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

Model Number PVS23

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Aortic Insufficiency (1715); Endocarditis (1834)

Event Date 03/15/2018

Event Type  Death  

Manufacturer Narrative

The initial reporter reported this event to the fda with uf/importer report (b)(4).The returned valve prosthesis was received in general good conditions.Some traces of blood were present.

Event Description

A perceval valve was implanted on (b)(6) 2018.On (b)(6) 2018, the patient's condition deteriorated due to severe ai.Exploratory reoperation was performed.Tee showed that the valve had slipped out of place.A new aortic valve (model unknown) was implanted in its place.

Manufacturer Narrative

Correction: based on the additional information received, the reported event was related to the valve not seating properly, and dislodgement of the valve was not confirmed.(b)(4) is therefore no longer applicable for this event.Visual inspection and dimensional analysis confirmed the absence of any manufacturing deficits or abnormalities.The manufacturing and material records for the perceval heart valve, model #icv1209 , s/n (b)(4), and nitinol stent component 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 #icv1209) perceval heart valve at the time of manufacture and release.Based on the information received, the repair performed and the patient's endocarditis contributed to the poor seating of the perceval valve, and the event is therefore considered to be related to the patient's condition.Furthermore, in the perceval instructions for use, it is stated that "use of the perceval s prosthesis is contra-indicated in.Subjects with active endocarditis", and the event therefore represents a failure to follow instructions.

Event Description

A perceval valve was implanted on (b)(6) 2018.On (b)(6) 2018, the patient's condition deteriorated due to severe ai.Exploratory reoperation was performed.Tee showed that the valve was out of place.An edwards magna ease was implanted in its place.The patient was an iv drug user with active endocarditis, which contributed to the perceval and magna ease both failing.Due to the endocarditis, the physician made repairs to the aorta and lvot during the perceval implant procedure, using pericardial patches.It was reported that because of the patches, the valve was never seated properly.There was no confirmation that the perceval dislodged, but rather that the valve was never seated properly.The patient died 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
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 7425902
• MDR Text Key: 105308914
• Report Number: 3004478276-2018-00171
• Device Sequence Number: 1
• Product Code: LWR
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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 Expiration Date: 11/05/2020
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 28 YR