MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tricuspid Regurgitation (2112); Vascular Dissection (3160)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is one of 5 manufacturer reports being submitted for this case. the date of the event(s) is unknown.According to the article the date range for this event is from september 2015 and november 2019.For this reason, the first day of the range was used as the occurrence date.The edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis.Deployment of the sapien 3 valve in the pulmonic valve is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.Per the instructions for use (ifu), cardiovascular injury, including perforation or dissection of valvular structures is a known potential complication associated with the tvr procedure. chordae tendinae rupture in tvr can occur during advancement of the guidewire, bav catheter, or delivery.In some cases intervention may not be required; however, if the rupture is significant it typically results in profound regurgitation and will require intervention to prevent permanent injury.In this case, there is no information to suggest a manufacturing nonconformance contributed to the event.  the cause of the tricuspid regurgitation is unknown as the article did not state the cause of the regurgitation, however may be due to procedural factors (device manipulation). there was no indication or allegation of a device malfunction.  complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Article reference: fukuda t, tan w, sadeghi s, lin j, salem m, levi d, aboulhosn j.Utility of the long dryseal sheath in facilitating transcatheter pulmonary valve implantation with the edwards sapien 3 valve.Catheter cardiovasc interv.2020 feb 19.Doi: 10.1002/ccd.28776.[epub ahead of print] pubmed pmid: 32073725.

Event Description

As reported through article, ¿utility of the long dryseal sheath in facilitating transcatheter pulmonary valve implantation with the edwards sapien 3 valve¿ a total of 94 patients were enrolled; 29 patients underwent tpvi with the sapien valve using the dryseal sheath and 65 underwent tpvi using the e-sheath. all patients who underwent tpvi with the sapien 3 valve, excluding those performed via hybrid approach, at our center between september 2015 and november 2019 were retrospectively reviewed and compared between two groups.There were nine procedural complications in the esheath group: new or worsening tricuspid regurgitation due to valve damage or chordal rupture occurred in four patients with native rvot morphologies and required surgical intervention in three of the four cases.Difficulty encountered during the edwards delivery system's passage through a complex network of rv inflow chordae and muscle into the rvot resulted in long valve delivery times (61 min 27 sec, 20 min 37 sec, and 16 min) for three of the cases with tricuspid regurgitation.One complication involving femoral venous dissection at the location of e-sheath placement required a few days of additional unanticipated hospitalization, however the patient improved without interventions.Otherwise, there were no venous access site complications requiring intervention or prolonged unexpected hospital stay in either group.The complications in the e-group involved, ¿aortic compression¿ requiring surgical removal of the valve, and valve migration requiring surgical removal of the valve.There were no rvot perforations or stent fractures in either group.

Manufacturer Narrative

Supplemental report to reference related manufacturer report no: 2015691-2020-11114, 2015691-2020-11115, 2015691-2020-11116, 2015691-2020-11118.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9875661
• MDR Text Key: 196649290
• Report Number: 2015691-2020-11117
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2017
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention