MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-018

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 05/13/2019

Event Type  Injury  

Event Description

On an unknown date, an 18mm amplatzer septal occluder was implanted.Following the procedure, on (b)(6) 2019, the device was reported to have embolized.On (b)(6) 2019, the device was removed from the patient percutaneously by snaring and re-sheathing.The defect was balloon-sized to 18mm using a 30mm pts sizing balloon (lot number: unknown) and the physician attempted closure with a 22mm amplatzer septal occluder (lot number: 6821072) and 26mm amplatzer septal occluder (lot number: 5562243).Both devices were reported to be mis-sized.Of note, the 26mm amplatzer septal occluder was impinging on the mitral valve.The physician elected to abandoned the procedure and surgical closure is planned for a future time.

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Supplemental report needed for implant date and anatomical difficulties.Correction: supplemental correction report needed for cause of case abandonment traced to patient anatomy.

Event Description

On (b)(6) 2019, an 18mm amplatzer septal occluder was implanted.Following the procedure, the device was reported to have embolized.On (b)(6) 2019, the device was removed from the patient percutaneously by snaring and re-sheathing.The defect was balloon-sized to 18mm using a 30mm pts sizing balloon (lot number: unknown) and the physician attempted closure with a 22mm amplatzer septal occluder (lot number: 6821072) and 26mm amplatzer septal occluder (lot number: 5562243).Both devices were reported to be mis-sized.Of note, the 26mm amplatzer septal occluder was impinging on the mitral valve.Additionally, the patient had multipls asds and challenging anatomical features which caused the mis-sizing.The physician elected to abandoned the procedure and surgical closure is planned for a future time.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• MDR Report Key: 8697322
• MDR Text Key: 147941315
• Report Number: 2182269-2019-00081
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019264
• UDI-Public: 05415067019264
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2019

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 5475335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 06/13/2019; 07/16/2019
• Supplement Dates FDA Received: 07/12/2019; 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention