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

Catalog Number CDS0705-NTW

Device Problem Failure to Advance (2524)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/16/2022

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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, the reported image resolution poor was associated with difficult visualization.The cause of the reported cardiac tamponade (pericardiocentesis) could not be determined.The cause of the reported failure to advance (low transseptal puncture) was due to challenging patient anatomy (extremely rotated heart).The reported patient effect of cardiac tamponade, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report cardiac tamponade requiring intervention.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4+.The transseptal puncture was challenging due to the rotated heart and visualization of the septum was also challenging.After steerable guide catheter (sgc) and clip delivery system (cds) insertion through the septum, m-knob was used to steer down to the valve, but they realized that the height of the transseptal puncture was not adequate enough.All troubleshooting steps to overcome the height were performed but there was still issues of height and aorta hugger.The team decided to remove the devices and re-puncture the septum.The second puncture was attempted at least five times to obtain a good tenting and height, but due to difficult images and the needle jumping from the thick part of the septum to the inferior part of the fossa, they could not gain enough height.The decision was made to abort the procedure.After the procedure, the patient developed cardiac tamponade and needed a drainage procedure.After the drainage the patient was recovering well and stable.According to the physician it is unknown when the tamponade occurred and what caused it.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: 16132115
• MDR Text Key: 307018630
• Report Number: 2135147-2023-00149
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 01/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 20907R1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 45 KG