MAUDE Adverse Event Report: EDWARDS LIFESCIENCES NOVAFLEX+ DELIVERY SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9355FS26

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), this was a transfemoral transcatheter pulmonary valve replacement (tpvr) case with a 26 mm sapien xt valve to be implanted in a pulmonic pre-stent using a novaflex+ delivery system and esheath.  during deployment, contrast solution was observed flowing out of the distal end of the balloon during inflation.The balloon was unable to inflate, therefore valve expansion was not possible.The system and valve were retrieved and exchanged with a 26 mm sapien 3 valve/ commander delivery system.  the s3 valve was implanted successfully and the patient was doing well post procedure.It was clarified that the preparation of the 26mm sapien xt /novaflex+ was per ifu.There were no problems during esheath insertion, advancing the catheter forward and alignment of the valve on the balloon.Due the complex anatomy the catheter had to do a loop in the atrium before moving into the pre-stented position.

Manufacturer Narrative

B5 field: it was clarified the devices were removed without difficulties.The delivery system was returned to edwards lifesciences for evaluation with the thv retrieved into the esheath.  visual inspection was performed and the following was observed:  the thv was aligned on the inflation balloon; the inflation balloon was not properly bonded to the nose tip, allowing blood to be observed on the inside of the inflation balloon.No relevant dimensional inspection could be performed due to the nature of the complaint.  functional testing was performed and upon inflating and deflating the delivery system balloon, leakage occurred at the location of the faulty balloon/nose tip bond.  during the manufacturing process, the entire delivery system was visually inspected for any defects.The inflation balloons and bonds were 100% visually inspected.The delivery systems (including the balloon catheter/final assembly) were 100% leak tested.Additionally, the work order underwent product verification testing as a requirement for lot release.  all testing passed specifications.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a lot history review was performed and revealed no other similar complaints for balloon leakage.  a review of the complaint history from september 2018 to august 2019 revealed no additional returned similar complaints for the novaflex+ delivery system (all models and sizes).  a review of complaint data for (b)(6) 2019 revealed that the complaint rate did not exceed the control limit for the applicable complaint trend category.A review of the risk management documentation was performed and 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 balloon leakage was confirmed based on the visual inspection.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint balloon leakage.No ifu/training manual deficiencies were identified and review of the complaint history revealed that the occurrence rate did not exceed the (b)(6) 2019 control limit for the trend category. per the photographs, a clean separation between the inflation balloon and nose tip was observed.A product risk assessment (pra) was previously initiated to investigate the nose tip-to-balloon bond separation issue.During the investigation, a manufacturing non-conformance was identified as a potential root cause for the failure mode.The investigation found that misalignment of the laser during distal balloon bonding could result in a loss of tensile strength in the area and a loss of hermetic seal to properly inflate the balloon.As it is possible that a manufacturing non-conformance will have contributed to the complaint event, a corrective/preventive action (capa) was initiated for further investigation and to track corrective actions.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: NOVAFLEX+ DELIVERY SYSTEM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9099361
• MDR Text Key: 196275993
• Report Number: 2015691-2019-03525
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 9355FS26
• Device Lot Number: 61497094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR