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

Model Number	CNA23
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported to the manufacturer through the persist registry as not related to the device, as the pacemaker was implanted postoperative the manufacturer requested the internal clinical review of this case.This event is being reported in a conservative manner as conduction disorder has been determined by medical judgment as related to the procedure but unknown if related to the device.
Event or Problem Description
On (b)(6) 2017 a crown prt 23mm was implanted via full-sternotomy.On (b)(6) 2017 the patient exhibited arrhythmias and conduction disorders-av block iii.A pacemaker was required postoperatively.
Additional Manufacturer Narrative
This event was reported to the manufacturer through the persist registry.The manufacturer has received clarification after a monitoring visit that no pacemaker was implanted and that the event is not related to the device.Based on this information this case will be closed at this time and can be re-visited if further information becomes available.
Event or Problem Description
On 30th may 2017, the manufacturer received clarification that no permanent pacemaker was implanted.The site has reported the event as not device related.

• 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
• MDR Report Key: 6595441
• Report Number: 3004478276-2017-00098
• Device Sequence Number: 808817
• Product Code: LWR
• UDI-Device Identifier: 00896208000528
• UDI-Public: (01)00896208000528(240)CNA23(17)211231
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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: 12/31/2021
• Device Model Number: CNA23
• Device Catalogue Number: CNA23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/28/2017
• 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; Disability
• Patient Age: 79 YR