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

Model Number 9-ASD-026

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

On (b)(6) 2020 during an implant procedure, the physician deployed a 9-asd-026 which deployed in a cobra shape.It was removed and replaced with a 9-asd-028.That patient remained stable throughout.

Manufacturer Narrative

Additional information: d10, g4, h1 h2, h3, h6 and h10.An event of an amplatzer septal occluder deploying with a cobra deformation was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, one video was received for analysis.Based solely on the aforementioned video, the occluder appeared to deploy in a cobra deformation.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.

Manufacturer Narrative

The reported event of an amplatzer septal occluder deploying with a cobra deformation could not be confirmed.One video was received from the field, which appeared to show an occluder deployed in a cobra deformation within the patient.However, the investigation confirmed the device met visual and functional 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.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10968880
• MDR Text Key: 220969471
• Report Number: 2135147-2020-00490
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 7137100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/21/2020; 01/19/2021
• Supplement Dates FDA Received: 12/30/2020; 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR