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

Model Number 9610ES14

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in ireland, a 26 mm sapien 3 valve was implanted in the aortic position via transfemoral approach.Per evaluation of the returned esheath a liner delamination was observed.Per medical opinion, the event was likely due to calcification.

Manufacturer Narrative

The 14f esheath was returned after being used in the procedure with the 26mm commander delivery system.No relevant videos, imagery, or photographs were provided for evaluation.Visual inspection of the returned device was performed and the following were observed a liner delamination was identified at the sheath distal tip, the c-marker band was intact, the delamination was circumferential, scratches were present along the sheath shaft, and the sheath fully expanded as designed.Due to nature of the complaint, no applicable functional or dimensional testing was performed.The complaint is confirmed through visual inspection of 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 no other similar complaints.The instructions for the 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 esheath underwent 100% inspection by both manufacturing and quality.Additionally, all manufacturing 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 non-conformance 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.Per the complaint description, [?]upon deployment, the balloon on the delivery system was not able to be inflated,' [?]valve was not finally deployed,' and [?]balloon is torn proximal to ic bond.' in such events, potential difficulty in withdrawing the delivery system into the sheath can increase, as the delivery system with crimped valve and torn balloon can get caught on the distal tip of sheath.Attempts to retract the delivery system back into the sheath in such a condition may lead to delamination of the liner near the distal tip.Damage to the soft tip supports that the valve may have caught on the tip of the sheath.While a definitive root cause is unable to be determined, available information suggests that procedural factors (withdrawal of crimped valve / torn balloon) may have contributed to the reported event.The complaint was unable to be 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.As such, neither a product assessment escalation, nor corrective or preventative actions are required.

• 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: 11328732
• MDR Text Key: 232595330
• Report Number: 2015691-2021-00264
• 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: 01/27/2021

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: 07/16/2022
• Device Model Number: 9610ES14
• Device Lot Number: 63310779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1