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

Model Number 9-ASD-020

Device Problem Human-Device Interface Problem (2949)

Patient Problems Low Blood Pressure/ Hypotension (1914); Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient with ventricular septal rupture was implanted with an amplatzer septal occluder and progressive hypotension, right ventricular failure, and residual shunt for the first four months of device implant occurred.The results of the investigation are inconclusive since the device remained implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying a 20mm amplatzer septal occluder that may be related to a residual shunt.Details are listed in the article, titled "spontaneous resolution of residual shunting in 2 compromised patients after amplatzer occlusion of postinfarction ventricular septal defects" case study 1: it was reported in the article that a (b)(6) year old woman was diagnosed with ventricular septal rupture after a subacute anteroseptal myocardial infarction (mi).A 20mm amplatzer septal occluder was implanted for an 11mm defect with thin surrounding tissue.A small residual shunt was observed transthoracic echocardiogram (tte).The patient was put on intra-aortic balloon bump (iabp) support and prescribed anticoagulant and antiplatelet medication.The patient's hemodynamic status improved.The iabp support was terminated postoperative day 1.The next, tte revealed increase shunt flow and the patient's condition deteriorated because of progressive hypotension and right ventricular failure.The anticoagulant and antiplatelet therapy was discontinued in hopes to promote thrombosis inside the aso.After intensive heart-failure management consisting of iabp reinsertion and diuretic therapy, the patient¿s hemodynamic status resolved.Iabp support ended postoperative day 28.The patient gradually improved.At 4 months, the shunt flow disappeared.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• 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: 9949139
• MDR Text Key: 187418297
• Report Number: 2135147-2020-00158
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR