MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0601-XTR

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with grade 4+.A mitraclip xtr was advanced to the mitral valve, and during knob rotation, and after several adjustments, the clip appeared to have an abnormal bend.A ruptured chordae tendineae and a damaged leaflet was observed.The clip was removed from the patient.After the clip was removed from the patient, a significant abnormal head segment curvature was observed on the steerable guide catheter (sgc), and the sgc bended abnormally.The procedure was completed with two clips implanted, but mr remained at a grade of 4+.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the returned device analysis was unable to confirm the reported deformation due to compressive stress associated with clip appearing to be bent.The reported difficult to remove - anatomy 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 from the lot.Based on information provided and the results of the returned device analysis (unable to confirm the reported deformation due to compressive stress associated with clip appearing to be bent), a cause for the reported bent clip (deformation due to compressive stress) and difficult to remove from anatomy could not be determined.Unspecified tissue injury was due to procedural conditions associated with the clip interacting with the anatomy.Tissue damage/injury is listed in the mitraclip system instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Serious injury/illness/impairment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 18062505
• MDR Text Key: 327242983
• Report Number: 2135147-2023-04840
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/27/2023

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: 05/22/2024
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 30523R1034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian