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

Model Number PVS25

Device Problem 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 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 30 seconds 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.(i was able capture this image).The crossclamp was then reapplied and heart stopped to remove the valve.The perceval 25/l was explanted and a perceval 23/m was used.Total bypass time 212 minutes.Total cross clamp time: 180 minutes.First cross clamp time: 105 minutes.

Manufacturer Narrative

Design history record review completed mar 31, 2017.The complete manufacturing and material records for the perceval heart valve, model icv1210, 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 icv1210) perceval heart valve at the time of manufacture and release.

Manufacturer Narrative

Conclusion codes, follow-up report #1 did not include conclusion code for user error.The likely root cause of this event with the perceval valve size large is due to mis-sizing the valve.

• 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: 6079288
• MDR Text Key: 59186233
• Report Number: 3004478276-2016-00133
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)190319
• 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,Followup
• Report Date: 05/26/2017

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: 03/19/2019
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2016
• 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