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

Catalog Number CDS0601-XTR

Device Problem Migration (4003)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/12/2023

Event Type  Injury  

Event Description

This is filed to report migration, recurrent mitral regurgitation, heart failure, atrial fibrillation, and mitral stenosis.It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4+, prolapsed anterior leaflet and prolapsed posterior leaflet.There were no allegations of device malfunction with the steerable guide catheter.A mitraclip xtr was implanted without issues, reducing mr to a grade of 2+.On (b)(6) 2023, the patient presented to the hospital due to heart failure, atrial fibrillation, and shortness of breath.Echocardiography revealed that the clip was still attached to both leaflets, but was no longer stable, causing mr to increase to a grade of 4+ and mitral stenosis to occur.On (b)(6) 2023, mitral valve replacement was performed.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated, and the reported migration (partial clip movement) appears to be due to patient conditions (prolapsed anterior and posterior leaflets).Mitral stenosis and recurrent mitral valve insufficiency/ regurgitation (mr) resulting in dyspnea, atrial fibrillation and heart failure/congestive heart failure appears to be due to the partial clip movement (migration).Heart failure, atrial fibrillation, mitral stenosis, mitral regurgitation and dyspnea are known possible complications associated with mitraclip procedures.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.Cine review: one (1) photograph of a computer monitor was provided in which three (3) echocardiographic still images can be visualized.All three images appear to be taken post procedurally, likely during the follow up appointment on (b)(6) 2023.The left and middle echo images capture an intercommissural and lvot view; the middle image also has color doppler.In the lvot views the clip appears to be attached to both leaflets with no indication of an slda or evidence of a cowl.The color doppler in the middle image indicates regurgitation is present, which aligns with the reported incident details.The third image on the right shows the pulse wave forms which suggests mitral stenosis and regurgitation is present, as reported.There were no images of the sgc provided and a comment regarding the reported "tears noted in the soft tip of the steerable guide catheter (sgc)" cannot be made.There are no other observations based on the photo / echo views provided.

• 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: 17906486
• MDR Text Key: 325341915
• Report Number: 2135147-2023-04423
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: 11/20/2023

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: 04/17/2024
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 30418R2037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: Asian