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

Model Number	CDS0701-XT
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The device is included in the correction notice issued by abbott on 06 sep 2022 for clips not being able to establish final arm angle (efaa) and/or clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).
Event or Problem Description
This will be filed to report a mitraclip that opened while locked.It was reported that a patient presented with grade 4 primary mitral regurgitation (mr).One mitraclip was implanted successfully.A second device, a mitraclip xt, opened while locked after deployment.Before opening, the clip angle was 10 degrees, and after detachment from the clip delivery system (cds), the xt opened to 20-25 degrees.The clip was stable and the procedure was completed with an mr grade of 1.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 from the lot.All information was investigated and based on information provided and without the device to analyze, a cause for the reported unintended movement associated with clip opened while locked could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.The device is included in the correction notice issued by abbott on 06 sep 2022 for clips not being able to establish final arm angle (efaa) and/or clip opening while locked (cowl) with the mitraclip and triclip delivery system(s).Additionally, the imaging provided by the account was further reviewed by an abbott senior staff clinical engineer.The reviewer noted that "one (1) fluoroscopic still image was provided.The image was taken post deployment of the second clip (reported device), with two fully deployed clips in view.The delivery catheter (dc) of the second cds can be visualized and is retracted into the steerable sleeve.The bottom left clip in the image appears to be in the fully closed position (~10°) indicating it is the first implanted clip that did not have a reported issue.The top right clip in the image is opened to a noticeably larger degree, as compared to the other clip; it is evident that this is the second implanted clip reported for cowl post deployment.The clip is angulated relative to the fluoro view making assessment of the arm angle challenging.The clip arm angle appears to be ~45° - 60°; this is an estimation based on visual assessment with the naked eye and is not confirmed.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."na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16621791
• Report Number: 2135147-2023-01362
• Device Sequence Number: 15284913
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 05/23/2023
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20524R132
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2024168-9/6/2022-003-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 65 KG