SAPIEN 3 ULTRA DELIVERY SYSTEM 9360TF26

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SAPIEN 3 ULTRA DELIVERY SYSTEM 9360TF26 manufactured by Edwards Lifesciences Llc.

Event Text Entries

[177373362] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9659317
• MDR Report Key: 9659317
• Date Received: 2020-02-03
• Date of Report: 2019-10-25
• Date of Event: 2019-09-30
• Report Date: 2019-10-25
• Date Reported to FDA: 2019-10-25
• Date Reported to Mfgr: 2020-02-03
• Date Added to Maude: 2020-02-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SAPIEN 3 ULTRA DELIVERY SYSTEM
• Generic Name: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Product Code: NPU
• Date Received: 2020-02-03
• Catalog Number: 9360TF26
• Lot Number: 62039549
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EDWARDS LIFESCIENCES LLC
• Manufacturer Address: ONE EDWARDS WAY IRVINE CA 92614 US 92614

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-03