MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER

Model Number EC65

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). An aortic dissection is a tear in the inner lining of the aorta. As a result, blood flows through this newly created false channel, which raises a flap that can occlude blood flow in the true lumen. There are small dissections that can occur that do not result in significant disturbances to blood flow and do not require intervention. In extreme cases, occlusion of blood flow to the coronary, carotid, or subclavian arteries can result in hemodynamic instability and/or death without surgical intervention. In this case, although there have been attempts to receive further information regarding the event, no additional details were provided. The device history record (dhr) review was not able to be completed as information regarding this device's lot number remains unknown. Trends are monitored on a monthly basis and if further information becomes available, a follow-up report will be submitted.

Event Description

Title - port access cardiac operations can be safely performed with either endoaortic balloon or chitwood clamp. Abstract - methods: all patients undergoing minimally invasive, port access, right thoracotomy operations from 1998 to 2012 at our institution were retrospectively analyzed. Patients undergoing aortic occlusion with the chitwood clamp (n
=
189) were compared with patients undergoing occlusion with the endoaortic balloon (n
=
875). Results: there was no statistical difference in the rate of dissection between patients undergoing aortic occlusion with an endoaortic balloon (1. 03%) and those receiving a chitwood clamp (1. 06%). Similarly, there was no difference in the rate of type a dissection between aortic occlusion strategies (endoaortic balloon
=
0. 57%, n
=
5, vs chitwood clamp
=
1. 06%, n
=
2, p
=
0. 28). No difference in the incidence of stroke was identified between the endoaortic balloon and the chitwood clamp (2. 2% vs 2. 1%, p
=
1. 0). Conclusions: minimally invasive cardiac operations using a peripheral cannulation strategy can be safely performed with minimal vascular adverse events incorporating either endoaortic balloon or chitwood clamp aortic occlusion. As experience with the endoaortic balloon is gained, the incidence of vascular adverse events can be reduced to nearly negligible rates. Summary - rate of intraoperative aortic dissection: total
=
1. 03%; type a
=
0. 57%; type a
=
0. 46%.

• Brand Name: ENDOCLAMP AORTIC CATHETER
• Type of Device: CLAMP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms: lfs-33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6541921
• Report Number: 3008500478-2017-00032
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: EC65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/08/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention