MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ; CATHETER, FLOW DIRECTED

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Type  Death  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the patient's blood pressure dropped.The valve was implanted, and the low blood pressure remained and never recovered.The patient died, and it was discovered that the pulmonary artery had been ruptured.It was reported that ruptured pulmonary artery was most likely caused by the insertion of a non-medtronic catheter (edwards swan-gang).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SWAN-GANZ
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17532627
• MDR Text Key: 321040631
• Report Number: MW5139534
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1