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

Model Number 9-ASD-MF-035

Device Problems Biocompatibility (2886); Human-Device Interface Problem (2949)

Patient Problem Thrombus (2101)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 35mm amplatzer cribriform occluder was selected for implant in a patient with a multifenestrated asd.The physician proceeded to complete the procedure according to the ifu, but after the device was deployed a small shunt across the septum was noted through tee.The physician decided to retract the device and remove the device from the patient.Once the 35 mm amplatzer cribriform occluder was removed it was found to have what appeared to be a clot on the device.The physician ordered additional heparin and rechecked the act.The act was confirmed at 270.A new 35 mm amplatzer cribriform occluder was selected for implant and through tee it was confirmed to have successfully occluded the multifenestrated asd.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in procedure.

Manufacturer Narrative

Additional information for: d10, g4, g7, h2, h3, h6, and h10.Corrected information for: h6.An event of residual shunt and thrombus was reported.The investigation confirmed the device met dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9856279
• MDR Text Key: 184305238
• Report Number: 2135147-2020-00124
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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 Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 7235019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/10/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention