MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; INTRODUCER, CATHETER

Model Number 9610ES14

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Edwards received notification from our affiliate in (b)(4).As reported, this was a case of an implant of a 26mm sapien 3 ultra valve, by transfemoral approach.There was no difficulty inserting the sheath into the patient.The insertion of the delivery system through the sheath was normal.After removal of the esheath, the tip was observed to have a ''crack in it'' and it was unclear if possible there may have been a missing piece of plastic.The possible missing piece was not removed from patient as it was not found.There was no patient injury reported and the patient left the procedure room in stable condition.As per medical opinion, the root cause is unknown, but could be due to calcification.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Manufacturer Narrative

The sheath was returned to edwards lifesciences for evaluation.The observations noted are preliminary pre-deco observations.The device was visually inspected.The 14f esheath was received with dilator inserted.The liner was fully expanded, with scratches visible along body sheath.The tip opened as designed.Due to the nature of the complaint and device returned condition (sheath liner expanded, tip opened), no functional testing or dimensional testing was performed.Review of the related work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.Imagery was returned for review.The 3mensio showed the patient's access vessels were sufficiently sized for safe use of the 14f esheath.Calcification was present.The post-procedural image of the sheath showed the tip opened as designed, fully intact, with no missing pieces.The tip appears slightly bend from use.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 distal tip separation was not confirmed as the alleged physical defect was not present on the returned device.Review of photo taken post procedure showed the tip opened as designed, fully intact, with no missing pieces.The possible ''missing piece'' was not removed from patient as it was not seen.There was no patient injury reported and the patient left the procedure room in stable condition.There was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.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.

Manufacturer Narrative

Supplemental report submitted to correct h6 - device code and h10 per further clinical and engineering review.This event of sheath distal tip separation was not confirmed during product evaluation.Per the engineering evaluation, the sheath was fully intact with no missing pieces but there was some damage to the distal tip.This event resulted in no patient harm and no device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.Based on the findings, this event is no longer mdr reportable.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 14987028
• MDR Text Key: 302722031
• Report Number: 2015691-2022-06724
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

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: 11/25/2023
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 64091213
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 09/09/2022; 09/20/2022
• Supplement Dates FDA Received: 09/13/2022; 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male