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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  Injury  

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, the cause of the reported slda was unable to be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that on (b)(6) 2017, a mitraclip procedure was performed to treat mitral regurgitation (mr).One nt mitraclip (lot: unk) was implanted successfully.Recently the patient developed dyspnea and heart failure symptoms due to severe recurrent mr grade 4+.The recurrent mr was due to the progression of the patient's heart failure.The nt mitraclip remained stable on the leaflets with no tissue or chordal damage.On (b)(6) 2024, a mitraclip intervention procedure was performed.Ntw lot: 30911r1040 was implanted.After deployment, the clip detached from the anterior leaflet.An additional mitraclip nt lot: 30808r2100 was implanted to stabilize the slda and reduce mr to grade 1-2.There was no clinically significant delay.

• 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: 18653900
• MDR Text Key: 334724808
• Report Number: 2135147-2024-00532
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30911R1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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