MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC

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

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Perforation (2001); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.D6 - the implant date is estimated.The additional patient effect of death reported in the article is captured under a separate medwatch report.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 death, heart failure, perforation, hypertension, hypotension, and hypoxia.Death, heart failure, perforation, hypertension, hypotension, and hypoxia are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, delayed treatment/therapy, 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.Article titled "transcatheter closure of iatrogenic atrial septal defect.".

Event Description

This research article was a questionnaire survey conducted to report clinical findings on iatrogenic atrial septal defect (iasd) after treatment with mitraclip in japan, as of august, 2020.This aim was in order to clarify the present state of occurrence of iasd associated with mitraclip procedures (steerable guide catheter) as well as percutaneous atrial septal defect closure for iasd in japan.Complications related to the iasd identified in the study included: heart failure related death due to delay to treatment, hypoxemia, length of stay (los), pulmonary hypertension, increased right atrial pressure, and decreased left atrial pressure.Amplatzer septal occluders were used for these iasds, resulting in improved clinical symptoms.Placement of atrial septal defect closure devices often results in rapid hemodynamic improvement.Details are listed in the attached article titled, "transcatheter closure of aatrogenic atrial septal defect.".

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• 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: 18211807
• MDR Text Key: 329039961
• Report Number: 2135147-2023-05190
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112239
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male