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

Model Number CDS0706-NT

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Pericardial Effusion (3271)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report unintended movement and a pericardial effusion.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4+ and a small left atrium.A mitraclip nt was selected for treatment.While steering down to the valve, with the knob turned 30-45 degrees, a cable break in the clip delivery system (cds) was observed under fluoroscopy.The cable break caused the clip to jump into the atrial wall.The patient then experienced a pericardial effusion, which required a pericardiocentesis.The pericardial effusion was noted to be related to the procedure.The procedure was completed with two clips implanted.The mr was reduced to grade 1-2+.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported break (cable break) was confirmed via device analysis.The reported unintended movement could not be replicated in a testing environment.Additionally, the clip cover was noted to be torn.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 reported pericardial effusion (medical treatment) was due to the unintended movement of the device, as the device interacted with anatomy.The reported unintended movement associated with the device moving in an unintended direction was due to the cable break.The reported/ observed break (cable break) associated with the ¿m¿ cable break was determined to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.The cause of the observed material split, cut or torn associated with the torn clip cover could not be determined.The reported patient effect of pericardial effusion, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.

Event Description

N/a.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 16916791
• MDR Text Key: 315063661
• Report Number: 2135147-2023-02074
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: 05415067037367
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2023
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 20919R1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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): Required Intervention
• Patient Sex: Male