MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER P.I. MUSCULAR VSD OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-VSDMUSCPI-024

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/04/2018

Event Type  Death  

Manufacturer Narrative

An event of a pericardial effusion and patient death 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2018, the patient had a procedure with a residual pericardial effusion that the user attributes to that procedure.On (b)(6) 2018, a 24 mm amplatzer p.I.Muscular vsd occluder was selected for closure of a post-infarct vsd.A 1 mm lv pericardial effusion was noted initially on fluoroscopy at the start of the procedure.During the procedure, the patient became hemodynamically unstable and experienced hypotension at which time a large effusion was detected.The physician deployed the device in the 1 mm defect and did no further intervention for the remaining defects due to the patient condition.Despite efforts made to stabilize the patient; it is reported the patient died in the icu the following day.

• Brand Name: AMPLATZER P.I. MUSCULAR VSD OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7734934
• MDR Text Key: 115545903
• Report Number: 2135147-2018-00096
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/31/2018

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: No Information
• Device Expiration Date: 11/30/2022
• Device Model Number: 9-VSDMUSCPI-024
• Device Catalogue Number: 9-VSDMUSCPI-024
• Device Lot Number: 6246609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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; Hospitalization; Required Intervention