MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CERTITUDE DELIVERY SYSTEM 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600SDS26A

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Activation Problem (4042)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The investigation is ongoing.

Event Description

26mm sapien 3 valve, 26mm certitude ds, 18 fr sheath during implant of a 26mm sapien 3 valve in the aortic position using transcarotid approach, the valve was deployed in a 75:25 aortic/ventricular position with 4cc less inflation volume.However, the delivery system balloon ruptured before the full inflation volume, resulting in the valve having a major waist and severe leak.The valve was not fully deployed but enough to achieve stability.The ruptured balloon would not pull through the 18fr sheath.The device was pulled with force and the delivery system separated at the balloon connection, including the internal delivery system wire.The tip of the delivery system was snared and attempted to be pulled back through the sheath with no success.Access was gained on the right femoral artery and the device was attempted to be pulled into the iliac then removed with a cut down.The device was successfully snared into the right iliac, but just to the abdominal bifurcation due to an acute calcified section in the iliac.The wire of the internal delivery system was still through the certitude sheath in the carotid, and also attached to the tip.A post bav with a new delivery system with 2cc less of inflation volume was performed and the valve was successfully inflated more ventricular.However, a moderate leak was still observed on tee.The valve was post dilated with 1cc less inflation volume and the delivery system balloon ruptured.The delivery system was able to be removed with the sheath as a unit.The carotid was still intact and functioning upon removal.Mild to trace leak was observed.Vascular surgery was called in to remove the tip of the first delivery system that was still in the patient¿s abdomen.The patient¿s abdomen was opened to remove the delivery system tip and internal wire of the delivery system.The patient had a very calcified root, a porcelain aorta, and the stj was concentric and bulbous.The patient was obese.A bav was not used.

Manufacturer Narrative

Additional information was received.Sections a2, a3, and b7 were updated.Per the patient¿s medical records, the patient failed medical treatment for bowel ischemia and returned to the operating room 5 days post procedure, with reopening of recent laparotomy and ascending colectomy.Patchy ischemia of the cecum without necrosis was noted.Postop, the patient was slow to awaken and had spontaneous movements on the left, but the right side was flaccid.Mri of the brain revealed multiple different vascular distributions of acute infarcts in keeping with shower of emboli.The largest overall area was in the left mca frontoparietal lobes.There was no hemorrhagic or mass effect associated with any of these infarcts.The patient¿s neuro status was monitored and there was minimal improvement.The patient¿s family refused a skilled nursing facility upon discharge, and the patient was discharged to a family member¿s home approximately 3 weeks post procedure.Per the instructions for use (ifu), potential risks associated with the overall procedure include thrombus formation, plaque dislodgment, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.It is the natural tendency of the body to form clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.There are multiple etiologies for bowel ischemia / infarction including embolization occurring after device manipulation, bav or valve deployment and these events can result in varying degrees of permanent impairment.Additionally, prolonged hypotension can contribute to decreased bowel perfusion and ischemia potentially leading to tissue necrosis.In this case, the cause of the bowel infarction could not be determined.However, it is possible the event was related to the mechanisms described above.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.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.No corrective or preventative actions are required.

Manufacturer Narrative

This is two of three manufacturer reports being submitted for this case.This case represents the first delivery system used.Please reference related manufacturer report number 2015691-2020-11795.The devices were not returned to edwards lifesciences for evaluation.Therefore, visual, functional, and dimensional analysis could not be performed.Imagery was provided by the complaint site which showed the distal tip/nose tip was separated from the remainder of the burst balloon.Dhr review did not reveal any manufacturing related issues that would have contributed to this complaint.A lot history review revealed no other similar complaints.A complaint history review from may 2019 to april 2020 revealed other similar complaints, but no manufacturing non conformances were identified during the investigation.A review of complaint data revealed that the complaint rate did not exceed the april 2020 control limit for the applicable complaint trend categories.The ifu, device preparation training manual, procedural training manual, and procedural manual were reviewed for guidance involving esheath and delivery system usage.Thv deployment: verify proximal balloon shoulder greater than 1 cm distal to the sheath marker.Unlock inflation device.Initiate rapid ventricular pacing ensuring 1:1 capture, sbp = 50 mmhg, and pulse pressure < 10 mmhg.Confirm placement of center marker within optimal initial center marker zone.Begin initial deployment with a controlled slow inflation.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon.Balloon should be fully deflated and un-flexed prior to retraction into sheath.Stop pacing and withdraw the balloon from the native valve.Delivery system removal and closure: be sure balloon is completely deflated and un-flexed prior to removal.Retract balloon into sheath.Detach the loader from the sheath.Remove the delivery system and loader from sheath.Remove the guidewire and sheath.Use standard apical closure techniques.Caution: patient injury could occur if the balloon is articulated or not deflated upon removal.Balloon rupture: if delivery system balloon ruptures or leaks during deployment without thv embolization do not use excessive force.Take care when removing the delivery system through the tip of the sheath, maintain guidewire position, and check for pv leaks under echo.If post-dilation needed, use a new delivery system.No ifu/training manual deficiencies were identified.During manufacturing of the 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-conformances contributed to the reported events.Per the instructions for use (ifu), balloon rupture and balloon separation following balloon rupture are potential risks of the tavr procedure.The physician training manuals recommend that the user not use excessive force when removing the balloon if the inflation balloon bursts during deployment.Transcatheter delivery balloon burst complaints have been previously investigated by edwards and documented in a technical summary.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 addition, the balloon burst increases the possibility of an obstacle (i.E.Patient's anatomy or sheath tip) interfering with retraction of the balloon/balloon material.The physician training manual provides the following instruction: if the inflation balloon leaks or bursts, do not use excessive force when removing the balloon.Per the report, the delivery system balloon ruptured before the full inflation volume, resulting in the valve having a major waist and severe leak.As noted, the patient had a very calcified root and porcelain aorta.Calcification can reduce the vessel profile leading to additional stress during transport of the delivery system through anatomy and during inflation.Contact of the balloon with calcification can lead to damage to the balloon.Per the report, the ruptured balloon would not pull through the 18fr sheath.The device was pulled with force and the delivery system separated at the balloon connection, including the internal delivery system wire.After the balloon bursts, the delivery system was experienced withdrawal difficulty during removal of the delivery system through sheath.Burst balloon may alter the balloon profile, and it led to caught on the tip of the sheath during delivery system retrieval.Per reported, additional force was used to remove the delivery system, subsequently, distal tip/nose tip was separated from delivery system.The complaints were confirmed.However, investigation of complaint history, lot history, and dhr revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Available information suggests that patient factors (calcification) and procedural factors (retrieval of burst balloon/excessive device manipulation) contributed to the complaint events.Since no edwards defect or ifu/training inadequacies was identified in the evaluation, and the complaint occurrence rate did not exceed the april 2020 control limit for the applicable trend category.Therefore, no corrective or preventative action nor pra is required at this time.

Manufacturer Narrative

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

• Brand Name: CERTITUDE DELIVERY SYSTEM 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10016328
• MDR Text Key: 191408060
• Report Number: 2015691-2020-11742
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: 9600SDS26A
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR