MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EVOQUE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Catalog Number 9850EV44

Device Problems Appropriate Term/Code Not Available (3191); Patient Data Problem (3197)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 12/17/2021

Event Type  Injury  

Event Description

The patient, (b)(6) was enrolled in a randomized clinical trial, the triscend ii trial, in which he was to undergo transcatheter tricuspid valve replacement using an investigational device.As part of the evaluation for the procedure, a cardiac computerized tomographic angiogram (cta) is performed and transmitted electronically to the sponsor for procedural planning (including selection of a valve size).To transmit the images, the study research coordinator requests a "deidentified" dvd of the cardiac cta from our radiology dept.The dvd is then provided with no identifying markings or code on the dvd itself.The dvd is then placed into an envelope with patient identifying information.On this occasion, 2 research dvds were ordered in this manner on the same day [date redacted] -- one for the patient above (b)(6) and one for (b)(6).For such requests, multiple patient studies can be requested using the same web-based request form.Two envelopes were provided, each with a dvd, which the research coordinator picked up on [date redacted].On the same day, [date redacted], the research coordinator copied the cta images from the dvd that was in the envelop belonging to (b)(6) onto her computer and then uploaded the files to (b)(6)'s profile on (b)(6), the imaging service used by edwards lifesciences for clinical trial image review.(b)(6) was approved for the triscend ii clinical trial by the sponsor and the screening committee.The patient then underwent the trial procedure (transcatheter tricuspid valve replacement [ttvr]) on [date redacted] using a 44 mm transcatheter heart valve.Upon initiation of the procedure, the procedural physician noted that the tricuspid valve annulus appeared larger than expected based on the cta.This discrepancy was discussed with the sponsor and the sponsor generated cta was re-reviewed to confirm the annular dimensions and the appropriate device size.We then proceeded with transcatheter tricuspid valve replacement (ttvr) as planned, using a 44 mm prosthesis.The initial procedure was deemed a success.The patient had only trivial paravalvular regurgitation via intra-procedure transthoracic echo, but the valve prosthesis appeared notably small compared to the annulus.On the next day, transthoracic echo demonstrated moderate to severe paravalvular regurgitation.On echo it appeared that the valve was no longer stable in the annulus.Given that the patient had received an oral anticoagulant and was otherwise clinically stable, the decision was made to delay cardiac surgery to remove and replace the valve prosthesis until [date redacted].Surgery was performed as planned, with removal of the transcatheter valve and implantation of a surgical valve prosthesis.The patient developed complete heart block and also received a permanent pacemaker on [date redacted].His post-operative course was otherwise smooth, and he was discharged from the hospital on [date redacted].On [date redacted], the research coordinator copied the cta images for (b)(6) from the dvd provided onto her computer.On [date redacted], the files were uploaded to (b)(6)'s profile on (b)(6).On [date redacted], the research coordinator received an email from the sponsor screening team notifying her that the images did not show evidence of prior surgical mitral valve repair.They asked that she re-check the images to confirm they were for the correct patient.To ensure that the images were correct, the research coordinator placed a new order for 9-024)'s cta images on [date redacted] and picked up the dvd on [date redacted].On the same day, she uploaded the images to (b)(6) under (b)(6)'s profile.Upon upload, she received an automated message that the cta images for (b)(6) had already been uploaded to (b)(6)'s profile in (b)(6) 2021.After receiving this message, the research coordinator placed a new order for (b)(6)'s cta images on [date redacted] in order to compare.At this point, it became apparent that the original dvds had been swapped.We reached out to our radiology department, who confirmed that the dvds are deidentified and that there is no way to tell them apart based on the dvd alone.The procedural physician has since reviewed the measurements provided for (b)(6)'s case in (b)(6) and felt that they more closely matched those of (b)(6)'s cta as well.In addition, we found that the (b)(6) imaging system generated an automated upload confirmation noting that the dates we provided for the ctas were incongruent with the dates embedded in the dicom images.However, the research team were not made aware of this discrepancy.We reported these events to the sponsor (edwards lifesciences) on [date redacted].We also reported the incident to our irb and filed protocol deviations for both patients with the sponsor documenting the incident.Manufacturer response for transcatheter tricuspid heart valve, evoque (per site reporter) edwards lifesciences had reported this incident to the fda.The fda requested that edwards lifesciences quality team come to the hospital and review investigation to date and our immediate corrective actions.Edwards lifesciences came on [date redacted] and approved all immediate and long term corrective action plans.

• Brand Name: EVOQUE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13522774
• MDR Text Key: 285543597
• Report Number: 13522774
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/11/2022,02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 9850EV44
• Device Lot Number: 7883186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 29930 DA
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White