MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CORP. EDWARDS LIFESCIENCES SWAN-GANZCCOMBO V (CCO/SVO2

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 08/31/2022

Event Type  Death  

Event Description

On (b)(6) 2022, removal of mitral valve nodule, redo aortic valve replacement, transesophageal echocardiogram central line insertion with swan placed after.On (b)(6) 2022, swan cath removed.Initial slight resistance, pt repositioned then catheter removed smoothly.Pt's bp immediately began to drop.Chest tube noted to have largely increased sanguinous output.Pt awake and talking throughout event.Plans made to go emergently to operating room.There was approximately 3 x 2 cm defect in anterior wall of the svc, just superior to the cavoatrial junction.The injury encompassed about 40% of the circumference of the svc.The svc had been clamped for a few minutes, and there was evidence of venous congestion in the innominate vein.Patch repair of large superior vena cava laceration.The pt appears to have tolerated the procedure satisfactorily.Transfer back to icu.Suspected that the swan had been looped by a suture at the time of operation.Either in the svc or right atrium, which could leave a small defect in the wall.

• Brand Name: EDWARDS LIFESCIENCES SWAN-GANZCCOMBO V (CCO/SVO2
• Type of Device: EDWARDS LIFESCIENCES SWAN-GANZCCOMBO V (CCO/SVO2
• Manufacturer (Section D): EDWARDS LIFESCIENCES CORP.; one edwards way
• MDR Report Key: 15502809
• MDR Text Key: 300773829
• Report Number: 15502809
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Distributor Facility Aware Date: 08/31/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White