FDA Adverse Event Death Summary report: Y

AMPLATZER AMULET

MDR report key: 19424469 · Received May 30, 2024

Report

Report Number: 2135147-2024-02456
Event Type: Death
Date Received: May 30, 2024
Date of Event: December 9, 2021
Report Date: May 30, 2024
Manufacturer: ABBOTT MEDICAL
Product Code: NGV
PMA / PMN Number: P200049
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AMULET LAAO REGISTRY REPORTS 12 INFECTION DEATHS WHICH ARE CONSIDERED DEATH EVENTS WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS NO ADDITIONAL INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. B2 - DATE OF DEATH: THE EARLIEST DATE OF DEATH WAS USED. D6A - IMPLANT DATE: THE EARLIEST IMPLANT DATE WAS USED.

Description of Event or Problem · 0

IT WAS REPORTED THROUGH AMULET LAAO REGISTRY DATA THAT AMPLATZER AMULET DEVICES MAY BE RELATED TO 12 INFECTION DEATHS WHICH ARE CONSIDERED DEATH EVENTS. THE RELATIONSHIP OF THE DEATH TO THE AMPLATZER AMULET DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. AMULET LAAO REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - GEN2201026. THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN 09 DECEMBER 2021 ¿ 24 JULY 2023. PATIENTS¿ MEAN AGE IS 81 YEARS, RANGING FROM 62 - 91 YEARS. 67% OF THE PATIENTS WERE MALE, 33% OF THE PATIENTS WERE FEMALE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1258767	AMPLATZER AMULET	CARDIAC PLUG	NGV	ABBOTT MEDICAL

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR	Male	Death