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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

The device is to be returned for evaluation.Investigation is ongoing.

Event Description

As reported, during valve deployment of a 29mm sapien 3 valve by transfemoral approach, it was noticed that the valve was not fully expanded.Inflation liquid was lost and therefore not possible to fully inflate the valve.The syringe was refilled in order to completely deploy the valve.At the end, the valve was fully inflated and good result.The patient is stable.After the commander delivery system was retrieved, it was observed that there was a pin hole on the balloon.

Manufacturer Narrative

The device was returned for evaluation.Visually inspection determined a pin hole leak was observed proximal to the i/c bond and the i/c bond is intact.The device was functionally tested and was unable to be de-aired.During the attempt to inflate the balloon, a leak was observed proximal to the i/c bond.Dimensional analysis was unable to be performed due to the location of the pin hole adjacent to i/c bond and rigidity of the balloon legs at the bond area.Cine images of valve deployment were reviewed and indicate that the valve appears almost fully expanded/deployed after the initial inflation despite the volume loss from the pin hole leak.Full deployment was subsequently achieved after additional volume was added for post-dilation.The valve was successfully deployed with good result and the patient was stable per the complaint summary.A device history review was performed and did not reveal any issues that could have contributed to this complaint event.The lot history review did not reveal similar complaint related to balloon-leakage.A review of complaint data for july 2016 revealed that the complaint rate did not exceed the commander delivery system control limit for the trend category, ¿leakage¿.No instruction for use or training deficiencies were identified.During crimp balloon manufacturing, the crimp balloons are visually inspected for general appearance, gross defects, and defects.The crimp balloon wall thickness is also 100% inspected.During manufacturing, the delivery system is inspected for the following: the inflation and crimp balloons are 100% visually inspected by manufacturing and quality for distorted/pinched folds, entire device is inspected for damage (e.G.Kinks, cuts), balloon catheters are 100% leak tested before final quality inspection, balloon burst pressure testing is performed on finished devices under a sampling basis during product verification testing and the tested samples must have a lower tolerance limit that is higher than the lower specification limit of 7 atm.These inspections make it unlikely that a pre-existing damage on the balloon was present on the device before leaving the manufacturing facility.The complaint for balloon leakage was confirmed as a pin hole leak was observed proximal to the i/c bond area.However, no manufacturing non-conformances were identified.It is unlikely that the delivery system left the manufacturing site with the observed damage on the balloon as the devices are 100% leak tested and visually inspected.Complaint history review indicates that other similar complaints for balloon leakage have been caused during removal of the balloon cover.However, in such cases, the issue is detected when the device is being de-aired.For this complaint, no issues with device de-airing were reported, which indicates that the damage may have occurred during use of the device in patient.It should be noted that the valve was able to be secured after initial inflation and subsequently fully deployed post-dilation with additional volume added.At this time, the exact root cause has not been determined.It is possible that device handling and manipulation during the device prep and during the procedure may have damaged the balloon material and caused the pin hole leak observed.No corrective or preventative action is required.

Manufacturer Narrative

The device was returned for evaluation.Visually inspection determined a pin hole leak was observed proximal to the i/c bond, however, the i/c bond is intact.The device was functionally tested and was unable to be de-aired.During the attempt to inflate the balloon, a leak was observed proximal to the i/c bond.Crimp balloon double wall thickness measurements were taken and met specifications.Cine images of valve deployment were reviewed and indicate that the valve appears to be almost fully expanded/deployed after the initial inflation despite the volume loss from the pin hole leak.Full deployment was subsequently achieved after additional volume was added for post-dilation.The valve was successfully deployed with good result and the patient was stable per the complaint summary.A device history review was performed and did not reveal any issues that could have contributed to this complaint event.The lot history review did not reveal similar complaint related to balloon-leakage.A review of the complaint history revealed that the occurrence rate for the commander delivery system did not exceed the (b)(6) 2016 control limits for the trend category of ¿damaged.¿ no instruction for use or training deficiencies were identified.During crimp balloon manufacturing, the crimp balloons are visually inspected for general appearance, gross defects, and defects.The crimp balloon wall thickness is also 100% inspected.During manufacturing, the delivery system components and assembled delivery system undergo the following inspections the following: the crimp balloon undergoes 100% balloon dimensional inspection for length, distal inner diameter (id), proximal id and wall thickness.The 100% visual inspection for general appearance / gross defects under magnification, foreign matter, impurities, contamination, fish eyes and gel spots the inflation balloon undergoes 100% balloon dimensional inspection for working length, balloon diameter, proximal and distal leg ids, proximal leg outer diameter (od), and double wall thickness, 100% visually inspected for witness lines, foreign matter, impurities, contamination, deformation on the cone, crow¿s feet, gel spots, fish eyes, and scratches, the laser bond between the inflation bond and the crimp balloon is inspected under 2.85x magnification for smooth bond joint with no gaps between components, the bond is inspected for bubbles, during the pleat and fold process the inflation balloon is visually inspected for scratches and distortion/ pinched folds, distorted/ pinched folds are inspected again in final inspection, 100% inspect the fully assembled commander delivery systems for defects and cosmetic appearance under minimum 2.5x magnification, mechanical damage, kinks, cuts, folds, and balloon scratches, and all bonds for gaps between components and for excessive bubbles present in the bond.The commander delivery system is leak tested to ensure that there are no holes or leaks in the inflation lumen for the balloon.Post leak test, the balloon covers and inflation balloon are inspected for any damage.Visual inspection was conducted prior to functional testing for physical defects such as kinks, cracks, missing or loose components.All units evaluated for this work order passed testing.Balloon burst pressure test and inflation balloon to crimp balloon bond strength test are performed on finished devices and passed the acceptance.The complaint for balloon torn was confirmed as a small tear proximal to the i/c bond was observed.However, no manufacturing non-conformances were identified during the engineering evaluation of the returned device (dimensional analysis, review of complaint history, lot history, dhr, and manufacturing mitigations).It is unlikely that the delivery system left the manufacturing site with the observed damage on the balloon as the devices are 100% leak tested and visually inspected.Complaint history review indicates that other similar complaints for balloon leakage have been caused during removal of the balloon cover.However, in such cases, the issue is detected when the device is being de-aired.For this complaint, no issues with device de-airing were reported, which indicates that the damage may have occurred during use of the device in the patient.It should be noted that the valve was able to be secured after initial inflation and subsequently fully deployed post-dilation with additional volume added.Although information was not provided on the location and condition of the valve alignment, it is known that performing valve alignment at a bend or angle can cause the thv to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.The gouges noted on the flex tip may provide evidence of this occurrence.If the thv is unseated during alignment it can result in higher than usual valve alignment forces, and can potentially contribute to the tear between the inflation balloon and crimp balloon if excessive force is used to try and achieve final alignment position.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment or delivery system retrieval.Engineering studies relating to balloon tears were performed to confirm these conditions and engineering was able to recreate high enough valve alignment forces to potentially cause a material failure in the area in question.While a definitive root cause was unable to be determined, it is possible that patient and/or procedural factors contributed to the reported event which subsequently led to flex tip gouging under compression and the eventual tear at the crimp balloon to inflation balloon bond.No preventative or corrective actions are required.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5837303
• MDR Text Key: 50904424
• Report Number: 2015691-2016-02384
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2018
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 60386785
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR