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

Model Number 9-PDA-005

Device Problem Material Deformation (2976)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

An 5mm amplatzer duct occluder was placed per ifu.The device appeared to "cobra head" and was removed.Device was replaced with a new 5mm amplatzer duct occluder.Patient was reported to be in stable conditon.

Manufacturer Narrative

An event of deformation upon deployment was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, two images were received for analysis.Based solely on the aforementioned photos, an amplatzer duct occluder appeared to deploy with some degree of tilt out of the distal end of the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10942770
• MDR Text Key: 219512218
• Report Number: 2135147-2020-00526
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: 00811806011127
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 9-PDA-005
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 7021548
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention