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

Model Number 9610TF29

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Vascular Dissection (3160)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device return is expected.

Event Description

As reported by our affiliates in (b)(6), during the alignment of a 29mm sapien 3 valve in aortic position, by subclavian approach, the valve was unable to advance within the markers on the balloon.The difficulty was felt during fine alignment.There was no pull past the warning marker.The first valve was retrieved through the sheath as per procedural manual as a whole unit.A second valve was implanted without any alignment problems.There was a dissection of the left subclavian artery.The left subclavian access was surgically repaired.On pod7, the patient was discharged.As per medical opinion, the root cause of the event was probably due to the lack of a straight portion in the ascending aorta.The dissection potentially occurred when the first valve was removed with the esheath.

Manufacturer Narrative

Correction to h6 component code and device code.Related mdr report 2015691- 2021- 04655 for liner delamination.The 29mm commander delivery system was returned to edwards lifesciences for evaluation, locked at the packaging position with no fine adjust or flex in use.The delivery system was fully inserted through the sheath with the loader assembly on the flex shaft.Visual inspection of the returned device was performed.The valve was partially inflated on the proximal inflation balloon.Flex tip gouges were observed.Review of procedural videos/imagery/photographs were performed and the 3mensio imagery showing moderately tortuous vessels.During pre-decontamination evaluation the valve was able to be successfully aligned on the inflation balloon using fine adjust and deployed.Fine adjustment functional testing showed no abnormalities, and the delivery system was able to inflate/deploy balloon with no issues.Due to the reported difficulties of valve alignment the collet/locknut engagement force measurement was taken for the complaint unit.Results indicate that the engagement force measurements met specification.Due to the nature of the complaint, no dimensional testing was performed.A lot history review of the related work order was performed and revealed no other complaints relating to the related complaint codes.As the returned device meets specification with no evidence to support a manufacturing/design defect has contributed to the complaint, a manufacturing mitigation review is not required.During pre-decontamination evaluation the valve was able to be successfully aligned on the inflation balloon using fine adjust and deployed.Fine adjustment functional testing showed no abnormalities, and the delivery system was able to inflate/deploy balloon with no issues.Due to blood remaining within the system, further functional testing was not able to be performed.A complaint history review on confirmed device complaints (returned and no product returned) from (b)(6) 2020 - (b)(6) 2021 for the commander (all models and sizes) was performed with the codes identified below.Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.Of the root causes identified, the following is potentially applicable to the complaint event: patient factors: tortuosity.The ifu for edwards commander delivery system, device preparation manual, procedural training manual, and commander subclavian-axillary procedural manual were reviewed.Per 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 and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.'' no ifu/training deficiencies were identified 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.According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.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 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 complaints were confirmed.However, a manufacturing non-conformance was not identified.A review of dhr, complaint history and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, ''difficulties were encountered during valve alignment and it was not possible to get the valve between the alignment markers.'' tension present in the system during valve alignment may result in higher forces necessary to align the valve, contributing the reported complaint event.Tension in the system may be induced by the following: if the balloon profile is altered, it may be difficult to advance the thv over balloon.The balloon profile may be affected by device preparation steps, such as inflating the balloon past the recommended 20-30% as instructed in ifu materials or leaving residual fluid in the balloon after de-airing.Per the imagery and as noted by the cer, tortuosity was present in the patient's vasculature.If tortuosity is present in the vasculature, it may be difficult to advance the thv over the balloon.Additionally, ''the lack of a straight portion in the ascending aorta'' was noted by the cer.If thv alignment is performed at an angle (non-straight section of aorta), this can cause the thv to unseat from the flex tip (non-coaxial placement of valve in relation to the flex tip) during alignment and ''dive'' into the lumen of the flex tip, as evidenced by the observed flex tip gouges.If the thv is unseated during alignment, it can result in additional valve alignment forces.Additionally, the valve was also returned partially inflated.Although it is unknown as to when the damage/inflation occurred (during the procedure or testing on the back table), it is possible withdrawal difficulty or excessive manipulation during withdrawal was experienced.Vessel tortuosity can create non-coaxial withdrawal angles, resulting in the distal end of the delivery system catching onto the sheath tip and subsequently contributing to withdrawal difficulties.It is also possible the valve was partially deployed prior to withdrawing the delivery system, further contributing to withdrawal difficulty as the profile of the crimped valve was altered.However, without further information, a definite root cause is unable to be determined.Available information suggests patient (tortuosity) and procedural factors (valve alignment performed in a non-straight section, non-coaxial withdrawal) contributed to the reported event.Since no product non-conformance was confirmed, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective/preventative actions are required.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.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12068810
• MDR Text Key: 258418857
• Report Number: 2015691-2021-03778
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)221221(10)63582970
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: 12/21/2022
• Device Model Number: 9610TF29
• Device Lot Number: 63582970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR