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

Model Number VFEM022

Device Problem Break (1069)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 03/16/2017

Event Type  Death  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.Manufacturing records were not reviewed as the lot number was not provided.Base on the information received, a definitive root cause could not be determined.The instructions for use (ifu) was 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: "contraindications for use femoral access cannulae are contraindicated for long-term use (> 6 hrs), including extra corporeal membrane oxygenation (ecmo) procedures." no further corrective or preventative actions are required at this time.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 received information that the subject cannula was inserted into this patient for ecmo treatment for 21 days.The patient was on the waiting list for lung transplantation.On the 21st day, the femoral cannula suddenly separated at the overmold section.Blood loss was noticed at the separation area which lead to the deterioration of the patient¿s condition.Then the patient expired.There was no external pressure on the femoral cannula.The customer did not exchange the cannula every six hours during the continuous ecmo due to contamination, miss-located position, or blood loss.

Manufacturer Narrative

Device evaluated by manufacturer: report of damaged cannula device was confirmed.As received, the cannula was in two separated sections.A clean break was observed between the two separated sections of the cannula.The cannula was kinked and flattened along the wire-reinforced section of the cannula body.There was no other visual damage or other abnormality found.All vfem022 devices are 100% leak tested during manufacturing activities.It was reported that the cannula had been in use for 21 days which is beyond the short term use (6 hours or less) described by the ifu.There is no data to support use of this device beyond the 6 hours indicated on the ifu.A root cause cannot be determined at this time.The complaint trend was assessed and it was found to be in control.No further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: VFEM FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms lfs33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6470461
• MDR Text Key: 72054164
• Report Number: 3008500478-2017-00021
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 58 YR