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

Model Number DUCT OCCLUDER II

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article "structure club japan live demonstration 2022 (p.59)" was reviewed it was reported that on march of an unknown year, a patient had an unknown mechanical heart valve implanted.In november of the same year, a paravalvular leak was found, and the valve was replaced with another unknown valve.In march of a different unknown year, the patients cardiac insufficiency exacerbated, and the paravalvular leak was observed again.It was deiced to attempt percutaneous paravalvular leak closure.There were 3 paravalvular leaks between 6 o'clock and 9 o'clock.It was also noted that the annulus was flailed partially.A 4mm x 4mm amplatzer duct occluder ii was implanted at the 9 o'clock position.Then a 6mm x 4mm amplatzer duct occluder ii was implanted in the 6 o'clock, and the paravalvular leak was unable to be controlled due to the flailed annulus.The 6mm x 4mm amplatzer duct occluder ii then fell out of its original position.A 16mm amplatzer vascular plug ii was the implanted into the 6 o'clock position.A 6mm x 4mm amplatzer duct occluder ii was then implanted at the 8 o'clock position to complete the procedure.7 days post operatively the 16mm amplatzer vascular plug ii embolized from the annulus.The 16mm amplatzer vascular plug ii was snared and removed from patient anatomy.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer duct occluder were reported in a research article in a subject population with multiple co-morbidities including failed annulus.Some of the complications reported were recurrence of patients cardiac insufficiency and embolization.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.A returned device assessment could not be performed as the device was not returned for analysis.Abbott also requested image for device/issue which was not provided by the field.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, as per instructions for use, "indications and usage the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus".

• Brand Name: AMPLATZER DUCT OCCLUDER II
• 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: 16474304
• MDR Text Key: 310591528
• Report Number: 2135147-2023-00972
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: 00811806011257
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUCT OCCLUDER II
• Device Catalogue Number: 9-PDA2-06-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male