MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMULET DELIVERY SHEATH 14F 80CM

Model Number DS-TV45X45-14F-080

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Death (1802); Ischemia (1942)

Event Date 02/08/2019

Event Type  Death  

Manufacturer Narrative

An event of an embolism, ischemia, and patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however the user suspected a deep breath by the patient during the procedure pulled air into the device.

Event Description

On (b)(6) 2019, a 25mm amplatzer amulet was selected for implant using a 14fr amplatzer torqvue delivery system.The amulet was prepared and flushed, and as the device was inserted into the delivery system, the patient spontaneously took a deep breath.The user suspected the breath contributed to air pulled into the delivery system.The physician noticed the air in the delivery system and used a syringe to aspirate.Immediately, the patient became symptomatic and the patient was resuscitated after two and a half hours with the use of an impella device.The patient was stabilized in a critical state, and several hours following the procedure, the patient expired from ischemia of the right coronary artery following air embolism of the procedure.Per report, the syringe was not held upright to ensure no air was introduced back into the loader.

• Brand Name: AMULET DELIVERY SHEATH 14F 80CM
• Type of Device: AMULET DELIVERY SHEATH 14F 80CM
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8406513
• MDR Text Key: 138343248
• Report Number: 2135147-2019-00071
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: DS-TV45X45-14F-080
• Device Lot Number: 6694025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention