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

Catalog Number CDS0702-XTW

Device Problems Positioning Failure (1158); Unstable (1667)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

This will be filed to report a device that was unable to straighten.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4.After applying the m knob for 30 minutes, it was noted that the clip no longer was able to be curved or straightened and the knob rotated freely.Subsequently, the clip was exchanged and the procedure was concluded with a resulting mr of grade <1.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

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.

Manufacturer Narrative

All available information was investigated, and the reported loose knob, unable to curve, and unable to straighten were confirmed via returned device 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 complaints reported from this lot.Based on available information and the returned device analysis, the cause of the observed broken cable and torn skive were unable to be determined.The reported loose knob, unable to curve, and unable to straighten were cascading events of the reported broken cable.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

N/a.

• 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: 17456008
• MDR Text Key: 320473947
• Report Number: 2135147-2023-03407
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 21128R1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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.