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

Model Number 9620TA26

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Device Slipped (1584); Obstruction of Flow (2423); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(6), during a transaortic tavr procedure, the patient¿s arterial blood pressure dropped to 30mmhg as the 26mm sapien 3 valve/certitude delivery system crossed the native valve.It was believed that the valve was obstructing blood flow, therefore the team opted to pull the delivery system back in order to let the patient recover, but the device was inadvertently pulled back too far into the sheath.This caused the valve to slip off the balloon.Attempts to remove the valve at the same time as the sheath and delivery system failed.The patient was placed on circulatory bypass in order to allow the physician to open the aorta and remove the valve that remained in the ascending aorta only by the guide wire.A surgical valve was implanted, and the patient was reported to be doing well after the procedure.

Manufacturer Narrative

Section f10, h6 and h10: the certitude delivery system was returned to edwards lifesciences for evaluation.During the pre-decontamination engineering evaluation, pin hole/ leakage was observed from the scuffs and 3-4 pin hole/leaks were observed when the balloon was inflated.Investigation is ongoing.

Manufacturer Narrative

Section d10, h6 and h10.Section h10: the returned device underwent further dimensional analysis.The double wall thickness of the inflation balloon was measured proximal to the tear.A thin wall could leave the balloon more susceptible to tears and may be indicative of a manufacturing nonconformance.All measurements were found to be within specification.Additionally, the distal shoulder was measured.The measurement did not meet specification.Due to the condition of the device, this measurement was not representative of the component during manufacturing.As the thv was displaced over the distal balloon shoulders during the procedures, the component may have been compressed causing it to be below specification.Imagery (video) of the complaint event was provided by site.In the video, the thv can be seen to move distally during retraction of the delivery system.The movement is caused by non-coaxial interaction between the sheath tip and thv.During manufacturing of the delivery system, the delivery system and components were 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.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformance that would have contributed to this complaint event.A lot history review was performed and revealed no similar complaints relating to the reported events.A review of complaint history from (b)(6) 2019 to (b)(6) 2020 revealed additional returned complaints for the reported withdrawal difficulty.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.No manufacturing nonconformance was identified during the evaluation.A review of complaint data revealed that the complaint rate did not exceed the (b)(6) 2020 control limit for the applicable complaint trending categories.The certitude delivery system, instructions for use (ifu), the device prepping manual, and the procedural training manual were reviewed for instructions involving device preparation and use.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are anticipated risks of the transcatheter heart valve procedure.Additional assessments of the failure mode are not required at this time.The complaints were confirmed.No manufacturing non-conformities were identified as no visual abnormalities were observed on the returned sample and the dimension measurements met specification.A review of dhr, lot history, complaint history and manufacturing mitigation's revealed that it is unlikely a manufacturing issue contributed to the complaints.Per the complaint description, ¿during procedure the patient arterial blood pressure drop to 30mm hg, when trying to cross the native valve due to the thv obstructing blood flood.The delivery system was pulled on to let the patient recover, but it was pulled to far back in the introducer.This made that the valve slip of the balloon of the delivery system¿.Based on the imagery review, when pulling the delivery system backwards, the thv was not coaxial with the sheath tip, causing it to get caught on the sheath tip and move distally on the delivery system inflation balloon.Non-coaxial positioning of the thv relative to the sheath tip, in addition to increased thv profile due to positioning over the distal balloon shoulders, may have contributed to difficulty retrieving the thv following valve movement.Manipulation of the devices during retrieval difficulty may have caused observed scuff marks on the delivery system balloon due to interaction between the thv and balloon, resulting in device leakage noted during evaluation.While a definitive root cause is unable to be determined, available information suggests that procedural factors (thv movement caused by non-coaxial positioning relative to sheath tip during delivery system retraction, thv retrieval difficulty due to non-coaxial retrieval and valve movement, balloon leakage due to device manipulation during retrieval difficulty) may have contributed to the complaint events.No corrective or preventative action is required.

Manufacturer Narrative

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

• Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9707552
• MDR Text Key: 190785627
• Report Number: 2015691-2020-10498
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/28/2020

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: 07/31/2021
• Device Model Number: 9620TA26
• Device Lot Number: 62463068
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 05/21/2020; 07/23/2020
• Supplement Dates FDA Received: 03/31/2020; 05/22/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 73