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

Catalog Number CDS0705-NTW

Device Problem Expulsion (2933)

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Foreign Body In Patient (2687); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 04/15/2023

Event Type  Death  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report a complete clip detachment.It was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.Two clips were implanted successfully and the procedure was concluded with a resulting mr of grade 1.On (b)(6) 2023, it was observed that one of the implanted clips completed detached from the leaflets and embolized in the abdominal aorta.The anterior and posterior leaflets were damaged as a result of the clip embolizing and the mr increased to severe.On (b)(6) 2023 a mitral valve replacement surgery was performed, the embolized clip remains stable in the patient at this time, and will be monitored.No additional information was provided.

Event Description

Subsequent to the previously filed reports, additional information was received stating on (b)(6) 2023 the patient died from stroke and intercranial hemorrhaging.

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 identified no similar complaints reported from this lot.Based on available information, a cause of the reported expulsion (complete clip detachment/ ccd) could not be determined.The reported embolism (embolized clip) and foreign body in patient were cascading events of the ccd.The reported tissue injury (damaged leaflets) appears to be related to the ccd as the leaflets would likely be torn during clip detachment.The reported recurrent mr was also due to the ccd.The cause of the reported cerebrovascular accident (stroke) and intracranial hemorrhage could not be determined.The reported death was due to the reported cerebrovascular accident (stroke) and intracranial hemorrhage.The reported patient effects of embolism, tissue injury, mitral regurgitation, death, bleeding, and cerebrovascular accident as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported surgical 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.This event and the imaging provided by the account were reviewed by the clinical r&d (research and development) staff engineer, and the reviewer stated the following: one x-ray was provided of the patient's abdominal region.In the image, the reported clip can be visualized and easily identified located in the patient's descending aorta (centrally located in the abdomen) which aligns with the reported incident details that the clip detached from both leaflets and "embolized in the abdominal aorta".Notably, the clip arms appear to be in the fully closed position of ~10°.While this is an estimation based on visual assessment with the naked eye and is not confirmed, it is apparent the clip arms are in a closed position, with no evidence that the clip experienced a post deployment cowl event.The event was further reviewed by an abbott medical affairs team.The reviewer stated the following: the patient underwent a mitraclip procedure for dmr on (b)(6) 2023; the patient was reported to have a ¿short¿ pmvl and ¿long, floppy¿ amvl.Two clips were deployed (ntw and nt) and mr improved significantly.On (b)(6) 2023, an echo showed severe mr and the ntw clip had embolized to the abdominal aorta but was in a stable position on x-ray.On (b)(6) 2023, the patient underwent open-heart surgery for mitral valve replacement.The surgeon¿s anatomic description noted torn amvl and pmvl.Post-operatively on (b)(6) 2023, the patient expired due to intracranial hemorrhage.While the mitraclip devices were not a direct cause of death, the embolized clip and associated tissue injury initiated a cascade of events which likely contributed to the patient¿s death.Of note, there was an initial report suggesting that there was a second procedure to retrieve the clip; however, abbott representative confirmed that no such procedure took place.

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 identified no similar complaints reported from this lot.Based on available information, a cause of the reported expulsion (complete clip detachment/ ccd) could not be determined.The reported embolism (embolized clip) and foreign body in patient were cascading events of the ccd.The reported tissue injury (damaged leaflets) appears to be related to the ccd as the leaflets would likely be torn during clip detachment.The reported recurrent mr was also due to the ccd.The reported patient effects of embolism, tissue injury, and mitral regurgitation, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported surgical 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.This event and the imaging provided by the account were further reviewed by the clinical r&d (research and development) staff engineer, and the reviewer stated the following: one (1) x-ray was provided of the patient's abdominal region.In the image, the reported clip can be visualized and easily identified located in the patient's descending aorta (centrally located in the abdomen) which aligns with the reported incident details that the clip detached from both leaflets and "embolized in the abdominal aorta".Notably, the clip arms appear to be in the fully closed position of ~10°.While this is an estimation based on visual assessment with the naked eye and is not confirmed, it is apparent the clip arms are in a closed position, with no evidence that the clip experienced a post deployment cowl event.

Event Description

N/a.

• 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: 16907503
• MDR Text Key: 314971886
• Report Number: 2135147-2023-02036
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 08/04/2023

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: 08/10/2023
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 20810R2052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/23/2023; 07/31/2023
• Supplement Dates FDA Received: 06/12/2023; 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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: 1 MITRACLIP
• Patient Outcome(s): Required Intervention; Death; Hospitalization