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

Model Number DUCT OCCLUDER

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Arrhythmia (1721)

Event Date 03/10/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 8/6 mm amplatzer duct occluder was chosen for a patent ductus arteriosus defect closure procedure using a amplatzer torqvue delivery system.The device was sized according to echocardiogram (echo).The device was implanted.After implant, the patient had develop an arrhythmia.An echocardiogram was performed revealing the device had embolized into the pulmonary artery.The device was snared and a new 12/10 mm amplatzer duct occluder was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

The previous report was submitted on 9/22/22 and failed ack 3.This report is being resubmitted at the request of the cesub help desk due to an infrastructure issue at fda.An event of device embolism was reported.The investigation confirmed the device met dimensional and visual specifications when analyzed at abbott.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 occluder which miss-sized, which caused the embolism.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 14235040
• MDR Text Key: 290257758
• Report Number: 2135147-2022-00229
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 8068729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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
• Treatment: AMPLATZER TORQVUE DS 9-ITV06F180/80
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 15 KG