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

Catalog Number CDS0601-XTR

Device Problems Entrapment of Device (1212); Incomplete Coaptation (2507)

Patient Problems Atrial Fibrillation (1729); Tachycardia (2095); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 02/02/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+, posterior flail, and enlarged atrium.A steerable guide catheter was inserted without issues and advanced to the mitral valve, and a mitraclip xtr was inserted and advanced into the left ventricle (lv).However, inability to curve and straighten the sgc occurred, and while in the lv, the clip became caught in chordae.Troubleshooting was performed but was not successful.The clip was unable to freed and a decision was made to implant the clip.However, due to patient anatomy and difficulties visualizing the clip during the procedure, difficulty accurately evaluating the length of leaflet insertion occurred.The clip was implanted on both leaflets, with chordae, where it was stuck.The mr was reduced to a grade of 1+.On february 4, 2024, the patient returned with atrial fibrillation and rapid heart rate.An echocardiogram was performed and revealed recurrent mr grade 4 and tissue damage.The clip had detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).On (b)(6) 2024, the patient underwent a mitral valve replacement surgery.

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 clip caught on chordae, slda, difficult imaging, and tissue injury were unable to be determined.The reported recurrent mr was a cascading event of the reported slda.The reported atrial fibrillation and tachycardia are likely cascading events of the reported recurrent mr.The reported patient effect of mitral regurgitation, atrial fibrillation, and tachycardia as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, surgical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

• 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: 18696256
• MDR Text Key: 335295627
• Report Number: 2135147-2024-00638
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: 30821R1034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian