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

Catalog Number CDS0706-XTW

Device Problems Off-Label Use (1494); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr), restricted esophagus, and thin leaflets for an off-label procedure on the tricuspid valve with a mitraclip.It was noted that imaging was very challenging due to a restricted esophagus that prevented trans-gastric imaging techniques.The first mitraclip (31113r3114) had a single leaflet device attachment (slda), and was detached from the septal leaflet.Per the physician, the slda was due to challenging imaging.A second clip was implanted to stabilize the first clip, and there were no issues noted with 2nd clip implant.A third clip (31113r3118) was then chosen for implant, but upon deployment it was unable to retract/separate the clip delivery system (cds) from the clip.Troubleshooting was attempted, such as; removed a knob, added a knob, removed +, then added +, rotated the guide clockwise, and counter clockwise.The cds could not be confirmed to separate 1 cm from the dc tip.Troubleshooting progressed to manually removing the gripper lines.The clip was able to be implanted successfully.The mr was reduced to grade 2.There was no adverse patient sequelae and no clinically significant delay.Patient status is stable.

Manufacturer Narrative

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

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.The investigation was unable to determine a cause for the difficulty deploying the clip.The reported poor image resolution was due to a restricted esophagus that prevented trans-gastric imaging techniques.The reported off-label use was due to the device being used on a tricuspid valve.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 19087064
• MDR Text Key: 339900314
• Report Number: 2135147-2024-01635
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)241114(10)31113R3118
• 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: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31113R3118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG