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	Obstruction/Occlusion (2422)
Date of Event	10/05/2022
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) 2022, a 4mm x 4mm amplatzer piccolo occluder was chosen for implant into a patent ductus arteriosus (pda) using an amplatzer torqvue lp delivery system.The dimensions of the defect were measured as 3.6mm x 4.9mm x 12.2mm.The sizing of the piccolo occluder was determined via angiography with measurement on the phillips system.Multiple catheters and wires were required to access the pda, but none of those devices used for initially crossing the defect were abbott products.The occluder was implanted into the pda, and upon release from the cable, the device embolized into the right pulmonary artery (rpa).This was determined by visualization of the device in the rpa under fluoroscopy.The device was retrieved using a transcatheter snare and removed from the patient.The operator believes the cause of the embolization was incorrect sizing of the device and position.The patient was reported as stable upon discharge from the hospital.
Additional Manufacturer Narrative
Additional information: d10, h6 - adverse event problem: added code 2017 medical device problem code.An event of device embolized into the right pulmonary artery 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.Based on the information received, the cause of the reported incident could potentially be related to the user not following the recommended sizing chart provided in the ifu.Please note that per the instructions for use, artmt600061587 version c, "warnings: accurate measurements of the ductus are crucial for correct occluder size selection" and "do an aortic angiogram or evaluate device position with echocardiography.Make sure the occluder is in the correct position.Make sure the occluder is stable.Make sure the occluder shape is correct.Measure occlusion of the pda and assess whether there is a residual shunt.".
Event or Problem Description
N/a.

• 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: 15712682
• Report Number: 2135147-2022-01881
• Device Sequence Number: 6621289
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/13/2023

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: 10/31/2024
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 7286807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE LP DELIVERY SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 2 KG