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

Model Number 9630TA26

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/09/2023

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our affiliates in germany, it was a case of an implant of a 26mm sapien 3 ultra valve in aortic position by transapical approach.Previous balloon aortic valvuloplasty was not performed.During the valve implantation, no extra volume was added to the balloon prior to inflation and 23 ml with the slow inflation technique was used.After the balloon was fully inflated, it burst, and the distal tip was separated.Despite this, the valve was deployed, and the position was acceptable.The proximal part of the balloon and the handpiece could be withdrawn in the introducer sheath.The introducer sheath was removed as a single unit, but the distal part of the balloon remained in the ascending aorta with the guidewire.The remaining balloon portion was fixed by a coil on the wire and the coil wire was wrapped around the guidewire.Due to the porcelain aorta and the calcified iliac access, the recovery had to be done by transapical access.A check flo extra large 24f sheath cook was used without dilator to expand the apex insertion and recover the distal part of the balloon.The check flo sheath and the distal balloon part were removed as a single unit.Unfortunately, closure of the apex was not possible due to tearing of the tissue and loss of sutures with pledgets after the removal of the cook check flo sheath.The patient passed away.As per medical opinion, the reason for the balloon burst was high degree of annulus and leaflets calcification and porcelain aorta.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.The returned device was evaluated, and the following was observed: radial balloon burst was confirmed at the distal portion.There was no missing balloon material.The inflation balloon single wall thickness was measured along the edges of the burst location.All measurements taken of the balloon single wall thickness met the specification.The complaints for balloon burst and distal tip component separation during use were confirmed by visual inspection of the returned device and imagery pro vided.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.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve (thv) procedure, additional assessment of the failure modes is not required at this time.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.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 transcatheter heart valve delivery systems are subject to increased risk of burst in a calcified landing zone.As per 3mensio report provided, high level of calcification was observed.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.As a result, although no withdrawal difficulties were reported, the applied pull force to remove the device could have 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 (excessive manipulation) contributed to the separation.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.No corrective or preventative actions are required.

• 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
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16264891
• MDR Text Key: 308385766
• Report Number: 2015691-2023-10435
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 9630TA26
• Device Catalogue Number: N/A
• Device Lot Number: 64398152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/06/2023
• Date Device Manufactured: 07/29/2022
• 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): Death; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female