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

Catalog Number CDS0706-XTW

Device Problems Incomplete Coaptation (2507); Deformation Due to Compressive Stress (2889); Unintended Movement (3026)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

The clip remains in the 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.Na.

Event Description

This is filed to report unintended movement.It was reported a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade 4.After deployment of the xtw clip, the clip arms opened to roughly 30 degrees.A second clip was then implanted to help stabilize the implanted clip.Mr was reduced to a grade of 1-2.There was no clinically significant delay in the procedure.No additional information was provided.

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 product issue.All information was investigated and based on the information provided, the reported unintended movement associated with clip opening while locked appears to be due to patient conditions and due to bi-leaflet prolapse.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.This event was further reviewed by a clinical staff engineer r&d, and the reviewer stated, ¿one (1) fluoroscopic still image was provided in which two fully deployed clips are in view, indicating the image was taken post deployment of the second clip (no reported issue).It was reported that the first clip (reported device) was implanted a2/p2 and is presumably the bottom clip in the image.The implant location of the second clip was not provided.Both clips are oriented such that the clip arm plane cannot be directly visualized, and there is overlap between the clip arms making assessment of the arm angles challenging.The relative location of the tips of the clip arms, for both clips, can be discerned and which can be used for a more generalized, indirect assessment of the clip arm angles.The tips of the posterior facing clip arms (for both clips) have a similar location along the vertical axis, as denoted by the yellow line in figure 1.The top clip in the image appears to have a slightly smaller tip-to-tip distance based on the general location of the tip of the anterior facing arm, as compared to the bottom clip, indicating the bottom clip is likely opened to a larger degree.To this end, the bottom clip in the image is presumed to be the incident device reported for cowl post deployment and appears to have a clip arm angle of ~30°.This is an estimation based on visual assessment with the naked eye and is not confirmed.No pre-deployment cine of the reported clip was provided; as such, no assessment or comment regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), when and/or by how much the clip opened, can be made.There are no additional observations based on the image provided.¿.

Event Description

It was reported a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade 4.After deployment of the xtw clip, the clip arms opened to roughly 30 degrees.A second clip was then implanted to help stabilize the implanted clip.Mr was reduced to a grade of 1-2.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, additional information was received stating that on (b)(6) 2023, the patient returned to the hospital.Echocardiography was performed and showed the two implanted clips had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device /slda), causing mr to increase to a grade of 4.It was also noted one of the grippers of the first clip was noted to be bent.

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 product issue.All information was investigated and based on the information provided, the reported unintended movement associated with clip opening while locked appears to be due to patient conditions and due to bi-leaflet prolapse.A cause for the reported slda and bent gripper, however, cannot be determined.The recurrent mitral valve insufficiency/ regurgitation (mr) appears to be due to the slda of both implanted clips.Mitral regurgitation is listed as a known possible complication associated with mitraclip procedures.Unexpected medical intervention 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 (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17725421
• MDR Text Key: 323147100
• Report Number: 2135147-2023-03935
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30522A1017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 11/10/2023; 02/22/2024
• Supplement Dates FDA Received: 11/20/2023; 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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: STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 72 KG