MAUDE Adverse Event Report: LIVANOVA USA, INC. RAP FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 200-150

Device Problem Split (2537)

Patient Problem Death (1802)

Event Date 03/08/2018

Event Type  Death  

Manufacturer Narrative

Patient identifier was not provided.Patient weight was not provided.The device lot number is unknown, as the packaging was discarded.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.During follow-up communication with the supplier of the device, livanova usa was informed that this type of issue has been seen in the past.The supplier indicated that in previous cases, the failure was attributed to "the use of a suture tightly applied around the point of failure of the cannula." additional follow-up communication with a clinical expert also presented this scenario as a likely cause.However, an investigation has not yet been performed, and it is unknown at this time how the cannula became split or if the device malfunction was in any way related to the patient death.Multiple attempts have been made to gather additional information from the customer regarding the duration of the ecmo procedure, the nature of the setup and device malfunction, and the cause of death of the patient.At this time, no additional information has been provided by the facility.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.

Event Description

Livanova received a report that the user experienced flow issues with the femoral venous cannula during an ecmo procedure on a female patient.Inspection of the cannula identified that it had split at the suture line.The report indicated that the patient was sick and was not doing well before the procedure had been initiated.The patient reportedly already had coded in the er twice.The patient expired on (b)(6) 2018.

Manufacturer Narrative

The involved cannula was returned to livanova for evaluation.Visual inspection confirmed that the cannula was split roughly 0.5" from the "50" mark on the device.The split was located distal to the mark and was such that there were two separate openings on the cannula, with a piece of tubing stuck in the middle that was secured by the section of tubing that was still intact.The edges of the split were slightly rough and not perfectly straight.The spring of the cannula was completely intact.The cannula has been forwarded to the supplier for additional evaluation.In addition, several unused cannula were also returned to livanova.The supplier has been notified and will conduct additional investigation related to the individual returned devices and their lot numbers.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova has received the response from the supplier regarding the investigation into this issue.The supplier reviewed the dhr, the expiration date and shelf life for the products used to manufacture this lot of cannula and no issues were found.No manufacturing process failures could be identified.During follow-up communication with the customer, livanova learned that the facility reportedly attempted to duplicate the failure and found that it could be reproduced if the sutures were secured around the cannula too tightly.Further clarification was requested about the length of the ecmo procedure.However, the customer declined to provide any further information.The actual cause of the patient demise was not reported.Reportedly the patient was very sick before the procedure.Based on the medical expertise preformed by livanova, it is possible the cannula split was caused by the user technique however the cause of the patient death remains unknown.This is the first time this kind of event is reported to livanova.Though an exact root cause of the cannula split could not be confirmed, a contributing factor to the event is potentially a too tight sutures around the cannula.For this reason livanova preventatively decided to initiate a capa to evaluate possible improvement.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: RAP FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7399657
• MDR Text Key: 104459668
• Report Number: 1718850-2018-00007
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200-150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 40 YR