MAUDE Adverse Event Report: EDWARDS LIFECSIENCES EDWARDS ESHEATH PLUS; INTRODUCER, CATHETER

Model Number 914ESPA

Device Problems Peeled/Delaminated (1454); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Device not returned.See manufacturing report number 2015691 2022 09511 and 2015691 2022 09514.For related events.

Event Description

As reported, during a tavr procedure using a 26mm sapien 3 ultra valve via transfemoral approach, the sheath, valve and delivery system was advanced through a aaa endograft.Upon exit of the sheath the valve had a bent strut on the distal end.The delivery system, sheath, and valve were all removed and during removal, there was withdrawal difficulty and sheath damage was noted, the imagery provided showed a liner strand.

Manufacturer Narrative

The esheath was returned, and visual inspection revealed that a kink was seen on the sheath shaft approx.5.25 from comnut, possibly due to packaging, a liner tear was seen starting approximately 1.5 from strain relief, the tear was approximately 9 in length, running all the way to the distal tip.Multiple liner strands were seen.The distal tip opened as designed, damage was noted approximately 3 distal of the strain relief and there were noticeable scratches seen on the distal tip.Dimensional inspection was performed for the event failure sheath liner torn and sheath liner strand; the liner thickness was measured along the liner tear and all measurements met specification.No dimensional testing was able to be performed for the event sheath damage due to device return condition.No functional testing was able to be performed due to device return condition.No imagery was provided therefore no imaging evaluation was performed.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.The returned device met specification with no evidence to support that a manufacturing/design defect contributed to the complaint, therefore a manufacturing mitigation was not performed.A lot history review was performed and revealed no other complaints relating to the complaints failure sheath liner torn, failure sheath liner strand and failure sheath damaged.The following instructions for use (ifu) and training manuals were reviewed; esheath+ introducer set ifu, ifu for commander delivery system, s3u with commander and esheath+ device prep manual and s3u with commander and esheath+ procedural manual.No ifu/training deficiencies were identified.A complaint history review on confirmed device complaints was performed.Of the root causes identified, procedural factors (bent valve strut, valve caught on liner, excessive manipulation), procedural factors (bent valve strut, valve caught on sheath, excessive manipulation) and procedural factors: valve caught on liner, excessive manipulation were identified as potentially applicable to the complaint event.A risk assessment was performed on the reported event and revealed no evidence of product non conformances or labeling/ifu inadequacies.The complaints for sheath liner torn, sheath liner strand, failure sheath damaged were confirmed based on evaluation of the returned device.No manufacturing nonconformance was identified.Review of the dhr, lot history, and complaint history also did not provide any indication that a manufacturing nonconformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.Per the complaint description, during a tavr procedure using a 26mm sapien 3 ultra valve via transfemoral approach, the sheath, valve and delivery system was advanced through a aaa endograft.Upon exit of the sheath the valve had a bent strut on the distal end.Additional information indicated that there was withdrawal difficulty and the valve dislodged off the balloon during withdrawal through the esheath and that the valve was pulled back in the sheath exit at the access site thereby damaging the sheath.Per evaluation of the returned device, in addition to the liner tear, there were multiple liner strands.It is likely that during the withdrawal difficulty the bent valve strut caught on the liner creating the liner tear and subsequently the liner strands.The sheath shaft may have also become damaged during the withdrawal difficulty with the crimped valve and any excessive manipulation applied to overcome it.As such, available information suggests that procedural (bent valve strut, withdrawal difficulty, excessive manipulation) factors may have contributed to the complaint events.Since no manufacturing nonconformances or labeling and ifu and training deficiencies were identified, no product nonconformance was confirmed.No corrective and preventative actions (capa) nor product risk assessment (pra) re escalation are required.

• Brand Name: EDWARDS ESHEATH PLUS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFECSIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15874682
• MDR Text Key: 306501775
• Report Number: 2015691-2022-09516
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 64528680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male