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

Model Number	9600LDS26A
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.Device discarded.
Event or Problem Description
As reported by a field clinical specialist, the patient underwent a transfemoral transcatheter valve replacement valve-in-valve procedure for a 26mm sapien 3 valve in a freestyle valve in pulmonic position.After delivery of a 24mm covered stent inside the freestyle valve, the 26mm s3 valve was crimped on the commander delivery system and loaded through the back of a 26f dryseal sheath.After many attempts, the physician could not pass the valve through the covered stent to deliver it.It was decided to bring the valve back into the 26f dryseal sheath.There was some tortuosity in the anatomy while drawing it back into the sheath.It was not aligning well so it was decided to pull the sheath and the valve out as one, however, when pulling the sheath and system back as one, the valve came off the tip of the delivery system and was floating on the wire in the right ventricle (rv).The patient was taken to surgery for the removal of the system and the valve.As the patient was stable with the stent on the wire in the rv, they did not want to remove the delivery system before surgery for concern of losing the wire position.Per the physician, it seemed as though the system was caught on something that they could not visualize, but was possibly the tricuspid valve.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaints for -thv dislodged off balloon during withdrawal through non-edwards sheath- and -difficult to track system through anatomy- were unable to be confirmed due to unavailability of the complaint device and/or applicable 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 and lot 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.Per complaint description -after many attempts, the physician could not pass the valve through the covered stent to deliver it.It was decided to bring the valve back into the 26f dryseal sheath.There was some tortuosity in the anatomy while drawing it back into the sheath.It was not aligning well so it was decided to pull the sheath and the valve out as one, however, when pulling the sheath and system back as one, the valve came off the tip of the delivery system and was floating on the wire in the right ventricle (rv).- as such it is possible the tortuosity present in the patient led to a sub-optimal delivery system path leading to the tracking difficulties noted.Subsequently, it is possible that tortuous anatomy lead to non-coaxial withdrawal of the delivery system through sheath, and the excessive manipulation exhorted to overcome those withdrawal difficulties led to the valve being dislodged from the balloon without applicable patient/procedural imagery, a definitive root cause was unable to be determined at this time.However, it is possible that patient factors (tortuosity) procedural factors (non-coaxial withdrawal, excessive manipulation) may have contributed to the complaint event.No manufacturing nonconformances were identified during evaluation.A definitive root cause is unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Common Device Name: 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: 15195474
• Report Number: 2015691-2022-07233
• Device Sequence Number: 12265501
• Product Code: NPV
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954(17)231208(10)64289389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: 9600LDS26A
• Device Catalogue Number: 9600LDS26A
• Device Lot Number: 64289389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male