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

Model Number 9-ACP-007-028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 07/20/2020

Event Type  Death  

Manufacturer Narrative

An event of the plug detaching from the cable and the patient passing away due to myocardial infarction accompanied by cardiac arrest after the occluder was fully recovered was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, four fluoroscopy clips were received for analysis.Based solely on the aforementioned videos, the device did appear to detach from the cable.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.

Event Description

On (b)(6) 2020, a 28mm amplatzer cardiac plug was selected for implant.During the procedure, while the occluder was 1/4 deployed for positioning and the "ball" was opened for positioning, it was observed that the wire rope was separated from the occluder.After "3-4 hours' effort", the occluder was fully recovered.However, then the patient experienced sudden myocardial infarction accompanied by cardiac arrest; suspected to be thrombosis related.Rescue measures were performed, however, after approximately 1 hour, the patient passed away.

• Brand Name: AMPLATZER CARDIAC PLUG
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10384537
• MDR Text Key: 202189426
• Report Number: 2135147-2020-00330
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 9-ACP-007-028
• Device Lot Number: 6539834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR