MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26J

Device Problem Inflation Problem (1310)

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 12/18/2023

Event Type  Injury  

Event Description

Per report received from japan, the patient underwent a transfemoral transcatheter aortic valve replacement (tavr) and received a 26mm sapien 3 ultra resilia (s3ur) valve.During valve alignment, although resistance was encountered, the s3ur valve could be placed on the balloon of a commander delivery system (ds).But when inflating the balloon of the ds to deploy the valve, only the left ventricle (lv) side of the valve was inflated about one-fourth and the balloon slipped toward lv.Therefore, the valve was pulled back to the lower artery and was deployed in the common iliac artery (cia).Then, a 9mm stent was placed over the valve.After that, the doctor opened a new 26mm tavr kit and completed the procedure.No patient injury such as vascular complication was reported.

Manufacturer Narrative

Investigation is ongoing.H3 other text: remains implanted.

Event Description

Per additional information received from japan, when the thv valve was pulled back to the cia, a dissection occurred on the right cia.Therefore, a stent was placed.

Manufacturer Narrative

A supplemental mdr is being submitted due to additional information received.Sections h6: clinical code and h10 has been updated.Investigation is still ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.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 event is not required at this time.The complaint for "valve alignment difficulty or inability - gross alignment," "inflation difficulty and/or incomplete inflation,", and "vascular dissection" were unable to be confirmed.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device preparation.Per event description, ".During valve alignment, strong resistance was encountered when pulling the balloon catheter- the left ventricle (lv) side of the valve was inflated about one-fourth and the balloon slipped toward lv- when the thv valve was pulled back to the cia, a dissection occurred on the right cia.Therefore, a stent was placed." valve alignment difficulty or inability - gross alignment the event description also stated the degree of tortuosity was mild in the access vessel and there was moderate calcification in the native valve.Also, the event description stated there was strong resistance when pulling the balloon catheter.Per the ifu, "if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage." therefore, it is possible the calcified and tortuous vasculature created resistance and led to difficulty in performing valve alignment due to the non-straight section of anatomy.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.Inflation difficulty and/or incomplete inflation additionally, calcified and tortuous anatomy can present challenging, constructive passageway and constrained conditions for the delivery system and contribute to the reported inflation of the balloon.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by ew, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.The minimum required vessel diameter for an (14 fr sheath is 5.5 mm).In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest that procedural factors (partially inflated valve was pulled back to the lower artery and was deployed in the common iliac artery) in addition to factors/mechanisms mentioned above 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: COMMANDER DELIVERY SYSTEM
• 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: 18499966
• MDR Text Key: 332722517
• Report Number: 2015691-2024-00330
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103211597
• UDI-Public: (01)00690103211597(17)250731(10)65236330
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9750CM26J
• Device Lot Number: 65236330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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: 83 YR
• Patient Sex: Female