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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

Device Problems Unintended Collision (1429); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

It was initially reported by compassion 3 clinical trial, the patient had a 29mm sapien 3 valve implanted in an existing edwards surgical valve in the pulmonic position.The pacemaker atrial lead wire was displaced during delivery system removal.An electorphysiology physician (ep) was was consulted, and patient went to implantable cardioverter defibrillator (icd) extraction with replacement.The event was discovered by during a monitoring visit.

Manufacturer Narrative

Update to h6, device code, type of investigation, investigation findings and investigation conclusion.Update to trial name: compassion s3 pas trial.The commander delivery system was not returned to edwards lifesciences for evaluation; therefore, no visual inspection, functional testing and dimensional testing is applicable.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.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u.Based on this review, no ifu training deficiencies were identified.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.The complaint for interventional device interacts with permanent pacemaker lead was unable to be confirmed due to lack of the returned device or applicable imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.As reported, "a 29mm sapien 3 valve implanted in an existing edwards surgical valve in the pulmonic position.The pacemaker atrial lead wire was displaced during delivery system removal." guidance in pulmonic procedural training manuals instruct the operator on patient screening, size verification, and landing zone site preparation, in addition to proper withdrawal technique of the delivery system.If the operator did not properly follow withdrawal techniques this may have resulted in the delivery system getting caught on the permanent pacemaker lead during withdrawal, resulting in the reported interaction with permanent pacemaker lead.In this case, available information suggests procedural factors (improper withdrawal technique) may have contributed to the reported event.Without the return of applicable imagery, a conclusive root cause is unable to be determined.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 ifu training deficiencies were identified for these reported.Therefore, no product risk assessment (pra) nor corrective or preventive actions are required for these events.

Manufacturer Narrative

The complaint for interventional device interacting with permanent pacemaker lead was confirmed empirically from medical records.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of the ifu and training manuals revealed no deficiencies.

• Brand Name: 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: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14106777
• MDR Text Key: 289228197
• Report Number: 2015691-2022-05065
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG