MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF23

Device Problems Material Rupture (1546); Component Missing (2306)

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

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

A 23 mm commander delivery system was returned from our (b)(6) affiliate with no exact identification and an incorrect complaint number referenced.Through investigation of the balloon burst no information could not be provided.During pre-decontamination evaluation, a balloon burst was observed on the 23 mm commander delivery system and majority of the balloon is missing.There is no report of any patient injury.

Manufacturer Narrative

The commander delivery system was evaluated.Visual inspection of the device revealed that the balloon burst was confirmed, and most of the material is missing.The balloon material was not returned.Functional or dimensional testing was not performed due to the condition of the returned device (balloon burst, separated, and missing balloon pieces).A review of manufacturing mitigations was performed.However, since the device work order was not provided, the revisions referenced were latest revisions through the date of occurrence.During the manufacturing process, the entire delivery system (including the crimp balloon, inflation balloon, and nose tip) is visually inspected and tested several times.Per procedure, the balloon is inspected dimensionally and visually.Prior to balloon pleat, fold and forming process, the balloon is 100% inspected.After the process, the balloon is 100% inspected for defects.The commander delivery system is 100% leak tested per procedure.During final inspection, the entire device is 100% distal to proximal visually inspected by both manufacturing and quality.In addition, visual inspected and inflation balloon/crimp balloon bond tensile testing was performed on the finished work order under a sampling basis during product verification testing per procedure.All samples tested met statistical acceptance criteria.These inspections and tests during manufacturing support that it is unlikely that a manufacturing non-conformance contributed to the reported event.A device history record (dhr) and lot history was unable to be performed as the lot number was not provided.A review of complaint history from (b)(6) 2018 through (b)(6) 2019 revealed additional returned complaints for the trend categories.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that patient/procedural factors contributed to the reported event.A review of complaint history revealed that the occurrence rate did not exceed the (b)(6) 2019 control limit for all the trend categories.The ifu, the prepping manual, and the training manual were reviewed for instructions involving the commander preparation and procedure.The training manual provides guidance on balloon rupture.The procedural training manual provides additional considerations during valve deployment: slow inflation during initial deployment may help with stability of the delivery system and thv during deployment, if considered, reposition only at the very early stage of deployment, do not exceed 20 seconds for inflation and deflation of the delivery system, always maintain control of the plunger of inflation device when releasing it and never lock the inflation device during bav or thv deployment.Note that failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, and lead to patient death or serious injuries associated with difficulty retrieving the delivery system and surgical intervention.If the delivery system balloon ruptures or leaks during deployment without thv embolization, do not use excessive force, take care when crossing the thv, tracking back over the arch and removing the delivery system (through the tip of the sheath.In addition, maintain guidewire position, check for pv leak under echo and if post dilation is needed, use a new delivery system.There was no ifu or training deficiencies identified.The complaints were confirmed by visual inspection of returned device; however, no manufacturing non-conformances were identified.Dimensional measurement was unable to be performed to determine presence of a manufacturing nonconformance due to the missing of balloon material.Based on a review of the complaint history, there was no indication that a manufacturing non-conformance contributed to the reported events.A review of manufacturing mitigations supports that the device has proper inspections in place to detect issues related to the reported events.Additionally, a review of the ifu and training manual revealed no deficiencies.In this case, due to insufficient information provided, the cause of balloon burst, and balloon separation could not be determined at this time.There was no additional patient information provided regarding vessel characterization.Multiple attempts were made for clarification; however, the information was not forthcoming.This complaint was created due to an incorrect device return, it was not linked to any particular procedure with associated patient¿s information or case notes.Therefore, the root cause of the balloon burst and separation in this case are unknown.A review of available information did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.No ifu/training manual deficiencies were identified, and review of complaint history revealed that the occurrence rates for the applicable trend categories did not exceed the (b)(6) 2019 respective control limits.Therefore, neither pra escalation nor corrective actions are required at this time.

Manufacturer Narrative

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

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9220673
• MDR Text Key: 188734659
• Report Number: 2015691-2019-03888
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 01/17/2020; 07/23/2020
• Supplement Dates FDA Received: 01/20/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1