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

Catalog Number CDS0702-XT

Device Problems Incomplete Coaptation (2507); Expulsion (2933)

Patient Problems Pulmonary Edema (2020); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report incomplete coaptation, expulsion, and tissue injury it was reported on (b)(6) 2023, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4, previous cardiac surgery, and thin and friable leaflets.Three clips were implanted, reducing mr to a grade of 2.On (b)(6) 2023, the patient returned to the hospital with a symptom of pulmonary edema.Echocardiography showed one of the implanted clips detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda), causing a chordal rupture and mr to return to a grade of 4.On (b)(6) 2023, an additional mitraclip procedure was performed to stabilize the slda.However, before deployment of the additional clip, the slda clip completely detached from both leaflets and moved to the right pulmonary vein.The additional clip was implanted, reducing mr to a grade of 3.On (b)(6) 2023, mitral valve replacement was performed and the embolized clip was removed.No additional information was provided.

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 identified no similar complaints from the lot.All available information was investigated, and the reported slda associated with the clip detaching from the posterior leaflet and ultimately expulsion of the clip (clip detaching from both the leaflets) appears to be related to patient¿s anatomical conditions (previous cardiac surgery, thin and friable leaflets).Unspecified tissue injury (chordal rupture), mitral valve insufficiency/ regurgitation (mr) and subsequent pulmonary edema appear to be related to the slda.Additionally, the reported embolism/embolus appears to be related to the complete clip detachment (expulsion).Embolism, tissue damage, edema, and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention, surgical intervention, removal of foreign body 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)
• Type of Device: 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: 17750588
• MDR Text Key: 323468908
• Report Number: 2135147-2023-03986
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2024
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 30130R1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP (X2)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White