MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM23A

Device Problem Particulates (1451)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 23mm s3 ultra valve in the aortic position.The initial valve was crimped onto the 23 commander delivery system.Upon initial insertion of the loader cap into the 14fr esheath, the implanting physician noted what appeared to be a string inside the loader cap near the valve.The devices were removed and upon further inspection there did appear to be a white, curled up thread less than an inch long inside the loader cap at the proximal end near the crimped valve.The team was unable to determine if the string was part of the outer skirt of the valve or string from a 4x4 surgical.The devices were discarded and not implanted into the patient.A new valve and delivery system were prepped and surgery was then completed successfully.There was no injury to the patient and they remained stable.Per follow-up, there were white surgical gauze towels used in the operating room as well.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.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 complaint for particulate was confirmed based on provided imagery.Due to 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, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.The complaint description states, -the implanting physician noted what appeared to be a string inside the loader cap near the valve.The devices were removed and upon further inspection there did appear to be a white, curled up thread less than an inch long inside the loader cap at the proximal end near the crimped valve.- additionally, -per follow-up, there were white surgical gauze towels used in the operating room as well.- the thread was noted inside the loader after the packaging been opened.As there was no report of particulates being observed prior to opening the packaging, it is likely that the particulate was introduced during device preparation.It is possible that a thread from white gauze towels in use in the operating room may have caught on the valve or loader during prep.As such, available suggests that procedural factors (device handling during prep) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.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: COMMANDER DS WITH SAPIEN 3
• Type of Device: AORTIC 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: 15306394
• MDR Text Key: 305504083
• Report Number: 2015691-2022-07548
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)240425(10)64345770
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23A
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 64345770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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 Sex: Female