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

Model Number PVS21

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Regurgitation (1716)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4) corp.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.Since the device is not available for return, no further investigation is possible at this time.Based on the information available, the root cause can be traced to an initial undersizing of the perceval s valve.In fact, considering the pre-operatively annulus measurement (23.1mm) and the comment reported (''there was a possibility that m size was able to be placed''), it is possible that the pvs21 was not the correct size for the patient's anatomy.The manufacturer has requested additional information on the event.Should further information be provided, a follow up report will be submitted.

Event Description

On (b)(6) 2020, a pvs21 was implanted as part of an avr performed in mics.In the preoperative measurement, the annulus measured 23.1 mm and the stj was 21.7 mm.During the sizing, the yellow end of the s sizer passed during sizing, but the white end did not pass through the stj.Since there was a margin in the yellow end of the sizer in the aortic valve measurement, an s size was selected and indwelled.Mild regurgitation was observed on the lcc side after the implant, but it was followed up because it was trace to mild.After that, moderate regurgitation was observed in both ar and mr, so avr and map were performed on (b)(6) 2020.The explanted pvs21 was replaced with a magna 21mm.In addition, since perceval had been going down toward to the lv side at the time of re-operation (up to about 5 mm), there was a possibility that m size was able to be placed.

Event Description

On (b)(6) 2020, a pvs21 was implanted as part of an avr performed in mics.In the preoperative measurement, the annulus measured 23.1 mm and the stj was 21.7 mm.During the sizing, the yellow end of the s sizer passed during sizing, but the white end did not pass through the stj.Since there was a margin in the yellow end of the sizer in the aortic valve measurement, an s size was selected and indwelled.Mild regurgitation was observed on the lcc side after the implant, but it was followed up because it was trace to mild.After that, moderate regurgitation was observed in both ar and mr, so avr (aortic valve replacement) and map (mitral annuloplasty) were performed on (b)(6) 2020.The explanted pvs21 was replaced with a magna 21mm.In addition, since perceval had been going down toward to the lv side at the time of re-operation (up to about 5 mm), there was a possibility that m size was able to be placed.There was a comment that it is necessary to accurately analyze ct in advance and consider referring to ct measurement when stj is narrow and it is difficult for the sizer to pass.Additional information was received identifying the following.The leak detected was perivalvular.The ar and mr was observed after surgery.The movement of the perceval valve was not identified intraoperatively.

Manufacturer Narrative

Additional information was received identifying the following.The leak detected was perivalvular.The ar and mr was observed after surgery.The movement of the perceval valve was not identified intraoperatively.The manufacturing and material records for the perceval heart valve, model #icv1208, s/n # (b)(6), 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 #icv1208) perceval heart valve at the time of manufacture and release.Since the device is not available for return, no further investigation is possible at this time.Based on the information available, the root cause can be traced to an initial undersizing of the perceval s valve.In fact, considering the pre-operatively annulus measurement (23.1mm) and the comment reported ("there was a possibility that m size was able to be placed"), there is indication that the pvs21 was not the correct size for the patient's anatomy.Based on the follow-up information the issues resultant from the under-sizing were not identified until after the procedure and an additional avr was required.Given the review of the device history record confirming the valve met all required standards and specifications at the time of manufacturer, and the information regarding the patient annulus size, the event root cause is deemed to be a user error ¿ mis-sizing.

• 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: 11103411
• MDR Text Key: 231952860
• Report Number: 1718850-2020-01221
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)230301
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/03/2020,04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 41