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

Model Number CDS0706-XTW

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 05/05/2023

Event Type  Injury  

Event Description

This is filed to report the clip opening, premature clip detachment and femoral vein bleeding requiring intervention.It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) grade 4.An xtw clip (21214r1117) was positioned on the valve.However, it was noted that the clip delivery system (cds) was curved more than 90 degrees, as the physician used an excessive amount of m knob.During establishment of final arm angle (efaa) the clip would reopen from 10 degrees to 70 degrees.The device was pulled back into the left atrium and while retracting the clip into the steerable guide catheter (sgc, 21103r1051), the physician pulled the clip hard.As a result, the clip detached from the cds but remained attached by the lock lines.The clip could not re-enter the sgc so the entire system was pulled into the right atrium and removed from the body intact.During this removal, sgc soft tip damage occurred from the clip gripper.Also, femoral vein bleeding was observed after the system was removed, and the patient became hypoxic from a right to left shunt formed from an atrial septal defect (asd).The vessel perforation was repaired with a surgical suture.Heparin was reversed and the patient was watched to make sure the bleeding stopped.This issue reportedly caused a clinically significant delay in the procedure.A femstop was placed on the right groin and the left groin was prepped and a new sgc was advanced via left femoral vein.A replacement mitraclip was successfully implanted, reducing mr to grade 1.After the procedure, an occluder was placed to treat the shunt from the asd.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Medical device problem code: 2017-failure to follow steps / instructions.The steerable guide catheter referenced in b5 will be filed under a separate medwatch report number.

Manufacturer Narrative

All available information was investigated, and the reported unintended movement (clip open - efaa), premature activation, device damaged by another device (caused damage), and improper or incorrect procedure or method 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, the reported unintended movement (clip open during efaa) appears to be due to excessive tension/ curves applied on the system.The reported premature activation associated with the clip detachment during cds retraction was due to procedural circumstances (i.E., user retracting the cds with excessive force).The reported device damaged by another device (caused damage), associated with the sgc soft tip damage, was due to the removal of detached clip over the sgc tip.The reported improper or incorrect procedure or method was associated with the user curving the cds more than 90 degrees.The reported hemorrhage and vessel perforation was due to the system removal with clip exposed, as the exposed clip could injure the femoral vein during retraction.The reported patient effects of hemorrhage and perforation of vessels, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported surgical intervention, delay to treatment/ therapy, unexpected medical intervention, and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.It should be noted that the mitraclip instructions for use states under 27.0 initial mitraclip g4 system positioning in the left atrium section that ¿do not deflect the sleeve tip more than 90 degrees as device damage may occur¿.Since the user curved the cds more than 90 degrees, this is considered as a deviation from the instructions for use (ifu).Furthermore, it was determined that over-torquing of the device contributed to the reported adverse event; therefore, an in-service to address the deviation from ifu will be requested.

• 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 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: 17004342
• MDR Text Key: 315999592
• Report Number: 2135147-2023-02318
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 07/10/2023

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 Expiration Date: 12/14/2023
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 21214R1117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male