MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a device embolized during an off label use of the device to close an apical puncture.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instruction for use, artmt 100103135 revision b "the amplatzer duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus".

Event Description

Reference manufacturing report: 2135147-2020-00040.It was reported through a research article identifying amplatzer devices that may be related to complications post procedure when the devices were used off label.Specific patient pool consists of 21 patients with a mean age of 73.6 and 60% female.Details are listed in the article, titled "complete percutaneous apical access and closure: short and intermediate term outcomes." between 2013 to 2018, 20 out of 21 cases of apical access closure was performed using an amplatzer device in an off-label fashion.One of the amplatzer adoii detached from the delivery cable prematurely, resulting in a minor complication of closure device embolization.The device was easily retrieved, and no sequelae resulted from the event.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

• Brand Name: AMPLATZER OCCLUDER (UNKNOWN)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9653310
• MDR Text Key: 178353822
• Report Number: 2135147-2020-00039
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 12/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention