MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PICCOLO OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDAP-03-02-L

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Embolism (1829)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 3/2 amplatzer piccolo occluder was selected for implant in a (b)(6) week old, (b)(6) g patient with the following patent ductus arteriosus(pda) dimensions of: 1.6mm at the pa end of the duct and a length of 10mm.During the procedure the device was placed intraductal, but the device initially pulled through the duct while attempting to place it, so the duct was recrossed and the physician attempted to place the device again.After multiple attempts at repositioning the device, the physician was able to get the device in what was deemed to be a good position.The physician noticed that the device initially moved after being released, so the physician watched it for a couple of minutes, but the device ultimately embolized into the left pulmonary artery (lpa) within a few minutes of releasing it.The physician was able to quickly remove the device with minimal difficulty using a 5mm gooseneck snare and a 4fr cook flexor sheath.The decision the was made to attempt closure with a 4/2 amplatzer piccolo occluder.After repositioning this device in the duct a couple of times, the physician was able to get the device in a good position within the duct.However, echo interrogation and angio through the delivery system revealed comprised lpa flow.Ultimately, the 4/2 device was not released from the cable and was subsequently removed from the patient.The decision was made to stop the procedure at this time and re-evaluate after the baby recovered.The tricuspid valve was thoroughly interrogated with echo, but appeared to be functioning normal at the end of the case.The patient remained stable throughout the procedure and there were no serious adverse events.Both devices were delivered through a 4fr tvlp (lot 7400232).The patient underwent surgical closure of the pda the following day and the patient is currently stable in the nicu.

Manufacturer Narrative

An event of embolism was reported.The investigation confirmed the device met functional and dimensional 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.A review of the measurements as reported from the field was performed.Per the instruction for use, arten600042307 version b, for a pda with a minimum diameter of 1.6 mm and a length of 10mm, a 3/2mm piccolo, the size of the embolized device, is recommended per the sizing table.The cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation on the embolism, per internal procedures.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11073256
• MDR Text Key: 223728649
• Report Number: 2135147-2020-00555
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: 05415067030979
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-03-02-L
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 7385256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 DA
• Patient Weight: 1