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

Model Number	CNA19
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/17/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer is conservatively reporting the event due to the unknown cause of death and device relationship.Since the device disposition remains unknown, no inspection on the device is possible at this time.Further investigation is ongoing and a follow up will be provided should further information become available.At this time, the root cause remains unknown.This report refers to the same patient as reported in report id # 3004478276-2020-00215.Unknown disposition.
Event or Problem Description
The manufacturer was informed that on (b)(6) 2020, a patient underwent a re-do aortic valve replacement procedure and received a crown prt model cna19.The patient passed away on (b)(6) 2020.No further information is presently available on the type of death nor on the device relationship.The patient has a re-do surgery on (b)(6) 2020 where a perceval valve was explanted (details in 3004478276-2020-00215).
Event or Problem Description
The manufacturer received additional information identifying the following: after the implant of the crown valve, on the second postoperative day, the patient was transferred from the icu to a standard hospital ward, stable and alert.The next day, a drop in hematocrit and weakness was observed.At the same time, a large hematoma was observed in the left groin, due to a possible rupture of the femoral artery (patient with severe peripheral vascular disease, who had been rejected for tavi).The patient was feeling great discomfort.The patient was taken to the icu again where the passed away due to possible intra-abdominal bleeding from the rupture of the pelvic-femoral artery.Based on the medical assessment received, the cause of death was the rapture of the femoral artery and it was not related to the re-do aortic valve replacement.
Additional Manufacturer Narrative
Updated sections: b4, b5, g3, g6, h1, h2, h6.Based on the additional information received, it was confirmed that the cause of death of the patient was the rapture of the femoral artery.The rupture of the femoral artery is not related to the livanova bioprosthesis implanted based on clinical knowledge.Furthermore, the information gathered from the medical note received confirmed that the patient had a severe peripheral vascular disease for which the patient was rejected for a tavi.The root cause of the reported event can be reasonably attributed to the patient's specific condition based on the information available.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 11099012
• Report Number: 3004478276-2020-00254
• Device Sequence Number: 838080
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)240229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 02/29/2024
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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: Death
• Patient Age: 76 YR
• Patient Weight: 65