and the 25¿mm device was initially selected based on these values; however, the 25mm device popped out during the tug test, prompting selection of the 28mm device.Tee and fluoroscopy were used during the procedure.The device shape at implant was described as compressed/sandwich, and no peri-lobe leak was observed.Multiple recaptures and multiple device attempts were required during implantation.On (b)(6) 2025, a post-discharge chest x-ray (dc cxr) was performed, which later demonstrated that the device had embolized; however, this finding was not identified during the initial imaging review.Subsequent evaluation determined that the device had migrated to the descending aorta.Review of the implant-day tee images showed the device appeared seated, though one view suggested a possible lack of posterior apposition that may have been attributable to imaging angle.Migration was later confirmed by x-ray, tte, and tee.The device had completely dislodged from the implant site.The implanter attributed the embolization to the patient¿s anatomy, including heavy pectinate structures and a possible change in the left atrial appendage (laa) following ablation conducted during the concomitant procedure.The embolization was first recognized during a routine postoperative 45-day tte, and no rhythm change occurred during the procedure.The lab staff were notified at a later date that an embolized device was present.Retrieval and explant were performed on (b)(6) 2025.The device was successfully retrieved from the descending aorta via groin (percutaneous) access, without complications.The embolized device did not cause obstruction or blockage of blood flow.Following retrieval, an laa closure was completed using a non-abbott device.The patient remained stable throughout the retrieval procedure, reported no symptoms related to the embolized device, and was discharged without complications.

• 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: 24169067
• Report Number: 2135147-2026-00418
• Device Sequence Number: 9111261
• Product Code: NGV
• UDI-Device Identifier: 00811806013503
• UDI-Public: (01)00811806013503(17)300331(10)10809129
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/24/2026

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-ACP2-010-028
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 10809129
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male