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

Catalog Number CDS0602-NTR

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

Patient Problems Anemia (1706); Death (1802); Unspecified Infection (1930); Mitral Valve Stenosis (1965); Heart Failure (2206)

Event Date 02/28/2020

Event Type  Death  

Manufacturer Narrative

(udi#): in the absence of a reported part number, the udi cannot be calculated.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article title, mitral stenosis and acute hemolytic anemia after mitraclipna.

Event Description

This is being filed to report the death, mitral stenosis, anemia, heart failure, infection and hospitalization.It was reported that this was a mitraclip procedure to treat severe mitral regurgitation (mr).Two ntr mitraclips were implanted.Post implant, the mean pressure gradient was 8mmhg.The patient returned three weeks post procedure with anemia and transthoracic echocardiogram (tte) noted the gradient had increased to 13mmhg.The patient was treated with diuretics and transfusion of an erythrocyte concentrate with good clinical-biological improvement and disappearance of signs.The patient was rehospitalized a week later heart failure and pneumonia.The patient was treated with medication however died 2 days later.Details are listed in the attached article: mitral stenosis and acute hemolytic anemia after mitraclip.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.Based on the information reviewed the reported mitral stenosis and anemia appear to be due to the implanted clips.A cause for the heart failure, infection, and death however, cannot be determined.Heart failure, infection, mitral stenosis and death are listed in the instructions for use (ifu) as 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 NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10734580
• MDR Text Key: 213036737
• Report Number: 2024168-2020-08901
• 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
• Report Date: 01/12/2021

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: CDS0602-NTR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR