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 Stroke/CVA (1770); Tricuspid Regurgitation (2112); Heart Failure (2206); Atrial Perforation (2511)

Event Date 03/17/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated.(udi#): in the absence of a reported part number, the udi number 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.Attachment: literature titled, right-to-left shunt through iatrogenic atrial septal defect after mitraclip procedure.

Event Description

This is filed to report a research article representing a summary of schemic stroke, atrial perforation, tricuspid regurgitation, heart failure and hospitalization it was reported through a research article identifying the mitraclip device which maybe be related to patient schemic stroke, atrial perforation, tricuspid regurgitation, heart failure and hospitalization.Details are listed in the attached article, titled right-to-left shunt through iatrogenic atrial septal defect after mitraclip procedure.No additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record review could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information reviewed, and due to the limited information available (article based on multiple individuals with no specific information regarding the individual patients), a cause for the reported cerebrovascular accident, heart failure, atrial perforation and tricuspid regurgitation (tr) cannot be determined.The reported patient effects of cerebrovascular accident, heart failure and atrial perforation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.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: 10351272
• MDR Text Key: 202076464
• Report Number: 2024168-2020-06373
• 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: 09/10/2020

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: 07/13/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability