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

Catalog Number UNK CDS

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

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Renal Failure (2041); Respiratory Failure (2484)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported cerebrovascular accident, renal failure, cardia arrest and respiratory failure.Cerebrovascular accident, renal failure, cardia arrest and respiratory failure are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.B3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided.The additional patient deaths reported in the article are captured under a separate medwatch report number.Attachment: ¿impact of home oxygen use on in-hospital outcomes in patients who underwent transcutaneous edge to edge repair¿.

Event Description

This is filed to report serious injuries.This research article was a retrospective study designed to evaluate the impact of home-o2 use in patients who underwent transcatheter edge-to-edge repair with a mitraclip device and show that their 30-day outcomes are similar to those not on home-o2.Complications identified in the study included: hospitalization, stroke, vascular complication, acute kidney injury, mechanical circulatory support use, cardiac arrest, respiratory failure and death.In conclusion the study highlights that transcatheter edge-to-edge repair using mitraclip can be safely performed in patients on home-o2 without an additional risk to short-term mortality.Optimization of underlying lung disease should be prioritized in order to improve the post-procedure course of these patients.No additional information was provided.Details are listed in the attached article titled, "impact of home oxygen use on in-hospital outcomes in patients who underwent transcutaneous edge to edge repair".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16843257
• MDR Text Key: 314270778
• Report Number: 2135147-2023-01869
• 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: 05/01/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/01/2023
• 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): Disability; Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female