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

Model Number 9-PDA-006

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

Patient Problem Foreign Body Embolism (4439)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had an iatrogenic ventricular septal defect and was implanted with an amplatzer duct occluder between may 2019 and november 2019.An event of device embolization was reported.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.Please note, per the amplatzer duct occluder instructions for use, artmt100092302 revision a "indications and usage: the amplatzer duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).".

Event Description

The article, "using the new amplatzer trevisio delivery cable to facilitate closure of atrial and ventricular shunts" was reviewed.This research article reported a case study on a (b)(6) year old patient weighing (b)(6) kg who underwent ventricular septal intervention with an amplatzer occlusion device between may 1 and november 30, 2019.The patient had an iatrogenic vsd following surgical myomectomy for hypertrophic cardiomyopathy.Attempts to deploy a 10/8 amplatzer duct occluder with the standard cable were hindered by the limited flexibility of the device within the septum, and the device ultimately embolized.After changing to the amplater trevisio cable, however, the defect was able to be closed with relative ease using a larger amplatzer duct occluder.The article concluded that the amplatzer trevisio delivery cable offers reduction in device tension prior to release and reorientation after release without sacrificing device pushability when compared to the traditional delivery cable for deployment of the amplatzer series of devices.The primary and correspondence author is j.T.Randall, the heart institute, children¿s hospital of colorado, aurora, co, united states of america with the email jess.T.Randall.Md@gmail.Com.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11244511
• MDR Text Key: 229162233
• Report Number: 2135147-2021-00045
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 9-PDA-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/28/2021
• 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: 5 YR
• Patient Weight: 18