FDA Adverse Event Injury Summary report: N

AMPLATZER SEPTAL OCCLUDER

MDR report key: 9265615 · Received November 1, 2019

Report

Report Number: 2135147-2019-00360
Event Type: Injury
Date Received: November 1, 2019
Date of Event: October 10, 2019
Report Date: November 20, 2019
Manufacturer: AGA MEDICAL CORPORATION
Product Code: MLV
UDI-DI: 00811806010199
PMA / PMN Number: P000039
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED EVENT OF DEVICE DEFORMATION COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET VISUAL AND FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

Description of Event or Problem · 1

ON (B)(6) 2019, A 24MM AMPLATZER SEPTAL OCCLUDER (LOT 6801896) WAS SELECTED FOR IMPLANT. THE ASO WAS ATTEMPTED TO DEPLOY IN THE ATRIAL SEPTAL DEFECT (ASD), BUT THE ASO DEFORMED INTO A COBRA-HEAD SHAPE DESPITE SEVERAL ATTEMPTS OF RE-DEPLOYMENT. THE ASO WAS REMOVED FROM THE PATIENT AND RESHAPED, AND THEN THE ASO WAS RETRACTED INTO THE LOADER AND PUSHED OUT OF THE LOADER, BUT THE ASO REMAINED DEFORMED. THE ASO WAS REPLACED WITH ANOTHER 24MM ASO; HOWEVER, IT MOVED OUT OF PLACE DURING THE TUG TEST AND WAS DEEMED TOO SMALL. THE SECOND ASO WAS REPLACED WITH A LARGER 26MM ASO, AND IT WAS DEPLOYED IN THE ASD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1063739	AMPLATZER SEPTAL OCCLUDER	TRANSCATHETER SEPTAL OCCLUDER	MLV	AGA MEDICAL CORPORATION	9-ASD-024	6801896	00811806010199

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention