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

Model Number 9600LDS29A

Device Problems Burst Container or Vessel (1074); Fracture (1260)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4).Investigation is ongoing.

Event Description

As reported by field clinical specialist (fcs), during the placement of the 29mm sapien 3 valve in a preexisting perimount valve in the pulmonic position, the commander balloon burst at full inflation.Nominal volume was used.Removal of the delivery system through the sheath was successful without issue.There was no reported injury to the patient.The sapien 3 valve did not require post dilation.  the preexisting valve had mild calcification.The prior surgical valve had a fractured crown prior to sapien 3 valve placement.

Manufacturer Narrative

Udi (b)(4) per initial report, the perceived root cause was possibly related to calcium.As the affected device was not returned, the investigation will be limited to review of photographs, videos, or imagery, review of dhr, review of lot history, review of complaint database for similar complaints, review of physician training and ifu, manufacturing mitigations, root cause, and fmea assessment.Review of photographs provided show the burst balloon post-procedure and show the fractured crown of the previous implanted surgical valve.Dhr review was performed for the components listed in the work orders that are relevant to the manufacturing of the devices and components that could potentially contribute to the complaint event.The work orders revealed no manufacturing non-conformance that would have contributed to the complaint event.A review of complaint history for the edwards commander delivery system (all models, all sizes) for the past 12 months (september 2017 to august 2018) revealed other similar complaints with returned devices for the complaint code ¿balloon ¿ burst¿.Thirty complaints were confirmed, but no potential manufacturing non-conformances that would have contributed to the complaints were identified.Available information suggested that the root causes were related to that detailed in a technical summary written by edwards lifesciences.The technical summary found that patient factors (i.E.Annular, stj, or leaflet calcification), can present a challenging anatomy for balloon inflation and can compromise the structure of the balloon wall even at low inflation pressures.One complaint was unable to be confirmed and no manufacturing non-conformances that would have contributed to the complaint were identified.Available information suggested that patient/procedural factors (balloon damaged during withdrawal difficulty) contributed to the complaint.Five complaints were confirmed, but no manufacturing non-conformances that would have contributed to the complaints were identified.Available information suggested that patient/procedural factors (annular calcification; over-inflation of balloon) contributed to the complaints.One complaint was not confirmed.There is no evidence of device malfunction or manufacturing non-conformance (alleged physical defect is not present).Available information indicates that it is likely the incorrect device was returned to edwards.No further engineering evaluation is needed.Two complaints are pending engineering evaluation.  a review of complaint history data for august 2018 revealed that the complaint occurrence did not exceed the control limit for the trend category of ¿balloon ¿ burst¿.The use of a sapien 3 (s3) with the commander delivery system (ds) for a tavr procedure by tf approach in the pulmonic position is not indicated for use in united states at this time.The ifu and training manuals in this section are for a tf procedure in the aortic position and were reviewed for relevant guidance for an s3 implant as well as esheath and commander ds use.The commander instructions for use (ifu) and device preparation training manual, and commander device preparation training manual were reviewed for instructions or guidance for proper preparation of the commander delivery system.Based on the review of the ifu/training manuals, no deficiencies were identified.During manufacturing process, the entire delivery system is visually inspected and tested several times.During general inspection for thv s3 balloons 100% visual inspection for critical dimensions is performed, including working length, balloon diameter, proximal and distal leg ids, proximal leg od, and double wall thickness.Also, 100% visual inspection for defects such as witness lines, contamination, mechanical damage, deformation, crow¿s feet, fish eyes, gel spots, and scratches.Ten (10) balloons are sampled for burst testing and additional visual inspection.During the crimp balloon molding process for thv, upon the completion of crimp balloon molding and annealing, the crimp balloons are 100% dimensionally and visually inspected.During the crimp balloon to inflation balloon laser bond, the laser weld joint is 100% visually inspected for bubbles and to ensure there is a smooth bond joint with no gaps between components.During balloon catheter laser bond prep, the balloon assembly is 100% visually inspected prior to laser bonding for any contamination.During balloon pleat, fold, & forming, prior to the process, the balloon is 100% visually inspected under 2.85x minimum magnification for balloon size (using a go/nogo gauge) and contamination.After the process, the balloon is 100% inspected for fold lines and rejected for distorted/pinched folds.During final inspection, 100% distal to proximal visual inspection is performed by both manufacturing and quality during the flex catheter and balloon catheter leak test, the commander delivery system is 100% leak tested.Post-leak test, there is a visual inspection of the balloon catheter.Additionally, the related work order underwent a product verification testing as a requirement for lot release.During the functional product verification testing for commander, visual inspection is performed for kinks, cracks, missing components, and missing small white marker band on balloon shaft (with unaided eye).The system is tested for balloon burst pressure after fatigue, and the lot was accepted.All samples passed product verification testing.Inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing issue contributed to the reported event.Based on the photos provided by the site, the complaint for ¿balloon ¿ burst¿ was confirmed.Due to the unavailability of the device, engineering was unable to perform visual, dimensional, and functional analysis.As a result, the presence of a manufacturing non-conformance was unable to be determined.A review of dhr, lot history, and complaint history did not reveal any manufacturing non-conformances which could have contributed to the complaint.Furthermore, a review of ifu/training materials revealed no deficiencies.Since the valve was successfully deployed, the balloon burst occurred upon inflation of the delivery system.As stated in the cer, ¿perceived root cause was possibly related to calcium¿ and ¿the preexisting valve had mild calcification¿.It is also possible that, upon completion of valve deployment, the inflation balloon was ruptured from coming into contact with the fractured crown of the previous surgical valve.In addition, review of available information suggests that the balloon burst was likely caused by patient factors (calcification).A detailed root cause analysis for similar returned balloon burst complaints has been summarized in a technical summary written by edwards lifesciences.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified annulus.As reported in the cer and the complaint description, ¿perceived root cause was possibly related to calcium¿ and ¿the preexisting valve had mild calcification¿.The presence of calcification 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.In addition, the use of a sapien 3 with the commander delivery system for a tavr procedure by tf approach in pulmonic position is not indicated for use in united states at this time.As such, off-label use may have contributed to the complaint event.As such, available information suggests that patient (calcification) and/or procedural factors (interaction with the fractured crown of the previous surgical valve, off-label use) may have contributed to the reported event.However, based on available information, a definitive root cause is unable to be determined.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 manufacturing non-conformances or labeling/ifu/training material training deficiencies were identified, no corrective actions are required.No product non-conformance was confirmed and this failure mode does not exceed the complaint trending control limits; therefore a pra escalation is not required.The complaint for ¿balloon ¿ burst¿ was confirmed but manufacturing non-conformances were unable to be confirmed due to no device return.Available information suggests that patient (calcification) and/or procedural factors (interaction with the fractured crown of the previous surgical valve, off-label use) may have contributed to the complaint event.Since no product non-conformances or ifu/training inadequacies were identified in the evaluation, and the control limit did not exceed the respective trend category, no corrective or preventive action is required at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7882356
• MDR Text Key: 120459776
• Report Number: 2015691-2018-03824
• 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,Followup
• Report Date: 08/28/2018

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: 05/21/2020
• Device Model Number: 9600LDS29A
• Device Lot Number: 61369222
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 10/18/2018; 07/23/2020
• Supplement Dates FDA Received: 10/19/2018; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR