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

Catalog Number CDS0706-XTW

Device Problem Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/13/2024

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.

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+, a mean pressure gradient of 1.1mmhg, several subvalvular chordae, large p2 into prolapsed posterior leaflet, small p2 flail, rotated heart, esophagus off midline, and low transseptal height for procedure.A mitraclip xtw was implanted.Another mitraclip xtw (30803a1079) was inserted and was advanced to the mitral valve.However, during deployment, when the grippers were pulled back, the clip spun and detached from the posterior mitral leaflet (pml), causing damage to the pml.The clip was implanted.Pre deployment images were reviewed, and the clip was observed to be properly aligned and leaflet insertion was confirmed.It was likely that a chord had also been grasped, which was not appreciated, causing the clip to detach from the pml.To stabilize the detached clip and further reduce the mr, another mitraclip xtw (30803a1081) was inserted, and grasping was performed.A successful grasp was achieved, but the gradient increased between 8mmhg and 10mmhg.After ungrasping the leaflets, the pressure gradient returned to baseline.The clip was removed from the patient.There were no reported patient adverse effects related to the increase in pressure gradient.It was noted that difficulties visualizing the second and third clip during the procedure occurred.The procedure was completed with two clips implanted, reducing the mr to a grade of 3-4+.The final mean pressure gradient was at 4.5mmhg.There was no clinically significant delay in the procedure.On (b)(6), 2024, the patient underwent mitral valve replacement surgery.

Manufacturer Narrative

In this case, two clips only (without the clip delivery system) were returned.The gripper being misaligned (product quality problem) was also confirmed.The reported entrapment of device- clip caught on chordae, image resolution poor n/a and incomplete coaptation-intraprocedure during use could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All information was investigated and based on the information provided and the analysis of the returned clip, the reported product quality problem associated with misaligned gripper appears to be related to the gripper being caught on the clip cover and giving it the appearance to be misaligned.A cause for how it became caught however, cannot be determined.Additionally, a cause for the reported slda cannot be determined as it cannot be definitively confirmed whether the gripper being caught on the clip cover or the clip becoming entangled with the anatomy contributed to the slda.Image resolution poor is related to procedural conditions associated with difficulties visualizing the clip during the procedure.The reported entrapment of device associated with a chord likely being grasped during procedure appears to be related to patient conditions (several subvalvular chordae, rotated heart and low transseptal height).Unspecified tissue injury (damage to the posterior mitral leaflet (pml)) appears to be due to the slda.Tissue damage is listed as a known possible complication associated with mitraclip procedures.Unexpected medical intervention, surgical 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.The additional cds0706-xtw device referenced in b5 is filed under separate medwatch report number.

• 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: 19044824
• MDR Text Key: 339433329
• Report Number: 2135147-2024-01555
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)240805(10)30803A1079
• 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: 06/04/2024

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: 08/05/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30803A1079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 06/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2023
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG