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

Model Number 9600LDS29A

Device Problems Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889)

Patient Problem Cardiac Perforation (2513)

Event Date 08/10/2021

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral mitral valve in valve (vinv) procedure for a 29mm sapien 3 valve in a non-edwards surgical valve, during advancement, the nose cone was able to be advanced to the non-edwards surgical valve, but the sapien 3 valve would not cross the transeptal puncture after 30 minutes of manipulation.The decision was made that there was 'too much memory' in the delivery system and it would not cross due to lack of 'pushability'.Contralateral access was obtained to redo the septostomy but was unsuccessful.After multiple attempts to advance, the delivery system was kinked and looped on itself into the inferior vena cava.The valve, delivery system, and esheath was removed as one unit.Access was obtained on the left femoral vein and the septostomy was performed again.A new esheath was placed, this time a lunderquist wire was placed into the left ventricle and a new 29mm s3 was prepped and advanced across the septal without difficulty and deployed.After pacing was stopped, the patient never recovered, and an effusion was noted at the apex of the left ventricle.The patient was not a candidate for open conversion.At this time, cpr was performed and the effusion was drained, however, there was no return of any arterial waveform.The physician's believe the right ventricle gave out and could not handle the pacing run and the new valve along with a wire perforation of the left ventricle.The patient's death was called on the table.

Manufacturer Narrative

Correction to h6 based on additional information received.The device was not returned to edward for evaluation, and the lot number was not provided by the site, therefore a device history record review and lot history review was unable to be conducted.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.Photos were provided from site and following was observed: the flex shaft was kinked.The following instructions for use (ifu) were reviewed: ifu for commander delivery system, s3 commander preparation training manual, and s3 commander procedural training manual.Supplement to edwards sapien 3: valve-in-valve patient screening and procedural training manual (mitral position).Based on this review, there were 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.The complaint for system component damaged, was able to be confirmed by provided photos, and delivery system difficult to cross septal wall was unable to be confirmed.However, due to the unavailability of the device, no manufacturing non-conformances were identified during the evaluation.Review of manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu/training materials revealed no deficiencies.As reported, 'the sapien 3 valve would not cross the transeptal puncture after 30 minutes of manipulation and after multiple attempts to advance the delivery system was kinked'.The excessive manipulation used to overcome the reported difficulty could cause damage to the delivery system components.Per the training manual, 'maintain edwards logo down throughout the procedure to prevent kinking of the delivery system' and 'to prevent kinking of the delivery system, do not torque the handle while rotating the flex wheel.' as reported, 'contralateral access was obtained to redo the septostomy this still did not help'.Difficulty crossing the septal wall can be caused by the following factors: flexing delivery system incorrectly, orienting e-logo incorrectly, patient anatomy not accurately assessed, user torques delivery system, and balloon shaft not locked after valve alignment.As it was reported that the device was manipulated and kinked during septal wall crossing, available information suggests procedural factors (use error) contributed to the reported event.Without the return of the complaint device or applicable imagery, a definitive root cause was unable to be determined.However, as such available information suggests procedural (excessive manipulation/use error) factors contributed to the events.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.No corrective and preventative actions nor a product risk assessment (pra) 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
• MDR Report Key: 12425788
• MDR Text Key: 270036315
• Report Number: 2015691-2021-05025
• Device Sequence Number: 1
• Product Code: NPT
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death