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

Catalog Number CDS0706-NTW

Device Problem Difficult to Open or Close (2921)

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

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.An ntw clip was inserted and grasping was performed.However, it was observed the clip arms would not fully close.It was noted that during preparation, the technician may not have been able to fully close the clip.This was not noted until after grasping was performed.Troubleshooting was performed, but the issue was unable to be resolved.The clip was retracted into the left atrium (la), but the clip arms were still unable to fully close, resulting in a clinically significant delay and prolonged anesthesia.The clip was retracted to the tip of the steerable guide catheter (sgc).The sgc and clip delivery system (cds) were removed together; however, the physician had to enlarge the groin incision in order to remove the devices.One clip was then successfully implanted, reducing mr to a grade of <1.Additional sutures and a vessel closure device were used to treat the enlarged groin incision.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.An ntw clip was inserted and grasping was performed.However, it was observed the clip arms would not fully close.It was noted that during preparation, the technician may not have been able to fully close the clip.This was not noted until after grasping was performed.Troubleshooting was performed, but the issue was unable to be resolved.The clip was retracted into the left atrium (la), but the clip arms were still unable to fully close, resulting in a clinically significant delay and prolonged anesthesia.The clip was retracted to the tip of the steerable guide catheter (sgc).The sgc and clip delivery system (cds) were removed together; however, the physician had to enlarge the groin incision in order to remove the devices.One clip was then successfully implanted, reducing mr to a grade of <1.Additional sutures and a vessel closure device were used to treat the enlarged groin incision.Subsequent to the initially filed report, additional information was received stating the steerable guide catheter (sgc) (31117r1060) was returned with the clip delivery system (cds) (30912a1076).The returned device analysis revealed the soft tip of the sgc was observed to be deformed and the hemostasis valve of the flush port was torn.

Manufacturer Narrative

All available information was investigated, and the reported unable to close clip was confirmed via returned device analysis.Additionally, it was observed that the lock line had slack, gripper lines were kinked, clip cover was torn and frayed, the coupler was also observed to be bent, and threaded stud was observed to be bent and not fully seated.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 reported unable to close clip and threaded stud not fully seated are likely due to the bent threaded stud and bent coupler.The observed lock line slack is likely a result of troubleshooting techniques.The cause of the observed bent threaded stud, bent coupler, kinked gripper lines, torn and frayed clip cover were unable to be determined.The reported delay to treatment/ therapy, medication required, and unexpected medical intervention 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 (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18952633
• MDR Text Key: 338301915
• Report Number: 2135147-2024-01299
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)240911(10)30912A1076
• 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: 05/16/2024

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: CDS0706-NTW
• Device Lot Number: 30912A1076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• 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