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

Model Number 9355FS26A

Device Problem Material Rupture (1546)

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

Event Date 10/04/2019

Event Type  malfunction  

Manufacturer Narrative

Udi (b)(4) per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.This device has not been returned to edwards for evaluation.Transcatheter delivery balloon burst complaints have been previously investigated by edwards and documented in a clinical technical summary written by edwards lifesciences.  a detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus.Analysis revealed that these types of ruptures are typically caused by puncture from calcium on the native aortic valve when the inflated delivery system balloon comes in contact with the native annular calcification at full inflation/deployment.In this case, the cause of the balloon burst is unknown.However, in addition to the mechanisms described above procedural factors (valve placed in pre-existing valve) may have contributed to the event.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

Per medical record review, during deployment of a 26mm sapien xt valve in a pre-existing edwards surgical valve, the novaflex delivery system balloon ruptured at maximal inflation.The valve was deployed with a single inflation of the balloon to 25ml.The valve was stable and in good position.  however since there was a balloon rupture, post-dilation with a non-edwards balloon was performed.The delivery system was removed through the non-edwards sheath and inspected.There appeared to be a pinpoint rupture.There were no reports of injury to the patient and the patient was transferred in stable condition to the pacu for recovery.

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: 9261858
• MDR Text Key: 194924066
• Report Number: 2015691-2019-04045
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: 9355FS26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR