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

Model Number	CDS0701-XT
Medical Device Problem Codes	Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This will be filed to report use of an expired device.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with tethered leaflets.It was noted imaging was challenging.An xt clip was inserted, but difficulties capturing the leaflets occurred.It was then discovered that the clip was being used past it's expiration date.Therefore, the clip was removed and the procedure was discontinued.Mr remained at a grade of 4.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H6: device code 2017 - use after expiration na.
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 did not indicate a lot-specific issue.Based on the available information, the reported failure to grasp leaflets appears to be due to a combination of challenging patient anatomy and procedural conditions.The reported challenging imaging is due to challenging patient anatomy.The reported improper or incorrect procedure or method is due to the user using the cds past the ¿use by¿ date.It should be noted that the mitraclip g4 system instructions for use (ifu), section 23.0 states ¿warning: do not use the mitraclip g4 system after the ¿use by¿ date stated on the package label, and never reuse or re-sterilize the system use of expired, reused, or re-sterilized devices may result in infection.¿ there is no indication of product issue with respect to manufacture, design or labeling.
Event or Problem Description
N/a.

• 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: 17267165
• Report Number: 2135147-2023-02902
• Device Sequence Number: 6059016
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 06/12/2023
• Device Model Number: CDS0701-XT
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20613R142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 81 KG