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

Model Number	AR-XXXXX
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 7198694
• Report Number: 1718850-2018-00001
• Device Sequence Number: 917545
• Product Code: DWF
• UDI-Device Identifier: 00803622103056
• UDI-Public: (01)00803622103056(240)AR-11114(17)180930(10)1625100037
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other