MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/10/2023

Event Type  Death  

Event Description

This is filed to report a patient death.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 3-4.A steerable guide catheter (sgc) and a mitraclip ntw were selected for treatment, but a pericardial effusion at the posterior wall of the left atrium occurred.Aspiration was attempted but was not successful due to the leak being too large.The pericardial effusion led to cardiac tamponade.Heparin was administered during the procedure.Cpr was performed but was not successful.No clips were implanted, and the mr remained at grade 3-4.The patient died.The cause of death was due to pericardial effusion.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

N/a.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported death and cardiac tamponade were due to the reported pericardial effusion.However, a cause for the reported pericardial effusion cannot be determined.Pericardial effusion, death, and cardiac are listed in the instructions for use (ifu) as known possible complications associated with the mitraclip procedures.The reported unexpected medical interventions and medication required were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17669761
• MDR Text Key: 322485829
• Report Number: 2135147-2023-03826
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Catalogue Number: SGC0701
• Device Lot Number: 30329R1058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 53 KG