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

Model Number 9610TF29

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), during implant of a 29 mm sapien 3 valve in the mitral position via transvenous approach into a preexisting surgical valve the balloon caught on the permanent pacemaker lead and dislodged it from the ventricle into the inferior vena cava (ivc).The patient was stable, and the temporary pacing lead was left in the situ should it be needed.The pacemaker lead remained in the ivc.The patient was in stable condition post procedure.No intervention was required.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.No imaging was received.During the manufacturing process, visual inspections and test are performed throughout the process.In this case, there is no evidence to support a manufacturing design defect potentially contributed to the complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history record review was performed and did not reveal any related complaints.The ifu for commander delivery system, device preparation manual, procedural training manual and supplemental to edwards sapien 3 valve-in-valve (v-in-v) patient screening and procedural training manual (mitral position) were reviewed.The supplemental edwards sapien 3 (v-in-v) procedural training manual for mitral position provides guidance on procedural considerations (coplanar view).The fluoroscopic viewing angle for valve positioning and deployment should be coplanar to the base ring of the surgical prostheses (if visible), the typical coplanar angle for mitral valve-in-valve is rao 40-60 degrees, and it is recommended to check the coplanar before draping the patient, so that ekg leads and/or other hardware are not in interference.No ifu or training deficiencies were identified.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 for interventional device interferes with permanent pacemaker lead was unable to be confirmed due to the unavailability of the device/applicable imagery.Due to the device not being returned for further evaluation, a potential manufacturing nonconformance was unable to be identified.A review of the dhr, lot history, 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.The exact cause of pacemaker lead dislodgement during a transseptal mitral procedure is unknown.However, some possible causes include: suboptimal anchoring of the pm lead, suboptimal/anomalous trajectory of the lead and suboptimal location of the septal puncture (too close to the pm lead) and/or device manipulation.In this case, the cause for device interference was most-likely due to procedural factors (removal of the delivery system).However, due to insufficient information, a definite root cause is unable to be determined 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.No ifu/labeling/training manual inadequacies were identified.Therefore, no product risk assessment no corrective or preventative action is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: MITRAL VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11641878
• MDR Text Key: 245924938
• Report Number: 2015691-2021-02367
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 63382084
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR