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

Model Number 9-ASD-028

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, a (b)(6) female patient undergoing asd occlusion procedure at (b)(6) was assessed for a size 27mm occluder.The physician tried different sizes of amplatzer septal occluders for the procedure.The user chose 28 mm, model 9-asd-028, lot# 5499930, and a 30 mm, model 9-asd-030, lot# 6121210.In the users attempts to deploy these devices they developed in a ¿cobra-head¿ formation.The user chose a 32 mm, model 9-asd-32.The device was successfully implanted.(b)(6) 2020 -pm the patient remained hemodynamically stable and the delay associated with changing devices did not endanger the patient¿s life.

Manufacturer Narrative

Additional information: d10, g4, h2, h3, h6 & h10.The reported event of device deformation could not be confirmed.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: 10164233
• MDR Text Key: 195539551
• Report Number: 2135147-2020-00283
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: 00811806010212
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 5499930
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 20