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	Insufficient Information (4580)
Date of Event	10/17/2023
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 5mm x 2mm amplatzer piccolo device was chosen for implantation into a 7 week old 1.4 kilogram patient.The 5mm x 2mm was determined to be too small so a 5mm x 4mm amplatzer piccolo was attempted to be implanted.The device was deployed but after release from the cable it migrated.The device was snared and removed.The patient remained stable throughout the procedure.No further devices were attempted and the patient underwent surgical ligation of the patent ductus arteriosus on (b)(6) 2023.
Additional Manufacturer Narrative
An event of device embolization to the left pulmonary artery and explant was reported.The embolized device was successfully retrieved by snare and removed from the body out of the lpa without issue.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.Based on the information received, the root cause of the reported incident could not be conclusively determined.However, it was noted that patient's pda was too large to be closed with available piccolo devices.
Event or Problem Description
It was reported that on (b)(6) 2023, a 5mm x 2mm amplatzer piccolo device was chosen for implantation into a 7 week old 1.4 kilogram patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 4.2 mm, length of 8 mm, and diameter at aortic ampulla of 5 mm.Sizing was determined via angiogram.The 5mm x 2mm was advancing to the pda, but it seemed unstable due to mis-sizing so a 5mm x 4mm amplatzer piccolo was attempted to be implanted.The device was implanted and stable on fluoroscopy imaging, but by the time echocardiographic imaging was brought up to confirm positioning, the device had completely dislodged and traveled to the left pulmonary artery.There was no obstruction of blood flow.The device was snared and removed.The patient remained stable throughout the procedure.There was no clinically significant delay and no patient consequences.No further devices were attempted and the patient underwent surgical ligation of the patent ductus arteriosus on (b)(6) 2023.The physician thought the patient's pda was too large to be closed with available piccolo devices.

• 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: 18092462
• Report Number: 2135147-2023-04917
• Device Sequence Number: 5993010
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/05/2023

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: 05/31/2024
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 7026235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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: 7 WK
• Patient Sex: Female
• Patient Weight: 1 KG