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

Catalog Number CDS0702-NT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 12/19/2023

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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, a restricted posterior leaflet, a posterior flail, and a dilated left atrium.It was noted imaging was difficult throughout the procedure.One xtw clip was inserted and successfully implanted.A second xtw clip (30919r1073) was inserted and deployed on the mitral valve.To further reduce mr, a third nt clip (30724r1061) was inserted.It was noted the clip was repositioned multiple times, and after grasping, the patient¿s blood pressure lowered.To treat the low blood pressure, medication was administered, but the patient¿s heart rate increased to 220 beats per minute (bpm).While grasping with the third clip, the second implanted clip detached from one leaflet and remained attached to the other leaflet (single leaflet device attachment/slda).To stabilize the slda, the third clip was repositioned and implanted, reducing mr to a grade of 3.There was no clinically significant delay in the 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 reported from this lot.Based on available information, the cause of the reported hypotension and tachycardia cannot be determined.The reported poor image resolution appears to be a cascading effect of the reported tachycardia.The reported difficulty to grasp the leaflets appear to be due to poor image resolution.Additionally, the reported patient effects of hypotension and tachycardia are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, a restricted posterior leaflet, a posterior flail, tethered leaflets, and a dilated left atrium.It was noted imaging was difficult throughout the procedure.One xtw clip was inserted and successfully implanted.A second xtw clip ((b)(6)) was inserted and deployed on the mitral valve.To further reduce mr, a third nt clip ((b)(6)) was inserted.It was noted the clip was repositioned multiple times, and after grasping, the patient¿s blood pressure lowered.To treat the low blood pressure, medication was administered, but the patient¿s heart rate increased to 220 beats per minute (bpm).While grasping with the third clip, the second implanted clip detached from posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).To stabilize the slda, the third clip was repositioned and implanted, reducing mr to a grade of 3.There was no clinically significant delay in the procedure.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 18489199
• MDR Text Key: 332602395
• Report Number: 2135147-2024-00188
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: CDS0702-NT
• Device Lot Number: 30724R1061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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: IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention