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

Model Number 914ESJ

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in (b)(6), during a transfemoral transcatheter aortic valve replacement (tavr) with a 20mm sapien 3 valve, while inserting the delivery system following a balloon aortic valvuloplasty (bav), the system became stuck at the common iliac artery.A decision was made to retract the system as a unit.During the retrieval of the valve into the loader, only the delivery system was pulled out and the valve remained stuck in the sheath.Eventually both devices were able to be withdrawn as set.New devices were used successfully.The strain relief section of the sheath was noted to be damaged.There was no patient injury.Pre-decontamination evaluation: a small vertical split on distal tip was observed.

Manufacturer Narrative

Per further engineering evaluation, it was observed that the hdpe was stretched and not split.  based on this new finding, 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: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11246077
• MDR Text Key: 232590711
• Report Number: 2015691-2021-00241
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 10/20/2021
• Device Model Number: 914ESJ
• Device Lot Number: 62712468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR