MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER® CRIBRIFORM OCCLUDER; CARDIAC OCCLUSION DEVICE

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information was obtained from a 25 april 2017 literature article titled, "second transcatheter closure for residual shunt following percutaneous closure of patent foramen ovale." the aim of this study was to evaluate the safety, feasibility, and mid-term outcomes of transcatheter residual shunt closure following percutaneous patent foramen ovale (pfo) closure.Methods and results: from 1994 to july 2016, 2679 patients underwent transcatheter pfo closure for treatment of presumed paradoxical embolism at the university hospital of bern.100 of the sample population of patients (3.7%) was referred for residual shunt closure and this subset is the study population.The indication for initial pfo closure was an ischemic cerebrovascular event in 85% of the patients.Patients underwent transoesophageal echocardiography (toe) for pfo diagnosis and repeat toe at 6 months for residual shunt assessment.All procedures were performed under fluoroscopic guidance only.At the initial procedure, 10 different devices made by multiple manufacturers were used.The amplatzer pfo occluder accounted for 54% and the amplatzer cribriform occluder for 28%.Six (6) of the 100 (6%) experienced a recurrent tia or ischemic stroke before a second intervention.Closure of the residual shunt was successful in all but 2 patients.A second amplatzer pfo occluder was used in the majority of the repeat interventions (76%).There were no complications.Toe was performed after 7±5 months in 88 patients (90%) and there was complete closure in 71 (81%).In 8 patients (0.3% of the cohort), a third device was implanted which resulted in complete closure of the defect.Conclusion: transcatheter residual shunt closure after initial percutaneous pfo closure can be safely performed under fluoroscopic guidance only and achieves complete closure in most patients.The use of larger devices, typically prompted by intricate anatomy, represents a risk factor for shunt persistence and need of reintervention.Doi: 0.4244/eij-d-17-00061.

• Brand Name: AMPLATZER® CRIBRIFORM 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6951451
• MDR Text Key: 89406015
• Report Number: 2135147-2017-00134
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• 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): Required Intervention