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

Catalog Number CDS0706-XT

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and posterior leaflet segment 1 (p1) flail for a mitraclip procedure.There were no imaging challenges.The first clip was implanted successfully.The second clip had some difficulty with grasping, but a grasp was achieved.The clip was perpendicular to line of coaptation and leaflet insertion assessment was satisfactory.The lock line was removed and it was noted that mr had worsened.A loss of leaflet capture occurred and the clip took off a chunk of the anterior leaflet.The posterior leaflet was still attached.The lock line was already removed, so the clip was deployed on the one leaflet.To further reduce the mr a third and fourth clip were implanted, with the intent of stabilizing the second clip.All other clips were implanted successfully, with exception of the xt clip (31122r1004).The xt was attempted to be steered in-between the second clip and third (xt).The movements/ maneuverability of the delivery catheter shaft was not as intended.There was an attempt to re-key the device, but it continued to be irregular.Per the physician the dc shaft was moving in the intended direction, but it did not feel normal.They were attempting to gain height above the valve, and during advancement the dc shaft was not moving as intended.The xt was removed and a replacement was implanted successfully (which was the 4th clip).The patient was stable and there was no clinically significant delay.

Manufacturer Narrative

All available information was investigated, and the reported unintended dc shaft positioning was not confirmed via returned device 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 and the returned device analysis, the cause of the reported unintended dc shaft positioning was unable to be determined.There is no indication of a product quality 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 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: 19193480
• MDR Text Key: 341257422
• Report Number: 2135147-2024-01858
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)241125(10)31122R1004
• 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
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 31122R1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• 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: MITRACLIP (X3); STEERABLE GUIDE CATHETER
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 136 KG