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

Model Number 9600TFX23A

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Event Description

As reported, during the procedure of a 23 mm sapien 3 valve in the pulmonic position in a conduit via transfemoral venous approach, a contained dissection was noted after a non-ew stent was placed in the pulmonic position.Another non-ew stent was placed to contain the dissection.Then the 23mm sapien 3 valve was deployed as usual.Post valve deployment, the patient's blood pressure did not recover.A dissection was noted at the top of the non-ew stent.The patient was placed on ecmo and cpr was initiated.Per report, the deployment of the sapien 3 valve caused the suture line of the conduit to break open.Another non-ew stent was implanted to contain the dissection, however post stenting rendered the sapien 3 valve non-functional and a non-ew valve was placed viv in the pulmonic position.The patient had a good result and was stable when she left the cath lab to the recovery unit.

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Event Description

As reported, during the procedure of a 23 mm sapien 3 valve in the pulmonic position in a conduit via transfemoral venous approach, a contained dissection was noted after a non-ew stent was placed in the pulmonic position.Another non-ew stent was placed to contain the dissection.Then the 23mm sapien 3 valve was deployed as usual.Post valve deployment, the patient's blood pressure did not recover.A dissection was noted at the top of the non-ew stent.The patient was placed on ecmo and cpr was initiated.Per report, the deployment of the sapien 3 valve caused the suture line of the conduit to break open.Another non-ew stent was implanted to contain the dissection, however post stenting rendered the sapien 3 valve non-functional and a non-ew valve was placed viv in the pulmonic position.The patient had a good result and was stable when she left the cath lab to the recovery unit.

Manufacturer Narrative

The following sections of this report have been updated: corrected h.6 device codes and investigation conclusions and added new information to h.6 type of investigation and investigation findings.The medical records clarified following regarding the event.Patient with right ventricle to pulmonary artery (rv-pa) conduit replacement with a homograft presenting now with moderate to severe stenosis.Angiography demonstrated a calcified homograft with an area of stenosis of the homograft valve.Upon discussion it was decided to perform covered stent dilation of the severely calcified homograft followed by a transcatheter pulmonic valve replacement (tpvr) procedure.There is foreshortening of the covered stents noted with expansion of deployment balloon.The patient was transferred to the icu in critical but stable condition.The patient was discharged home on post op day 5 in stable improved condition.Per the instructions for use (ifu), cardiovascular or vascular injury, such as perforation or damage (dissection) of vessels, myocardium or valvular structures including rupture of the rvot that may require intervention are known potential adverse events associated with the overall thv procedure and may require intervention.The ifu warns that correct sizing of the valve into the non-compliant rvot conduit or failing bioprosthesis (landing zone) is essential to minimize risks.Too small of a valve may result in paravalvular leak, migration, or valve embolization; whereas too large of a valve may result in residual gradient (patient-prosthesis mismatch) or rvot rupture.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv.The patient screening manual instructs the operator on the proper landing zone assessment, including pre-stenting considerations.Per the training manuals, in presence of pre-stenting, prosthesis sizing should be based on the diameter of the valvuloplasty balloon at full inflation.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures are also included.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that patient and procedural factors (calcified homograft with placement of non-edwards covered stents x2 prior to thv deployment) may have caused or contributed to this event.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 this adverse event is not required at this time.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 monthly, 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: 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13510254
• MDR Text Key: 286264008
• Report Number: 2015691-2022-03885
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)220429
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: 9600TFX23A
• Device Catalogue Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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 Sex: Female