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

Catalog Number	CDS0701-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4+.Xtw clip ((b)(6)) was implanted with no reported issue, reducing mr to grade 1-2.On (b)(6) 2023, the patient was presented with recurrent mr of grade 4+.The clip was observed to detach from the posterior leaflet (single leaflet device attachment (slda)), which was believed to be due to worsening of mr.A new posterior leaflet flail was observed due to the slda.Additional mitraclip procedure was performed to stabilize the slda clip and reduce mr.During preparation of xtw clip ((b)(6)), the clip arm would not open.After multiple attempts, it was decided not to use the clip.Another xtw ((b)(6)) clip was prepped per instruction for use (ifu) and was inserted into the steerable guide catheter (sgc).After the clip was placed in the left atrium, the physician decided to remove the cds and sgc due to low transseptal puncture and perform another transseptal puncture.With the clip being removed from the sgc, the xtw clip ((b)(6)) was not used as per ifu.After successful transeptal access, another xtw clip ((b)(6)) was opened, prepped per ifu and was successfully implanted with adequate mr reduction and stabilized the slda clip.Mr was reduced to grade 1-2.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.
Additional 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 that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and a cause for the reported slda associated with the clip detaching from the posterior leaflet cannot be determined.Unspecified tissue injury and mitral valve insufficiency/regurgitation appears to be related to the slda.Tissue damage and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical 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.

• 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: 18291431
• Report Number: 2135147-2023-05395
• Device Sequence Number: 6668075
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/08/2024

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: 03/08/2023
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20309R132
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female