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

Catalog Number CDS0705-XTW

Device Problem Expulsion (2933)

Patient Problems Endocarditis (1834); Myocardial Infarction (1969); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a mitraclip procedure was performed on (b)(6) 2023 to treat degenerative mitral regurgitation (mr) grade 4.The patient presented with barlow's disease, degenerated scallops, thickened leaflet sections, and a chordal rupture.An xtw was implanted a2p2 successfully, reducing mr to grade 1+.The patient was reported to be stable.On (b)(6) 2023, the patient was admitted to a different health institution with symptoms of myocardial infarction.The patient underwent catheterization, during which the mitraclip xtw was observed to be fully detached from both leaflets and located in the right coronary ostium.The clip was snared and removed with assistance from vascular team.The clip was observed to be closed at the same angle as when implanted.Mr had worsened to grade 4+.After the clip removal procedure, the patient remained unstable with the use of an intra-aortic balloon (iabp) and was admitted.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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported expulsion, myocardial infarction, and endocarditis were unable to be determined.The reported embolization, worsening mr, and removal of foreign body are cascading events of the reported expulsion.The reported patient effects of embolism, myocardial infarction, mitral regurgitation, and endocarditis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, unexpected medical intervention, unexpected medical intervention, and removal of foreign body were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 18119571
• MDR Text Key: 327928969
• Report Number: 2135147-2023-04974
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/19/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2024
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30307R1109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male