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

Catalog Number CDS0705-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

The clip remains in 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.The additional cds0705-xtw device referenced in b5 is filed under separate medwatch report number (b)(4).

Event Description

It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (mr), small posterior mitral leaflet (pml), and opposing extensive anterior mitral leaflet (aml) flail from a ruptured primary chordae (the flail involved the majority of a2 scallop and extending to a3) for a mitraclip procedure.During grasping with a mitraclip xtw (31206r1091), a broken gripper line was observed.The clip was removed and replaced.The replacement mitraclip xtw (31031r1006) was the first clip implanted successfully and was well-inserted post-deployment.It was noted that the first clip had movement on the leaflets due to the residual redundant tissue/ flail.A second clip (30726r1119), an ntw was attempted to be placed to further reduce the mr and stabilize the movement of the first clip.By the time the second clip was ready to insert it was noted that the pml had started to slip from the first implanted clip (31031r1006).A rocking motion was observed from the first clip.A single leaflet device attachment (slda) was witnessed on both fluoroscopy and transesophageal echocardiogram (tee).The pml was detached.Per the physician, the slda was due to extensive aml flail, residual pathology, and the rocking motion of the clip causing pressure on the grasping area.After the detachment, the slda clip made contact with the second clip.The continuous motion of the slda and the short pml contributed to the inability to grasp and capture with the second clip.The second clip did not contribute to the slda.The procedure was discontinued and the mr was grade 4.The patient will require mitral valve surgery.A surgical decision has not been determined due to thrombocytopenia.Per the physician, thrombocytopenia was due to heparin and sepsis, and not related to the mitraclip or the procedure.On (b)(6) 2024, a mitral valve replacement with a bioprosthetic was performed.Additionally, atrial septal defect (asd) closure was performed.In the physician's opinion, the asd noted during surgery was caused by the steerable guide catheter (sgc) during the mitraclip procedure.The patient is doing well with no post-operative complications.

• 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: 19119249
• MDR Text Key: 341004827
• Report Number: 2135147-2024-01723
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648288647
• UDI-Public: (01)08717648288647(17)241030(10)31031R1006
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 31031R1006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2023
• 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: STEERABLE GUIDE CATHETER