MAUDE Adverse Event Report: LIVANOVA USA, INC. AORTIC ROOT CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number AR-XXXXX

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

During follow-up communication, it was reported that the trauma occurred during cannula insertion.The cannula material was reported to be a "very hard structure" that "crushed" the aorta upon insertion.The patient has reportedly been discharged, and the product has been destroyed and is unavailable for return for investigation.No further clarification has been provided on how the cannula was able to crush the aorta, and livanova has not received any other reports for this type of issue.This is the only complaint against this lot number, which has a build quantity of (b)(4).The dhr was inspected and no deviations or non-conformities related to the reported issue were identified.If any additional pertinent information is received, it will be provided in a supplemental report.Device not available for return.

Event Description

Livanova received a report that the aortic root cannula caused trauma to the patient's aorta.During further communication, it was revealed that the user feels the material is hard and the aorta is "crushed" when the cannula is attached.

Manufacturer Narrative

The involved product was not made available for return to livanova usa and there was no available inventory of the reported lot number or representative cannula tips for evaluation.One box of aortic root cannula (ar-11114) was pulled from available stock for inspection.These 10 cannula were visually examined and closely studied in regards to damage to or stiffness of the tip, and structural integrity.No issues were identified during this analysis.A review of the product specification found that neither the material nor the manufacturing process for the cannula tip has changed.As an in-depth investigation could not be performed, a root cause could not be determined.

• Brand Name: AORTIC ROOT 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: 7198694
• MDR Text Key: 97474088
• Report Number: 1718850-2018-00001
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)AR-11114(17)180930(10)1625100037
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K972503
• 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
• Report Date: 03/07/2018

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: 09/30/2018
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11114
• Device Lot Number: 1625100037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• 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): Other