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

Model Number	9600LDS26A
Medical Device Problem Codes	Burst Container or Vessel (1074); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-05874.Investigation is ongoing.
Event or Problem Description
As reported by filed clinician specialist, a 25mm surgical valve failed due to pulmonic insufficiency.A 26mm balloon was taken up and bvf was performed.The 26mm sapien 3 (s3) valve was prepped +1cc and advanced without difficulty.The valve was deployed in good position.In the process of trying to pull the delivery system balloon back out of the valve it was noted that the outflow of the s3 frame was bending inward due to being caught on the delivery balloon.The system was readvanced distally, rotated, and tried to remove again unsuccessfully.The decision was made to reinflate the delivery balloon, unfortunately the balloon ruptured due to making contact to the point of the s3 outflow frame.The delivery system was tried to be removed again but it was still stuck.A second site of venous access was obtained in the lfv to advance a second balloon to help free the delivery system from the valve.The balloon was advanced across the s3 and inflated multiple times before the commander delivery system could be removed leaving the s3 outflow frame bent still.The delivery system would not come completely back into the sheath.The nose cone was still outside of the sheath.The delivery system and 14 esheath were removed through the right groin and a new percutaneous vascular closure device and figure-of-eight suture was placed in the rfv.There was no report of patient injury or any other required intervention.The balloon was noted to have a circumferential tear.Upon assessing the s3 valve no insufficiency was noted and a peak-to-peak gradient of 13mm was taken.The decision was to leave the valve alone due to the concern of a second 25-26mm balloon rupturing on the stent frame and being in the same position again.
Additional Manufacturer Narrative
Cine images, pre-op ct images were returned and reviewed by an edwards proctor.Per the imaging review, the 26mm sapien 3 (s3) valve was deployed within the pre-existing surgical valve in the pulmonic position in a good position.The outflow of s3 valve appeared slightly under expanded.After balloon deflated, the delivery system (ds) appeared stuck within the s3 valve.The pigtail catheter was across valve with commander ds.Multiple injections were performed, however they were unable to identify the reason ds remained stuck.The bav catheter was seen across the valve.Multiple bav inflations of the s3 valve with the commander ds still across were performed.The commander ds was removed from the s3 valve.The full bav was performed, the s3 valve outflow appeared fully expanded.Some struts on outflow appeared bent.The pig-tail catheter was across the valve, angio showed no pvl.The 26mm s3 valve appeared to be function well.The impression: they were unable to determine why the commander ds was stuck within the 26mm s3 valve post deployment from images provided.However, may be due to wire bias and balloon material catching on valve frame strut.Multiple bavs with commander still across valve caught on strut may have contributed to the frame damage.
Additional Manufacturer Narrative
The 26mm commander delivery system was returned to edwards lifesciences for evaluation, unlocked at packaging position with no flex or fine adjust in use.The delivery system was fully inserted through the sheath.Visual inspection of the returned device found the radial balloon burst on balloon (distal).There were no missing pieces on balloon.Due to the condition of the returned device, no functional testing was performed.Single wall thickness of the inflation balloon was taken.An out of specification measurement could make the material more susceptible to leakage/damage and be indicative of a manufacturing non-conformance.Measured components met the specifications.A lot history review of the related work order was performed and revealed no other complaints relating to the complaint codes below.During the manufacturing process, the following visual inspections and tests are performed throughout the process.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.Additionally, the work order underwent product verification testing as a requirement for lot release.Five (5) lot samples were taken for testing.Of note, no failures occurred during product verification testing and the lot was released.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.Device preparation manuals, device training manual, commander delivery system pulmonic ifu, and procedural training manual were reviewed.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.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 complaints were confirmed by the imagery and returned device.However, no manufacturing non-conformance was identified during the evaluation.A review of the dhr, manufacturing mitigations, complaint history review, 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, ''in the process of trying to pull the delivery balloon back out of the valve we noticed the outflow of the s3 frame was bending inward due to being caught on the delivery balloon.The system was readvanced distally and rotated and tried to remove again unsuccessfully.'' the difficulty withdrawing the thv may have been related to the guidewire bias and tip or expanded balloon material becoming caught on the frame.However, a definite root cause is unable to be determined.As reported, ''the decision was made to reinflate the delivery balloon unfortunately the balloon ruptured i think due to making contact to the point of the s3 outflow frame.'' from the imagery provided, upon removing the delivery system from the deployed valve, the valve frame appeared to distort due to excessive manipulation, causing a valve strut to bend.It is likely the bent strut interacted with the balloon upon inflation, leading to the burst.As reported, ''the delivery system would not come completely back into the sheath.'' as the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which could possibly lead to the sheath distal tip damage during withdrawal.Available information suggests procedural factors (bent valve strut, withdrawal of burst balloon, guidewire bias/balloon caught on frame).The complaint for withdrawal difficulty from the valve was confirmed.However, no manufacturing nonconformance was identified during the evaluation available information suggests procedural factors (guidewire bias/balloon caught on frame).No ifu/labeling/training manual inadequacies or manufacturing non-conformances were identified.Therefore, no corrective or preventative actions are required at this time.The complaint for balloon burst was confirmed.However, no manufacturing nonconformance was identified during the evaluation.Available information suggests procedural factors (bent valve strut).No ifu/labeling/training manual inadequacies or manufacturing non-conformances were identified.Therefore, no corrective or preventative actions are required at this time.The complaint for withdrawal difficulty from sheath was confirmed.However, no manufacturing nonconformance was identified during the evaluation.Available information suggests procedural factors (withdrawal of burst balloon).No ifu/labeling/training manual inadequacies or manufacturing non-conformances were identified.Therefore, no corrective or preventative actions are 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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: 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: 12685031
• Report Number: 2015691-2021-05875
• Device Sequence Number: 4099659
• Product Code: NPT
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954(17)230303(10)63680347
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: 9600LDS26A
• Device Catalogue Number: 9600LDS26A
• Device Lot Number: 63680347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 12/08/2021; 01/07/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/15/2021; 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown