MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VFEM VENOUS DRAINAGE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number VFEM022

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 04/13/2015

Event Type  Death  

Event Description

As reported, a surgeon experienced two (2) issues with use of a 22fr.Femoral venous cannula during re-do cardiac surgery for coronary artery bypass grafting (cabg) in a large male patient.The surgeon first had difficulty inserting the 22fr.Femoral venous cannula.Then, during cardiopulmonary bypass, suboptimal flow was noted.One day after surgery, the patient expired.It was noted prior to surgery, the patient was ¿very sick.¿ the plan was to use a 24fr.Cannula because of the patient¿s large size but the cannula had not yet been delivered to the hospital.The surgeon elected to proceed with the case and used the available 22fr.Femoral venous cannula.This smaller cannula was challenging to insert and it did not have optimal flow which complicated the case and extended the cross-clamp time.

Manufacturer Narrative

Attempts to follow up for device return have been unsuccessful thus far.At this time a definitive root cause has not been able to be determined, but it appears operational context and the patient¿s body habitus were potential contributing factors to this adverse outcome.If additional information is obtained, a supplemental mdr will be submitted.

• Brand Name: VFEM VENOUS DRAINAGE CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4774893
• MDR Text Key: 22038035
• Report Number: 3008500478-2015-00030
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K123303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2015

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 Model Number: VFEM022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/15/2015
• 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): Death