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

Catalog Number	CDS0701-XT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
This is filed to report a clip that opened during 'establish final arm angle' (efaa).It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr), a prolapsed posterior mitral leaflet, and a posterior 2 flail for a mitraclip procedure.The target was anterior 2 and posterior 2 leaflets (a2/p2).The device was prepared and operated per instructions for use (ifu) and passed function inspection during prep.The second clip was placed medially to the xtw on a2/p2.During initial 'establish final arm angle' (efaa), the clip slightly opened.The second clip was unlocked, opened to 60 degrees, and relocked to troubleshoot.Efaa was repeated and the clip slightly relaxed again, but there was no change to mr (opening noticed was noticed on fluoroscopy).The clip was implanted, and the mr was reduced to grade 1-2.Per the physician, the device settled.The clip was stable on the leaflets.There were no adverse patient effects or clinically significant delay.No additional information was provided.
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 and without the device to analyze, the cause of the reported clip open during efaa was unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Imagine review: one (1) fluoroscopic still image was provided in which two fully deployed clips can be visualized.One clip is circled in yellow, presumably the reported device, and appears to have a clip arm angle of ~20° - 30°; this is an estimation based on visual assessment with the naked eye and is not confirmed.While it is evident the xt clip (reported device circled in yellow) is opened to a larger degree than the xtw clip (no reported issue), it does not present with a significantly larger arm angle, comparatively.No pre-deployment cine of the reported clip was provided; as such, no assessment or comment regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), when and/or by how much the clip opened, can be made.There are no additional observations based on the image provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 17886564
• Report Number: 2135147-2023-04372
• Device Sequence Number: 7289570
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2023
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 21103R1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic