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

Model Number 916ESPA

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524); Material Integrity Problem (2978); Activation Problem (4042)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 valve in the aortic position via transfemoral approach, when trying to advance the first esheath it penetrated the seam on the esheath at the iliac bifurcation due to tortuosity.Resistance was felt when advancing the valve.The team could not advance valve any further.After getting the valve back in to sheath the device was removed as a unit.A longitudinal tear towards the end of the sheath at the seam and closer to the hub was observed.The vessel was dilated prior to new sheath going in.The team prepped a new valve and delivery system and delivered the valve without any complication.The patient is stable and there were no issues with iliacs.Per engineering findings on returned device, there was no strain relief damage observed on sheath.Liner strand was observed approximately 2" from distal tip.

Manufacturer Narrative

A supplemental mdr is being submitted to correct the reportability of the event previously reported.Engineering evaluation of the returned device confirmed a hdpe strand (sheath damaged) found with length of about 1.25 inches.There was no liner strand observed.Based on these results, this complaint is no longer considered to be a reportable event and a corrected report is being submitted.

• 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: 15611102
• MDR Text Key: 306681340
• Report Number: 2015691-2022-08608
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)240328(11)2203292164302110
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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: 03/28/2024
• Device Model Number: 916ESPA
• Device Lot Number: 64302110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2022
• 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