MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EZ GLIDE AORTIC CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS25

Model Number EZS21TA

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation- the device has been returned to edwards for evaluation.It is pending evaluation.Upon completion of the evaluation a supplemental mdr will be submitted.Attempts to retrieve additional information has been unsuccessful.If additional information is received a supplemental mdr will be submitted.These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The cause of the event cannot be determined.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information regarding an 21 arterial cannula.Patient arrived @ approx 2315 from or on va ecmo w/ open chest.Per surgical team/anesthesia attending, bleeding and rv failure in or as well as prolonged/multiple pump runs.Patient w/ blood seeping from under esmark/ioban on arrival.Required continuous infusion of blood products/fluid for maintaining bp/ecmo flows.Bleeding from around esmark/ioban increased greatly throughout next few hours.Decision made @ approx 0300 to perform emergent chest exploration/washout.Upon exploration, aortic cannula found to have multiple holes/cracks in cannula.Cannula exchanged with improved hemostasis and hemodynamics.There were no abnormalities with the placement of the cannula.Appears to be a cannula defect.Clarified line defect for ecmo- line was not cracked, but 2 small holes were visualized after item was removed from patient.Patient experienced progressive bleeding attributed to coagulopathy and the holes (unknown what time the holes developed).

Manufacturer Narrative

H11.Corrected data: device has been returned to edwards for evaluation as is pending evaluation.A supplemental mdr will be submitted upon receipt of additional information.H3 and d10.

Manufacturer Narrative

H10.Additional manufacturer narrative: the device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

H3.Device evaluation: the device was returned to edwards for evaluation.Customer complaint of "hole/crack" and leakage on the cannula was confirmed with assessment.Device was returned with visible traces of blood and examined in the biohazard area of the lab.A leak test was performed on the catheter at 420mmhg.Multiple leakages were observed on the wire reinforced section of the cannula body.No other visual damage, contamination, or other abnormalities were found to the device.H10.Additional manufacturer narrative: the complaint was confirmed.The cause of the event cannot be determined at this time as further investigation is being performed.A supplemental mdr will be submitted when new information is learned.

Manufacturer Narrative

H10.Additional manufacturer narrative: the event was traced to component failure.The root cause of the event cannot be determined at this time.Added h6 result and conclusion code.

• Brand Name: EZ GLIDE AORTIC CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS25
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10885431
• MDR Text Key: 217717891
• Report Number: 3008500478-2020-00213
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/29/2020

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: 01/20/2023
• Device Model Number: EZS21TA
• Device Catalogue Number: EZS21TA
• Device Lot Number: 258770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 12/14/2020; 12/16/2020; 01/06/2021; 01/27/2021
• Supplement Dates FDA Received: 12/14/2020; 01/05/2021; 01/18/2021; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR