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Model Number 9600TFX23A
Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Patient Problems Death (1802); Embolism (1829); Injury (2348)
Event Date 06/28/2018
Event Type  Death  
Manufacturer Narrative
Udi number: (b)(4) registry. The investigation is ongoing. This is one of two manufacturer reports being submitted for this case.
Event Description
During implant of a 23mm sapien 3 valve in the aortic position, the valve embolized into the ventricle. The valve was attempted to be pulled back to the annulus and a second 23mm sapien 3 valve was implanted. The second valve also embolized and the patient expired.
Manufacturer Narrative
The death box was unselected and the required intervention to prevent permanent impairment was selected. Please reference related manufacturer report no: 2015691-2018-02986 additional information was received. This patient needed an aortic valve replacement, but was not a surgical candidate due to history of three open heart surgeries including an arterial switch operation (aso) for treatment of transposition of great arteries (tga). A tf tavr procedure was performed as the patient had no other treatment options. A 23mm sapien 3 valve was prepped with nominal volume and deployed in the aortic position. However, there was not much calcification for the valve to hold on to and it embolized into the left ventricle. The valve was pulled partially back into the annulus with the delivery system, but it was not in optimal position and it was decided to do a valve-in-valve procedure. A second 23mm sapien 3 valve was prepped with an additional 2cc of inflation volume. During deployment, both valves embolized to the left ventricle. Multiple attempts to pull the valves back into the aortic root were performed without success. The patient started to decompensate, with severe ai and severe mr and subsequently passed away despite resuscitation measures. The aortic annulus diameter measured approximately 21 mm with mild calcification. The sinotubular junction (stj) diameter measured 15 mm. Per the report, the sapien 3 valve embolization was thought to be related to the patient¿s mild annular calcification. It was felt that during the attempts to pull the sapien 3 valves back up, the mitral valve apparatus may have been inadvertently injured (torn), contributing to the patient¿s decompensation and subsequent demise. Although the mitral regurgitation was confirmed by echo, the nature of the mitral injury was unable to be determined from the images. The edwards sapien 3 transcatheter heart valve is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality
3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator). Per the instructions for use (ifu), valve embolization is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure. There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction, minimally or bulky/severely calcified aortic leaflets, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator. The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations. Physicians are extensively trained by edwards before they are qualified to use the sapien thv. Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures. The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device. Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment. In patients with high-risk anatomical features for ventricular embolization (i. E. Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. Investigation results suggest/indicate the patient¿s mild annular calcification was a likely contributing factor for the sapien 3 valve embolization. The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. 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.
Manufacturer Narrative
Corrected data: event problems codes, event problem and evaluation codes. Reference capa-(b)(4).
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Manufacturer (Section D)
1 edwards way
irvine CA 92614
Manufacturer (Section G)
1 edwards way
irvine CA 92614
Manufacturer Contact
frances preston
1 edwards way
irvine, CA 92614
MDR Report Key7712981
MDR Text Key114797677
Report Number2015691-2018-02986
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/21/2020
Device Model Number9600TFX23A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/23/2018 Patient Sequence Number: 1