MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN MITRACLIP; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Arrhythmia (1721); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Endocarditis (1834); Unspecified Infection (1930); Mitral Regurgitation (1964); Pulmonary Edema (2020); Tissue Damage (2104); Heart Failure (2206)

Event Date 04/11/2020

Event Type  Death  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article titled, a case of acute exacerbation of mitral regurgitation due to infective endocarditis after the mitraclip procedure and undergoing emergency mitral valve replacement.

Event Description

This is filed to report recurrent mitral regurgitation (mr), heart failure, tissue damage, endocarditis, pulmonary edema, cardiac arrest, infection and death.It was reported through a research article that a patient underwent a mitraclip procedure to treat mitral regurgitation (mr).A mitraclip was successfully implanted, reducing mr to mild.However, after the procedure, the patient experience heart failure symptoms; therefore, medication was administered.It was noted that after the procedure, the patient had catheter-related bloodstream infections.101 days after the procedure, the patient returned to the hospital and mr had worsened due to a mitral valve perforation due to infective endocarditis.Pulmonary edema was noticed and continuous hemodiafiltration (chdf) was performed.However, the pulmonary edema did not improve, resulting in dyspnea.Due to the poor health of the patient, mitral valve replacement was performed.After the patient was intubated, bradycardia and cardiac arrest occurred.The patient was able to be resuscitated and the mitral valve replacement was successfully performed.Two days after the mitral valve replacement, the patient was extubated but developed arrythmia several times.However, the patient was in a stable condition.35 days later, the bacteria in the blood stream reappeared.14 days later, the patient passed away.Details are listed in the article, titled ¿a case of acute exacerbation of mitral regurgitation due to infective endocarditis after the mitraclip procedure and undergoing emergency mitral valve replacement.¿ no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record could not be performed as the part and lot information regarding the complaint device was not provided.Based on the available information, a cause for the reported heart failure, infection, endocarditis, pulmonary edema, bradycardia, cardiac arrest, arrhythmia, and death could not be determined.The reported recurrent mitral regurgitation (mr) and tissue damage appear to have been cascading events of the reported endocarditis.The reported dyspnea appears to have been a cascading event of the reported pulmonary edema.The reported patient effects of recurrent mr, heart failure, tissue damage, endocarditis, pulmonary edema, dyspnea, bradycardia, cardiac arrest, infection, arrhythmia, and death are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.The reported additional therapy/non-surgical treatment, hospitalization, treatment with medication(s), and surgical procedure were results of case-specific circumstances, as medication was administered to treat the heart failure, continuous hemodiafiltration was performed to treat the pulmonary edema, and the patient was hospitalized to undergo mitral valve replacement surgery.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: UNKNOWN MITRACLIP
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11170241
• MDR Text Key: 226799845
• Report Number: 2024168-2021-00438
• 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
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 55