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

Catalog Number CDS0705-XTW

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/03/2024

Event Type  Injury  

Event Description

The article, ¿free-floating left atrial ball thrombus following transcatheter edge-to-edge mitral valve repair with the mitraclip device¿, presents a case study of an 80-year-old man with severe secondary functional mitral regurgitation (mr), previous myocardial infarction, long-standing persistent atrial fibrillation and heart failure for a mitraclip procedure.Transesophageal echocardiography (tee) showed a severe mr jet between the a2 and p2 (anterior and posterior scallops 2).One xtw was implanted and the mr was reduced to trivial.The mitral valve orifice area (mva) decreased from 6.66 to 2.66 cm2.And mean mitral pressure gradient increased from 1.0 to 3.0 mm hg after mitraclip therapy.The patient was prescribed apixaban to manage atrial fibrillation.Ten months after mitraclip therapy, the patient was switched from apixaban to warfarin because his renal function had deteriorated.Fourteen months after mitraclip therapy, tte showed a free-floating mass in the left atrium (la) which intermittently obstructed the mitral valve orifice.The patient¿s mr was mild, with a mean mitral pressure gradient of 3.0 mm hg.The patient underwent emergency surgical removal of the mass in the la, and la appendage occlusion.Histopathological examination of the excised mass revealed an organized thrombus and the diagnoses was la ball thrombus (labt).The patient had no embolic event and was discharged and prescribed apixaban for 2 weeks post-surgery.In conclusion, mitraclip therapy reduces mr and mva and increases the mitral valve pressure gradient, affecting hemodynamics and stagnating the la blood flow.Atrial fibrillation and inadequate anticoagulation can increase the risk of labt formation.To date, there are no appropriate recommendations for postprocedural antithrombotic treatment.In the context of a low-flow la state due to reduced mr and mva after mitraclip therapy, optimal antithrombotic treatment and frequent follow-up are essential.The primary and correspondence author is (b)(6).

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B3: date of event was estimated to (b)(6) 2024, date of publication.D4: the udi is unknown as the part and lot numbers were not provided d4: lot number was not provided.D6a: implant date was estimated to (b)(6) 2023, 14 months prior to date of publication.A: as this event is from a literature review, the specific patient weight was not provided.The article is attached as article - e-216974.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record could not be performed as the lot information was not provided.Based on the information reviewed and due to the limited information available, a cause for the reported thrombus cannot be determined; however, thrombus is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Medication required, surgical intervention and hospitalization were a result 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 (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: 19210366
• MDR Text Key: 341359580
• Report Number: 2135147-2024-01905
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: CDS0705-XTW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male