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

Model Number 9-PFO-025

Device Problem Unintended Movement (3026)

Patient Problem Embolism (1829)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Product #1 pi main [pi-2019-0218774-01].Pi assign [pi-2019-0218774-01-01].Pi task [pi-2019-0218774-01-01-001.] the 25 mm amplatzer pfo occluder was received in the product performance engineering lab in a shipping container and was decontaminated.The occluder was grossly and microscopically examined, and no anomalies were found.It met dimensional specifications per drawing 90167768 revision h when measured with a caliper.Two measurements were taken of both the discs at two approximately perpendicular locations.The proximal disc measured 24.78 and 25.18 mm; and the distal disc measured 18.16 and 18.17 mm.The device was loaded into a test 8f loader and deployed.The proximal disc initially deployed in a bulbous formation.Light pressure was applied to the edges of the disc, which immediately reformed to proper conformation, meeting functional specifications.Product #1 pi main [pi-2019-0218774-01].An event of embolization after depolyment was reported.The 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 and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

Event Description

A 25 mm amplatzer pfo occluder was selected for the procedure.The device was determined to be too small.It was reported that the device embolized after deployment and a snare was used to retrieve the device.No patient consequences reported.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9261405
• MDR Text Key: 166798457
• Report Number: 2135147-2019-00359
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2024
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7176873
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization