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

Catalog Number	9-PDAP-05-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 (b)(6) 2024, a 5 mm x 4 mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure using a 4f amplatzer torqvue lp delivery system for a 12kg patient.The pda minimal diameter was 2mm, and the diameter at aortic ampulla was 7-8mm.The sizing of the device was determined by angiography.The device was successfully implanted.On (b)(6) 2024, a follow up imaging was conducted, and showed the occluder was dislocated completely from the implant state.The physician mentioned inappropriate device size was the cause of embolization.The device was removed by a minimally invasive procedure by using a snare.The retrieval of the device was considered as a emergency procedure.A new 4mm amplatzer duct occluder was implanted.The patient was reported stable.
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.Information from the field indicated that a follow up imaging was conducted, and showed the occluder was dislocated completely from the implant state.The physician mentioned inappropriate device size was the cause of embolization.The device was removed by a minimally invasive procedure by using a snare.The retrieval of the device was considered as a emergency procedure.A new 4mm amplatzer duct occluder was implanted.Based on the information received, the cause for the reported device embolization appears to be related to procedural conditions (inappropriate device size selection).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: 18978676
• Report Number: 2135147-2024-01343
• Device Sequence Number: 6035970
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: (01)05415067031044(17)261231(10)8304090
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/18/2024

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-PDAP-05-04-L
• Device Lot Number: 8304090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 12 KG