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

Model Number 9-ASD-011

Device Problem Material Deformation (2976)

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

Event Date 09/16/2020

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, during an asd procedure, the physician used a size 11 mm asd device, after balloon sizing measurement.As indicated, he used a 7f trevisio delivery system.After placement the device appeared on imaging to be misshaped, "concaved." at some point, he attempted to retrieve the asd device with the trevisio delivery system, and was unable to retrieve.The trevisio sheath lumen prolapsed outwards, making it impossible for the device to be retrieved back into sheath the physician made the decision to release the device and the device was determined to be fine and it remains in place.Related manufacturer reference number: 2135147-2020-00406.

Manufacturer Narrative

An event of the device being misshapen and inability to retract the device was reported.The device was later released from the delivery system and determined to be appropriately implanted.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, artmt 100092311 revision b "caution: do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure( such as svc, pv, mv, cs, ao).".

Event Description

Related manufacturer reference number :2135147-2020-00406.

• 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: 10658116
• MDR Text Key: 210694037
• Report Number: 2135147-2020-00435
• Device Sequence Number: 1
• Product Code: MLV
• 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: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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-011
• Device Catalogue Number: 9-ASD-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM; AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM
• Patient Age: 64 YR
• Patient Weight: 80