MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET DS; CATHETER, PERCUTANEOUS

Catalog Number UNK AMPLATZER AMULET DS

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Amulet laao registry reports 64 patients with hematoma at access site, hemorrhage, bleeding at access site, and retroperitoneal bleed.No devices were returned.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.D6a: the earliest implant date was used.

Event Description

It was reported through amulet laao registry data that amplatzer amulet devices may be related to 64 hematoma at access site, hemorrhage, bleeding at access site, and retroperitoneal bleed adverse events which are considered serious injury.The relationship of the serious injury 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 (b)(6) 2021 ¿ (b)(6)2022.Patients¿ mean age is 79 years, ranging from 52 - 94 years.50% of the patients were male, 50% of the patients were female.

• Brand Name: AMPLATZER AMULET DS
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 17406734
• MDR Text Key: 319876854
• Report Number: 2135147-2023-03280
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: GEN2201026
• Number of Events Reported: 64
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER AMULET DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Male