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

Model Number 9600LDS29A

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Inflation Problem (1310); Difficult to Remove (1528); Failure to Align (2522); Failure to Advance (2524)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by field clinical specialist (fcs), during the transapical pulmonic placement of a 29mm sapien 3 in a conduit, there was difficulties encountered. the physician decided to mount the valve on to the commander delivery system balloon prior to insertion through the non-edwards 24fr dry seal sheath.He requested that valve alignment be performed outside of the sheath, prior to the insertion of the delivery system through the sheath.The delivery system with valve were unable to advance through the sheath.The valve and delivery system were removed, leaving the sheath in place.The physician then attempted to push the valve and delivery system (valve still aligned on the balloon) through a different (medtronic) sheath, which was not inserted in the body.The delivery system and valve was not able to advance.The team then decided to pull the valve back onto the delivery system and re-crimp.The valve and delivery system was then advanced through the initial 24fr dry seal sheath (still implanted in the patient).After insertion, initially, there was difficulty aligning the valve onto the balloon in the patient.The valve as able to be aligned after multiple attempts, but the team was unable to inflate the balloon to deploy the valve.It was believed that there may be a hole in the balloon.It should be noted that the balloon had a bend due to patient anatomy.The damage to the balloon could have occurred during valve alignment, or due to the conduit stents.The patient was taken to open heart surgery to remove the devices.At last report, the patient was in surgery.The patient survived the surgery.The devices are not available for return.No photos of the device, or procedural imaging is available for return.

Manufacturer Narrative

Update to f2, g4, h2, and h10.A voluntary medwatch mw5094875 was opened on (b)(6) 2020.The document was reviewed, and there is no new information to report regarding this case.Investigation is ongoing.- attachment: [2020-04689 voluntary medwatch.Pdf].

Manufacturer Narrative

Update to g4, h2, h6, and h10.  no procedural videos/imagery/photographs were provided for evaluation.The device was not returned for evaluation as it was discarded by the site.The work order related to the components which could have contributed to the complaint event were reviewed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the related complaint codes. the complaint for leakage, difficulty with valve alignment, and withdrawal difficulty were unable to be confirmed and the complaint occurrence rate did not exceed may 2020 control limit for the trending categories.Therefore, a complaint history review is not required.During the manufacturing process, the delivery system was visually inspected and tested several times.Additionally, work orders undergo product verification testing on a sampling basis as a requirement for lot release.Of note, no failures occurred during product verification testing and the lot was released.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint per the complaint description, the patient underwent a pulmonic valve replacement through the transapical approach in a conduit.The sapien 3 (s3) with the commander delivery system (ds) is currently indicated for native aortic valve, aortic bioprosthetic valve, and mitral surgical prosthetic valve replacement.The ifu and training manuals are for a tf procedure in the aortic or in a surgical bioprosthetic mitral valve position and were reviewed for relevant guidance for an s3 implant using a commander ds.The ifu warns that if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.A review of ifu/training materials also revealed no deficiencies.Based on the review of the ifu/training manuals, no deficiencies were identified.The complaints were all unable to be confirmed, as no device-related photos were provided.Additionally, since the device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis, and therefore no manufacturing nonconformances were able to be identified.A review of lot history, device history record (dhr), and manufacturing mitigations did not reveal any indications that a manufacturing nonconformance contributed to the event.The delivery system leak was not able to be identified.However, per the complaint description and cer, there was delivery system insertion difficulty requiring multiple attempts to advance the delivery system through the different sheaths both inside and outside of the patient.The multiple insertion attempts may strain the system, weakening the inflation and crimp balloon bond which could subsequently tear during valve alignment.Additionally, ¿the balloon had a bend due to patient anatomy¿.Performing valve alignment in a non-straight section of the patient¿s vessel may result in increased forces to be applied to the bond area which could potentially tear the balloon.Additionally, the balloon may have come into contact with the stents of the conduit potentially puncturing the balloon, creating a channel for leakage.As such, available information suggests that patient (vessel tortuosity; conduit stents) and procedural (multiple delivery system insertion attempts) factors may have contributed to the reported event.However, without the physical device or relevant imagery, a definitive root cause is unable to be determined at this time.Per the complaint description, it was noted that the balloon had a bend due to patient anatomy, signifying patient vessel tortuosity.Performing valve alignment in tortuous vasculature can result in higher forces required to align the valve, leading to difficulty during valve alignment.As such, available information suggests that patient factors (vessel tortuosity) may have contributed to the reported event.However, without the physical device or relevant imagery, a definitive root cause is unable to be determined at this time.Per the complaint description, valve alignment difficulty was experienced and a bend in the balloon was noted, which likely is because the patient had tortuous vessels.Tortuous vasculature would not enable coaxial delivery system retrieval through the sheath, as the delivery system would be more susceptible to being caught on the sheath tip.Additionally, a non-edwards sheath was used which may have not been compatible for system retrieval with a crimped valve.As such, available information suggests that patient (vessel tortuosity) procedural (usage of non-edwards sheath) factors may have contributed to the reported events.However, without the physical device or relevant imagery, a definitive root cause is unable to be determined at this time.A review of edwards lifesciences risk management documentation was performed for this case.  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.  since no edwards defect, which could have resulted in the complaints, were confirmed, no preventative or corrective actions are required.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were confirmed and the complaint rate did not exceed the may 2020 control limits for the applicable trend category, a product risk assessment (pra) escalation.The complaints were unable to be confirmed.While a definitive root cause was unable to be determined, the available information suggests that patient (vessel tortuosity; conduit stents) and procedural factors (multiple delivery system insertion attempts, usage of non-edwards sheath) may have contributed to the complaint event.Since no product non-conformances or ifu/training manual deficiencies were identified and the complaint occurrence rate did not exceed the may 2020 control limit for the relevant trend category, no corrective or preventative actions, nor pra are required at this time.

Manufacturer Narrative

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

• 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
• MDR Report Key: 10169456
• MDR Text Key: 199672966
• Report Number: 2015691-2020-12199
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: 9600LDS29A
• Device Lot Number: 62835084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/07/2020; 07/15/2020; 07/23/2020
• Supplement Dates FDA Received: 07/15/2020; 07/20/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR