MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EMBOL-X GLIDE PROTECTION SYSTEM; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number EXMMD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded at the hospital.The reported complaint was confirmed by the edwards representative that was present at the case during in-service training.Based on the information received, the root cause mostly likely was use error.The instructions for use (ifu) were reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following instructions and warnings: ¿locate the desired cannulation site on the ascending aorta.Using the appropriate surgical technique, place purse string sutures at the desired cannulation site.To insure the cannula component will be firmly attached, use double purse string sutures.With a slight ¿hooking¿ motion, insert the cannula tip in through the incision site placing the curved tip away from the aortic valve.Assure penetration of the cannula tip into the aorta by observing that the cannula component fills with blood.The cannula vent plug or cap will prevent back bleeding during cannula component insertion.To assure proper device introduction when using the introducer port the cannula component must be positioned, so that the introducer port is perpendicular to the vessel.The tip end flange or suture bump must also be fully abutted against the vessel.The base of the cannula component must be held to prevent excess movement when manipulating the cannula or when using the introducer port.Failure to do so may cause injury to the vessel.Position the aortic cross clamp at least 2.0 cm away from the cannula access device.Failure to do so may result in difficulty with insertion and removal of devices from the introduction port.¿ additionally, ¿prior to deployment of the (filter), verify that the (access device) is flat against the aorta and that the filter is being deployed perpendicular to the surface of the aorta.Failure to do so may result in excessive resistance and subsequent damage to the aorta.¿ additional in-service training and follow-up case support was conducted in response to this event.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Event Description

Edwards learned that during the use of an embolic protection system, there was an aortic injury.Through interview with the surgeon, it was noted the base of the cannula was not held "flush" to the aorta during port manipulation.The cannula lifted up from the aorta during obturator removal.Then, during filter insertion, the filter punctured the aorta resulting in the injury to the ventral surface of the aorta.After insertion, the filter was seen exiting from the surface of the aorta.The filter was removed and the cannula was used without additional problems.The aortic injury, described as a small hole, was repaired with a stitch; there was a minimal impact in the patient.The devices were discarded and not available for return.This case was a proctored case to "sign-off" the second surgeon for device use in a planned clinical trial.This was the first time the trainee surgeon used this product.The proctor used this device on two other prior occasions.Both users previously received product training and received subsequent inservicing prior to this case.

Manufacturer Narrative

Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.The complaint trend was assessed and found to be in control.

• Brand Name: EMBOL-X GLIDE PROTECTION SYSTEM
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: neil landry ; one edwards way; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5151312
• MDR Text Key: 28294129
• Report Number: 3008500478-2015-00058
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/28/2015

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: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: EXMMD
• Device Lot Number: 60026023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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): Other