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

Catalog Number	CDS0601-NTR
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921); Noise, Audible (3273)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All available information was investigated, and the reported gripper line break and inability to raise the gripper arm were confirmed.The reported difficult removal from anatomy could not be replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.The reported noise could not be replicated in a testing environment as it was likely a symptom of the cable break.Additionally, the gripper line was observed to be deformed (bent).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.The broken gripper line was submitted to the materials characterization lab for analysis.Based on available information, the reported inability to raise the gripper arm is a cascading event of the broken gripper line.A cause for the reported broken gripper line could not be conclusively determined.A cause for the difficult removal from anatomy could not be conclusively determined.The reported noise was likely a cascading event of the broken gripper line.The observed bent gripper line is likely a cascading event of the difficult removal from anatomy.The reported tissue injury appears to be a cascading event of the difficult removal from anatomy.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is 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 quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+, restricted posterior leaflet, dilated left atrium (la), and dilated left ventricle (lv).A steerable guide catheter (sgc) and a mitraclip xtr were inserted, and the clip was implanted without issues.To further reduce the mr, a mitraclip ntr was inserted without issues.However, while applying the plus and minus knobs oof the sgc, it was noted that it was too flexible, and could no longer straighten the sgc.While the ntr was in the valve, it was observed that one gripper was not functioning as intended.The clip had become caught in chordae.Troubleshooting was performed, and the clip was able to be removed from the chordae.However, it was observed that a chordal rupture occurred., the clip was removed from the patient.While outside the patient, it was observed that the gripper line was broken.Another clip was inserted and implanted without issues, reducing the mr to a grade of 2-3.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 19594922
• Report Number: 2135147-2024-02975
• Device Sequence Number: 8410442
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)241121(10)31122R1058
• 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
• Device Explanted 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,Followup
• Report Date (Section B): 07/17/2024

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: 31122R1058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian