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

Model Number PVS25

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Septic Shock (2068); Multiple Organ Failure (3261)

Event Date 05/09/2018

Event Type  Death  

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1210 , s/n # (b)(4), 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 #icv1210) perceval heart valve at the time of manufacture and release.Based on the information and reports received from the site, the device appeared to have a good functionality over time and prior to the event, with good mean gradients and no leaks.Given this, the event can reasonably be concluded as not device-related.Device location not presently known.

Event Description

The manufacturer was informed on the event through the (b)(6) registry.On (b)(6) 2016, the patient received a perceval pvs25 to replace his native, steno-insufficient aortic valve.The device was successfully implanted, with a transvalvular mean gradient of 7mmhg and no central/perivalvular leak.The conditions remained good at the 3 months follow up visit (5mmhg and no leaks) and at 1 year follow up visits (6mmhg and no leaks).On (b)(6) 2018, the patient was admitted to the hospital in septic shock and died on (b)(6) 2018 for multi-organ failure.On the day of the admission to the hospital, a tee was performed for further investigation on the event.There was no signs of mitral valve endocarditis, but a prosthetic valve endocarditis could not be excluded.Ct exam did not show any evidence of septic embolism.The surgeon started antibiotic treatment with ampicillin, flucloxacillin and gentamicin.(b)(6) was detected in the initially preserved blood cultures, which was more sensitive to the initiated antibiotic treatment.The patient had a wet gangrene of the left big toe, which was partially amputated on the same day.The patient's conditions continued to worsen up until (b)(6) 2018, when the patient died under good symptom control of his severe underlying disease.

• Brand Name: PERCEVAL SUTURELESS AORTIC VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, british columbia V5J5M-1 ; CA V5J5M1
• MDR Report Key: 8057838
• MDR Text Key: 126880920
• Report Number: 3004478276-2018-00332
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)200615
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2018

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: Health Professional
• Device Expiration Date: 06/15/2020
• Device Model Number: PVS25
• Device Catalogue Number: ICV1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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): Death
• Patient Age: 80 YR