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

Model Number 9600LDS26A

Device Problem Material Rupture (1546)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported through medical records review, regarding a 26mm sapien 3 valve in a pre-existing edwards lifesciences surgical valve in the mitral position via transcatheter/transseptal approach via right femoral vein access, once the 26mm commander delivery system and valve were advanced and positioned across the mitral valve, the commander delivery system balloon ruptured; the valve stayed in place.Successful implantation was achieved with invasive hemodynamic measurement - mean gradient of 4 mmhg.No adverse events were experienced by the patient.The delivery system and sheath were withdrawn without issue.Closure devices were deployed with excellent hemostasis achieved.The patient was transferred to the short-stay area in satisfactory condition.Post op information did not list any tvr related complications.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 of balloon burst was unable to be confirmed as no returned device nor applicable imagery was provided for the evaluation.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.A review of the manufacturing mitigation 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, '26mm commander delivery system and valve were advanced and positioned across the mitral valve, the balloon rupture and the valve stayed in place successfully'.It was noted an additional +2ml was added to the nominal volume as per the case notes.The prescribed nominal inflation volume is provided in the ifu.Nominal inflation volume for a 26mm s3 thv/commander delivery system is 23ml.It is possible once the balloon past the target fill volume, it is subjected to pressures high enough to cause the balloon to burst.The 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, no corrective and preventative actions nor product risk assessment (pra) is 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.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12316118
• MDR Text Key: 266307940
• Report Number: 2015691-2021-04648
• Device Sequence Number: 1
• Product Code: NPU
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1