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

Model Number 9-PDAP-05-02-L

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

Patient Problems No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Date 10/06/2020

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 5/2mm amplatzer piccolo occluder was selected for implant in a 32 day old, (b)(6) kg patient with patent ductus arteriosus(pda) dimensions of: length 11mm, pulmonary end 2.9mm, diameter 3.49mm and an aortic end of 3.5mm.During the procedure the device was placed intraductal, but was determined to be mis-sized too large.When the device was deployed, it caused mild obstruction to the lpa and the device was removed without incidence.The device was exchanged for a 4/2mm amplatzer piccolo occluder and was successfully implanted.It was reported that there was a 20 minute delay in the procedure, but the patient did not experience any adverse events.The patient remained hemodynamically stable throughout the procedure and the patient has recovered and is doing well.The customer alleges an issue with the sizing of the device only, with no malfunction.This event is being conservatively reported pending feedback from the physician if the delay was clinically significant.

Manufacturer Narrative

An event of left pulmonary artery obstruction during implant of a 5/2 amplatzer piccolo occluder 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.A 4/2 size device was reportedly subsequently reported.Per the instructions for use arten600042307 rev.B table t2, this replacement 4/2 device was the correctly sized device given the measurements provided from the field, and the oversizing was a potential contributing factor to the reported obstruction.

• 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: 10791748
• MDR Text Key: 214765521
• Report Number: 2135147-2020-00461
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 7432691
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 DA
• Patient Weight: 1