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

Model Number 916ESA

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is underway.This is one of two manufacturer reports being submitted for this case.  please reference related manufacturer report no: 2015691-2020-15210.

Event Description

A 26 mm sapien 3 valve was implanted in the aortic position via transfemoral approach.No injuries were reported.Upon return of the esheath a liner delamination was observed.Per medical opinion, the event was likely due to patient factors calcified annulus and iliac.

Manufacturer Narrative

The esheath was returned for evaluation.No applicable imagery was provided for review.Visual inspection revealed the sheath liner delamination.5 inches in length from the distal tip.Sheath liner bunching was observed near the distal tip.The sheath was fully expanded and opened as designed.The c marker band was present.Hpde stretching was observed at the distal tip opening.Due to the nature of the complaint no functional or dimensional testing was able to be performed.The complaint was confirmed through visual inspection of the returned device.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the edwards esheath introducer set and no deficiencies were identified.During the manufacturing process, the esheath is visually inspected and tested several times.During manufacturing, the esheath shaft component was 100% inspected.During the final inspection, the lots are subject to product verification (pv) testing on a sampling basis.All samples passed product verification testing for this lot number.These inspections and tests during the manufacturing process support that it is unlikely that a nonconformance contributed to the reported complaint.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 complaint for sheath distal tip liner delamination was confirmed based on the visual inspection of the returned device.However, no manufacturing non-conformances were identified during the evaluation.Reviews of the dhr, lot history, and complaint history, revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint 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 liner delamination was present out of the box.Available information suggests that procedural factors (withdrawal of burst balloon) may have contributed to the reported event.The complaint event was confirmed.No manufacturing nonconformances were identified.No labeling ifu training inadequacies have been identified.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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-15210.

• 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: 11328139
• MDR Text Key: 232563589
• Report Number: 2015691-2021-00263
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR