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

Catalog Number CDS0601-XTR

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Difficult to Open or Close (2921); Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/22/2024

Event Type  Injury  

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 a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+, prolapsed posterior leaflet, and restricted posterior leaflet.A mitraclip xtr was inserted but the axis of clip changed after entering the left ventricle, resulting in an aortic hugger.The clip was withdrawn into the left atrium to close the clip.However, the clip suddenly closed, and the clip arm was hooked on part of the anterior lobe.An ultrasound was performed and revealed that the tissue damage occurred.Therefore, the clip was removed from the patient.The clip was inspected outside of the patient, and white valve tissue was observed on the clip arm.The patient¿s valve was damaged.The procedure was discontinued with no clips implanted.The mr remained at grade 4+.

Manufacturer Narrative

All available information was investigated and the reported clip jumpiness and sleeve steering issue were not confirmed via returned device analysis.The reported difficulty/delayed positioning and difficult to remove from anatomy (clip arm hooked on anterior lobe) could not be replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.The investigation was unable to determine a cause for the reported clip jumping and sleeve steering issue.The reported difficulty/delayed positioning and clip caught on anatomy (anterior lob) appear to be due to the reported sleeve steering issue.The reported tissue injury appears to be related to the clip caught on anatomy.Tissue injury is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no additional intervention was performed.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the previously filed report, additional information was received.While closing the arm positioner, the clip had jumped closed.

• 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: 18903250
• MDR Text Key: 337652986
• Report Number: 2135147-2024-01118
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)240820(10)30821R1032
• 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: 04/18/2024

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 Catalogue Number: CDS0601-XTR
• Device Lot Number: 30821R1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: Asian