MAUDE Adverse Event Report: LIVANOVA CANADA CORP CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number	CNA25
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.The manufacturer is in the process of receiving further information from the physician.It is not yet known which valve was explanted.For the purpose of this report the manufacturer has listed cna23, this event could also be for the cna25 - (b)(4).This will be clarified through supplementary report once more information is available.Not yet determined if device available.
Event or Problem Description
On the (b)(6) the manufacturer was notified through patient tracking of both a crown prt size 23 and crown prt size25 valve that were implanted in a patient on (b)(6) 2017.
Additional Manufacturer Narrative
Please note this event was originally reported referencing the crown prt size 23mm, after clarification from the physician this has now been updated in the follow up emdr to referencing the crown prt size 25mm, s# (b)(4), as specified in the event description.Device not returned to manufacturer.
Event or Problem Description
The manufacturer was notified through patient tracking of 2 crown prt devices implanted in the same patient on (b)(6) 2017 ( cna23 - s# (b)(4) and cna25 - s# (b)(4)).On follow up with the physician it was determined that there was a failure to implant the crown size 25mm intra-operative due to mis-sizing as determined by the physician.The size 25mm was removed and the crown size 23mm was then implanted.The additional x-clamp and cpb time was negligible.The patient is doing well.The explanted device is not available for analysis.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 6694573
• Report Number: 3004478276-2017-00131
• Device Sequence Number: 16336485
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)190831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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
• Operator of Device: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: CNA25
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 12/12/2017
• 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: Required Intervention
• Patient Age: 54 YR