MAUDE Adverse Event Report: LIVANOVA CANDA CORP PERCEVAL SUTURELESS AORTIC VALVE; TISSUE HEART VALVES

Model Number PVS23

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

Device discarded.

Event Description

On (b)(6) 2018, a percival pvs23 was implanted in aortic position through a full sternotomy.After the closure of the aorta, it was noticed that one of the leaflets were not opening correctly, because the device was mis-sized/oversized.The device was then explanted and replaced with an edwards magna ease.The patient remained stable during the procedure and did fine after surgery.The patient seemed to have normal anatomy.The percival pvs23 was discarded.

Manufacturer Narrative

Corrected data: the device code selected for the initial report submitted was # (b)(4) (appropriate term/code not available).The code was now corrected to (b)(4).The manufacturing and material records for the perceval heart valve, model #icv1209, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada 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.Since the device was discarded, no inspection of the actual prosthesis can be performed.However, based on the surgeon's judgment and on the sizing of the device ultimately implanted, the root cause of the event can be attributable to the oversizing of the perceval valve.

Event Description

On 03 oct 2018, a perceval pvs23 was implanted in aortic position through a full sternotomy.After the closure of the aorta, it was noticed that one of the leaflets were not opening correctly, because the device was mis-sized/oversized.The device was then explanted and replaced with an edwards magna ease 21mm.The patient remained stable during the procedure and did fine after surgery.There were only 20 minutes added to the x-clamp time.The patient seemed to have normal anatomy.The perceval pvs23 was discarded.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 8224390
• MDR Text Key: 132342688
• Report Number: 3004478276-2019-00110
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)201203
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR