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

Model Number	CNA25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposed of by hospital.
Event or Problem Description
On (b)(6) 2018 a crown prt cna25 was implanted.On (b)(6) 2018 the patient complained of discomfort during a dental treatment.The patient was transported to the hospital.On (b)(6) 2018 the patient received a re-operation and the valve was explanted and an sjm abbott/regent 21 mm mechanical valve was implanted.It was included in the report that infective endocarditis was present.In addition it was reported that valve malfunction was not suspected.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna25, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.Because the valve was not available no further investigations were possible.The site reported that valve malfunction was not suspected.In addition, the device history record review confirmed proper sterilization of the device occurred at the time of manufacture and release.If any species were present on the tissue valve before sterilization, they would be killed very easily by the liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde, formaldehyde and alcohol, all of which are highly effective against infectious species.The manufacturer has validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.In addition, the sterile packaging solution used for shipment of crown valves is a 4% formaldehyde solution; the valves remain in this extremely antimicrobial solution until they are opened during surgery.Therefore, there is no risk of valve contamination post-sterilization.Due to the aforementioned reasons the suspected root cause of the event cannot reasonably be attributed to any factor intrinsic to the device in question and the root cause is thus deemed to be due to the patient condition.If further information is received the manufacturer will re-assess the investigation.

• 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 V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7501385
• Report Number: 3004478276-2018-00186
• Device Sequence Number: 160336
• Product Code: LWR
• UDI-Device Identifier: 00896208000535
• UDI-Public: (01)00896208000535(240)CNA25(17)200731
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: Physician
• Device Expiration Date: 07/31/2020
• Device Model Number: CNA25
• Device Catalogue Number: CNA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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: Required Intervention
• Patient Age: 74 YR