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

Model Number 9-ASD-MF-018

Device Problem Off-Label Use (1494)

Patient Problems Endocarditis (1834); Hemolysis (1886); Mitral Regurgitation (1964); Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article identifying amplatzer cribriform occluder that may be related to a sever hemolysis developed with pigmenturia, acute kidney injury, and ongoing blood transfusion required.Specific patient information is documented as unknown.Details are listed in the attached article, titled transcatheter repair of anterior mitral leaflet perforation.A transesophageal echocardiogram (tee) revealed torrential mitral regurgitation (mr) owing to 2 adjacent perforations in the a3 scallop of the anterior mitral valve leaflet (combined diameter of 10 mm), believed to be the sequelae of endocarditis.On an unknown date a 18mm amplatzer cribriform occluder was used for a mitral valve leaflet.On an unknown date the 18mm was snared and removed.A 20mm cardioform septal occluder (gore medical) was implanted.A few weeks later the patient was re-admitted for worsening heart failure and a tee was performed and confirmed worsening mr.The patient was referred to another center where a mitral valve replacement surgery was performed.

Manufacturer Narrative

Correction: please retract this report 2135147-2020-00074, the same issue was previously reported as 2135147-2020-00062.

• Brand Name: AMPLATZER CRIBRIFORM 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: 9745930
• MDR Text Key: 181824620
• Report Number: 2135147-2020-00074
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-018
• Device Catalogue Number: 9-ASD-MF-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• 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: 66 YR