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

Model Number PVS21

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

The devices has not been evaluated by the manufacturer as it was not returned to manufacturer.Reporting event due to possible device malfunction.Further investigation will be carried out on the device as soon as returned to manufacturing facilities.

Event Description

An attempt was made to implant a perceval valve.It was reported that the valve would not collapse properly prior to implant.After explanting the valve the physician felt there was a structural issue with the frame.The valve was then replaced with a new perceval valve of same size and it was implanted successfully.

Manufacturer Narrative

Preliminary visual inspection confirmed the absence of non-conformities according to valve specifications.A simulation of the collapsing phases was performed using the returned valve and a demonstration accessory kit, in an attempt to replicate the reported event.No problems were encountered during the positioning of the valve.Some difficulty was encountered during the collapsing phase.In particular, some elements of the metallic outflow crown were overlapped.Nevertheless, it was still possible to correctly cover the metallic stent with the dual holder sheath.The inflow portion was correctly captured by the holder.Based on the event description, it is not possible to confirm whether the identified overlapping is related to the difficulty encountered with the collapsing procedure.It was stated that the valve could not be collapsed; however, the investigation performed did not specifically reproduce this report.Nevertheless, it should be noted that a specific warning on the overlapping phenomena is included in the perceval ifu: "warning: check that the struts are evenly collapsed and their elements are not overlapped." the manufacturing and material records for the perceval heart valve, model #icv1208 , s/n # (b)(4), and nitinol stent, as they pertain to the reported event, were retrieved and reviewed by quality engineering at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model #icv1208) perceval heart valve at the time of manufacture and release.Based on the investigations performed, the collapsing difficulty may be attributable to the overlapping phenomenon identified, although this cannot be confirmed.Given that the ifu of the device warns that the stent should be inspected for overlapping, the event can reasonably be deemed a failure to follow instructions.Additional information was received clarifying that the valve was not explanted.The collapsing issue occurred prior to implant.The event description was updated to reflect the information received.

Event Description

An attempt was made to implant a perceval valve.It was reported that the valve would not collapse properly prior to implant.The valve was then replaced with a new perceval valve of same size and it was implanted successfully.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 7887672
• MDR Text Key: 120708488
• Report Number: 3004478276-2018-00292
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)201111
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR