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

Model Number 9620TA29

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/05/2022

Event Type  Injury  

Event Description

As reported from our affiliates in (b)(6), this was a 29mm sapien 3 case by transaortic approach in aortic position.While deploying the valve, the certitude delivery system balloon burst at full inflation.Despite the balloon burst, the valve was well implanted, and no post dilation was needed.Afterwards, it was not possible to remove the certitude delivery system through the sheath, and an additional cut in the aorta near the puncture was needed to be able to remove the system.Post procedure, the patient was transferred in stable condition to the icu.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in (b)(6), this was a 29mm sapien 3 case by transaortic approach in aortic position.While deploying the valve, the certitude delivery system balloon burst at full inflation.Despite the balloon burst, the valve was well implanted, and no post dilation was needed.Afterwards, it was not possible to remove the certitude delivery system through the sheath, and an additional cut in the aorta near the puncture was needed to be able to remove the system.Post procedure, the patient was transferred in stable condition to the icu.

Manufacturer Narrative

Component codes, device codes, type of investigation, investigation findings, and investigation conclusions.The 29mm certitude delivery system was returned partially inserted through the sheath.A loader cap remained on the steering tube.A guidewire was received inserted through guidewire lumen.The certitude delivery system was fully inspected, and the following was observed: balloon burst was confirmed, both radially and longitudinally burst.The distal tip was separated, and the entire guidewire lumen was received detached from handle.No balloon material appears missing.No damage was observed from the returned sheath.Due to the nature of the complaint (burst balloon), no functional testing was able to be performed.The complaint was confirmed through visual inspection.The inflation balloon single wall thickness was measured along the edges of the burst location.A thickness deviating from the specification could be indicative of an issue during manufacturing of the component, as a thin wall could contribute to the observed burst.All measurements taken of the balloon single wall thickness met the specification.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the risk management documentation was performed, and 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 burst, withdrawal difficulty, and distal tip separation were confirmed by visual inspection of the returned device.However, no manufacturing non-conformance was identified during the evaluation.Dimensional inspection of the returned balloon revealed that the balloon wall thickness was within specification.No visual abnormalities were observed on the returned sample.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.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.A detailed root cause analysis for similar returned balloon burst complaints has been summarized in the technical summary.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 landing zone.Per complaint description, "the certitude delivery system balloon burst at full inflation.Despite the balloon burst the valve was well implanted" and "it was not possible to remove the certitude delivery system through the sheath." the cases notes revealed the patient had a "severe calcified aortic valve." 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.As the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92509
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13367518
• MDR Text Key: 285650129
• Report Number: 2015691-2022-03651
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: 9620TA29
• Device Catalogue Number: N/A
• Device Lot Number: 63517444
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male