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

Model Number N/A

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

Patient Problem Hematoma (1884)

Event Date 08/01/2022

Event Type  Injury  

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 reported hematoma was due to procedural circumstances.The reported patient effect of hematoma, as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The reported minor injury/ illness/ impairment was the result of case-specific circumstances as no specific treatment was given to the reported hematoma.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a hematoma.It was reported that on (b)(6) 2022, a mitraclip procedure was performed for a functional mitral regurgitation (mr) with a grade of 4.It was noted that the patient had restricted leaflet motion, a coaptation gap medial of a2/p2, and a thick lipomatous septum.The clip delivery system (cds) was advanced in the patient and two attempts to grasp the leaflets were made, but each time it ended up too medial with little reduction in mr.During the third grasping attempt, an intracardiac hematoma was noted on the superior aspect of left atrium and verified under transesophageal echocardiogram (tee) with a size of 6.08 cm.Procedure was aborted and the physician started monitoring the hematoma under tee.The physician believes the hematoma was caused from a dissection plane during difficulty gaining transseptal access with a non-abbott wire.However, the mitraclip system may have contributed to the propagation of the hematoma.No additional information was provided.

• 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: 15279672
• MDR Text Key: 298456579
• Report Number: 2135147-2022-00876
• 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
• Report Date: 08/23/2022

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: 03/13/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20311R192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male