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

Model Number	9600SDS26A
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by a field clinical specialist, a patient underwent a transcarotid procedure with a 26mm sapien 3 valve inside a pre-existing 27mm freestyle valve in aortic position.This was a planned left carotid access case using a 26mm certitude delivery system and sheath system.The sheath, valve, and delivery system were prepped per ifu.The 26mm sapien 3 valve was deployed with 24cc per physicians request.During balloon inflation, the balloon had ruptured.The valve was deployed at 60/40 position.The surgeon had difficulty pulling the balloon back into the sheath.As a result, the carotid artery was torn and needed surgical repair.The patient remained stable during the procedure.As per follow-up with the fcs, the valve was deployed at 60/40 intentionally due to calcium.The valve was post-dilated because the valve was underdeployed not due to pvl.The balloon was partially inflated when it burst.There was 1cc extra volume added to the balloon prior to the inflation.The inflation technique used was slow and 24cc of volume was used for inflation.The perceived root cause of the balloon burst is due to the calcium.The device was getting caught at the distal tip during withdrawal.There was coaxial alignment of the delivery system upon re-entry into the distal end of the sheath.There was no crossing difficulty and there was no retained volume in the balloon.The team waited approx.2 minutes between deflation and withdrawal.The issue was resolved by the physician pulling the device out without having the balloon in sheath.
Additional Manufacturer Narrative
Investigation is ongoing.H3 other text : not returned.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaint for "balloon burst" was unable to be confirmed due to lack of device return or applicable imagery.Available information suggests calcification and over-inflation likely contributed to the event as the customer reported that "during balloon inflation, the balloon had ruptured." the customer also stated, "the valve was deployed at 60/40 intentionally due to calcium" and "there was 1cc extra volume added to the balloon prior to the inflation." the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst 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.While the prescribed nominal inflation volume is provided in the ifu, it is possible that extra inflation volume was used (over-inflation), subjecting the balloon to pressures high enough to cause the balloon to burst.The complaint for "difficulty or inability to withdraw system through vasculature" was unable to be confirmed due to lack of device return or applicable imagery.Available information suggests that withdrawal of burst balloon likely contributed to the event as the customer reported that "the device was getting caught at the distal tip during withdrawal." as the balloon was burst, the altered balloon profile could have made it more susceptible to catch on the distal end of the sheath tip which would have then led to the experienced retrieval difficulty.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS CERTITUDE DELIVERY
• 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 ewards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18196731
• Report Number: 2015691-2023-17716
• Device Sequence Number: 17780574
• Product Code: NPT
• UDI-Device Identifier: 00690103194159
• UDI-Public: (01)00690103194159(17)250406(10)64913936
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 04/06/2025
• Device Model Number: 9600SDS26A
• Device Lot Number: 64913936
• Was Device Available for Evaluation?: No
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• 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: Male