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

Model Number N/A

Device Problems Positioning Failure (1158); Unstable (1667); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

This is filed to report the unintended movement and m knob issues.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were successfully implanted.A third clip delivery system (cds) (nt 11118r103) was advanced and during positioning m knob was applied.It was immediately observed on fluoroscopy that the clip jumped to it's original position.The physician described the feeling that a lot of tension was released from the knob.Following attempts to steer with the m knob were unsuccessful and the cds was replaced.The new clip was successfully implanted reducing the mr to a grade of 1.There was no clinically significant delay in the procedure and no adverse patient effects.After the procedure, the clip that was removed was checked on the table.It was noted that the m knob was completely loose without any transmission of movements seen on the shaft.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The returned device analysis confirmed the positioning failure associated with inability to curve the tip as the ¿m¿ cable was noted to be broken at the radiopaque tip ring.The reported unstable/loose knob and unintended movement of the clip delivery system (cds) however, was not confirmed.A review of the lot history record identified no manufacturing nonconformities that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All information was investigated and the positioning failure of unable to deflect the tip appears to be related to the observed cable break.However, a cause for the observed cable break, unstable/loose knob and unintended movement of the cds could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were successfully implanted.A third clip delivery system (cds) (nt 11118r103) was advanced and during positioning m knob was applied.It was immediately observed on fluoroscopy that the clip jumped to it's original position.The physician described the feeling that a lot of tension was released from the knob.Following attempts to steer with the m knob were unsuccessful and the cds was replaced.The new clip was successfully implanted reducing the mr to a grade of 1.There was no clinically significant delay in the procedure and no adverse patient effects.After the procedure, the clip that was removed was checked on the table.It was noted that the m knob was completely loose without any transmission of movements seen on the shaft.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: 15278949
• MDR Text Key: 305500142
• Report Number: 2135147-2022-00871
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: N/A
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 11118R102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2021
• 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: 2 IMPLANTED MITRACLIPS; STEERABLE GUIDE CATHETER