MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP; MITRAL VALVE REPAIR DEVICES

Catalog Number	CDS0601-NTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade 4+.The mean pressure gradient (mpg) was 1mmhg.It was noted imaging was challenging due to an enlarged atrium, posterior flail, and long posterior leaflet.During the procedure, the physician stated there was a delay in steerable guide catheter (sgc) when positioning the device.The procedure was continued without replacing the sgc.An xtr clip (31221r1003) was inserted and advanced into the left ventricle (lv).However, while in the lv, the clip became caught in chordae.Troubleshooting was performed, but the clip was unable to be removed from chordae.Although still attached, the clip was able to be deployed on both leaflets.Mr decreased to a grade of 3+ and the mpg increased to 5mmhg.An ntr clip (31122r1048) was then inserted and deployed without issues, reducing mr to a grade of 1+.It was noted the mpg increased to 6mmhg, but the physician was satisfied with the results of the procedure.The following day, echocardiography was performed and showed the ntr clip had detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), causing mr to increased to a grade of 4+.
Additional 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 reported slda was due to procedural conditions and patient anatomy.The reported poor imaging resolution was due to patient anatomy.The reported mitral valve insufficiency/ regurgitation was due to the reported slda.Mitral regurgitation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP
• Common Device Name: 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: 20373904
• Report Number: 2135147-2024-04902
• Device Sequence Number: 6868406
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)241121(10)31122R1048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2024
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 31122R1048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 55 KG