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

Model Number 914ESJ

Device Problems Difficult to Remove (1528); Failure to Align (2522); Material Split, Cut or Torn (4008)

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

Event Date 04/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

As reported, during a tavr procedure, after the 26mm sapien 3/commander delivery system were advance into a slightly tortuous section of the aorta, the team was unable to perform valve alignment.The decision was made to pull the commander delivery system into the esheath and remove everything as a unit.Removal of the esheath and delivery system was difficult and arterial calcium was noted on the system upon removal.There was coaxial alignment of the delivery system upon reentry into the distal end of the sheath.After the esheath was withdrawn, it appeared to have split.The patient remained hemodynamically stable; however cell saver was initiated.A new esheath, 26mm sapien 3 valve and 26mm commander delivery system were opened and prepped per ifu.The new esheath and delivery system devices were inserted, without difficulty.After successful valve deployment, the commander delivery system and esheath were removed, and brisk femoral flow was noted via angiography.A photo provided of the first esheath used during the procedure, confirmed a liner tear.

Manufacturer Narrative

Section h10: this complaint was confirmed to be a duplicate file.The investigation findings will be submitted under mfgr.Report #2015691-2020-11802.

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10019626
• MDR Text Key: 191273145
• Report Number: 2015691-2020-11771
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 914ESJ
• Device Lot Number: 62355895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/02/2020
• Supplement Dates Manufacturer Received: 06/04/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 64