MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Arrhythmia (1721); Bradycardia (1751); Hypoxia (1918); Pericardial Effusion (3271)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 4mm x 2mm amplatzer piccolo occluder was selected for implant on (b)(6) 2024 using a 4f amplatzer torqvue low profile catheter for a 16 day old patient with a weight of 0.955kg for a patent ductus arteriosis (pda) with a minimal ductus diameter of 1.98mm and a ductus length of 5.33mm.Pre-echocardiogram velocities were measured as the descending aorta (da) at 1.89m/s and the left pulmonary artery (lpa) as 1.46m/s.The defect was measured as 8.24mm at the largest diameter on the aortic side.Echocardiogram (echo) and fluoroscopy was used for the procedure.During the procedure, when the occluder was placed intraductal into the pda, velocities changed 1.45m/s for the lpa and 2.2m/s for the da.No residual shunts were observed.The occluder was released from the delivery cable.Post-implant the delivery sheath appeared under fluoroscopy near the occluder.The delivery sheath was pulled back and the occluder was observed to have moved slightly towards the lpa, causing the velocity to increase to 1.95m/s.Four attempts were made to snare the occluder with a 8f non-abbott snare and 4f non-abbott introducer sheath.The wire position was through the right ventricular outflow tract and into the main pulmonary artery trying to retrieve the occluder.The patient's hemodynamics went down when the retrieval sheath was across the tricuspid valve.The patient also had decreased oxygen, heart rate, and left ventricle function.As the patient's vitals decreased the physician performed chest compressions with the retrieval sheath still in the heart, causing a large circumferential pericardial effusion.A drainage was placed.The decision was made to wait for the patient to stabilize and then have the occluder surgically removed.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that post-implant of piccolo device the delivery sheath appeared near the occluder under fluoroscopy; the delivery sheath was pulled back and the occluder was observed to have moved slightly towards the lpa, causing the velocity to increase.Information from field indicated that four attempts were made to snare the occluder, the patient's hemodynamics went down when the retrieval sheath was across the tricuspid valve.Reportedly, the patient had decreased oxygen, heart rate, and left ventricle function.As the patient's vitals decreased chest compressions were performed with the retrieval sheath still in the heart, causing a large circumferential pericardial effusion.Cine review was performed at abbott, there was a small circumferential pericardial effusion noted, and the device was shown with slight protrusion into lpa on echocardiogram.A review of the ductal measurements as reported from the field was performed which indicated that the recommended size device per instructions for use was used.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.Based on information received the cause of reported device migration is consistent with operational context.The cause of reported patient effects of hypoxia, bradycardia and arrhythmia appears to be a cascading effect from attempts to snare the device.The reported medical intervention was result of case-specific circumstances as the migrated device was attempted to be snared, chest compressions were performed for decreased vitals, and a drainage was placed for perforation.Field indicated that the decision was made to wait for the patient to stabilize to surgically remove the occluder.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 21137792
• Report Number: 2135147-2025-00268
• Device Sequence Number: 15161025
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: (01)05415067031006(17)270930(10)8739006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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-PDAP-04-02-L
• Device Lot Number: 8739006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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: 3.2F MERIT ENSARE; 4F COOK FLEXOR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 16 DA
• Patient Sex: Male
• Patient Weight: 1 KG