MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number PVS23

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 10/05/2016

Event Type  Injury  

Event Description

The manufacturer was notified on 05-oct-2016 of the following: the first valve that was used has been reported as a separate event.(livanova case #(b)(4); 3004478276-2016-00133).The patient is a (b)(6) male who had been treated for endocarditis, having avr, mvp, cabg x3 using lima and right greater saphenous vein.Intra-op annulus was measured at 22mm and no stj measurement was taken to figure out a ratio.Three distal graft were performed before the valves.The surgeon open the left atrium and placed 28mm carbiomedics annuloflo ridge ring on the mitral then closed the left atrium.Next he opened the aorta to debride the leaflets and inspect the annulus.There were no abscesses or damage to the annulus from the endocarditis.He started sizing and felt that the large size valve was correct.Valve was prepared according to ifu with no problems while the surgeon placed the three guide sutures 2mm below the nadir.Valve was lowered and checked before deployed.Valve looked good and was balloon at 4atms for 30seconds with warm saline.Valve was inspected again after ballooning and no issues were seen.The aortotomy was closed and two proximals were done.Crossclamp was removed and heart de-aired.First look at echo the valve had migrated into the valsalva.The crossclamp was then reapplied and heart stopped to remove the valve.This report is for the second valve used: after resizing the valve the medium transparent end passed and the white passed with some force but not a lot.The medium valve was chosen since the large valve dislodge and the surgeon couldn't find a reason for it dislodging.The medium valve and accessories were opened and the valve prepared again with no issues and the guide sutures were placed again 2mm below the nadir.Valve was lowered and deployed.This time the after deployment surgeon noticed it was to high on the left sinus side and removed the valve to be prepared again.Using the same guide sutures the valve was lowered and deployed.This time the valve was at the correct depth with no annulus showing and deployed with no problems.The surgeon then ballooned the valve at 4atms for 30secs with warm saline.The blue collar was at the top of the leaflets and when the balloon was deflated the surgeon inspected the valve and saw the medium valve had pushed up on the left and non coronary sinus sides.Surgeon stated that the ring was pushing in on the aorto-mitral continuity and this is the reason.So the valve was removed and a 23mm solo valve was implanted.Total bypass time 212 minutes, total cross clamp time: 180 minutes, first cross clamp time: 105 minutes, second cross clamp time: 75minutes.

Manufacturer Narrative

Design history record review was completed on mar 29, 2017.The complete manufacturing and material records for the perceval heart valve, model icv1209, s/n (b)(4), were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model icv1209) perceval heart valve at the time of manufacture and release.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6079301
• MDR Text Key: 59188744
• Report Number: 3004478276-2016-00134
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)190315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2019
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 97