MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 06/21/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date in 2012, an unknown size amplatzer septal occluder was successfully implanted.On (b)(6) 2023, the patient presented to the hospital with chest pain and symptoms of heart attack.An embolized thrombus was seen via angiogram and the patient had experienced a myocardial infarction (mi).The physician stated that the device was oversized and was not in contact with the septum.It was unknown whether any intervention was provided.The device remained implanted at the time of last report.The patient was reported as stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of thrombus was reported.Information from the field indicated that the device was implanted on 2012 and developed a thrombus which embolized and resulted in a myocardial infarction.It was reported that the device was "oversized" and the discs weren't in contact with the septum.The patient's international normalized ratio (inr) and medical history was requested but unknown.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17326383
• MDR Text Key: 319137851
• Report Number: 2135147-2023-03035
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• 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): Other; Hospitalization