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

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

Patient Problems Stroke/CVA (1770); Mitral Regurgitation (1964); Heart Failure (2206)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The udi is unknown because the part number and lot number were not provided.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 cerebrovascular accident, recurrent mitral regurgitation (mr), and heart failure could not be determined.The reported patient effects of cerebrovascular accident, recurrent mr, and heart failure as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported additional therapies/non-surgical treatments, hospitalization, and surgical procedure were results of case-specific circumstances to treat the instances of described patient effects/complications in the study.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article, titled "incidence and outcomes of early mitral valve reintervention after mitraclip.".

Event Description

This is filed to report cerebral accident, heart failure, medical intervention, surgical intervention, and prolonged hospitalization.It was reported through a research article identifying mitraclip devices that were related to the following outcomes: cerebral accident, recurrent mitral regurgitation, heart failure, medical intervention, surgical intervention, prolonged hospitalization, and death.Specific patient information is documented as unknown.Details are listed in the article, titled incidence and outcomes of early mitral valve reintervention after mitraclip.¿ no additional information was provided.

• Brand Name: UNKNOWN MITRACLIP
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11186321
• MDR Text Key: 227570463
• Report Number: 2024168-2021-00516
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability