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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Premature Activation (1484); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/20/2023

Event Type  Injury  

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 Description

This is filed to report clip caught in chordae, gripper actuation issues, unintended movement, premature activation, foreign body in patient, and embolism it was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4.An xtw clip was inserted and advanced into the left ventricle (lv).Grasping was performed, but a jet observed medially and laterally of the clip.Therefore, the clip was brought back into the left atrium (la).It was noted an aortic hugger occurred, so additional steering was performed.The clip was advanced back into the lv but was noted to move more than anticipated, resulting in the clip becoming entangled in chordae.Troubleshooting was performed but the clip was unable to be removed from chordae.It was noted the clip delivery system (cds) handle was more than likely turned 540 degrees while attempting to remove the clip from the chordae.It was then observed the anterior gripper was not functioning and was stuck on the arm of the clip and the clip had detached from the cds, resulting in a clinically significant delay in the procedure.The lock line (ll) was still attached to the clip; therefore the physician decided to remove the cds and steerable guide catheter (sgc).After the cds was removed from the anatomy, it was observed the mandrel was broken.It is unknown if the portion of the mandrel remained in the anatomy.Mr remained at a grade of 4.The patient was then transferred to another hospital to undergo surgical intervention.It was noted the lock line remained attached to the clip and was sticking out of the groin incision.Later that day, the patient underwent cardiac surgery to remove the entrapped clip.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received.On (b)(6) 2023, the patient underwent mitral valve replacement.On (b)(6) 2023, the patient passed away due to sepsis.In the physician¿s opinion, the mitraclip xtw did not cause or contribute to the death.

Manufacturer Narrative

All available information was investigated.The reported premature activation, unintended movement, and difficult single gripper actuation could not be replicated in a testing environment due to the device returned condition.The reported entrapment of device (clip caught on chordae) and difficult or delayed positioning (anatomy) during use could not be replicated in a testing environment as these were related to patient anatomy or procedural operational circumstances.Returned device analysis confirmed the reported actuator coupler break.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 product issue.Based on the available information, a cause for the reported unintended movement could not be confirmed.The reported entrapment of device (clip caught on chordae) and difficult/delayed positioning (anatomy) appear to be cascading events of the unintended movement.The reported premature activation is due to the observed coupler break.The reported break appears to be the observed coupler break.The coupler break and difficult to open or close (gripper actuation ¿ single) appear to be cascading events of the entrapment of device.The reported foreign body in patient and embolism are related to the broken l-lock tab and is a cascading event of the entrapment of device.The reported unchanged mr is a cascading event of the entrapment of device.The reported unrelated death is due to worsening patient condition (sepsis) per case details.Embolism, mr, and death are listed in the ifu as known possible complications associated with mitraclip procedures.The reported surgical intervention, hospitalization, removal of foreign body, and delay to treatment/therapy are the results of case-specific circumstances.There is no indication of 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: 16549559
• MDR Text Key: 311369538
• Report Number: 2135147-2023-01206
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 20804R1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization