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

Catalog Number CDS0706-NTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Unspecified Tissue Injury (4559)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4.The leaflets were grasped and performed a full assessment of the grasp including gradient, 3d tissue bridge, and leaflet insertion.At this point, the patient started to become unstable with tachycardia and low blood pressure and it was decided by the physician to deploy the clip.After the pin had been pulled after the second establish final arm angle (efaa), it was determined by the imager that the posterior leaflet was no longer as stable as previously, possibly due to the tachycardia.The leaflet was observed to tear.At this point, the deployment steps were continued since the pin had already been pulled.The patient was monitored after the procedure, no effusion was noted after the procedure.Patient was stabilized by anesthesiologist using various medications.Final mr was at grade 2.

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.Based on available information, the cause of the reported tissue injury, tachycardia, and hypotension were unable to be determined.The reported patient effects of tissue injury, tachycardia, and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment and medication required were results 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 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: 18856899
• MDR Text Key: 337118570
• Report Number: 2135147-2024-01036
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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
• Report Date: 03/07/2024

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 Expiration Date: 04/11/2024
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30413R1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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): Other