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

Model Number DUCT OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

The article was reviewed.This research article is a prospective single center experience to evaluate patient's risk of hypotension post pda occluder implant.On an unknown date, an 8mm by 6mm amplatzer pda occluder was chosen for implant.Prior to the procedure, the pda diameter was measured at the side of pulmonary artery was 2.5mm, the side of aorta was 7.5mm and its length was 7.1mm.The device was delivered via the pulmonary artery.Although there was trivial residual shunt, the device was successfully implanted, and the procedure was completed.After the procedure, the intraprocedural imaging was reviewed and it was seen that the superior end of the device disc protruded 2.5mm into the aorta.The following day, the echocardiography confirmed that the trivial residual shunt was still present but no increasing blood velocity at aortic arch was confirmed within the extraction range.Two years later, the echocardiography revealed that the disc of the device was still protruded into the aorta although there was no increasing blood velocity in aortic arch area.7 years after the procedure, the same findings was observed on the echocardiography images.The patient had no hypertension at the time of the last check, however, 15mmhg pressure gradient has been observed for ankle-brachial index (abi).As of present, no improvement has been confirmed across the ages.The patient is at risk for hypertension and an increase pressure gradient in the future.The primary author and correspondence author of the article is satoshi nakano md, 2-1-1, iwate 0283695, japan.

Manufacturer Narrative

As reported in a research article residual shunt was observed post-implant procedure and 7 years after the the device was implanted.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.H6 medical device problem code: code 2616 removed.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: 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: 16607655
• MDR Text Key: 311925913
• Report Number: 2135147-2023-01327
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Female