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

Catalog Number CDS0702-NTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); Fatigue (1849); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/23/2023

Event Type  Injury  

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

It was reported that on (b)(6) 2023, a patient presented with grade 4 degenerative mitral regurgitation (mr) and a prolapsed posterior 3 (p3) segment for a mitraclip procedure.One mitraclip ntw was implanted successfully on anterior 3 (a3) / p3.The mr was reduced to grade <1.The patient was discharged after a transthoracic echocardiogram (tte) on 24mar2023.On 17may2023, during a follow-up tte, a single leaflet device attachment (slda) was observed.The posterior mitral leaflet (pml) was detached.The mr was recurrent at grade 3-3+, commissural and medial from the slda.The patient was symptomatic with heart failure symptoms of fatigue and dyspnea.The slda was likely due to the prolapse becoming detached.On 15dec2023, a second clip intervention was performed.One ntw was implanted commissural at a3/p3.The mr was reduced to grade 1.The patient is stable.There were no adverse patient sequelae or clinically significant delay.

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.All available information was investigated, and the reported single leaflet device attachment (slda) per the physician is related to patient anatomy.The reported mr, dyspnea, fatigue and hf are cascading effects of the reported incomplete coaptation.Additionally, the reported patient effect of mr, dyspnea, fatigue, hf are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported hospitalization and medical intervention 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: 18409690
• MDR Text Key: 331503658
• Report Number: 2135147-2023-05743
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/24/2024

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 Expiration Date: 08/15/2023
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 20815R2082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization