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

Catalog Number CDS0701-XTW

Device Problem Migration (4003)

Patient Problems Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6)2021, a mitraclip procedure was performed to treat mitral regurgitation grade 4.A xtw (lot: 00718u307) was implanted successfully, reducing mr to grade 2.Four weeks after the procedure, mr was recurrent grade 4 due to a torn posterior leaflet.The clip remained securely attached to the anterior leaflet.No intervention was performed at the time.On (b)(6)2024, a mitraclip re-intervention was performed to treat severe degenerative mitral regurgitation causing severe dyspnea.The original original xtw clip (00718u307) was attached to the anterior leaflet but there was a small amount of posterior leaflet grasped.A ntw mitraclip (lot; 31108r1106) was attempted to be implanted.After multiple unsuccessful attempts at grasping and capturing the leaflets, the clip was removed.A replacement xtw (lot: 31113r1022) was implanted successfully lateral to the original xtw clip (00718u307).The procedure ended with mr reduced to grade 2.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and a cause for the reported migration (partial clip movement) cannot be determined.Additionally, a cause for the unspecified tissue injury resulting in recurrent mitral valve insufficiency/regurgitation (mr) cannot be determined.Dyspnea; however, is a cascading effect of the recurrent mr.Mitral regurgitation, tissue damage/injur and dyspnea are known possible complications associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 19068026
• MDR Text Key: 339668342
• Report Number: 2135147-2024-01603
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: (01)08717648231001(17)210720(10)00718U307
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/02/2024

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 Expiration Date: 07/20/2021
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00718U307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 66 KG