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

Model Number PVS25

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

The event related to the second valve used will be reported as a separate event.(b)(4) (3004478276-2016-00159).

Event Description

The manufacturer was notified on (b)(6) 2016 of the following: the surgeon attempted to implant a perceval with the guidance of a proctor.The first valve that was used, deployed low in position due to excessive force.The first valve was removed, a second perceval 25/l was used was malpositioned and deployed supra-annularly.The second perceval valve was removed and a mosaic size 27mm valve was used instead.

Manufacturer Narrative

The following were changed: device evaluated by mfr?, result code.

Event Description

Attempted to implant perceval with proctor guidance.Valve deployed subannularly.Additional details (nov 5 e-mail from sales): there did not appear to be any device related issues.He attempted to implant 2 valves but did not seat either one accurately.The first one deployed to low due to excessive force.The second deployed supra-annular.The valves used were: pvs25 sn (b)(4), pvs25 sn (b)(4).After explanting the second perceval, he decided to use a medtronic mosaic 27 tissue valve.The patient follow a normal post-op course without complication.Both of the valves listed above were shipped back to customer service in the us using the appropriate explant kits.Certainly this was not a device related issue, it was a technique issue.Additional info (nov 8 sales e-mail): my best guess would be that it added approximately 30 minutes to the cross clamp and pump time.I do know that the patient followed a normal postop course with no complications.Additional info (nov 10 sales e-mail): the surgeon was dr (b)(6) at (b)(6) hospital in (b)(6).

Manufacturer Narrative

Corrected data: corrected data, on supplemental medwatch #1 awareness date should have stated apr 6, 2017.(b)(4).Analysis: the complete manufacturing and material records for the perceval heart valve, model icv1210, s/n (b)(4), were pulled and reviewed by quality control at (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a perceval heart valve at the time of manufacture and release.The gross examination was completed and results showed that the valve appeared to be in general good conditions.According to the current procedure at the time of release, the visual examination showed that there was no non conformities.No irregularities were found while performing the dimensional analysis.Based on the information that was provided, there was no device failure suspected or found during analysis.The event was a result of user technique during implantation where the device was malpositioned.

• 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
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125650
• MDR Report Key: 6126453
• MDR Text Key: 60844767
• Report Number: 3004478276-2016-00158
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)190602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2019
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention