MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Embolism (1829); Endocarditis (1834); Fatigue (1849); Fever (1858); Inflammation (1932); Mitral Regurgitation (1964); Pain (1994); Sepsis (2067); Tissue Damage (2104); Diminished Pulse Pressure (2606)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Dates of event, tests, and implant: estimated dates.The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is being filed to report pain, inflammation, endocarditis, tissue damage, worsening mitral regurgitation, fever, embolism, pain, sepsis, treatment with medication, and prolonged hospitalization.It was reported based on literature review, that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.It was noted previous bioprosthetic aortic valve replacement.On an unknown date, one clip was successfully deployed, reducing mr to 1+.Approximately 14 months later, the patient returned with pain in the left calf.An echocardiogram revealed a large mass indicating endocarditis and worsening mr.The patient developed malaise and a fever with evidence of inflammation.The clip remained stable on both leaflets.The patient continued to experience pain and the large mass had disappeared but embolized into multiple smaller masses in the vicinity of the mitraclip.Although the clip was stable, the anterior leaflet seemed partially damaged.The patient was treated with antibiotics, but the patient remains in pain with endocarditis.The patient remained hospitalized and was noted to have sepsis and diminished pulse.There was no clinically significant delay in the procedure.Additional details are provided in the attached article.No additional information was provided.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record could not be performed as the lot information was not provided.Based on the information reviewed, a cause for reported pain in the calf, endocarditis and tissue damage.Could not be determined.The worsening mitral regurgitation resulting in fatigue, and diminished pulses appears to be cascading effects of tissue damage.Sepsis resulting in inflammation and fever, embolism appears to be cascading effects of endocarditis.The reported patient effects of endocarditis, sepsis, fever, tissue damage, worsening mitral regurgitation, embolism, pain, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effect(s), and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was added: the patient had a weak left-sided pedal and popliteal pulses.No additional information was provided.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9775580
• MDR Text Key: 183491868
• Report Number: 2024168-2020-01904
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

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 Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/19/2020; 07/20/2020
• Supplement Dates FDA Received: 03/31/2020; 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR