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

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

Patient Problems Pulmonary Embolism (1498); Anaphylactic Shock (1703); Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Renal Failure (2041); Heart Failure (2206); Pericardial Effusion (3271)

Event Date 04/20/2019

Event Type  Injury  

Manufacturer Narrative

The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article titled, "incidence and in-hospital safety outcomes of patients undergoing percutaneous mitral valve edge-to-edge repair using mitraclip: five-year german national patient sample including 13,575 implants.¿.

Event Description

This is filed to report failure, stroke, endocarditis, pulmonary embolism, pericardial effusion, shock, renal failure and atrial fibrillation.It was reported through a research article that from 2011 to 2015, 13,575 patients underwent percutaneous mitral valve repairs using the mitraclip.Over the five year period, the mitraclip may have contributed to heart failure, stroke, endocarditis, pulmonary embolism, pericardial effusion, shock, renal failure, atrial fibrillation and medical intervention.Details are listed in the attached article, titled ¿incidence and in-hospital safety outcomes of patients undergoing percutaneous mitral valve edge-to-edge repair using mitraclip: five-year german national patient sample including 13,575 implants.¿ no additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record review could not be performed as the part and lot information regarding the complaint devices was not provided.Based on the information reviewed, and due to the limited information available (article based on multiple individuals with no specific information regarding the individual patients), a cause for the heart failure, cerebrovascular accident, endocarditis, pulmonary embolism, pericardial effusion, anaphylactic shock, renal failure and atrial fibrillation cannot be determined.The reported patient effects of heart failure, stroke (cerebrovascular accident), endocarditis, pulmonary embolism, pericardial effusion, anaphylactic shock, renal failure and atrial fibrillation as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.Attachment: article titled, ¿incidence and in-hospital safety outcomes of patients undergoing percutaneous mitral valve edge-to-edge repair using mitraclip: five-year german national patient sample including 13,575 implants.

• Brand Name: UNKNOWN MITRACLIP
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10302278
• MDR Text Key: 199702616
• Report Number: 2024168-2020-06051
• 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: 08/24/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 77 YR