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

Model Number 9600LDS23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Intimal Dissection (1333)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Thv/tvt registry.  investigation of this event is ongoing.

Event Description

Per the field clinical specialist report, during a tf tavr procedure, there was a right side iliac dissection found upon removal of the esheath.A stent was placed.The patient was stable at case end.  the minimum luminal diameter on the access vessel measured 5.6 mm on the right side with mild calcification and no tortuosity.No difficulties with sheath placement or explant.No issues inserting or retracting delivery system were reported.The cause of the dissection was unknown.Additional information provided by the physician, the vascular injury may be associated with potentially difficult or problematic withdrawal of the delivery system through the sheath.

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.A review of imaging was performed and revealed during valve deployment (from a separate but related case) the flex tip was over the triple marker during deployment.However, after retrieval, the physician noted that the flex tip was over the proximal tapered section of the inflation balloon.Additionally, the 3mensio report revealed that the patient¿s right access vessel was mildly calcified and the minimum luminal diameter measured 5.6mm.During balloon manufacturing, the balloon was 100% inspected for the following: working length, balloon diameter, and double wall thickness measurements.The balloon are visually inspected and rejected for mechanical damage and deformation.During manufacturing, the delivery system crimp balloon undergoes the following inspections: distal and proximal balloon id, and single/double wall thickness.The balloons are inspected for the following: fish eyes, crow¿s feet, deformation, gel spots and contamination.During the pleat and fold process, the inflation balloon was visually inspected for tears, distorted/pinched folds, wrinkles, and contamination.Additionally, the balloon diameter is inspected using go and no-go gages.Per procedure delivery systems are 100% leak tested.The assembled delivery system was 100% inspected by both manufacturing and quality for balloon scratches, tears, wrinkles, and excessive adhesive on or within the balloon.During product verification (pv) testing, five sample devices from all lots are tested.All tested samples from work order # (b)(4) passed pv testing.During testing the samples are visually inspected for physical defects such as kinks and cracks and loose or missing components.The retrieval force through the sheath is tested: tested samples had utl of 13n, which is below usl of 38n.Locknut/collet engagement force is tested and tested samples had ltl of 65n, which is above lsl of 47n.Inspections during the manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported complaint.A device history record (dhr) performed revealed no issues that would have contributed to the complaint events.A lot history review of work order # (b)(4) was performed and revealed no other complaints relating to ¿delivery system ¿ withdrawal difficulty¿.A review of the complaint history from march 2017 to february 2018 revealed other complaints for ¿delivery system ¿ withdrawal difficulty¿ for the commander delivery system (all sizes).Review of these complaints identified that nine complaints were confirmed and was related to patient/procedural (withdrawal of burst balloon through sheath) factors as potential root cause for the issue.Since no manufacturing non-conformities were found, a corrective or preventative action was not required.The occurrence rate did not exceed the february 2018 control limits for the trend category ¿withdrawal difficulty¿.The instructions for use (ifu), device preparation manual, and training manual were reviewed for instructions or guidance for proper use of the esheath and no 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.Due to the unavailability of the device or any relevant imagery, the complaint for ¿delivery system ¿ withdrawal difficulty¿ was unable to be confirmed and engineering was unable to perform any visual, functional, or dimensional analysis.As a result, presence of a manufacturing non-conformance was unable to be identified.However, a review of dhr, lot history, complaint history, and manufacturing mitigations revealed that it is unlikely a manufacturing issue contributed to the complaint.Additionally, a review of ifu/training manuals revealed no deficiencies.Although no imagery for this case was available, imagery from a separate, but possibly related case was provided.In the imagery, it was shown that the flex tip was over the triple marker during valve deployment.However, after retrieval, the flex tip was pushing against the proximal balloon taper.The following scenarios could have occurred to cause the balloon shaft to slip: the device was possibly not fully locked, and slipped during removal: per procedure, the flex tip should be positioned over the triple marker and the balloon shaft should be locked prior to removal.The balloon shaft would have slipped, especially if pulling from the balloon shaft during retrieval.The device was locked, yet the balloon shaft may have possibly slipped distal during removal.It is possible that retrieving the delivery system by pulling from the balloon shaft caused the balloon shaft to slip particularly during retrieval through the esheath hub.Retrieving the flex tip through the seals of the esheath could have provided additional resistance/force thereby moving the balloon shaft if pulling on the balloon shaft during retrieval.Alternatively, it is possible that withdrawal difficulty was related to the patient¿s vessel geometry.Per report, it was stated that the patient¿s access vessel was calcified and had a mld was 5.6 mm, which is slightly larger than the minimum vessel requirement of 5.5 mm per procedure.Complications during withdrawal could be caused by small/calcified vessel conditions.A definite root cause is unable to be determined at this time, but based on given information, patient/procedural factors may have contributed to the complaint event.The complaint for ¿delivery system ¿ withdrawal difficulty¿ was unable to be confirmed as the device or any relevant imagery for this specific case was provided.Since applicable devices were not returned, it cannot be determined if a manufacturing non-conformance contributed to the complaint event.However, available information suggests that patient/procedural factors (borderline mld 5.6), contributed to the reported event.Review of complaint history revealed that the occurrence rate did not exceed the february 2018 control limit for the trend categories ¿withdrawal difficulty¿.Since no manufacturing non-conformances, labeling, training, or ifu deficiencies were identified, no corrective and preventative action is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7329343
• MDR Text Key: 102066052
• Report Number: 2015691-2018-00834
• Device Sequence Number: 1
• Product Code: NPT
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: 9600LDS23A
• Device Lot Number: 61030116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention