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

Model Number PVS23

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis (2100)

Event Type  Injury  

Event Description

The manufacturer received information on an early possible hypo-attenuated leaflet thickening with reduced leaflet motion in a (b)(6) yrs old female patient after perceval valve implantation.The patient received a perceval pvs23 (size m) on (b)(6) 2020.A concomitant bypass procedure was performed (lima ¿ lad; cabg - om).An uneventful surgery was reported, no leakage of the valve prosthesis, and the immediate mean gradient was below 10mmhg.A transthoracic echo (tte) was taken on the postoperative day (pod) 1, which showed: mean gradient of 18mmhg (peak 25mmhg), with no regurgitation; lvot obstruction signal; the patient complained shortness of breath throughout the next days.The tte on pod 7 showed a mean gradient of 35-38mmhg.The tte on pod 11 showed a mean gradient of 38mmhg (max gradient was 59mmhg).The leaflets were reportedly opening poorly with an ava of 0.8-0.9 cm2.Two weeks after the implant, on (b)(6) 2020, the perceval valve was explanted.The patient ultimately received an edwards inspiris 21mm.The patient had a good outcome after surgery.The explanted perceval pvs23 showed all three leaflets covered entirely with a 1 ¿ 1.5mm thick fibrin coat which made impossible for the leaflets to open properly /fully.It is reported that the patient received aspirin from pod 1 with low molecular heparin and warfarin from pod 3.The patient did not have coagulation disorders.The patient's preoperative inr was 0.93, the postoperative one was of 1.10.

Manufacturer Narrative

The manufacturing and material records for the perceval heart valve, model #icv1209, 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 #icv1209) perceval heart valve at the time of manufacture and release.The device was returned to the manufacturer for investigation and it was received on 09 dec 2020.Further investigation is ongoing and, once completed, an update will be provided to this reporting activity.

Event Description

Based on the medical judgment received, the slightly increased aptt of 41.3 s (normal range 26.0-36.0) or a gfr of 81 (pre-operative irregular lab findings) is not believed to have any influence of causing a halt syndrome or thrombosis.The patient received adequate postimplant warfarin and aspirin therapy, so a thrombosis oft he lealflets can be ruled out.In addition, this would have been of a distinctive structure and appearance.As reported, it looked like a totally even distributed fibrin layer into all sinuses and upon the leaflets of the perceval prosthesis.The remainder of the information previously submitted remains unchanged.

Manufacturer Narrative

Gross examination revealed a pliable bioprosthesis.A visual inspection of the returned prosthesis was performed and showed the absence of pre-existing defects.X-rays of the subject valve showed no calcification.Histological analysis showed the presence of small thrombus depositions on the leaflet¿s surfaces.The collagen bundles were locally disrupted, homogenated and-or defibrated.A pericardial delamination was detected on one leaflet.Bacteria were not detected with the gram stain.Since the fibrin coat, detected at the time of explant, was not returned with the prosthesis, no further investigation was possible.Based on the available information, it is not possible to draw a definitive conclusion for the reported event.The small thrombus deposition detected in the returned device, along with the fibrin coat deposition reported in the event (not returned to the manufacturer) could have contributed progressively to the obstruction and limitation of leaflets mobility inducing a reduction of the effective orifice area causing the observed high gradient.However, ultimately it is not possible to confirm the exact root cause that contributed to the fibrin layer deposition and reported event.

• 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: 10857098
• MDR Text Key: 216845708
• Report Number: 3004478276-2020-00234
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000429
• UDI-Public: (01)00896208000429(240)ICV1209(17)230922
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: PVS23
• Device Catalogue Number: ICV1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80