MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0601-XTR

Device Problems Difficult to Open or Close (2921); Expulsion (2933); Mechanical Jam (2983); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 03/02/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat eccentric degenerative mitral regurgitation (mr) with a grade of 4+ and prolapsed posterior leaflet.A steerable guide catheter (sgc) was inserted without issues, but while operating the device, the head of the sgc could not follow coaxial movement of the sgc arm outside the body in vivo.A mitraclip xtr was inserted and implanted.A second mitraclip xtr was placed on the mitral valve.While attempting to deploy the clip, difficulties removing the lock line occurred.Troubleshooting was performed and the lock line was removed.After the gripper line was removed, the shaft separated, and the clip jumped opened.After deployment, the clip detached from the leaflets.To remove the clip, a snare was inserted.Multiple attempts to snare out the clip were made but were not successful.The clip could not be removed.Therefore, the procedure was discontinued.The mr was at a grade of 1+.There was no clinically significant delay in the procedure.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional (sgc0301) device referenced in b5 is filed under separate medwatch report number (b)(4).

Manufacturer Narrative

In this case, the reported unintended movement-clip open ¿ locked, difficult to open or close-clip jumping, and expulsion-ccd (complete clip deployment)/gripper line removed could not be replicated in a testing environment.The returned device analysis however, confirmed the reported mechanical jam associated with inability to remove the lock line and was determined to be related to the knot identified on the lock line (material deformation).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.A review of the complaint history did not indicate a lot-specific product issue.Based on the information reviewed, while the inability removing the lock line appears to be the result of the observed knot (material deformation), a cause for how the knot formed could not be determined.Additionally, a cause for the reported unintended movement associated with clip opening while locked and clip jumping open resulting in expulsion (clip detaching from both the leaflets) cannot be determined.Embolism and foreign body in patient appear to be related to procedural conditions associated with the clip detaching from both the leaflets (expulsion).Emboli is a known possible complication associated with mitraclip procedures.Unexpected medical intervention, 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 XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 18973947
• MDR Text Key: 338546495
• Report Number: 2135147-2024-01334
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)240820(10)30821R1040
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/24/2024

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 Catalogue Number: CDS0601-XTR
• Device Lot Number: 30821R1040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization