FDA Adverse Event Summary report: N

AMPLATZER DELIVERY SYSTEM

MDR report key: 1843578 · Received September 24, 2010

Report

Report Number: 2135147-2010-00146
Date Received: September 24, 2010
Date of Event: September 2, 2010
Report Date: September 28, 2010
Manufacturer: AGA MEDICAL CORPORATION
Product Code: DQY
PMA / PMN Number: P000039
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Description of Event or Problem · 1

ACCORDING TO THE INITIAL INFORMATION RECEIVED AN 8F AMPLATZER 45° DELIVERY SYSTEM (ADS45) AND A 17MM AMPLATZER SEPTAL OCCLUDER (ASO) WERE USED INITIALLY TO ATTEMPT TO CLOSE THE ATRIAL SEPTAL DEFECT (ASD). THE SUPERIOR RIM OF THE SEPTUM DID NOT HOLD THE LEFT ATRIAL (LA) DISC OF THE ASO AND DID NOT SEEM TO NOT SEAT SECURELY IN THE DEFECT. THE 17MM ASO WAS REMOVED AND A 19MM ASO WAS ATTEMPTED. AFTER SEVERAL ATTEMPTS TO POSITION THE 19MM ASO IT SPONTANEOUSLY RELEASED IN THE LEFT ATRIUM. THE LA DISC APPEARED TO STILL BE SECURED IN THE LEFT UPPER PULMONARY VEIN WHICH HELD THE ASO IN THE LEFT ATRIUM. THE 8F ADS45 WAS IMMEDIATELY EXCHANGED FOR A 9F AMPLATZER 45° EXCHANGE SYSTEM (B)(4). USING A 10MM GOOSE NECK SNARE THE "THREADED" CONNECTOR OF THE 19MM ASO WAS SNARED AND THEN PULLED BACK INTO THE 9F AES45 AND SUBSEQUENTLY REMOVED FROM THE PATIENT. THE PATIENT WAS SENT HOME AFTER CONSULT FOR SURGICAL REPAIR OF THE ASD. PLEASE REFERENCE MDR# 2135147-2010-00145 FOR THE 19MM ASO INVOLVED IN THIS EVENT. THE 19MM ASO AND 8F ADS45 WERE RETURNED TO AGA MEDICAL AND ARE CURRENTLY IN ANALYSIS. ONCE THE ANALYSIS IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AMPLATZER DELIVERY SYSTEM	DELIVERY SYSTEM	DQY	AGA MEDICAL CORPORATION	9-DEL-8F-45/80	1002109542

Patients

Seq	Age	Sex	Outcome	Treatment
1	4 YR		Required Intervention