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

Catalog Number UNK CDS

Device Problem Activation Problem (4042)

Patient Problems Arrhythmia (1721); Mitral Regurgitation (1964); Tachycardia (2095); Tissue Damage (2104); Heart Failure (2206)

Event Date 11/15/2011

Event Type  Injury  

Manufacturer Narrative

Estimated dates.The clip remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature: echocardiographic and clinical outcomes of mitraclip therapy in patients not amenable to surgery.The additional death and malfunctions referenced are being filed under separate medwatch report #.

Event Description

This is filed to report recurrent mr, tissue damage, tachycardia, arrhythmia, surgical procedure, intervention, heart failure and re-hospitalization.It was reported in an article summary that mitraclip devices can be related to single device leaflet attachment (slda), failure to deploy, recurrent mr, tissue damage, surgical procedure, intervention, arrhythmia, tachycardia, re-hospitalization, heart failure and death.Specific patient and procedural information is not known.Additional details can be found in the attached article "echocardiographic and clinical outcomes of mitraclip therapy in patients not amenable to surgery".

Manufacturer Narrative

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 part number were not provided.All available information was investigated.The reported patient effects of tissue damage, tachycardia, arrhythmia and heart failure appear to be due to procedural circumstance/operational context.Additionally, the reported recurrent mitral regurgitation is likely an outcome of slda.The reported patient effects of tissue damage, mr, tachycardia, arrhythmia and heart failure as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.Lastly, additional therapy/non-surgical treatment (blood transfusion, additional mitral valve procedure and additional mitral clip procedure), surgical procedure and hospitalization are a result of case specific circumstances as documented within the research article.There is no indication of a product issue with respect to manufacture, design or labeling.The udi is unknown because the part number and lot number were not provided.Na.

• 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: 10843979
• MDR Text Key: 216366366
• Report Number: 2024168-2020-09555
• 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: 12/30/2020

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: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention