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

Model Number PVS21

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Aortic Valve Stenosis (1717); Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the device was ultimately implanted successfully.The event was attributed to a procedural error, and there was no evidence to suggest a problem with the device.As such, no device deficiency is suspected and no investigation is warranted.It was reported that the event was attributable to inadvertent traction on the atrial retractor during the mitral re-repair.As reported in the perceval ifu, "in case of concomitant procedures these must be performed as much as possible prior to perceval s implantation.After perceval s implantation, manipulation of the heart and/or of the ascending aorta, if required, should be done gently; should an atrial retractor be placed, take care not to compress the ascending aorta.These maneuvers may lead to unknown effects on the implanted valve, including displacement and folding." thus, the reported event is clearly identified in the perceval instructions for use, and is a known, inherent risk of the procedure.The event was reported in a conservative manner due to the involvement of the device in the event, and the potential for patient harm.However, no device deficiency or inadequacy of the ifu has been identified, and the event is attributable to procedural error.Device still implanted.

Event Description

The manufacturer was notified of the following event via a journal article titled "intraoperative displacement of a perceval sutureless prosthesis" (authors: falcetta, pascarella, bertini, pratali, bortolotti).It was reported that a mitral valve repair was performed concomitantly with an aortic valve replacement in which a perceval valve was implanted.After weaning from bypass, residual mitral regurgitation was identified due to inadequacy of the repair, and repeated mitral repair was required.During the second attempt at mitral repair, the perceval was displaced.The displacement was identified after weaning from bypass, and attribute to inadvertent traction on the atrial retractor during the mitral re-repair.The perceval valve was therefore removed, recollapsed and reimplanted.It was reported that the patient recovered uneventfully, with a stable mitral repair and normal functioning of the perceval prosthesis two months post-operatively.

• 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 V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 7636397
• MDR Text Key: 112273356
• Report Number: 3005687633-2018-00171
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2018

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: Physician
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 83 YR