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

Model Number 9610ES16

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4).This is one of two manufacturer reports being submitted for this case.This report represents the sheath used in the case.Please reference related manufacturer report number 2015691-2020-15197.The investigation is ongoing.

Event Description

As reported by our affiliates in (b)(6), during implant of a 29mm sapien 3 valve in the aortic position by right percutaneous transfemoral approach, the native valve was unable to be crossed.The valve and delivery system were attempted to be withdrawn through the esheath without success.The valve had been partially inflated in the abdominal aorta, and an aortic rupture occurred.Bleeding control was performed with endovascular technique, (occlusive balloon in aorta and covered stent in iliac vessel) however, the patient was ultimately taken to the operating room and required a surgical cut down.During the night, patient expired due to the abdominal aortic rupture.As per medical opinion, the unsuccessful attempt to withdraw valve and delivery system through the esheath was a likely contributing factor for the event.During pre-decontamination evaluation, the sheath liner was found to have full circumferential liner delamination with length of 3in from the distal tip.There was stretching of the hdpe near distal tip, distal tip damage, and scratches noted along shaft.

Manufacturer Narrative

The devices were returned to edwards lifesciences for evaluation.During visual analysis of the esheath, it was observed the sheath liner was expanded as designed, the sheath liner was circumferentially delaminated at the distal tip 3 inches in length, the marker band remained attached to the torn sheath liner, there were scratches along sheath shaft with many concentrated at the distal end, there were hdpe stretch near distal tip, and there were gouge marks on the hdpe and soft tip.Due to nature of the complaint, no applicable dimensional inspection or functional testing was performed.The complaint is confirmed through visual inspection of returned device.Dhr review did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other similar complaints.A review of complaint history on confirmed device complaints (returned and no product returned) from january 2020 to december 2020 revealed other similar complaints, but no manufacturing non-conformances were identified.The ifu, device preparation training manual, and procedural training manual were reviewed for instructions/guidance for preparation and use of the devices.Per the procedural training manual, the thv can be retrieved through sheath only before thv deployment (still crimped).Ensure the thv is centered on the flex tip.Ensure delivery system is locked.Retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip.Ensure the edwards logo on the sheath handle is facing upward.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not re-use the sheath, thv or delivery system once thv is retrieved.Note: crimped thv aligned on balloon is larger than crimped thv off balloon.Take care if deciding to retrieve.Do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.Retrievability is based on preclinical testing.No ifu/training deficiencies were identified.During manufacturing, the esheath 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.The complaint was confirmed upon visual inspection of the returned device.However, no manufacturing non-conformances were identified in the returned sample.A review of dhr, lot history, complaint history, and manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu/training materials revealed no deficiencies.Furthermore, as there was no note of abnormalities during device preparation, it is unlikely that the sheath distal tip liner delamination was present out of the box.Per the report, after visual inspection, it was reported that there was damage in the distal tip of the esheath.In such events, potential difficulty in withdrawing the valve and delivery system into the sheath can increase, if the valve is retracted with excessive force.Attempts to retract the delivery system back into the sheath in such a condition may lead to delamination and stretching of the hdpe.Gouge marks observed further shows that non-coaxial withdrawal of the valve into the sheath likely occurred.While a definitive root cause is unable to be determined, available information suggests that procedural factors (device manipulation, non-coaxial withdrawal) may have contributed to the reported event.The complaint for sheath distal tip - liner delamination was confirmed.However, no manufacturing nonconformance were identified during evaluation.While a definitive root cause is unable to be determined, available information suggests that procedural factors (device manipulation, non-coaxial withdrawal) may have contributed to the reported event.Since no manufacturing non-conformances, labeling, training, or ifu deficiencies were identified, no corrective and preventative action, risk assessment is required at this time.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.

• 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: 11284103
• MDR Text Key: 230615725
• Report Number: 2015691-2021-00254
• 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
• Report Date: 02/04/2021

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: 05/18/2022
• Device Model Number: 9610ES16
• Device Lot Number: 63196825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR