MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA DELIVERY SYSTEM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Catalog Number 9360TF26

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

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

Event Date 09/30/2019

Event Type  malfunction  

Event Description

Elderly female who has a hx of htn, hyperlipidemia, copd, cad s/p cabg 2013 with mv/tv ring, afib not on anticoagulation d/t gi bleed but with laa ligation at cabg with recent chf hospitalization with severe aortic stenosis was admitted for tavr procedure.During the procedure, on initial balloon inflation for placement of the valve the balloon ruptured and attempts to remove the device resulted in separation of the balloon and the nose cone away from the delivery devise.It was noted this was still on the delivery wire and not a free embolus.Multiple attempts were made to retrieve (l femoral sheath to snare it also used) but were unsuccessful.Open procedures were decided necessary and proceed to performed an emergency left femoral cut-down, left common femoral artery endarterectomy and pericardial patch repair superficial femoral artery.The retained nose cone and balloon found lodged in the common femoral artery (noted very tight).No embolic phenomena were found down left superficial femoral artery and intact pulse with good hemostasis.All pieces of balloon were felt per tech and md present to have been found.Balloons are known to rupture during these procedures.It was felt that it could have been caused by a calcific plaque which may have compromised the balloon.The rupture led to retention of the device and ultimately the need for the additional procedure for retrieval.

• Brand Name: SAPIEN 3 ULTRA DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9659317
• MDR Text Key: 177373362
• Report Number: 9659317
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9360TF26
• Device Lot Number: 62039549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA