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

Model Number 9600TFX20A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received a call from a patient stating that her 20mm sapien 3 valve malfunctioned.As reported, while the patient was out shopping, all of a sudden her 'body filled with fluid' and she was urgently sent to the hospital.She underwent tavr in tavr with a 23mm non-edwards device within the pre-existing sapien 3 valve.The patient was not upset about her experience and is thankful she feels better.

Event Description

Edwards received additional information through review of medical records.During a follow up visit 1 years and 5 months post tavr procedure the patient was reported to have persistent moderate paravalvular leak (pvl) with recent admission for heart failure.The patient was medically treated with diuretics.The patient was clear that the dyspnea on exertion started a couple of months prior and reported to have been feeling well by the 2-year follow up visit.A tee was done showing at least moderate pvl, which appeared to be 2 dominant leaks rather than a continuous circumferential leak.A ct scan was done which appeared to show a well-expanded valve without significant calcification in the landing zone.Suspicion was that the valve landed too high, right at the virtual annulus at the left coronary cusp in the non-coronary cusp.The aortic insufficiency (ai) was stable: intra-op tte reported trivial ai, post-operative day-1 echo showed mild ai, and trivial gradients, with mean gradient (mg) of 11mmhg; mild-moderate ai on the 1-year follow up echo, mg of 18mmhg.The serial echoes post tavr have shown progressive ai, paravalvular in nature.It was decided to perform a valve in valve (viv) procedure to treat the pvl.The patient underwent a viv procedure with a 23mm non-ew valve.Post deployment the pvl was resolved.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.Per the instructions for use (ifu), valve malposition requiring intervention 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 malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction (stj), minimally or bulky/severely calcified aortic leaflets, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could 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.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.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 3 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 malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, the root cause of the malposition cannot be determined based on the available information.It is possible that the event was related to one of the risk factors mentioned above.The cause of the pvl worsening cannot be determined, but it may be related to cardiac remodeling or progression of disease process.There was no allegation or indication of a device malfunction.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 12694400
• MDR Text Key: 278341010
• Report Number: 2015691-2021-05917
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194005
• UDI-Public: (01)00690103194005(17)170427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: 9600TFX20A
• Device Catalogue Number: N/A
• Device Lot Number: 4916754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female