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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm by 2mm amplatzer piccolo occluder was successfully implanted intraductally.The patent ductus arteriosus (pda) minimal diameter was measured to be 2.9mm, the pda diameter at the aortic ampulla was measured to be 6.1mm, and the pda length was measured to be 6.1mm.On the same day, it was observed that the device embolized to the left pulmonary artery.The embolized device was snared and removed in an emergency procedure.Three days later on (b)(6) 2023, a smaller 4mm by 2mm amplatzer piccolo occluder was intraductally implanted.Immediately, this device also embolized to the right pulmonary artery.Preserved flow was reported after the device embolized.Bilateral pneumothorax occurred and bilateral surgical drainage was performed.The device was not explanted due to hemodynamic instability.The patient was reported as stable and in recovery.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of embolization of the 5/2 and 4/2mm piccolo occluders was reported.A returned device assessment could not be performed as the 5/2 occluder 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 cause of the reported incident could have been as a result of unfavorable anatomy.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 for the defect would have been a 4/2mm occluder.(the size of the second occluder used).Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Subsequent to the previously filed report, the following information was received: the first device embolized immediately after release from the delivery cable.The embolized device was explanted and the 4mm by 2mm amplatzer piccolo occluder was implanted also on (b)(6) 2023.The patient became hypotensive after the second device embolized and adrenaline was administered to treat the hypotension.The surgical drainage was done emergently to prevent permanent impairment or death.The second embolized device remained implanted.The patient was extubated and was reported as stable.

• 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: 16448481
• Report Number: 2135147-2023-00706
• Device Sequence Number: 5599756
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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 Expiration Date: 06/30/2025
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7580932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 2 KG