MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-017

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a (b)(6) female with sinus rhythm who was implanted with a 17mm amplatzer septal occluder.An event of thrombus formation was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "angioscopic evaluation of atrial septal defect closure device neo-endothelialization", was reviewed.This research article presents a case study on a (b)(6) female with sinus rhythm who was implanted with a 17mm amplatzer septal occluder.The patient was on aspirin and clopidogrel antithrombotic therapy after the procedure.6 months post-procedure the patient underwent angioscopy to evaluate new-endothelialization of the closure device.Thrombus formation was noted on the amplatzer septal occluder.No additional information was provided.The article concluded that neo-endothelialization on the closure devices varied 6 months after implantation.Notably, poor endothelialization and thrombus attachment were observed around the central areas and on the larger devices.The primary and correspondence author of the article is yasuhiro tanabe, md, phd, division of cardiology, department of internal medicine, st.Marianna university school of medicine, 2-16-1 (b)(6).

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12763302
• MDR Text Key: 282008834
• Report Number: 2135147-2021-00461
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-017
• Device Catalogue Number: 9-ASD-017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Female