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 Anemia (1706); Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Transient Ischemic Attack (2109); Heart Failure (2206); Pericardial Effusion (3271)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Dates of event and implant: dates estimated.(udi#): in the absence of a reported part number, the udi number cannot be calculated.The clip remains implanted.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Article titled, procedural trends, outcomes, and readmission rates pre-and post-fda approval for mitraclip from the national readmission database (2013¿14).

Event Description

This is filed to report post procedure, heart failure, pericardial disease, atrial fibrillation, arrhythmia, endocarditis, hypotension, ischemic stroke, renal failure, hemorrhage, anemia, and re-hospitalization events occurred.It was reported through a research article identifying the mitraclip device which maybe be related to heart failure, pericardial disease, atrial fibrillation, arrhythmia, endocarditis, hypotension, ischemic stroke, renal failure, hemorrhage, anemia, and re-hospitalization.Details are listed in the attached article, titled procedural trends, outcomes, and readmission rates pre-and post-fda approval for mitraclip from the national readmission database (2013¿14).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 lot and part number was not provided.Based on the information available, a definitive cause for the reported patient effects could not be determined.The reported patient effects of heart failure, atrial fibrillation, arrythmia, endocarditis, pericardial effusion, hypertension, shock, renal failure, hemorrhage as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Hospitalization was a result of case-specific circumstances.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: UNKNOWN MITRACLIP
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10638530
• MDR Text Key: 210175158
• Report Number: 2024168-2020-08302
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability