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

Catalog Number	9-PDAP-03-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 07 november 2024, a 3-4mm amplatzer piccolo occluder was chosen for implant with a 4f amplatzer torqvue lp delivery sheath for patent ductus arteriosus (pda) closure in a 3-week-old, 1017g patient.The pda minimal diameter measured 1.7mm.During procedure, the physician confirmed placement of the 3-4mm amplatzer piccolo was in the correct position with no obstruction to the aorta and left pulmonary artery, the device was stable, and there was no clinically significant residual shunt.After the piccolo occluder was deployed intraductally, it embolized into the pulmonary artery.A decision was made to retrieve and explant the device via transcatheter snare.A replacement 4-2mm amplatzer piccolo device was implanted with the same 4f amplatzer torqvue lp delivery sheath.It was then reported catheter infection was suspected and antibiotic treatment was administered.There was no report of any bends/kinks observed in the delivery sheath.There was no report of any contact with intracardiac tissue during occluder deployment.The patient's status was reported as unstable but not related to the event.
Additional Manufacturer Narrative
An event of migration or expulsion of device (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 specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the cause for the reported device embolization could not be conclusively determined.The patient effects of unspecified infection could not be determined.The reported unexpected medical intervention was results of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 20853263
• Report Number: 2135147-2024-06122
• Device Sequence Number: 15517858
• Product Code: MAE
• UDI-Device Identifier: 05415067030986
• UDI-Public: (01)05415067030986(17)250228(10)7441937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 9-PDAP-03-04-L
• Device Lot Number: 7441937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2020
• 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: Required Intervention
• Patient Age: 21 DA
• Patient Sex: Unknown
• Patient Weight: 1 KG