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

Model Number PVS23

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

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

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

The returned pvs valve was received in generally good condition.Investigation is ongoing.

Event Description

An attempt was made to implant a perceval valve; however, problems were encountered during the collapsing procedure.It was reported the perceval pvs23 could not be collapsed because the outflow stent did not collapse completely and could not be covered by the plastic sheath.In an attempt to address the issue, a large accessory kit was opened, but could not collapse the valve either.A new valve was then opened.Difficulty was also encountered during the attempted collapse of the second valve (the second valve is reported in a separate event, (b)(4)).Ultimately, a traditional sutured valve was implanted.The patient had no adverse consequences as a result of the event, but the procedure was delayed by at least 20-25 minutes.

Manufacturer Narrative

After decontamination, a visual inspection was performed.The results confirmed the absence of pre-existing defects.The simulation of the valve collapsing, performed with the returned device and a demo accessory kit was completed with no difficulties.Furthermore, he manufacturing and material records for the perceval heart valve, model #icv1209 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering.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.Based on the performed analysis, the reported collapsing difficulties were not observed during the collapsing replication and then cannot be explained by any factor intrinsic in the involved device.The possible root cause can be related to the valve positioning too far forward in the dual collapser leading a lack on contact between the outflow crown and the internal teeth of the dual collapser; this aspect makes it impossible to properly collapse 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
• MDR Report Key: 8701883
• MDR Text Key: 148146864
• Report Number: 3004478276-2019-00190
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)220419
• 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: 07/19/2019

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: 04/19/2022
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 78