MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation is ongoing.

Event Description

As reported, during a transfemoral tavr case with a 26mm s3u valve, the valve was successfully deployed in the patient's annulus, but at the end of deployment the delivery system balloon ruptured.The valve was well-seated, no post-dilation was necessary.The patient had a small aortic root with a narrow, calcified stj.The rupture was most likely caused by calcification on the stj.There was no negative impact to the patient and the delivery system was able to be removed from the patient without any injury.The devices were discarded and are not available for return.The delivery system was prepped with -1 cc.

Manufacturer Narrative

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

Manufacturer Narrative

Imagery was provided by the site and the presence of calcification on the stj was observed.Calcification was also noted in the annulus and leaflet.A lot history review was performed and revealed no other complaints relating to ¿balloon ¿ burst¿.A dhr review was performed.The review of the work orders did not reveal any manufacturing non-conformance that would have contributed to the complaint event.A complaint history review is not required because the event was unable to be confirmed.The ifu, device preparation manual, and device training manual were reviewed for guidance and instruction on device preparation and usage.The valve should be deployed with the device provided by edwards lifesciences.Slow inflation should be used and may help with stability of the delivery system and thv during deployment.If the delivery system balloon bursts or leaks during deployment without thv embolization, take care when crossing the thv, tracking back over the arch and removing the delivery system.No ifu/training deficiencies were identified.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The event was unable to be confirmed.Due to no device being returned for evaluation, no visual inspection, functional testing, or dimensional analysis was able to be performed.As such, a manufacturing non-conformance was unable to be determined.Review of the dhr, lot history and manufacturing mitigations provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials revealed no deficiencies.As reported, ¿the patient had a small root with a narrow, calcified stj (25.4mm) and the height from the annulus to the stj was 20.2mm.The rupture was most likely caused by calcification on the stj.¿ the presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Available information suggests that patient factors (calcification) may have contributed to the complaint event.However, a definitive root cause was unable to be determined.Since no edwards defect was identified, no corrective/preventative actions are required.Additionally, since no product non-conformance was confirmed, a product risk assessment escalation is not required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10405444
• MDR Text Key: 205344084
• Report Number: 2015691-2020-13104
• 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,Followup
• Report Date: 07/22/2020

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 Expiration Date: 04/16/2022
• Device Model Number: 9750CM26A
• Device Lot Number: 63131047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 07/23/2020
• Supplement Dates FDA Received: 09/17/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR