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

Model Number	EZS21TA
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional narratives: 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.This can result, in extreme cases, in occlusion of blood flow to the coronary, carotid, or subclavian arteries, and can result in hemodynamic instability and/or death without surgical intervention.There are small dissections that can occur that do not result in significant disturbances to blood flow and do not require intervention.Dissections may result in serious injury, death, and/or require medical or surgical intervention.H3: product evaluation: customer report of suture ring migration was unable to be confirmed through visual observations.As received, the suture ring was located approximately 1inch proximal from tip.No visual damages or abnormalities were found.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that the surgeon dissected the aorta while cannulating using a ezs21ta ez glide intra-operatively.As reported the patient had pad and abdominal aortic disease pre-operatively.The planned procedure was cabg x 5 and a possible mvr.The access was open.After institution of cpb the tee showed a possible localized dissection flap in the descending thoracic aorta just distal to the subclavian artery take off.The surgeon felt that the ring on the ez glide cannula was able to move too easily which resulted in the cannula going too deep and hitting the back wall of the aorta.No abnormality was noted during device preparation.A stent graft was sewn into the descending thoracic aorta to repair the area.The surgeon continued to use the same device to finish the case.The patient was doing well and expected to be discharge to home soon.The surgeon asked edwards to evaluate the device to make sure there are not any apparent manufacturing issues.Per product evaluation no defect of the suture ring was confirmed.
Additional Manufacturer Narrative
H10: additional narratives updated d4, h4, and h6 per new information received based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

• Brand Name: EZ GLIDE AORTIC PERFUSION CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18101024
• Report Number: 2015691-2023-17340
• Device Sequence Number: 18060003
• Product Code: DWF
• UDI-Device Identifier: 50690103172107
• UDI-Public: (01)50690103172107(17)260516(11)230517(10)386459
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2026
• Device Model Number: EZS21TA
• Device Lot Number: 386459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown