MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-025

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Embolism/Embolus (4438)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported on (b)(6) 2021, a 25 mm amplatzer pfo occluder was chosen for procedure.An 8 fr torqvue delivery sheath was used to deliver the device however when detached from the delivery cable, the device appeared to not close the patent foramen ovale (pfo) as it should have.A transesophageal echocardiogram was performed which revealed the device was held open by a unknown anatomical structure in the right atrium, near the aortic rim portion.A bubble study was performed and a large amount of bubbles were present in the left atrium due to the pfo not being closed.The decision was made to not use the snare to retrieve the device but to transfer the patient for surgical removal and repair of defect.The patient remained stable throughout the procedure.No further information has been provided.

Manufacturer Narrative

An event of residual shunt, due to the device being held open by an unknown anatomical structure.And removal of the device was reported.A more comprehensive assessment could not be performed, as the device remains implanted.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12032212
• MDR Text Key: 257172712
• Report Number: 2135147-2021-00232
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7661833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR