MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; PULMONIC VALVE, PROSTHESIS, PERCUTANEOUSY DELIVERED

Model Number	9600LDS23A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.A supplemental report will be submitted upon completion.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-05051.
Event or Problem Description
Edwards received notification from a field clinical specialist that during a pulmonic tavr in a previous surgical valve, two 9600tfx sapien 3 23 mm valves were implanted.As reported, the first valve was deployed was post dilated with a 20 mm atlas balloon.This caused a 'flail' leaflet.The leaflet looked torn.A second valve 9600tfx sapien 3 23 mm valve was required and during deployment, the commander balloon ruptured causing the preexisting conduit to dehisced at the distal sutures the patient was taken to surgery to repair.Patient is stable and recovering in icu.
Additional Manufacturer Narrative
The device was not returned for evaluation, therefore a no product return engineering evaluation was performed.The device history record (dhr) was reviewed and the work orders 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 this event.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 balloon burst was unable to be confirmed as neither the device nor applicable imagery was returned.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 during the evaluation.Additionally, a review of the lot history, dhr and manufacturing mitigations 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.As reported, 'during deployment, the commander balloon ruptured causing the preexisting conduit to dehisced'.Per case notes, an extra volume of '+1ml' was added do the balloon prior to the inflation.The prescribed nominal inflation volume is provided in the ifu as 17ml.Adding additional volume can lead to balloon overinflating.Subjecting the balloon to pressures high enough to cause the balloon to burst may have led to the reported complaint event.However, due to no device return, a definite root cause was unable to be determined.Available information suggests that procedural factors (over-inflation) may have contributed to the reported event.Since no product non-conformances, labeling or ifu/training manual deficiencies were identified, neither corrective/preventative actions nor product risk assessment (pra) are required at this time.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.
Additional Manufacturer Narrative
An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect common device name, product code, and pma number.A correction to fields d2 and g4 is being submitted in this supplemental report.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: PULMONIC VALVE, PROSTHESIS, PERCUTANEOUSY 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: 12436121
• Report Number: 2015691-2021-05052
• Device Sequence Number: 3939708
• Product Code: NPV
• UDI-Device Identifier: 00690103193947
• UDI-Public: (01)00690103193947(17)230225(10)63675102
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2021
• 2 Devices were Involved in the Event: 1 2

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: 02/25/2023
• Device Model Number: 9600LDS23A
• Device Catalogue Number: N/A
• Device Lot Number: 63675102
• 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: 08/12/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 11/29/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/14/2021; 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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: Required Intervention
• Patient Sex: Male