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

Catalog Number CDS0706-XTW

Device Problem Difficult to Open or Close (2921)

Patient Problems Vasoconstriction (2126); Numbness (2415); Diminished Pulse Pressure (2606)

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4+.A mitraclip xtw was chosen for implantation.During preparation, opening and and closing the clip was difficult.During the procedure, the clip had a lock issue, the clip could only opened to 120 degrees.After troubleshooting, the clip was able to open and close normally.The clip was able to be implanted, reducing mr to trace.After the procedure, the patient developed numbness in toes and weak pulse.The access site suture was loosened, but the issue did not resolve.The physician was unsure if the stenosis was related to the mitraclip or the patient's medical history.The patient received stents in the iliac artery.There was no delay in procedure.

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 from the lot.All available information was investigated and based on information provided and without the device to analyze, a cause for the reported difficult to open or close associated with difficulty opening the clip and difficulty closing the clip could not be determined.Additionally, a cause for the reported numbness in toes, weak (diminished) pulse and vasoconstriction (iliac stenosis) could not be determined.Diminished pulse is a known possible complication associated with mitraclip procedures.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.

• 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: 18670862
• MDR Text Key: 334950614
• Report Number: 2135147-2024-00588
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30918R1059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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