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

Model Number 9-PDAP-05-04-L

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

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 (b)(6) patient with the following patent ductus arteriosus(pda) dimensions of: length 12mm and diameter of 3.1mm underwent pda closure.After angiogram measurements, which were consistent with tte measurements, a 5/4 amplatzer piccolo occluder was prepped and delivered intraductal to the pda.Echo showed some mild residual shunting around the device, and also the pa disk appeared to be just outside of the pa ampule, with doppler showing some flow restriction.The 5/4 device was recaptured and repositioned, with the same result.The 5/4 device was never released, and was recaptured and removed.A 5/2 amplatzer piccolo occluder was then delivered to the defect with the same results as the 5/4 device.The device was never released, it was removed and a mvp plug was deployed with no residual shunting or pa impingement.The patient remained stable throughout the procedure and with the exchanging of several devices, the procedure was extended significantly.The overall procedure time was just over 2 hours.The patient is currently recovering.

Manufacturer Narrative

Additional information for: d9, g3, g6, h2, h3, h6, and h10 an event of mild residual shunt was reported.The investigation confirmed the device met 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.The cause of the reported incident could not be conclusively determined.Please note per the instruction for use, arten600042307 version b, that for a pda with a minimum diameter of 3.1mm and a length of 12mm a 4-2mm piccolo is recommended per the sizing table.

• 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: 10963192
• MDR Text Key: 220176920
• Report Number: 2135147-2020-00529
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 7395383
• 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: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 1 MO
• Patient Weight: 1