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

Catalog Number CDS0705-NTW

Device Problems Product Quality Problem (1506); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3-4.A ntw mitraclip was chosen for implantation.During deployment when attempting to remove the lock line, the lock line was tightly entangled in the locking lever.It was able to be untied by the physician and the procedure was completed normally.The mr was reduced to trace.There was no reported patient consequences and no clinically significant delay.No additional information provided.

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 that on (b)(6) 2023 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3-4.A ntw mitraclip was chosen for implantation.During deployment when attempting to remove the lock line, the lock line was tightly entangled in the locking lever.No knots were present.It was able to be untied by the physician and the procedure was completed normally.The mr was reduced to trace.There was no reported patient consequences and no clinically significant delay.

Manufacturer Narrative

All available information was investigated, and the reported product quality problem (n/a) could not be confirmed via returned device analysis.The reported physical resistance / sticking (lock line - difficulty) could not be replicated in a testing environment.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 analysis, a cause of the reported product quality problem (n/a), associated with a lock line entanglement, could not be determined as no issue was identified during device analysis.The reported physical resistance / sticking (lock line - difficulty), associated with the difficult lock line removal, appears to be due to the lock line being entangled on the lock lever.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: 18376164
• MDR Text Key: 331132445
• Report Number: 2135147-2023-05658
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 30619R1040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/18/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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 Age: 74 YR
• Patient Sex: Male