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

Model Number PVS25

Device Problems Positioning Failure (1158); Difficult to Fold, Unfold or Collapse (1254); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer is following up to retrieve additional information on the event and on the device disposition.Should additional information be received, a follow up report will be provided.It should be noted that an explanted prosthesis must not be reimplanted per the perceval ifu, as the integrity is no longer ensured.It is possible that the difficulties encountered after the first implant attempt resulted from the off-label decision to attempt to re-reimplant the same valve.Further investigation is ongoing.Device disposition unknown.

Event Description

On (b)(6) 2019, a perceval size l (pvs25) implant attempt occurred.The device was correctly collapsed using the correct procedure and with good collapsing pressure.It was noted that the cap on the end of the holder only just captured the entire circumference of the inlet ring (tissue end).The valve was deployed but the surgeon noted that it was higher on one side as he could see annulus.The device was consequently explanted (leaving the guiding sutures in place) and a decision was made to recollapse the same device.Two other attempts to collapse the device were made with the same accessories but on each attempt, the inlet ring was not fully enclosed by the holder cap - part of it was protruding.Another attempt of collapsing was made with a new holder, but the same outcome was observed.A new valve pvs25 was opened and used with the second accessory kit.The valve was correctly collapsed and deployed with no issues.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model#: icv1210, 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#: icv1210) perceval heart valve at the time of manufacture and release.The manufacturer is pending the return of the device from the field.Once received, additional investigation will be performed and a follow-up report will be submitted.

Event Description

On (b)(6) 2019, a perceval size l (pvs25) implant attempt occurred.The device was correctly collapsed using the correct procedure and with good collapsing pressure.It was noted that the cap on the end of the holder only just captured the entire circumference of the inlet ring (tissue end).The valve was deployed as expected but was not positioned correctly.It was noticed that the valve sat slightly higher on one side, likely due to inadequate tension on the guide sutures.The device was consequently explanted, leaving the guiding sutures in place, and a decision was made to recollapse the same device.Two other attempts to collapse the device were made with the same accessories but on each attempt, the inlet ring was not fully enclosed by the holder cap - part of it was protruding.Another attempt of collapsing was made with a new holder, but the same outcome was observed.A new valve pvs25 was consequently opened and used with the second accessory kit.The latter valve was correctly collapsed and deployed with no issues.A short increase in the cross-clamp time is reported for this event (less than 20 min).The patient remained stable throughout the procedure, with an uneventful recovery and discharge.

Manufacturer Narrative

Fields updated: b4, d10, g4, g7, h1, h2, h6.The device was returned to the manufacturer and it was received on 28 feb 2020.Along with the prosthesis, two accessory kits were also received, although it was not specified with which order the accessories were used.After decontamination, the valve was visually inspected according to the standard procedure without highlighting elements of non-conformity.A collapsing simulation was then performed using the returned prosthesis and both accessory kits.The valve was correctly collapsed and released with both accessories received.Based on the performed analysis, the reported event cannot be explained by any factor intrinsic in the involved prosthesis or accessories because it was not possible to reproduce the claimed collapsing difficulties (67 - no problem detected).As reported, the valve was correctly collapsed at the first attempt of implant, which failed due to malpositioning of the device (61 - unintended use error caused or contributed to event).Based on livanova's experience, it is possible that the claimed collapsing difficulties could be related to an incomplete radial reduction of the valve or to a valve mispositioning (i.E.Too far forward in the dual collapser), which makes it difficult to correctly capture of the inflow side of the valve.Nevertheless, it should be noted that an explanted prosthesis must not be reimplanted per the perceval ifu, as integrity is no longer ensured.As such, the decision to attempt to re-implant the same prosthesis was made off label.

• Brand Name: PERCEVAL SUTURELESS AORTIC HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9447394
• MDR Text Key: 175194368
• Report Number: 3004478276-2019-00329
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)230711
• 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,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2023
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention