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

Catalog Number	9-PDA-004
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported through a literature article, ¿wire snare close loop: a novel technique to retrieve embolized devices¿, a 22-month-old female patient with a patent ductus arteriosus.It was reported that a 6-4-mm amplatzer ductal occluder type 1 (ado-1) was chosen for implant.After release of the device, it was noted the device embolized immediate into the right pulmonary artery.A decision was made to retrieve the device via transcatheter snare but was unsuccessful.The device was successfully removed from the patient using a wire snare close loop novel method.The article concluded this novel technique describes a safe and more reliable method to retrieve embolized ado-1 devices.This technique can also be used to retrieve other embolized devices, as an alternative to, or when other standard techniques are not feasible.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, "wire snare close loop: a novel technique to retrieve embolized devices", was reviewed.The article presented a case study of a 22-month-old female patient with a patent ductus arteriosus.It was reported that on an unknown date, a 6-4-mm amplatzer ductal occluder type 1 (ado-1) was chosen for implant.After release of the device, it was noted the device embolized immediate into the right pulmonary artery.A decision was made to retrieve the device via transcatheter snare but was unsuccessful.The device was successfully removed from the patient using a wire snare close loop novel method.The article concluded this novel technique describes a safe and more reliable method to retrieve embolized ado-1 devices.This technique can also be used to retrieve other embolized devices, as an alternative to, or when other standard techniques are not feasible.[the primary and corresponding author was manish bansal, lillie frank abercrombie section of cardiology, texas children¿s hospital, baylor college of medicine, 6651 main street, e 1920, houston, texas 77030, usa, with corresponding e-mail: mbansal@bcm.Edu].

• Brand Name: AMPLATZER DUCT OCCLUDER
• 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: 18013034
• Report Number: 2135147-2023-04693
• Device Sequence Number: 12629836
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: 00811806011110
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDA-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 22 MO
• Patient Sex: Female