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

Catalog Number CDS0702-XTW

Device Problems Expulsion (2933); Mechanical Jam (2983); Unintended Movement (3026)

Patient Problem Embolism/Embolus (4438)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 4.The clip was placed a2/p2.During deployment steps, prior to removal of the lock line, it was ensured that there were no knots on that line.During removal of the lock line, the lock line was met with resistance nearly halfway and could not be pulled any further.It was decided to continue with the removal of the clip delivery system (cds).During attempts to release the clip, the clip was observed to open and was noticed to be hanging free in the lock line in the left atrium.Due to low ejection fraction (ef) that was pre-existing and the need to remove the opened clip from the left atrium, the patient went into surgery for heartmate 3 implantation.The clip was removed from the left atrium and heartmate was implanted.This has reportedly caused clinically significant delay.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported mechanical jam (lock line - inability) was confirmed via returned device analysis.The reported expulsion (ccd) and unintended movement (clip open while locked) could not be replicated in a testing environment.Additionally.A knot was observed on the lock line 2.5cm away from one manufacturing-cut end.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 and the results of device analysis, the reported mechanical jam (lock line - inability), associated with the inability to remove lock line during clip deployment, was due to a knot on the lock line.The reported unintended movement (clip open while locked) appears to be due to interaction with the lock line during the clip deployment sequence, as the lock line remained attached to the clip implant and posed a risk of unlocking the clip.The reported expulsion (ccd, complete clip detachment) was due to the clip opening after mechanical separation of the clip implant.A cause of the observed knot on the lock line could not be determined.The reported clip embolizing in patient was a result of the clip expulsion.The reported patient effect of embolism, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported removal of foreign body, surgical intervention, and delay to treatment/ therapy 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 (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: 18376233
• MDR Text Key: 331183314
• Report Number: 2135147-2023-05660
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30801R2073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/20/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White