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

Model Number CVD0091

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

An event of residual shunt was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.An initial review of complaints data was reviewed as a component of the complaint handling risk review per wi (b)(4).The medical device problem and aho codes are consistent with the hazards/harms identified for this product family, and no new hazards or harms were identified.

Event Description

It was reported in an article, titled "percutaneous closure of pfo in patients with reduced oxygen saturation at rest and during exercise: short- and long-term results" that patients with respiratory symptoms were selected from databases containing all patients percutaneously closed between january 2000 and september 2018 in a retrospective multicenter study.Three amplatzer septal occluders where reportedly used in the study.One of the sixteen patients had a clinically irrelevant residual shunt across the device post procedure.The patient was re-admitted for surgical intervention, but the procedure was not successful due to unknown technical issues.Additional information could not be obtained.

• 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: 10003036
• MDR Text Key: 189842763
• Report Number: 2135147-2020-00173
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

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: CVD0091
• Device Catalogue Number: CVD0091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention