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

Catalog Number	CDS0701-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
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 quality issue.Based on available information, the reported incomplete coaptation (slda, single leaflet device attachment), associated with the clip detaching from the posterior leaflet, appears to be due to patient condition (violent coughing from infection).The reported tissue damage and worsening mr were due to the slda.The reported shortness of breath was a secondary effect of increased mr.The reported patient effects of mitral regurgitation, tissue injury, and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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 2-3.One clip was implanted, reducing mr to grade 2.Sometime in november 2023, a follow-up imaging was performed, and the clip was noted to be stable on the leaflets.On 15dec2023, the patient was presented with shortness of breath.Transthoracic echocardiogram (tte) was performed showing that the clip detached from the posterior leaflet (single leaflet device attachment (slda), but was only attached to one chord and the anterior leaflet.Leaflet damage was observed, and mr was noted to worsen to grade 4+.The patient had infection and violent coughing, which was theorized be what might have caused the slda.In the physician¿s opinion, the implanted clip did not cause or contribute to the infection.On (b)(6) 2023, the patient underwent additional mitraclip procedure to treat what now is a degenerative mitral regurgitation (mr) with grade 4+.Two clips were implanted with no reported issue, reducing mr to grade 1-2.However, the pressure gradient increased from pre-procedural 8mmhg to 10mmhg.The physician is satisfied with the result despite the gradient is 10mmhg.There was no clinically significant delay in the procedure and no adverse patient sequelae.

• 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: 18484174
• Report Number: 2135147-2024-00169
• Device Sequence Number: 9077821
• Product Code: NKM
• UDI-Device Identifier: 08717648230981
• UDI-Public: 08717648230981
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/10/2024

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: 04/20/2023
• Device Catalogue Number: CDS0701-XT
• Device Lot Number: 20420R144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 82 KG