MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0502

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

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Mitral Regurgitation (1964); Nausea (1970)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced is being filed under a separate medwatch report.

Event Description

This is filed to report endocarditis and increased mitral regurgitation (mr).It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat functional mr with a grade of 4.Two clips were implanted reducing mr to 1.On (b)(6) 2019, the patient reported nausea due to ileus (stomach ache).The patient was re-admitted.On (b)(6) 2019, vegetation on the valve was noted, but overlooked as it was small.C-reactive protein (crp) value was increasing to about 4, blood culture was examined.Examination revealed the patient had infective endocarditis with (b)(6).On (b)(6) 2019, it was confirmed that the clips were stable, but vegetation was greater between the two clips and mr increased to 3.The patient is on antibiotic treatment.On (b)(6) 2019, the patient remains on antibiotics as (b)(6) and size of vegetation has not changed.A transesophageal echocardiography (tee) is scheduled for a later date.No additional information was provided.

Manufacturer Narrative

Internal file: (b)(4).Patient identifier added.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 incidents reported from this lot.The investigation determined the reported patient effects of infection, recurrent mitral regurgitation and nausea appears to be related to the endocarditis.However, a conclusive cause for the endocarditis cannot be determined.The reported patient effects of endocarditis, infection, recurrent mr and nausea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8731423
• MDR Text Key: 149095005
• Report Number: 2024168-2019-05051
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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: 09/15/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80914U124
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR