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

Model Number	OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
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 (b)(6) 2023, a 4mm by 2mm amplatzer piccolo occluder was implanted in a 6 week, 1.6kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 1.7 mm, length of 9 mm, and diameter at aortic ampulla of 2.5 mm.It was reported that on (b)(6) 2023, that the device embolized into the pulmonary artery.The device was explanted without incidence.The patient remained stable throughout the explant procedure.The patient is reported to be recovering.No additional information was provided.
Additional Manufacturer Narrative
An event of embolization of the 4/2mm piccolo occluder was reported.A returned device assessment could not be performed as the device 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.Information from the field indicated that the physician believed that the reported event could have been caused by significant systemic hypertension.However, a review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, the recommended size devices for patients <2kg the appropriate sized occluder for the defect would have been a 3/2mm occluder.Based on the information received, the cause of the reported incident could potentially be related to the mis-sizing of the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: the physician used a 4mm by 2mm piccolo instead of the recommended 3mm by 2mm piccolo because it was believed it would better fir the anatomy of the patient.It was reported that on (b)(6) 2023, that the device migrated in the pulmonary artery.It is believed this migration was due to significant systemic hypertension.The device was explanted via transcatheter snare without incidence, and the pda spontaneously closed without further intervention.The patient remained stable throughout the explant procedure.The patient is reported to be recovering.Patient weight updated to 1.3 kg.No additional information was provided.

• 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: 16384984
• Report Number: 2135147-2023-00540
• Device Sequence Number: 12189060
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• 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: 2023
• Device Explanted Year: 2023
• 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): 04/03/2023

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 Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 8544670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/26/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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: Required Intervention
• Patient Age: 6 WK
• Patient Sex: Unknown