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

Model Number 9610TF23

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in (b)(6).This was a pulmonic valve-in-valve case of a 23mm sapien 3 valve inside a 25mm non-edwards surgical valve due to degeneration and stenosis.During the procedure, the balloon of the commander delivery system burst circumferentially during the injection of the last cc's of contrast.The inflation device was filled with 2 cc extra, but the balloon burst at nominal volume, without the extra 2 cc.The sapien 3 valve was successfully released and was functioning correctly at the end of the procedure.When removing the delivery system, the balloon did not fit inside the dry seal introducer.The shaft had to be separated from the balloon, and with the help of a lasso, was pulled out of the patient using a second access and a second dry seal introducer through the jugular vein.The patient was well after the procedure.The delivery system was not available for return as a type a infection test was not performed on the patient.

Manufacturer Narrative

The device was not returned for evaluation.A device history review (dhr) was unable to be performed as no lot number information was provided.A lot history review was unable to be performed as no lot number information was provided.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.Imagery was provided by the site and revealed the following: the nose tip with attached inflation balloon and guidewire lumen separated from the flex shaft, and there was a radial burst of the inflation balloon.The ifu, procedural training manual, and device preparation manual were reviewed.The latest revisions in accordance with the occurrence date of the event were reviewed since no lot number information was provided for the commander delivery system, as they are the most relevant and representative of procedural steps.Prior to deployment check to ensure: thv is exactly between the valve alignment markers; flex tip is on the triple marker; balloon lock is locked.Perform thv deployment: unlock the inflation device; confirm thv position; begin initial deployment with a slow, controlled inflation; reposition thv as necessary; fully inflate and hold for 3 seconds to ensure complete deployment; completely deflate the balloon and withdraw the balloon.Additional considerations: verify flex tip is on triple marker to ensure full inflation of balloon during deployment and ensure stability of delivery system during thv deployment.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.If considered, reposition only at the very early stage of deployment.Always maintain control of the plunger of inflation device when releasing it.Never lock the inflation device during balloon predilation or thv deployment.Delivery system removal: completely unflex the delivery system; ensure flex tip is still over the triple marker; ensure balloon lock is locked.Ensure the balloon is completely deflated.Maintain guidewire position in lpa.If using gore dryseal sheath: retract sheath and delivery system into the vena cava; retract balloon into the gore dryseal sheath; remove commander delivery system.Caution: patient injury could occur if the delivery system is not completely unflexed prior to removal.Based on the review, no ifu or training deficiencies were identified.A complaint history review on confirmed device complaints (returned and no product returned) from february 2021-january 2022 for the commander delivery system (all models and sizes) revealed additional similar complaints for balloon burst and withdrawing difficulty.Available information suggested that patient and/or procedural factors may have contributed to the complaint events.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.Since no product non-conformances were identified, a product risk assessment (pra) escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.The complaint for balloon burst was confirmed by the provided imagery.As the device was not returned for evaluation, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.A review of the device history record, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.The complaint description states: "during procedure, the balloon of the commander delivery system burst circumferentially during the injection of the lasts cc of contrast." while the balloon is sufficiently designed and tested for the rated burst pressure well above their inflation pressure, interaction between the balloon and the struts of the degenerating pre-existing valve can compromise the structure of balloon wall, even at low implantation pressures, through mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As such, available information suggests that patient factors (pre-existing valve) may have contributed to the reported event.The complaint for withdrawal difficulty was confirmed by provided imagery.As the device was not returned for evaluation, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.A review of the device history record, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.The complaint description states: "when removing the delivery system, the balloon did not fit inside the dry seal introducer." the balloon burst likely altered the balloon profile.The altered balloon material likely made it more susceptible to be caught on the sheath tip during withdrawal, subsequentially resulting in the reported withdrawal difficulty.As such, available information suggests procedural factors (withdrawal of burst balloon) could have contributed to the event.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13487437
• MDR Text Key: 286263961
• Report Number: 2015691-2022-03844
• Device Sequence Number: 1
• Product Code: NPV
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 19 YR