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

Catalog Number CDS0702-XTW

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

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/13/2022

Event Type  Injury  

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.Based on available information, the reported cerebrovascular accident (treatment with medication(s)) associated with the stroke was due to the septic embolization.The reported sepsis (treatment with medication(s)) and hemorrhage (treatment with medication(s)) associated with the septic embolization, the reported endocarditis (treatment with medication(s)) associated with the vegetation on the clip, and the reported mitral valve insufficiency/ regurgitation (recurrent mr), were due to the infection.The reported infection (treatment with medication(s)) appears to be due to the radial arterial cannula.The reported patient effects of endocarditis, mitral regurgitation, cerebrovascular accident, hemorrhage, infection, and sepsis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report an infection, recurrent mitral regurgitation, hemorrhagic stroke, sepsis and intervention.It was reported that on (b)(6) 2022, a mitraclip procedure was performed to treat grade 4 functional mitral regurgitation (mr).One clip was implanted with no reported issue.Signs of infection presented during the hospital stay.The source of infection was thought to be from the radial arterial cannula.A large vegetation on the mitraclip and severe mr was observed.Transient improvement was noted, but then progressive decline with antibiotic treatment.The patient was ischemic, then suffered a hemorrhagic stroke due to a septic embolism.The patient was in poor condition, mechanically ventilated, and remained septic.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 16454263
• MDR Text Key: 310364980
• Report Number: 2135147-2023-00763
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Report Date: 02/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2023
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 21018R1035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 50 YR
• Patient Weight: 70 KG