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

Model Number 9610TF29

Device Problems Break (1069); Leak/Splash (1354); Failure to Advance (2524); Material Deformation (2976); Mechanical Jam (2983); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device return is in progress.A supplemental report will be submitted upon evaluation completion.

Event Description

As reported by our affiliate from finland, a 29mm sapien 3 transcathter valve was implanted during a mitral valve in valve procedure by vena cava vein approach.During the procedure, the commander delivery system (crimped with 29 mm valve) was brought through the esheath to inferior vena cava vein.When doing the valve alignment a bigger resistance in a catheter as normal when doing valve alignment was noticed, but it was possible to finish the alignment using the fine tuning knob, as normally.The valve was between the markers.The procedure continued towards right atrium.When arriving to the atrium, there was a pacemaker lead which stuck between the valve struts when trying to reach trans septal opening.The lead was stuck to the struts quite tight and was very difficult to release.After many attempts to manage to release the lead, the decision was to try to continue through the septum opening.It was not possible to manage to go through the opening and after few attempts, the decision was to cancel and remove the catheter from the patient.There was moderate resistance while removing the ds through the esheath.The entire system was removed through the esheath.When inspecting the commander catheter, it was noticed that the balloon was broken/burst.The balloon leakage was noticed after ds retrieval.A new catheter and a new valve was used and the valve was successfully implanted.The procedure went well and the patient outcome was good.As per medical opinion, what was the root cause of the balloon damage may have been during insertion through the esheath or due to interaction with atrial lead/atrial septal crossing.

Manufacturer Narrative

Supplemental report submitted update h6 device code.Per pre decontamination evaluation observations, the balloon torn was found.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The visual inspection of the returned device was performed and the following was observed: valve returned crimped on inflation balloon.Minor flex tip gouges.The crimp balloon was torn proximal to i/c (inflation balloon/crimp balloon) bond.Flex shaft kink located 1.25 inches from the flex tip.Flex shaft compression located 3.5inches from the flex tip.Functional testing of the returned device was performed and full valve alignment (gross and fine adjust) was able to be performed with no issues.With the balloon shaft locked at the valve alignment position, the balloon shaft was able to be pulled to 67.6n without any slipping observed which met specification.The device history record (dhr) was reviewed and the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating 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 the failure mode is not required at this time.The complaints for gross alignment difficulty and balloon tear were confirmed based on the provided imagery and condition of the returned device.The complaint for device interferes with permanent pacemaker lead was unable to be confirmed due to unavailability of applicable imagery.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, complaint history review 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.Available information suggests procedural factors (valve alignment in a non straight section of the anatomy / high alignment forces) may have contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.For the complaint of balloon torn, potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessment (pra).As identified in the pra, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.Potential sources of high forces, which will impact difficulty with aligning the valve, include performing valve alignment in tortuous vasculature.Performing valve alignment in a non straight section can cause the valve to dive into the lumen of the flex tip where part of the crimped valve slides into the flex tip lumen, as evidenced by the flex tip gouges.If the thv is unseated (non coaxial placement of valve in relation to the flex tip) during alignment, it can result in higher than usual valve alignment forces (as evidenced by the flex shaft compression) and can potentially weaken the crimp balloon and cause tension to the system.Per the training manual, 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.Available information suggests procedural factors (valve alignment in a non straight section of the anatomy / high alignment forces) may have contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.A capa was previously initiated to address this failure mode.The exact cause of pacemaker lead interaction during a transseptal mitral procedure is unknown.However, some possible causes include: suboptimal anchoring of the pacemaker lead, suboptimal/anomalous trajectory of the lead, suboptimal location of the septal puncture (too close to the pacemaker lead).Due to insufficient information provided, a definite root cause is unable to be determined at this time.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action is required at this time.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.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11690989
• MDR Text Key: 248557812
• Report Number: 2015691-2021-02562
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)221006(10)63435183
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 63435183
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/05/2021; 06/28/2021
• Supplement Dates FDA Received: 05/19/2021; 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR