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

Model Number N/A

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem Embolism/Embolus (4438)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report the broken clip arm and device embolization requiring intervention.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022 to treat functional mitral regurgitation (mr) with a grade of 4.An nt clip was advanced and several attempts were made to use the clip but the transesophageal echocardiogram (tee) did not have good visualization of the posterior arm and the posterior leaflet.As a result, there was loss of leaflet capture.The decision was made to remove the clip from the patient.While removing the clip from the patient, the clip arm broke.An attempt was made to retrieve the clip with a snare.The clip was half snared and retracted into the right femoral vein.While the physician was making a small incision at the femoral artery to retrieve the clip, the clip embolized into the inferior vena cava.A bioptome was used to capture the clip and retract it back into the right femoral vein.Then the clip was able to be removed from the femoral vein cutdown.The procedure continued and one xtw clip was implanted reducing the mr to 2.There was a reported delay in the procedure due to the surgical intervention.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 identified no similar complaints reported from this lot.Based on the information reviewed, the reported positioning failure (leaflet capture-clip not implanted) was due to the challenging patient anatomy (restricted posterior leaflet, rotated heart, paced wire in right atrium) and poor image resolution.The report image resolution had poor visualization of the clip during the procedure was due to rotated heart (visualization difficult to the lay out of the posterior leaflet).A cause for the reported break of the clip could not be determined.Embolism/embolus is listed in the ifu as a known possible complication associated with mitraclip procedures.The reported embolism of the clip was due to the incision at the femoral artery to retrieve the clip.The reported required delay to treatment/therapy, unexpected medical intervention, surgical intervention, and removal of foreign body were results 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
• 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: 15252964
• MDR Text Key: 298167974
• Report Number: 2135147-2022-00814
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230943
• UDI-Public: 08717648230943
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-NT
• Device Lot Number: 20310R217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention