MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-PFO-025

Device Problems Difficult or Delayed Positioning (1157); Obstruction of Flow (2423); Failure to Disconnect (2541)

Patient Problem Thrombus (2101)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of difficulty unscrewing the device from the delivery cable and thrombus on the distal disc could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, a 25mm amplatzer pfo occluder was selected for use.After positioning the pfo occluder, then the device failed to unscrew from the delivery cable, so the device was re-sheathed and withdrawn from the patient.The user manually unscrewed the occluder without any issues, and the pfo occluder and delivery system were washed with physiological serum.The pfo occluder was reloaded and re-deployed in the defect.An echocardiogram revealed a thrombus on the distal disc and heparin (4000) was administered as treatment of the thrombus.Then the pfo was released from the delivery cable and successfully implanted.The patient is reported to be stable.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7361572
• MDR Text Key: 103170030
• Report Number: 2135147-2018-00038
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6265358
• Other Device ID Number: 00811806011288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR