MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMULET DELIVERY SHEATH 12F 80CM; DELIVERY SYSTEM

Model Number DS-TV45X45-12F-080

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

An event of "pericardial effusion" 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.Device was discarded.

Event Description

During a procedure to implant a 20mm amplatzer amulet (acp2) using a 12f amplatzer torqvue 45x45 delivery sheath (tv45x45), a pericardial effusion was noted and reported to be the result of a perforation of the left atrial appendage (laa) by the tv45x45.The acp2 was positioned in the laa but not released therefore the device was recaptured and removed.The procedure was postponed.Per report, the perforation was related to user inserting the sheath to deep into the laa during the procedure.

Event Description

On (b)(6) 2017, during a procedure to implant a 20 mm amplatzer amulet (acp2) using a 12f amplatzer torqvue 45x45 delivery sheath (tv45x45), a pericardial effusion was noted and reported to be the result of a perforation of the left atrial appendage (laa) by the tv45x45.The acp2 was positioned in the laa but not released therefore the device was recaptured and removed.In the context of an elective interventional device-based atrial appendage closure, the left atrial appendage ostium was accidentally perforated by the user inserting the sheath too deep in the appendage during the procedure.As a result, a hemodynamically relevant pericardial effusion occurred, which was evacuated via two pericardial drains.The patient required cardiopulmonary resuscitation.Intubation was difficult and false intubation occurred initially.The patient was resuscitated for approximately 90 minutes in total until return of spontaneous circulation with sinus rhythm was reached.The patient was then sent to the theater via the cardiac surgery intensive care unit for further treatment.An approximate 2 mm tear was seen on the laa ostium, which was closed by suture.In view of the highly unfavorable prognosis, a discontinuation of the treatment of the highly unstable patient was agreed by interdisciplinary consensus.The patient died on (b)(6) 2017.

• Brand Name: AMULET DELIVERY SHEATH 12F 80CM
• Type of Device: DELIVERY SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7001302
• MDR Text Key: 91058184
• Report Number: 2135147-2017-00145
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: DS-TV45X45-12F-080
• Device Lot Number: 5993572
• Other Device ID Number: 05415067028037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2017
• 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): Death; Hospitalization; Required Intervention