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

Model Number 9-PDAP-04-04-L

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

Patient Problem Embolism (1829)

Event Date 04/24/2020

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 4-4 amplatzer piccolo was selected for implant for a patent ductus arteriosus (pda) in a (b)(6) old (b)(6) female patient.The pda has the following dimensions: minimal diameter: 3.4mm, aortic ampulla diameter: 4.6mm, length: 10.0mm.The device placement was intraductal.The device embolized into the left pulmonary artery upon release.The device was retrieved and exchanged with a 5-2 piccolo (lot # 7277280).The patient is currently stable, clinically well, and weaning off respiratory support.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

Manufacturer Narrative

The device subject to the embolization complaint was not returned, and therefore a physical analysis was not able to be completed.There were no additional complaints related to the manufacturing lots of the complaint device or replacement device.There were no observed artifacts related to the design, or assembly, or device acceptance inspections that indicate the design or the manufacture of the present occluder device is the root cause of the observed, post-implant embolization.The documented surgical intervention of removal and replacement with a device of a different size resulted in a positive outcome.The replacement, re-sized device remains implanted.

Manufacturer Narrative

Additional information for g4, g7, h2, h6, and h10.An event of embolization was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis, and the investigation was limited to the device history record and reported dimensions of the pda taken during imaging in the field.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 instructions for use arten600042307 rev.A sizing table t3 for patients less than or equal to 2 kg found that the correct size for the reported pda was a 5-2 piccolo occluder.The under-sizing of the 4-4 occluder and causal relationship to the subsequent embolization could not be independently verified; however, the successfully implanted 5-2 piccolo occluder is further evidence of device under-sizing which was a potential contributing factor to the device embolization.

• 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: 10090221
• MDR Text Key: 192154163
• Report Number: 2135147-2020-00222
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• 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,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 7014911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 DA
• Patient Weight: 2