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

Model Number 9600TFX26A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Investigation of event is ongoing.

Event Description

As reported by a field clinical specialist, a 26 mm sapien 3 valve was implanted into a pre-stented surgical pulmonic conduit for stenosis via transfemoral approach.Post deployment, moderate to severe regurgitation was observed, which in the physicians opinion was central leak ¿ although it was unable to be confirmed by cine or echo.The valve was deployed with entire nominal volume (23 cc), but it appeared under-deployed; so a non-edwards 26mm balloon was used to post-dilate and fully expand the valve.A second 26 mm sapien 3 valve was prepped and implanted valve in valve (viv).The valves were then post dilated.Post implant of the second valve the physicians noted that same moderate to severe central leak persisted.The case was aborted and patient will be considered for future surgery.The patient is currently in stable condition.

Manufacturer Narrative

The product was not returned for evaluation.No relevant photograph, imagery, or video were provided.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparations and the training manual were reviewed for instructions or guidance for proper use of the device and no deficiencies were identified.During the manufacturing process, the sapien 3 valve frames are 100% visually inspected and tested several times.During manufacturing the valve was 100% inspected by both manufacturing and quality.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A review of edwards lifesciences risk management documentation was performed for this case.  the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.  the complaint for valve regurgitation central leak was unable to be confirmed as relevant imagery were not provided for evaluation.A review of the dhr, and lot history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of manufacturing mitigations supports that proper inspections are in place to detect issues relating to the complaint.A review of the ifu and training manuals revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported, ¿post implant of a 26 mm sapien 3 valve in the pulmonic position via transfemoral approach into a pre-stented surgical conduit for stenosis moderate to severe central leak was observed¿ post implant of the second valve the central leak persisted¿.Per procedure training manual, ¿place the thv completely within the landing zone and avoid positioning the distal (outflow) half of the thv within any residual stenosis which may affect proper leaflet function.¿ the first thv was placed on a pre-stented surgical conduit.It could be possible that central leak observed with the first valve was due to improper positioning of the thv outflow, which may have impacted proper leaflet function.Additionally, as stated in case notes, valve was post-dilated as it appeared under-deployed after inflation with nominal volume.It is possible that diameter of the conduit prevented valve from fully expanding.Incomplete valve expansion can impact the functionality of the leaflets and result in regurgitation.As reported, central leak persisted with the second valve.Central regurgitation could also occur from leaflet overhang.It is possible that central leak persisted due to improper positioning of the second valve.If the valve was positioned improperly, leaflet overhang from the first valve could have impacted the functioning of the second valve.However, without further imagery, this root cause could not be confirmed.Since relevant imagery or sufficient information are not provided, a root cause is unable to be determined at this time.The complaint was unable to be confirmed.Due to the unavailability of the device, it cannot be determined if a manufacturing nonconformance contributed to the reported event.No labeling/ifu/training inadequacies were identified.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.

Manufacturer Narrative

Additional information: h10 this is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-14266.An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).A correction to field g4 is being submitted in this supplemental report.

• Brand Name: EDWARDS SAPIEN 3¿ TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10801253
• MDR Text Key: 215050369
• Report Number: 2015691-2020-14267
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2022
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Date Device Manufactured: 06/02/2020
• 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 Age: 26 YR
• Patient Sex: Female