MAUDE Adverse Event Report: EDWARDS LIFESCIENCE COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problem Particulates (1451)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards field clinical specialist a hair was inside the packaging of this 26mm commander delivery system.It was observed before opening the package but the packaged was opened to inspect further to be sure it was not on the outside of the packaging.A second 26mm commander delivery system was opened and used for the procedure.The first commander delivery system and packaging was discarded.

Manufacturer Narrative

The device was not returned; therefore, a device evaluation could not be performed.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint codes below.As the particulate was found on the pouch, prior complaints related to particulate found on other packaging parts (corrugated box shelf box) and device parts (delivery system inflation, gw port yconnector balloon) were excluded from the review.During manufacturing, the device is both visually inspected and tested several times throughout the process.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.Review of procedural videos, imagery, and photographs were performed and the following was observed hair like particulate found inside top portion of pouch, near the chevron seal area.Instruction for use (ifu) for commander delivery system and device preparation manual were reviewed and no ifu or training deficiencies were identified.A complaint history review on confirmed device complaints (returned and no product returned) from march 2020 february 2021 for all edwards pouch packaged thv products was performed with the codes identified below.Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.As the particulate was found on the pouch, prior complaints related to particulate found on other packaging parts (corrugated box shelf box) and device parts (delivery system inflation, gw port yconnector balloon) were excluded from the review.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.A manufacturing nonconformance was confirmed.However, due to no device returned for evaluation, the characteristics of the fiber cannot be determined through chemistry testing, and therefore, the source of contamination is unable to be identified.A review of the manufacturing line revealed that a manufacturing nonconformance may have contributed to the complaint event.Due to an increase of particulates seen in device pouches, product risk assessment (pra) was previously initiated to further investigate the cause and assess the risk associated with particulate, contamination.To address the issue, corrective actions were implemented as part of corrective action preventative action (capa).Since the complaint occurrence rate did not exceed the february 2021 control limit , and review of pra indicates that there is no change in risk level, no further action is required.The pra remains applicable.The complaint is confirmed and the product nonconformance was identified.Capa was previously initiated to address particulates found within the pouch and is currently in the implementation phase.The capa has moved into the implementation phase on 30-april-2021 which was prior to the termination of all work orders listed in this evaluation.As such capa is applicable to this complaint.The capa owner has been notified.In addition, due to the source of particulate is unable to be determined, as a precautionary measure, an awareness communication emphasizing the importance of in process mitigation on foreign particulate during manufacturing was performed in edwards draper facility.The reported event was confirmed based the provided imagery.A definitive source for the particulate is unable to be determined at this time as the device was not returned.Occurrence of these events in sealed pouches suggests that a manufacturing non conformance may have contributed to the complaint.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• MDR Report Key: 11423062
• MDR Text Key: 249091081
• Report Number: 2015691-2021-01689
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)220921(10)63418474
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1