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

Model Number 9-PDAP-05-04-L

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problems Embolism (1829); Foreign Body Embolism (4439); No Clinical Signs, Symptoms or Conditions (4582)

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 an unknown date, a 5/4 amplatzer piccolo occluder was selected for implant in a 6 month old patient with the following patent ductus arteriosus(pda) dimensions: minimal diameter of 3mm, length of 5mm and ampulla of 6.5mm.The device was successfully implanted in the patient, but later that day the device embolized into the left pulmonary artery(lpa) and the patient returned to the cath lab for device removal and new implantation of a device.The 5/4 amplatzer piccolo occluder was successfully retrieved with no complications and a 5/4 amplatzer duct occluder was implanted with good position.

Event Description

On (b)(6) 2020, a 5/4 amplatzer piccolo occluder was selected for implant in a 6 month old, 5.798kg patient with the following patent ductus arteriosus(pda) dimensions: minimal diameter of 3mm, length of 5mm and ampulla of 6.5mm.The device was successfully implanted intraductal in the patient, but later that day the device embolized into the left pulmonary artery(lpa) and the patient returned to the cath lab for device removal and new implantation of a device.The 5/4 amplatzer piccolo occluder was successfully retrieved using a 10mm snare with no complications and a 5/4 amplatzer duct occluder was implanted with good position.The patient is currently discharged.

Manufacturer Narrative

An event of device embolization was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation on piccolo embolizations, per internal procedures.Please note per the instruction for use, arten600042307 version b, that for a pda with a minimum diameter of 3mm and a length of 5mm in a patient weighing more than 2kg, a 4/4mm piccolo is recommended per sizing table t2.

Event Description

The previously reported incident will no longer be captured in this manufacturing report number as it has already been captured in manufacturing report: 2135147-2020-00444.Please refer to manufacturing report: 2135147-2020-00444.

Manufacturer Narrative

Please note, the previously reported incident will no longer be captured in this manufacturing report number as it has already been captured in manufacturing report: 2135147-2020-00444.

• 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: 11174068
• MDR Text Key: 227003884
• Report Number: 2135147-2021-00025
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

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-PDAP-05-04-L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/21/2021; 10/21/2021
• Supplement Dates FDA Received: 01/24/2021; 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6