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

Model Number 9600LDS29A

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by the edwards lifesciences affiliate, regarding a 29mm sapien 3 valve in the pulmonic position in a pre-existing surgical valve via transfemoral approach.The balloon rupture during deployment.Surgical valve stent in place but not fully expanded.Unable to remove the delivery system, balloon was stuck in the surgical valve stent.Patient went to surgery.Delivery device removed in surgery.Magna surgical valve place.Patient was stable during entire procedures.Reported doing well.Product picked up and will be returned for evaluation.Gore dry seal used vs esheath, heprin/act stable throughout.

Manufacturer Narrative

The device was returned for evaluation.The returned device was visually examined, and the following was observed: flex tip and entire balloon assembly not returned.Device was cut at proximal flex shaft.Kink at flex shaft near warning marker due to packaging extreme curvature on flex shaft 9.5 inch cut end of flex catheter.The reported balloon burst was unable to be confirmed.The reported withdrawal difficulty event was confirmed empirically through returned product evaluation.However, no manufacturing non-conformance was identified during the evaluation.An existing technical summary written by edwards lifsciences 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 thv delivery systems are subject to increased risk of burst in a calcified landing zone.As reported the balloon rupture during deployment.Surgical valve stent in place but not fully expanded.Unable to remove the delivery system.Per notes, there was moderate calcium in landing zone.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.It is possible the burst balloon got caught on the pre-existing valve due to its altered profile, creating withdrawal difficulties.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.The technical summary also outlines the instructions for valve deployment.Ifu/training manuals as identified in the technical summary 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) contributed to the withdrawal.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
• Type of Device: PULMONARY 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: van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 17495764
• MDR Text Key: 320753730
• Report Number: 2015691-2023-15147
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)250319(10)64967592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Lot Number: 64967592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• 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 Sex: Female