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

Model Number	CNA19
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Regurgitation (1716); No Information (3190)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 a crown prt size 19 was implanted.After declamping, the valve's opening-closing movement was checked with echocardiography; a leak from the leaflet coaptation was confirmed.The physician commented that the movement of marked leaflet appeared poor and stiff compared to others.The volume of the leak was not at an acceptable level and the valve was explanted and a new crown prt size 19 was implanted.Normal movement was observed with no leak.The patient is in good condition after the operation.
Additional Manufacturer Narrative
On (b)(6) the echocardiography report was received: tee ¿ initial images show a bioprosthetic aov with abnormal coaptation between the leaflet in the right and left sinus position.The right coronary cusp seems to have restricted opening and therefore does not allow for proper coaptation of the other leaflet.The non-coronary cusp is normal.There are 2 jets of ao regurg: one is small and central.The second is significant and corresponds to the non-coapting area mentioned above (between rc and lc cusps).Overall, the ar seems to be at least moderate to severe.
Additional Manufacturer Narrative
The complete manufacturing and material records for the crown prt aortic pericardial heart valve, model cna19, s/n (b)(4), were retrieved and reviewed by quality control at livanova (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.
Additional Manufacturer Narrative
The returned product was received in an explant kit and in the original plastic jar and appeared in good conditions showing some traces of blood on the inflow side and it presented an ink mark on one leaflet in the outflow side.After decontamination, the valve was visually inspected showing a quite rigid leaflets according with the customer description.On the outflow side, a cut on the second leaflet and a minor sign (i.E.Surgical tweezer) near to the third post were observed.The hydrodynamic testing conducted on the returned prosthesis confirmed that the device was showing a normal leaflet kinematics with a regurgitation fraction in compliance with requirement of (b)(4).

• 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: 6717256
• Report Number: 3004478276-2017-00135
• Device Sequence Number: 999001
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)171130
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2017

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: 11/30/2017
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 08/31/2017; 09/29/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 08/14/2017; 09/26/2017; 10/24/2017
• 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