MAUDE Adverse Event Report: ABBOTT MITRACLIP G4 STEERABLE GUIDE CATHETER; MITRAL VALVE REPAIR DEVICES

Model Number SGC0701

Device Problem Biofilm coating in Device (1062)

Patient Problems Air Embolism (1697); Ischemia Stroke (4418)

Event Date 08/04/2022

Event Type  Death  

Event Description

During mitraclip procedure, patient suffered a large air embolus immediately after the clip delivery system was inserted into the steerable guide catheter.No obvious source of the air.Clip delivery system was removed.Air was removed from the patient's heart and patient was stabilized.The clip delivery system was reintroduced and small amount of air entered body again.Again, no obvious breaks in the system.The patient remained stable enough to continue with procedure.All devices removed from body.A new steerable guide catheter was used and two new clip delivery systems.

• Brand Name: MITRACLIP G4 STEERABLE GUIDE CATHETER
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 15976086
• MDR Text Key: 305432771
• Report Number: 15976086
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231025
• UDI-Public: (01)08717648231025
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20304R208
• 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: 10/13/2022
• Distributor Facility Aware Date: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP G4 CLIP DELIVERY SYSTEM XTW: LOT: 20330R116, UDI#: (B)(4).
• Patient Outcome(s): Death; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White