MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-NT

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

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 04/04/2024

Event Type  Death  

Event Description

It was reported that on 14mar2024, patient presented with grade 4 degenerative mitral regurgitation (mr), a dilated left atrium (la ), and calcified chordae and leaflets for a mitraclip procedure.The steerable guide catheter (sgc) was inserted.However; the sgc was unable to advance, resulting in a kink towards the distal tip.Therefore, the sgc was removed and replaced.Two clips were then successfully implanted.However, the mr color in the echocardiogram appeared severe at the end of the case.The mr grade was unchanged from baseline.The mr remained a grade of 4.There were no adverse patient effects and no clinically significant delay in the procedure.On 15mar2024, the patient died one day post-mitraclip procedure.Per the physician, the mortality was suspected to be related to the mitraclip procedure.The clip remained stable on both leaflets.During post-procedural analysis, the physician suspects the second clip caused chordal damage, which resulted in a small flail, and subsequently explained the mr color observed in the echocardiogram.While implanting the second clip, the damage was able to be treated, but the mr remained.It is unknown what caused the patient's death, but it is suspected to be related to the procedure by one of the implanters.

Manufacturer Narrative

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

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19193555
• MDR Text Key: 341235646
• Report Number: 2135147-2024-01859
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)240926(10)30926A1043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• 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
• Report Date: 04/26/2024

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 Catalogue Number: CDS0706-NT
• Device Lot Number: 30926A1043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2023
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death