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

Model Number CDS0701-XTW

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

Patient Problems Atrial Fibrillation (1729); Multiple Organ Failure (3261)

Event Date 08/13/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed for patient death.It was reported that on (b)(6) 2022, a patient presented with 4+ degenerative mitral regurgitation (mr) prolapsed flail, and redundant leaflets.Two mitraclips were implanted.The grasp was sufficient in all views and angles.There was no device malfunction or adverse patient effect.On a later date, (b)(6) 2022, the patient presented to the emergency room with shortness of breath and an increased mr grade of 4+.It was noted that the xtw mitraclip had embolized into the proximal descending aorta.The clip was snared and retrieved in a 20 french sheath.There was tissue visualized in the clip post retrieval.Another xtw mitraclip was implanted more medial than the original embolized xtw.The mr was reduced to grade 1.In the physician's opinion, the embolization was due to patient anatomy (redundant leaflets).On (b)(6) 2022, patient death occurred.Per the physician, the patient was stable and aware post-procedure.The patient had an episode of atrial fibrillation which was mismanaged by the fellow.The patient decompensated and went into multi-organ failure.There was no tissue damage observed and the re-do mitraclip was stable and well-seated (cds-20329r124).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.Based on available information, the cause of the reported atrial fibrillation was unable to be determined.The reported multiple organ failure and death were cascading events of the atrial fibrillation as the patient was mismanaged by the fellow.The reported patient effect of atrial fibrillation and death, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality 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: 15478699
• MDR Text Key: 300555252
• Report Number: 2135147-2022-01347
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20329R124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 92 YR
• Patient Sex: Female