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

Model Number 9600LDS29A

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Difficult to Remove (1528); Failure to Align (2522)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  Death  

Manufacturer Narrative

The investigation is underway.This is one of two manufacturer reports being submitted for this case.

Event Description

As reported by a field clinical specialist, a 29 mm sapien 3 valve was implanted in the aortic position via transfemoral approach.Post implant the valve was observed to be too ventricular and had central aortic insufficiency.The patient arrested and cpr was required.A second 29 mm sapien 3 valve was prepped for valve in valve.During deployment the balloon had a pinhole leakage and the valve was unable to expand.All devices were removed without issue.Upon removal a pinhole was observed on the balloon.All devices were discarded.A third 29 mm sapien 3 valve was prepped and successfully implanted valve in valve without issue.Post procedure tte revealed an effusion and a sternotomy was performed.The patient was in stable condition post procedure.Per medical opinion, the cause of the injury was unknown.The physician did not known if it was a wire or pacemaker lead.

Manufacturer Narrative

Please reference manufacturer report number 2015691202101813.The product was not returned for evaluation.Procedural imagery provided by the site showed significant calcification present in the native annulus.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the device and no deficiencies were identified.During the manufacturing process the commander delivery system is visually inspected and tested several times.During manufacturing, the balloon component was 100% inspected.During the final inspection, the device underwent 100% inspection by both manufacturing and quality.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis.All samples passed product verification testing for this lot number.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 balloon leakage was unable to be confirmed as no photos were provided and the device was not returned.A review of the lot history, dhr, and manufacturing mitigations did not reveal any indications that a manufacturing non-conformance contributed to the event.A review of the ifu training materials also revealed no deficiencies.Calcification present in the patients native annulus and leaflets can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure , calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Additionally, a preexisting s3 valve was present in the annulus.It is possible the interaction between the balloon with an existing valve and or stent may compromise the balloon wall during inflation.As such available information suggests patient factors calcification and stent could have contributed to the reported event.The complaint event was unable to be confirmed.Due to the unavailability of the device, it cannot be determined if a manufacturing nonconformance has contributed to the reported event.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 labeling ifu training inadequacies have been identified.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.

Event Description

Post procedure the patient was transferred to icu in critical condition.Approximately one hour post procedure the patient expired.

Manufacturer Narrative

Additional information received: a2: date of birth.B5: event description updated.B3: date of death.H1: death added.The investigation remains ongoing.

Manufacturer Narrative

Correction h6 device codes failure to align and difficult to align added.

Manufacturer Narrative

The devices were not returned for evaluation.Patient imagery was received and found calcification present in the native annulus/leaflets and calcification and tortuosity present in the patient access vessels and descending aorta.A device history review (dhr) was performed and 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 the complaint codes below.As the valve was able to be moved onto the inflation balloon, prior complaints related to similar events (recoil, does not engage, unable to rotate) were excluded from review.During manufacturing, the device is both visually inspected and tested several times throughout the process.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.The following ifu and training manuals were reviewed for guidance and instruction on device preparation and usage involving the commander delivery system and esheath usage: edwards commander delivery system, us, device preparation manual and procedural training manual.Based on the review of the ifu/training manuals, no deficiencies were identified.As the reported events were unable to be confirmed, a complaint history review is not required.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.Since no product non-conformances or ifu/training manual deficiencies were identified, no escalation to a product risk assessment (pra) was required.Since no edwards defect was identified, no corrective or preventative actions (capa) are required.The reported events were unable to be confirmed, as no device-related photos were provided.Additionally, since the device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis, and therefore no manufacturing non-conformances were able to be identified.A review of lot history, dhr, did not reveal any indications that a manufacturing non-conformance contributed to the event.A review of ifu/training materials also revealed no deficiencies.Potential sources of high forces, which will also impact difficulty with aligning the valve, include performing valve alignment in tortuous vasculature.Per the imagery provided, the patients access vessels and descending aorta were slightly tortuous.Additionally, performing valve alignment in a non-straight section of the vessel can cause valve diving (thv become unseated from the flex tip).If the thv is unseated during alignment, the valve can become non-coaxial and can result in high valve alignment forces thus increasing difficulty with valve alignment.If the valve is unseated during alignment, it can result in interaction between the valve and the crimp balloon, which may have punctured the balloon and resulted in the reported pinhole.Additionally, calcification present in the patient native annulus, sinus and leaflets.The presence of calcification can create a challenging anatomy for balloon inflation.Calcified nodules can compromise the structure of the balloon wall.It is possible that the interaction between the balloon with an existing calcification may compromise the balloon wall during inflation.It is possible the presence of tortuosity may have contributed to non-coaxial withdrawal of the delivery system into the sheath, contributing to withdrawal difficulty.Although the source and nature of the leakage is unknown, if the balloon profile was altered, this would further contributing to difficulty in retracting the valve inside the sheath tip.As such, available information suggests patient factors (calcification/tortuosity) and/or procedural factors (high alignment forces/non-coaxial withdrawal, withdrawal of damaged balloon) could have contributed to the reported event.

• 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: 11467617
• MDR Text Key: 245464394
• Report Number: 2015691-2021-01814
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 0069010193961
• UDI-Public: (01)0069010193961(17)220811(10)63357904
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/09/2021

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: 08/11/2022
• Device Model Number: 9600LDS29A
• Device Lot Number: 63357904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 04/21/2021; 04/23/2021; 05/05/2021; 09/09/2021
• Supplement Dates FDA Received: 04/26/2021; 04/27/2021; 05/10/2021; 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR