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

Catalog Number CDS0706-XTW

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 04/04/2024

Event Type  Injury  

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 (31026a2017) 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.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

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 quality issue.Based on available information, the cause of the reported difficult grasping/capturing and tissue injury were unable to be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.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 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: 19193287
• MDR Text Key: 341164620
• Report Number: 2135147-2024-01856
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241025(10)31026A2017
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31026A2017
• Was Device Available for Evaluation?: No
• 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?: No
• Date Device Manufactured: 10/27/2023
• 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; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 136 KG