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 Anemia (1706); Angina (1710); Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Mitral Regurgitation (1964); Myocardial Infarction (1969); Tachycardia (2095); Heart Failure (2206)

Event Date 10/01/2008

Event Type  Injury  

Manufacturer Narrative

Dates estimated.(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.Literature title, incidence, timing, causes and predictors of early and late re-hospitalization in patients who underwent percutaneous mitral valve repair with the mitraclip system.

Event Description

This is being filed to report heart failure, atrial fibrillation, post procedural intubation, bleeding, stroke, hypotension, hypertension, recurrent mitral regurgitation, arrythmia, angina, myocardial infarction, ventricular tachycardia, anemia, implantation of a balloon pump, additional mitraclip procedure, surgical procedure, and hospitalization.It was reported through a research article identifying mitraclip that may be related to patient heart failure, atrial fibrillation, post procedural intubation, bleeding, stroke, hypotension, hypertension, recurrent mitral regurgitation, arrythmia, angina, myocardial infarction, ventricular tachycardia, anemia, implantation of a balloon pump, additional mitraclip procedure, surgical procedure and hospitalization.Specific patient information is documented as unknown.Details are listed in the attached article: incidence, timing, causes and predictors of early and late re-hospitalization in patients who underwent percutaneous mitral valve repair with the mitraclip system.No additional information was provided.

Manufacturer Narrative

D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for analysis.Additionally, a review of the lot history record and complaint history for the reported lot could not be conducted, because the lot number and serial number were not provided.The reported patient effects of angina, arrhythmia, tachycardia, hypotension, heart failure, anemia, cerebrovascular accident, atrial fibrillation, hemorrhage, hypertension and myocardial infarction are related to procedural circumstances.The reported patient effects of angina, arrhythmia, tachycardia, hypotension, mitral regurgitation, heart failure, anemia, cerebrovascular accident, atrial fibrillation, hemorrhage, hypertension and myocardial infarction as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.

• 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: 10892150
• MDR Text Key: 217952902
• Report Number: 2024168-2020-09852
• 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: 01/07/2021

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: 10/29/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR