MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610ES16

Device Problems Crack (1135); Difficult to Insert (1316)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Atrial Perforation (2511)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during implant of a 29 mm sapien 3 valve, by transfemoral approach, difficulty inserting the 16fr esheath into the patient was noted.After full insertion of the 16fr esheath, the valve was opened and crimped.Bleeding of the common iliac artery due to perforation was noted.The patient's pressure went down.A covered stent was placed on the damaged part of the vessel.Upon removal of the esheath from the patient, a small crack at the tip of the sheath was found.The tavi procedure was aborted and the patient was transferred for post-management care.The patient's minimum luminal diameter (mld) measured 8mm to 9mm at the common femoral artery.

Manufacturer Narrative

The esheath was not returned to edwards for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.No photo was provided.During manufacturing of the esheath and components are inspected several times throughout the manufacturing process.The sheath shaft is 100% inspected for defects.During final inspection, the esheath undergoes 100% inspection by both manufacturing and quality.In addition, during product verification (pv) testing, the sheath is tested and inspected on a work order sampling basis and tested for force, seam separation, post expander testing and visual defects.The units from the work order passed pv testing.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 records (dhr) review did not reveal any issues that could have contributed to the reported events.A review of lot history did not reveal other complaints relating to the reported event.The esheath introducer ifu, device preparation training manual, and procedural training manual were reviewed for instructions and guidance for proper preparation and use of the device.The procedural training manual provides guidance of sheath insertion.The proximal tapered end of the sheath is larger in diameter, hydrate sheath but do not wipe off hydrophilic coating, insert the sheath with the edwards logo facing upward so the seam remains down to ensure proper sheath performance, insert slowly with continuous motion to minimize friction, ensure fully expandable portion remains completely within the vessel for proper hemostasis, ensure the sheath tip is inserted beyond the aortic bifurcation (above the renal arteries), and do not use if the sheath is damaged (such as, kinked or stretched) additional considerations: heparin should be given prior to sheath placement to ensure act greater or equal 250 sec, use stiff wire (for peripheral access only) in case of peripheral tortuosity, utilize wires such as supracore, meier (boston scientific), lunderquist (cook), apply tension to wire to provide firm rail for placement, always observe fluoroscopy during insertion, proper screening is critical to reducing vascular complications, know position of sheath tip in the aorta, perform contrast injection if; angulated aorta, aneurysms, and significant aortic atherosclerosis.Push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification, do not force sheath and once inserted, suture the sheath in place.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.The complaints for sheath distal tip torn and sheath insertion and suturing difficulty introducing sheath were unable to be confirmed as no applicable imagery and a device for evaluation.As the device was not returned, engineering was unable to perform any visual inspection, functional testing or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint event.A review of ifu/training materials revealed no deficiencies.Per the complaint description, "the insertion of the sheath into the patient was not as easy as it usually is.After full insertion of the esheath, the valve was opened and crimped.However, after approximately three minutes, the team stopped the procedure".As reported the patient had severely calcified and moderately tortuous vessels.Per the training manual, "push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification." the presence of calcification and tortuosity can create a challenging pathway for the sheath upon insertion.Additionally, it is possible that combined with interaction with access vessel calcification, the sheath was excessively manipulated to overcome the resistance experienced during sheath insertion, leading to the damage of the sheath distal tip.In this case, available information suggests that patient (calcification/tortuosity) and procedural factors (excessive manipulation) contributed to the reported event.However, without the device available for evaluation, a conclusive root cause was unable to be determined.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11389189
• MDR Text Key: 233950184
• Report Number: 2015691-2021-01594
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: 9610ES16
• Device Lot Number: 63299619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention