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

Catalog Number CDS0706-XTW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 07/26/2023

Event Type  Death  

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.The investigation determined the reported death appears to be related to patient condition (gastrointestinal (gi) hemorrhage).However, a cause for the reported infection cannot be determined.Death and infection are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report an unspecified infection and death.It was reported that on (b)(6) 2023, a patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.Three mitraclips were implanted to reduce the mr to grade 1-2.On (b)(6) 2023, the patient was admitted for a gastrointestinal (gi) hemorrhage that was unrelated to the mitraclips.Additionally, on transesophageal echocardiogram (tee), a mass was visualized on one of the xtw mitraclips that was implanted.The mass was suspected to be a vegetation.Per the physician, endocarditis was suspected, but could not be confirmed.The infection was undetermined.The patient was discharged, and ten days later on (b)(6) 2023, the patient passed away.Per the physician the mitraclip procedure was unrelated to the patient's death.The cause of death was from the gi hemorrhage, but the mass on the mitraclip could not be disqualified from being a contributing factor.No additional information was provided.

• 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: 17745283
• MDR Text Key: 323398663
• Report Number: 2135147-2023-03977
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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
• Report Date: 09/14/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2023
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 20922R1008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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: 2 IMPLANTED MITRACLIPS.
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Male