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

Catalog Number CDS0706-XTW

Device Problems Device Damaged by Another Device (2915); Expulsion (2933); Migration (4003)

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 03/07/2024

Event Type  Death  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (mr), heart failure, and an acute posterior leaflet flail for a mitraclip procedure.Two mitraclips were implanted and the mr was reduced to grade <1.On (b)(6) 2024, it was noted that the clips were stable with mild mr.On (b)(6) 2024, a complete clip detachment (ccd) was observed and the mr was worsened.The mr was worsened to grade 4+.The clip embolized and migrated to the right subclavian artery.The patient underwent a non-abbott heart pump procedure the week of (b)(6) 2024, which was due to progression of heart failure.Per the physician, the heart pump came into contact with the clip and contributed to the ccd.The interaction is believed to have initially caused a single leaflet device attachment (slda), which progressed to a ccd.The slda cannot be confirm, but ccd was confirmed by transesophageal echocardiogram.Additionally, disease progression of mitral valve disease contributed to the ccd.On (b)(6) 2024, the clip was explanted with a snare and surgical cutdown was performed to remove it from the vessel.A second clip intervention was unfeasible due to the leaflet damage where the clip was initially implanted, and due to the degenerative nature of the valve.The next day, on (b)(6) 2024, the patient expired.The documented cause of death were two massive strokes with a midline shift.In the physician's opinion, the device interaction and subsequent complications from the mitraclip ccd contributed to further heart failure complications and the patient's death.

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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported device damaged by another device (dislodged) appears to be related to procedural condition.The reported migration and subsequent expulsion (complete clip detachment) were due to the device damage by another device in conjunction with disease progression.The reported heart failure and tissue injury appear to be related to patient conditions.Mr, cerebrovascular accident, intracranial hemorrhage, and subsequent death appear to be due to pre-existing heart failure, valve degeneration, device interaction and subsequent complications from the complete clip detachment contributed to further heart failure complications.Mr, death, heart failure, tissue injury, cerebrovascular accident, and intracranial hemorrhage are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, unexpected medical intervention, and surgical intervention, and were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 19014702
• MDR Text Key: 339053491
• Report Number: 2135147-2024-01448
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241022(10)31024A1058
• 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,Followup
• Report Date: 05/16/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31024A1058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• 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: IMPELLA; MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Male