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

Catalog Number CDS0706-XTW

Device Problems Premature Activation (1484); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

H6: device code 2017 - failure to follow steps / instructions.The device was not returned for 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, the cause of the reported difficult to remove from anatomy and sleeve steering issues were unable to be determined.The reported improper or incorrect method or procedure was associated with the user not re-inserting the cds into the sgc during removing the clip.The reported tissue injury was a cascading event of the reported difficult to remove from anatomy.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report unintended movement, difficult to remove, and tissue injury it was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4, enlarged atrium, chordal rupture, and restricted/thin posterior leaflet.One xtw clip was inserted and successfully deployed on the mitral valve.To further reduce mr, an additional xtw clip was inserted.While in the left ventricle (lv), unintended movement occurred and the clip became caught in chordae.Standard troubleshooting was performed and the clip was freed from chordae.However, a chordal rupture occurred.The clip was advanced back into the lv, but again became caught in chordae.The clip was able to be removed, but while in the left atrium (la), it was observed a perforation on the leaflet had occurred.At this time, the steerable guide catheter (sgc) had lost septal access and slipped back into the right atrium (ra).The physician decided to pull the clip through the septum and remove both devices at the same time.It was noted after the clip was pulled into the ra, it was not fully retracted into the sgc.While retracting both devices, the clip because stuck and a vascular cut down was performed in order to remove the mitraclip devices.The procedure was discontinued and mr was reduced to a grade of 3-4.There was no clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

The device was not returned for 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, the cause of the reported difficult to remove from anatomy, sleeve steering issues, and premature activation were unable to be determined.The reported improper or incorrect method or procedure was associated with the user not re-inserting the cds into the sgc during removing the clip.The reported tissue injury was a cascading event of the reported difficult to remove from anatomy.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect -impact code 4641 removed.

• 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: 17862196
• MDR Text Key: 324817292
• Report Number: 2135147-2023-04289
• 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: 11/01/2023

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: 05/20/2024
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30522R1047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 76 KG