MAUDE Adverse Event Report: AGA MEDICAL CORPORATION; DELIVERY SYSTEM

Model Number DS-TV45X45-12F-080

Device Problem Biocompatibility (2886)

Patient Problem Pericardial Effusion (3271)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, (b)(6) year old male patient weighing (b)(6) kg scheduled for laao because of atrial fibrillation and gastric bleeding.A 25mm amplatzer amulet was successfully implant using 12f amulet delivery sheath.During the procedure patient received 7000 units of heparin.Upon successfully implanting the device a small 5mm pericardial effusion was observed.The specific cause for pericardial effusion is unknown.The patient was old and the laa has a lot of trabeculations.The physician adjusted the delivery system a few times to get the proper delivery angle.The effusion was noticed after the device was deployed.No pre-op echo was available.Imaging was done with fluoroscopy and intra-cardiac echography.Ice imaging showed ostium of 21mm and landing zone of 20mm, fluoroscopy showed ostium at 25mm and landing at 19mm.The physician completed the procedure by removing the delivery system and using perclose to close the ivc.The patient remained hemodynamically stable throughout and post procedure.

Manufacturer Narrative

An event of pericardial effusion after device implant was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10428522
• MDR Text Key: 204202353
• Report Number: 2135147-2020-00370
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: DS-TV45X45-12F-080
• Device Lot Number: 7036680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59