MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number CDS0601-XTR

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Mitral Valve Stenosis (1965); Shock (2072); Tachycardia (2095); Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/31/2023

Event Type  Death  

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a patient death.It was reported that on (b)(6) 2023 mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4+, and a prolapsed anterior leaflet.Two clips were successfully implanted, reducing mr to <1.On (b)(6) 2023, the patient passed away.It was noted after the procedure, the patient experienced functional hemodynamic disorders in the patient heart which included atrial fibrillation, ventricular tachycardia, weakened myocardial contractility, unsynchronized systolic times of the ventricles and atria, mitral insufficiency.The physician stated the implanted clips were stable on the leaflets, but implantation of the two clips eventually led to the heart becoming unstable.This resulted in heart failure, subsequently leading to death.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received: the patient experienced shock and mitral stenosis occurred.No additional information was provided.

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.Based on available information, the cause of the reported shock, mitral stenosis, arrhythmia associated with the ventricular desynchrony, tachycardia associated with the ventricular tachycardia, atrial fibrillation, heart failure/congestive heart failure, and death / expired could not be determined.The reported patient effect of death, heart failure, arrhythmia, tachycardia, and atrial fibrillation, shock, and mitral stenosis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 device codes 2130 and 4451 removed.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 16806994
• MDR Text Key: 313920064
• Report Number: 2135147-2023-01797
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 20817R148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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
• Treatment: IMPLANTED MITRACLIP
• Patient Outcome(s): Death