MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29 MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Regurgitation (1964); Injury (2348)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The investigation is ongoing.

Event Description

As reported by a field clinical specialist, a 29 mm sapien 3 valve was implanted in the native mitral position via transeptal approach.Post implanted mitral regurgitation was observed.A second 29 mm sapien 3 valve was implanted (viv).The regurgitation was resolved.

Manufacturer Narrative

Additional information: 68 years old.Dob (b)(6) 1951 a3: female b5 event description: during deployment the valve position was thought to be correct, however due to the anatomy and the location of the mitral annular calcification, it was deemed to be too atrial after deployment and the resulting in paravalvular leak (pvl) between open cells.A second 29 mm sapien 3 valve was implanted (viv).The pvl was resolved.Per latest report the patient was stable.B7: mitral stenosis, mitral regurgitation, cad with stent in 5/2019, hld, complete heart block with placement of dual chamber pacer at time of procedure on 12/11/19, htn, diabetes type 2, morbid obesity f10: device code malposition 2616, 1457 paravalvular leak, 527 valve the edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The device was not available for evaluation, as it remains implanted in the patient.It is to be noted that in this case the sapien 3 valve was implanted in the native mitral annulus, which is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien xt valve in this scenario.Per the instructions for use (ifu), valve malposition requiring intervention and perivalvular leak are known potential complications associated with bioprosthetic heart valves.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.There are multiple patient and procedural factors that alone or in combination can cause or contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.In this case, there was no indication a product deficiency contributed to this adverse event.Per the authors, the valve was placed too atrial due to the patient¿s anatomy resulting in mitral regurgitation (pvl).There was no allegation or indication that these adverse events were related to 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.

Event Description

During deployment the valve position was thought to be correct, however due to the anatomy and the location of the mitral annular calcification, it was deemed to be too atrial after deployment and the resulting in paravalvular leak (pvl) between open cells.A second 29 mm sapien 3 valve was implanted (viv).The pvl was resolved.Per latest report the patient was stable.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29 MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9516876
• MDR Text Key: 178112559
• Report Number: 2015691-2019-04920
• Device Sequence Number: 1
• Product Code: NPU
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2019

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: 10/01/2021
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 01/02/2020; 07/23/2020
• Supplement Dates FDA Received: 01/17/2020; 12/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR