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

Catalog Number CDS0705-NTW

Device Problems Failure to Advance (2524); Difficult to Open or Close (2921); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

This is being filed to report the device moving in an unintended direction and inability to invert the clip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) was advanced but when in the ventricle, the cds moved unintendedly to the medial side and could not reach the mitral valve.The clip was retracted to the left atrium (la) where the clip opened to 180 degrees however was then unable to invert.It was also noted the movement of the delivery catheter (dc) handle was stiff; therefore the cds was removed.One clip was implanted, reducing the mr to 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

All available information was investigated, and the reported unintended movement (dc shaft positioning), physical resistance/sticking, failure to advance and difficult to open or close (clip open inability-anatomy) cannot be replicated in a testing environment.Additionally, broken and corroded actuator coupler, scratched and bent l-lock tabs, and deformed harness were observed.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 incidents reported from this lot.Based on available information and the results of the analysis, a cause of the reported unintended movement (dc shaft positioning) could not be determined.The reported failure to advance appears to be related to the reported unintended movement.The cause for the reported difficult to open or close (clip open inability ¿ anatomy) and physical resistance (stiffness in dc handle) could not be determined.The observed actuator coupler corrosion appears to be related to salinity remained in device post-procedure.The cause for the observed broken actuator coupler, scratched and bent l-lock tabs, and deformed harness could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14277531
• MDR Text Key: 290780137
• Report Number: 2024168-2022-04785
• 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: 07/12/2022

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 Expiration Date: 09/01/2022
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 10902R136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 71 KG