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

Catalog Number CDS0702-XTW

Device Problems Off-Label Use (1494); Physical Resistance/Sticking (4012)

Patient Problem Pericardial Effusion (3271)

Event Date 03/20/2024

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) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.The patient presented with a pre-existing pericardial effusion.The steerable guide catheter (sgc) was inserted successfully.The xtw clip delivery system (cds) was then inserted into the sgc and straddled confirmed.When steering towards the valve on the cds, resistance with the medial (m)/lateral (l) knob was noted.M-knob was removed.It was then noted that the pericardial effusion had worsened.The effusion was located at the posterior wall of the left atrium.The mitraclip cds and sgc were removed from the patient and pericardiocentesis was performed successfully.It was ultimately decided to move the patient to surgery to complete the valve repair, the effusion was repaired as well.The patient had a prolonged stay in the intensive care unit (icu).

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 reported resistance of the knob and pericardial effusion.Pericardial effusion is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported off-label use was due to the triclip steerable guide catheter (tsgc) being used on a mitral valve.The reported unexpected medical intervention, surgical intervention, and hospitalization were results 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: 19099620
• MDR Text Key: 340103635
• Report Number: 2135147-2024-01676
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231018
• UDI-Public: (01)08717648231018(17)241029(10)31031R1111
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/20/2024

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: CDS0702-XTW
• Device Lot Number: 31031R1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• 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: TRICLIP STEERABLE GUIDE CATHETER (TSGC)
• Patient Outcome(s): Hospitalization; Required Intervention