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

Catalog Number UNK CDS

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

Patient Problem Death (1802)

Event Date 12/14/2020

Event Type  Death  

Manufacturer Narrative

Date of event: dates estimated.The device will not be returned for evaluation; the clip was implanted.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article title: "transcatheter edge-to-edge repair with mitraclip in systolic heart failure with ischemic versus nonischemic cardiomyopathy.".

Event Description

This is filed to report death reported via an article.It was reported through a research article identifying the mitraclip device which may be related to patient death.Details are listed in the attached article, transcatheter edge-to-edge repair with mitraclip in systolic heart failure with ischemic versus nonischemic cardiomyopathy.No additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history record could not be performed, as the part and lot information regarding the complaint devices was not provided.Based on the available information, a cause for the reported patient effect of death could not be determined.The reported patient effect of death is listed in the mitraclip system instructions for use (ifu), and is known possible complication associated with mitraclip procedures.There is no indication, of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11373681
• MDR Text Key: 233335545
• Report Number: 2024168-2021-01437
• 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: 04/02/2021

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: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death