MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CATHETER UNKNOWN

Model Number SWAN GANZ UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/15/2021

Event Type  Death  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.

Event Description

Per received medical records, the patient presented with worsening shortness of breath.Pre-op tee showed an ejection fraction of 50%, moderate as, the valve was rocking with severe pvl, and moderate-severe mr.The patient underwent redo aortic valve replacement and mitral valve repair with a non-ew ring.Direct inspection of the aortic valve found it was only held by approximately half the sutures.The entire left commissure and the right left commissure had dehisced.The valve was excised, a 23mm inspiris valve was implanted and tied down with the cor-knot device.Post-op echo showed good ejection fraction, trivial perivalvular leak, and not much regurgitation.There were significant difficulties at the end of the case as the swan ganz catheter was sewn on as the innominate vein was oversewed.Upon removal of the catheter significant bleeding occurred.Overall, the patient tolerated the procedure well and was taken to the intensive care unit in stable condition.Postoperatively the patient had complications of aki, ards, and respiratory failure.On pod # 4, the patient developed profound hypotension, coded and expired.

Manufacturer Narrative

9/22/21: correction to h1 from serious injury to death.This correction in this supplemental is being done because the patient expired from profound hypotension.The initial mdr had section h1 marked as serious injury, but the patient ultimately expired.It is known that the sutures for the valve were sewn into the catheter, which caused bleeding upon removal of the catheter.It is not known if the bleeding from the removal of the catheter was responsible for the death of the patient.Due to the death of the patient a correction is being submitted to convey the correct information that happened to the patient in section h1.

• Brand Name: SWAN-GANZ CATHETER UNKNOWN
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 12085692
• MDR Text Key: 258957022
• Report Number: 2015691-2021-03817
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR