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

Model Number 9-PDA2-06-04

Device Problem Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, an amplatzer duct occluder ii was selected for implant.On (b)(6) 2020, the device embolized into the left pulmonary artery.The device was retrieved and the patient was reported to be stable.

Manufacturer Narrative

Additional information: b5, d10, h3, h6, h10.An event of device embolization was reported.The results of this 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.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2020, an amplatzer duct occluder ii was selected for implant.On (b)(6) 2020, the device embolized into the left pulmonary artery.The device was retrieved, and the patient underwent surgery to correct the issue.The patient was reported to be stable.

Manufacturer Narrative

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

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9823330
• MDR Text Key: 184306843
• Report Number: 2135147-2020-00084
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: 00811806011257
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PDA2-06-04
• Device Catalogue Number: 9-PDA2-06-04
• Device Lot Number: 7126006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• 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 Age: 3 YR
• Patient Weight: 11